Important information about Depakote for women who could become pregnant

See Full Depakote Prescribing Information

About the use of DEPAKOTE® (divalproex sodium) Tablets

Please read this leaflet carefully before you take DEPAKOTE® (divalproex sodium) tablets. This leaflet provides a summary of important information about taking DEPAKOTE to women who could become pregnant. If you have any questions or concerns, or want more information about DEPAKOTE, contact your doctor or pharmacist.

Information For Women Who Could Become Pregnant
DEPAKOTE can be obtained only by prescription from your doctor. The decision to use DEPAKOTE is one that you and your doctor should make together, taking into account your individual needs and medical condition.

Before using DEPAKOTE, women who can become pregnant should consider the fact that DEPAKOTE has been associated with birth defects, in particular, with spina bifida and other defects related to failure of the spinal canal to close normally. Approximately 1 to 2% of children born to women with epilepsy taking DEPAKOTE in the first 12 weeks of pregnancy had these defects (based on data from the Centers for Disease Control, a U.S. agency based in Atlanta). The incidence in the general population is 0.1 to 0.2%.

Information For Women Who Are Planning to Get Pregnant

• Women taking DEPAKOTE who are planning to get pregnant should discuss the treatment options with their doctor.

Information For Women Who Become Pregnant While Taking DEPAKOTE

• If you become pregnant while taking DEPAKOTE you should contact your doctor immediately.

Other Important Information About DEPAKOTE Tablets

• DEPAKOTE tablets should be taken exactly as it is prescribed by your doctor to get the most benefits from DEPAKOTE and reduce the risk of side effects.
• If you have taken more than the prescribed dose of DEPAKOTE, contact your hospital emergency room or local poison center immediately.
• This medication was prescribed for your particular condition. Do not use it for another condition or give the drug to others.

Facts About Birth Defects
It is important to know that birth defects may occur even in children of individuals not taking any medications or without any additional risk factors.

 

This summary provides important information about the use of DEPAKOTE to women who could become pregnant. If you would like more information about the other potential risks and benefits of DEPAKOTE, ask your doctor or pharmacist to let you read the professional labeling and then discuss it with them. If you have any questions or concerns about taking DEPAKOTE, you should discuss them with your doctor.

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Manufactured by Abbott Pharmaceuticals PR Ltd. Barceloneta, PR 00617
Revised 09/2004

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See Full Depakote Prescribing Information

Detailed Info on Signs, Symptoms, Causes, Treatments of Bipolar Disorder

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The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse. Last updated 09/2004.

Copyright © 2007 Healthyplace Inc. All rights reserved.

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• Cybersexual Addiction Quiz - A quiz to determine if you are addicted to cybersex or viewing cyberporn.
• Internet Addiction Test - A test for on-line users to determine if they may be addicted to the Internet.
• Test for Obsessive Online Stock Traders - If you think you may spend too much time trading stocks over the Internet, then take this quiz.
• Test for Compulsive Online Gamblers - If you spend too much time at the virtual casinos, then take this quiz to see if you're hooked.
• Test for Online Auction Addiction - Do you spend too much time at eBay or uBid? Does winning the bid mean more than getting the actual item? Then take this quiz to see if you may be addicted to online auction houses.
• The Partner's Addiction Test - A test for spouses or partners of potential Internet addicts.
• The Parent-Child Internet Addiction Test - A guide for parents to evaluate if their son or daughter may be dealing with an addiction to the Internet.

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next:  Are You Addicted to Cybersex?
~ all center for online addiction articles
~ all articles on addictions

Jeffrey Beadle wrote:

Why do you choose to overlook that the disease model of Alcoholism began in the 1700s? It was declared a disease by Dr. Benjamin Rush in Philadelphia, PA and by other doctors in Europe during the same period.

Is it true that Alcoholic's digest and break down Alcohol differently from non Alcoholic's?

Is it controversial that there are some things that science may never fully understand?

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Dear Jeff:

Indeed, Benjamin Rush originated the disease theory of alcoholism in the latter part of the eighteenth century. Do you know that, in his disease theory, it was necessary only to abstain from ardent spirits but not cider or wine? On the downside, do you know that Benjamin Rush conceived of minority political group dissent, lying, and murder as mental illnesses (in the latter cases, at least, anticipating modern developments in psychiatry), and he also defined "negritude" as a special type of leprosy. So, the fact the disease theory was "declared" a disease by the Colonial physician—although not really widely adopted in the U.S. until the Temperance movement promoted Rush's views of the inevitable progression of alcoholism in the middle of the next century—proves. . . . (Incidentally, I maintained your capitalization of "Alcohol" and "Alcoholic" because these remind me of Colonial writings.)

Jeff, the acetaldehyde theory of alcohol breakdown, advanced by James Milam in his widely popular book, Under the Influence, is now not well accepted, even by those who assert a large role for genes in alcoholism. I deal with this in any number of places: see the genetics index of my library, an overview of which I provide in one of my FAQs. I debated Milam at an NIAAA conference in 1988, and it was an eye-opening experience. Mr. Milam, who now calls me a liar, was not well-focused and spent most of his time engaging in ad hominem attacks of Herb Fingarette, who Milam claimed was supposed to be his opponent (after the debate, Enoch Gordis joked to me about Milam's mental state).

Milam's piece de resistance was an impassioned description of the plight of alcoholic Native Americans. However, Native Americans do seem to support well the notion of acetaldehyde explanations for alcoholism, since Asian groups which share the Native American trait of the quick breakdown of alcohol do not share a ready susceptibility to alcoholism.

Your question about things that "science may never fully understand" is very intriguing. I might also say that when people don't really understand something, they seek answers in many places. To me, the resort to half-baked genetic explanations is actually very parallel to the search for angels, psychic revelations, and belief in the afterlife—magical solutions for irresolvable human problems which it depresses people to think we cannot solve.

Very best,
Stanton

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Brand Name: Strattera
Generic Name: Atomoxetine HCI

Strattera is a non-amphetamine medication for treatment of ADHD in children, adolescents and adults. Usage, dosage, side effects of Strattera.

Strattera Medication Guide
Strattera Patient Information

Contents:

Box Warning
Description
Clinical Pharmacology
Indications and Usage
Contraindications
Warnings
Precautions
Drug Interactions
Adverse Reactions
Drug Abuse and Dependence
Overdose
Dosage and Administration
Supplied

Strattera Patient Information (in plain English)

Warning

Suicidal Ideation in Children and Adolescents - STRATTERA (atomoxetine) increased the risk of suicidal ideation in short-term studies in children or adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Anyone considering the use of STRATTERA in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be monitored closely for suicidality (suicidal thinking and behavior), clinical worsening, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. STRATTERA is approved for ADHD in pediatric and adult patients. STRATTERA is not approved for major depressive disorder. Pooled analyses of short-term (6 to 18 weeks) placebo-controlled trials of STRATTERA in children and adolescents (a total of 12 trials involving over 2200 patients, including 11 trials in ADHD and 1 trial in enuresis) have revealed a greater risk of suicidal ideation early during treatment in those receiving STRATTERA compared to placebo. The average risk of suicidal ideation in patients receiving STRATTERA was 0.4% (5/1357 patients), compared to none in placebo-treated patients (851 patients). No suicides occurred in these trials. (See WARNINGS and PRECAUTIONS, Pediatric Use).

 

Description

STRATTERA® (atomoxetine HCl) is a selective norepinephrine reuptake inhibitor. Atomoxetine HCl is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NO-HCl, which corresponds to a molecular weight of 291.82. The chemical structure is:

Atomoxetine HCl is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. OCH3NHCH3-HCl

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STRATTERA capsules are intended for oral administration only.

Each capsule contains atomoxetine HCl equivalent to 10, 18, 25, 40, 60, 80, or 100 mg of atomoxetine. The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and other inactive ingredients. The capsule shells also contain one or more of the following: FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink.

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Clinical Pharmacology

Pharmacodynamics and Mechanism of Action

The precise mechanism by which atomoxetine produces its therapeutic effects in Attention-Deficit/Hyperactivity Disorder (ADHD) is unknown, but is thought to be related to selective inhibition of the pre-synaptic norepinephrine transporter, as determined in ex vivo uptake and neurotransmitter depletion studies.

Human Pharmacokinetics

Atomoxetine is well-absorbed after oral administration and is minimally affected by food. It is eliminated primarily by oxidative metabolism through the cytochrome P450 2D6 (CYP2D6) enzymatic pathway and subsequent glucuronidation. Atomoxetine has a half-life of about 5 hours. A fraction of the population (about 7% of Caucasians and 2% of African Americans) are poor metabolizers (PMs) of CYP2D6 metabolized drugs. These individuals have reduced activity in this pathway resulting in 10-fold higher AUCs, 5-fold higher peak plasma concentrations, and slower elimination (plasma half-life of about 24 hours) of atomoxetine compared with people with normal activity [extensive metabolizers (EMs)]. Drugs that inhibit CYP2D6, such as fluoxetine, paroxetine, and quinidine, cause similar increases in exposure.

The pharmacokinetics of atomoxetine have been evaluated in more than 400 children and adolescents in selected clinical trials, primarily using population pharmacokinetic studies. Single-dose and steady-state individual pharmacokinetic data were also obtained in children, adolescents, and adults. When doses were normalized to a mg/kg basis, similar half-life, Cmax, and AUC values were observed in children, adolescents, and adults. Clearance and volume of distribution after adjustment for body weight were also similar.

Absorption and distribution - Atomoxetine is rapidly absorbed after oral administration, with absolute bioavailability of about 63% in EMs and 94% in PMs. Maximal plasma concentrations (C_max) are reached approximately 1 to 2 hours after dosing.

STRATTERA can be administered with or without food. Administration of STRATTERA with a standard high-fat meal in adults did not affect the extent of oral absorption of atomoxetine (AUC), but did decrease the rate of absorption, resulting in a 37% lower C_max, and delayed Tmax by 3 hours. In clinical trials with children and adolescents, administration of STRATTERA with food resulted in a 9% lower C_max.

The steady-state volume of distribution after intravenous administration is 0.85 L/kg indicating that atomoxetine distributes primarily into total body water. Volume of distribution is similar across the patient weight range after normalizing for body weight.

At therapeutic concentrations, 98% of atomoxetine in plasma is bound to protein, primarily albumin.

Metabolism and elimination - Atomoxetine is metabolized primarily through the CYP2D6 enzymatic pathway. People with reduced activity in this pathway (PMs) have higher plasma concentrations of atomoxetine compared with people with normal activity (EMs). For PMs, AUC of atomoxetine is approximately 10-fold and Css,max is about 5-fold greater than EMs. Laboratory tests are available to identify CYP2D6 PMs. Coadministration of STRATTERA with potent inhibitors of CYP2D6, such as fluoxetine, paroxetine, or quinidine, results in a substantial increase in atomoxetine plasma exposure, and dosing adjustment may be necessary (see Drug-Drug Interactions). Atomoxetine did not inhibit or induce the CYP2D6 pathway.

The major oxidative metabolite formed, regardless of CYP2D6 status, is 4-hydroxyatomoxetine, which is glucuronidated. 4-Hydroxyatomoxetine is equipotent to atomoxetine as an inhibitor of the norepinephrine transporter but circulates in plasma at much lower concentrations (1% of atomoxetine concentration in EMs and 0.1% of atomoxetine concentration in PMs). 4-Hydroxyatomoxetine is primarily formed by CYP2D6, but in PMs, 4-hydroxyatomoxetine is formed at a slower rate by several other cytochrome P450 enzymes. N-Desmethylatomoxetine is formed by CYP2C19 and other cytochrome P450 enzymes, but has substantially less pharmacological activity compared with atomoxetine and circulates in plasma at lower concentrations (5% of atomoxetine concentration in EMs and 45% of atomoxetine concentration in PMs).

Mean apparent plasma clearance of atomoxetine after oral administration in adult EMs is 0.35 L/hr/kg and the mean half-life is 5.2 hours. Following oral administration of atomoxetine to PMs, mean apparent plasma clearance is 0.03 L/hr/kg and mean half-life is 21.6 hours. For PMs, AUC of atomoxetine is approximately 10-fold and Css,max is about 5-fold greater than EMs. The elimination half-life of 4-hydroxyatomoxetine is similar to that of N-desmethylatomoxetine (6 to 8 hours) in EM subjects, while the half-life of N-desmethylatomoxetine is much longer in PM subjects (34 to 40 hours).

Atomoxetine is excreted primarily as 4-hydroxyatomoxetine-O-glucuronide, mainly in the urine (greater than 80% of the dose) and to a lesser extent in the feces (less than 17% of the dose). Only a small fraction of the STRATTERA dose is excreted as unchanged atomoxetine (less than 3% of the dose), indicating extensive biotransformation.

Special Populations

Hepatic insufficiency - Atomoxetine exposure (AUC) is increased, compared with normal subjects, in EM subjects with moderate (Child-Pugh Class B) (2-fold increase) and severe (Child-Pugh Class C) (4-fold increase) hepatic insufficiency. Dosage adjustment is recommended for patients with moderate or severe hepatic insufficiency (see DOSAGE AND ADMINISTRATION).

Renal insufficiency - EM subjects with end stage renal disease had higher systemic exposure to atomoxetine than healthy subjects (about a 65% increase), but there was no difference when exposure was corrected for mg/kg dose. STRATTERA can therefore be administered to ADHD patients with end stage renal disease or lesser degrees of renal insufficiency using the normal dosing regimen.

Geriatric - The pharmacokinetics of atomoxetine have not been evaluated in the geriatric population.

Pediatric - The pharmacokinetics of atomoxetine in children and adolescents are similar to those in adults. The pharmacokinetics of atomoxetine have not been evaluated in children under 6 years of age.

Gender - Gender did not influence atomoxetine disposition.

Ethnic origin - Ethnic origin did not influence atomoxetine disposition (except that PMs are more common in Caucasians).

Drug-Drug Interactions

CYP2D6 activity and atomoxetine plasma concentration - Atomoxetine is primarily metabolized by the CYP2D6 pathway to 4-hydroxyatomoxetine. In EMs, inhibitors of CYP2D6 increase atomoxetine steady-state plasma concentrations to exposures similar to those observed in PMs. Dosage adjustment of STRATTERA in EMs may be necessary when coadministered with CYP2D6 inhibitors, e.g., paroxetine, fluoxetine, and quinidine (see Drug-Drug Interactions under PRECAUTIONS). In vitro studies suggest that coadministration of cytochrome P450 inhibitors to PMs will not increase the plasma concentrations of atomoxetine.

Effect of atomoxetine on P450 enzymes - Atomoxetine did not cause clinically important inhibition or induction of cytochrome P450 enzymes, including CYP1A2, CYP3A, CYP2D6, and CYP2C9.

Albuterol - Albuterol (600 mcg iv over 2 hours) induced increases in heart rate and blood pressure. These effects were potentiated by atomoxetine (60 mg BID for 5 days) and were most marked after the initial coadministration of albuterol and atomoxetine (see Drug-Drug Interactions under PRECAUTIONS).

Alcohol - Consumption of ethanol with STRATTERA did not change the intoxicating effects of ethanol.

Desipramine - Coadministration of STRATTERA (40 or 60 mg BID for 13 days) with desipramine, a model compound for CYP2D6 metabolized drugs (single dose of 50 mg), did not alter the pharmacokinetics of desipramine. No dose adjustment is recommended for drugs metabolized by CYP2D6.

Methylphenidate - Coadministration of methylphenidate with STRATTERA did not increase cardiovascular effects beyond those seen with methylphenidate alone.

Midazolam - Coadministration of STRATTERA (60 mg BID for 12 days) with midazolam, a model compound for CYP3A4 metabolized drugs (single dose of 5 mg), resulted in 15% increase in AUC of midazolam. No dose adjustment is recommended for drugs metabolized by CYP3A.

Drugs highly bound to plasma protein - In vitro drug-displacement studies were conducted with atomoxetine and other highly-bound drugs at therapeutic concentrations. Atomoxetine did not affect the binding of warfarin, acetylsalicylic acid, phenytoin, or diazepam to human albumin. Similarly, these compounds did not affect the binding of atomoxetine to human albumin.

Drugs that affect gastric pH - Drugs that elevate gastric pH (magnesium hydroxide/aluminum hydroxide, omeprazole) had no effect on STRATTERA bioavailability.

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Clinical Studies

The effectiveness of STRATTERA in the treatment of ADHD was established in 6 randomized, double-blind, placebo-controlled studies in children, adolescents, and adults who met Diagnostic and Statistical Manual 4th edition (DSM-IV) criteria for ADHD (see INDICATIONS AND USAGE).

Children and Adolescents

The effectiveness of STRATTERA in the treatment of ADHD was established in 4 randomized, double-blind, placebo-controlled studies of pediatric patients (ages 6 to 18). Approximately one-third of the patients met DSM-IV criteria for inattentive subtype and two-thirds met criteria for both inattentive and hyperactive/impulsive subtypes (see INDICATIONS AND USAGE).

Signs and symptoms of ADHD were evaluated by a comparison of mean change from baseline to endpoint for STRATTERA- and placebo-treated patients using an intent-to-treat analysis of the primary outcome measure, the investigator administered and scored ADHD Rating Scale-IV-Parent Version (ADHDRS) total score including hyperactive/impulsive and inattentive subscales. Each item on the ADHDRS maps directly to one symptom criterion for ADHD in the DSM-IV.

In Study 1, an 8-week randomized, double-blind, placebo-controlled, dose-response, acute treatment study of children and adolescents aged 8 to 18 (N=297), patients received either a fixed dose of STRATTERA (0.5, 1.2, or 1.8 mg/kg/day) or placebo. STRATTERA was administered as a divided dose in the early morning and late afternoon/early evening. At the 2 higher doses, improvements in ADHD symptoms were statistically significantly superior in STRATTERA-treated patients compared with placebo-treated patients as measured on the ADHDRS scale. The 1.8-mg/kg/day STRATTERA dose did not provide any additional benefit over that observed with the 1.2-mg/kg/day dose. The 0.5-mg/kg/day STRATTERA dose was not superior to placebo.

In Study 2, a 6-week randomized, double-blind, placebo-controlled, acute treatment study of children and adolescents aged 6 to 16 (N=171), patients received either STRATTERA or placebo. STRATTERA was administered as a single dose in the early morning and titrated on a weight-adjusted basis according to clinical response, up to a maximum dose of 1.5 mg/kg/day. The mean final dose of STRATTERA was approximately 1.3 mg/kg/day. ADHD symptoms were statistically significantly improved on STRATTERA compared with placebo, as measured on the ADHDRS scale. This study shows that STRATTERA is effective when administered once daily in the morning.

In 2 identical, 9-week, acute, randomized, double-blind, placebo-controlled studies of children aged 7 to 13 (Study 3, N=147; Study 4, N=144), STRATTERA and methylphenidate were compared with placebo. STRATTERA was administered as a divided dose in the early morning and late afternoon (after school) and titrated on a weight-adjusted basis according to clinical response. The maximum recommended STRATTERA dose was 2.0 mg/kg/day. The mean final dose of STRATTERA for both studies was approximately 1.6 mg/kg/day. In both studies, ADHD symptoms statistically significantly improved more on STRATTERA than on placebo, as measured on the ADHDRS scale.

In 2 identical, 9-week, acute, randomized, double-blind, placebo-controlled studies of children aged 7 to 13 (Study 3, N=147; Study 4, N=144), STRATTERA and methylphenidate were compared with placebo. STRATTERA was administered as a divided dose in the early morning and late afternoon (after school) and titrated on a weight-adjusted basis according to clinical response. The maximum recommended STRATTERA dose was 2.0 mg/kg/day. The mean final dose of STRATTERA for both studies was approximately 1.6 mg/kg/day. In both studies, ADHD symptoms statistically significantly improved more on STRATTERA than on placebo, as measured on the ADHDRS scale.

Adults

The effectiveness of STRATTERA in the treatment of ADHD was established in 2 randomized, double-blind, placebo-controlled clinical studies of adult patients, age 18 and older, who met DSM-IV criteria for ADHD.

Signs and symptoms of ADHD were evaluated using the investigator-administered Conners Adult ADHD Rating Scale Screening Version (CAARS), a 30-item scale. The primary effectiveness measure was the 18-item Total ADHD Symptom score (the sum of the inattentive and hyperactivity/impulsivity subscales from the CAARS) evaluated by a comparison of mean change from baseline to endpoint using an intent-to-treat analysis.

In 2 identical, 10-week, randomized, double-blind, placebo-controlled acute treatment studies (Study 5, N=280; Study 6, N=256), patients received either STRATTERA or placebo.

STRATTERA was administered as a divided dose in the early morning and late afternoon/early evening and titrated according to clinical response in a range of 60 to 120 mg/day. The mean final dose of STRATTERA for both studies was approximately 95 mg/day. In both studies, ADHD symptoms were statistically significantly improved on STRATTERA, as measured on the ADHD Symptom score from the CAARS scale.

Examination of population subsets based on gender and age (<42 and ≥42) did not reveal any differential responsiveness on the basis of these subgroupings. There was not sufficient exposure of ethnic groups other than Caucasian to allow exploration of differences in these subgroups.

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Indications and Usage

STRATTERA is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).

The effectiveness of STRATTERA in the treatment of ADHD was established in 2 placebo-controlled trials in children, 2 placebo-controlled trials in children and adolescents, and 2 placebo-controlled trials in adults who met DSM-IV criteria for ADHD (see CLINICAL STUDIES).

A diagnosis of ADHD (DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that cause impairment and that were present before age 7 years. The symptoms must be persistent, must be more severe than is typically observed in individuals at a comparable level of development, must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and must be present in 2 or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes, lack of sustained attention, poor listener, failure to follow through on tasks, poor organization, avoids tasks requiring sustained mental effort, loses things, easily distracted, forgetful. For the Hyperactive-Impulsive Type, at least 6 of the following symptoms must have persisted for at least 6 months: fidgeting/squirming, leaving seat, inappropriate running/climbing, difficulty with quiet activities, "on the go," excessive talking, blurting answers, can't wait turn, intrusive. For a Combined Type diagnosis, both inattentive and hyperactive-impulsive criteria must be met.

Special Diagnostic Considerations

The specific etiology of ADHD is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but also of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of DSM-IV characteristics.

Need for Comprehensive Treatment Program

STRATTERA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Drug treatment is not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential in children and adolescents with this diagnosis and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe drug treatment medication will depend upon the physician's assessment of the chronicity and severity of the patient's symptoms.

Long-Term Use

The effectiveness of STRATTERA for long-term use, i.e., for more than 9 weeks in child and adolescent patients and 10 weeks in adult patients, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use STRATTERA for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).

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Contraindications

Hypersensitivity

STRATTERA is contraindicated in patients known to be hypersensitive to atomoxetine or other constituents of the product (see WARNINGS).

Monoamine Oxidase Inhibitors (MAOI) STRATTERA should not be taken with an MAOI, or within 2 weeks after discontinuing an MAOI. Treatment with an MAOI should not be initiated within 2 weeks after discontinuing STRATTERA. With other drugs that affect brain monoamine concentrations, there have been reports of serious, sometimes fatal reactions (including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma) when taken in combination with an MAOI. Some cases presented with features resembling neuroleptic malignant syndrome. Such reactions may occur when these drugs are given concurrently or in close proximity.

Narrow Angle Glaucoma

In clinical trials, STRATTERA use was associated with an increased risk of mydriasis and therefore its use is not recommended in patients with narrow angle glaucoma.

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Warnings

Suicidal Ideation

STRATTERA increased the risk of suicidal ideation in short-term studies in children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Pooled analyses of short-term (6 to 18 weeks) placebo-controlled trials of STRATTERA in children and adolescents have revealed a greater risk of suicidal ideation early during treatment in those receiving STRATTERA. There were a total of 12 trials (11 in ADHD and 1 in enuresis) involving over 2200 patients (including 1357 patients receiving STRATTERA and 851 receiving placebo). The average risk of suicidal ideation in patients receiving STRATTERA was 0.4% (5/1357 patients), compared to none in placebo-treated patients. There was 1 suicide attempt among these approximately 2200 patients, occurring in a patient treated with STRATTERA. No suicides occurred in these trials. All events occurred in children 12 years of age or younger. All events occurred during the first month of treatment. It is unknown whether the risk of suicidal ideation in pediatric patients extends to longer-term use. A similar analysis in adult patients treated with STRATTERA for either ADHD or major depressive disorder (MDD) did not reveal an increased risk of suicidal ideation or behavior in association with the use of STRATTERA.

All pediatric patients being treated with STRATTERA should be monitored closely for suicidality, clinical worsening, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes. Such monitoring would generally include at least weekly face-to-face contact with patients or their family members or caregivers during the first 4 weeks of treatment, then every other week visits for the next 4 weeks, then at 12 weeks, and as clinically indicated beyond 12 weeks. Additional contact by telephone may be appropriate between face-to-face visits.

The following symptoms have been reported with STRATTERA: anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania and mania. Although a causal link between the emergence of such symptoms and the emergence of suicidal impulses has not been established, there is a concern that such symptoms may represent precursors to emerging suicidality. Thus, patients being treated with STRATTERA should be observed for the emergence of such symptoms.

Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients who are experiencing emergent suicidality or symptoms that might be precursors to emerging suicidality, especially if these symptoms are severe or abrupt in onset, or were not part of the patient's presenting symptoms.

Families and caregivers of pediatric patients being treated with STRATTERA should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to healthcare providers. Such monitoring should include daily observation by families and caregivers.

Screening Patients for Bipolar Disorder - In general, particular care should be taken in treating ADHD in patients with comorbid bipolar disorder because of concern for possible induction of a mixed/manic episode in patients at risk for bipolar disorder. Whether any of the symptoms described above represent such a conversion is unknown. However, prior to initiating treatment with STRATTERA, patients with comorbid depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.

Severe Liver Injury

Postmarketing reports indicate that STRATTERA can cause severe liver injury in rare cases. Although no evidence of liver injury was detected in clinical trials of about 6000 patients, there have been two reported cases of markedly elevated hepatic enzymes and bilirubin, in the absence of other obvious explanatory factors, out of more than 2 million patients during the first two years of postmarketing experience. In one patient, liver injury, manifested by elevated hepatic enzymes (up to 40 X upper limit of normal (ULN)) and jaundice (bilirubin up to 12 X ULN), recurred upon rechallenge, and was followed by recovery upon drug discontinuation providing evidence that STRATTERA caused the liver injury. Such reactions may occur several months after therapy is started, but laboratory abnormalities may continue to worsen for several weeks after drug is stopped. Because of probable underreporting, it is impossible to provide an accurate estimate of the true incidence of these events. The patients described above recovered from their liver injury, and did not require a liver transplant. However, in a small percentage of patients, severe drug-related liver injury may progress to acute liver failure resulting in death or the need for a liver transplant.

STRATTERA should be discontinued in patients with jaundice or laboratory evidence of liver injury, and should not be restarted. Laboratory testing to determine liver enzyme levels should be done upon the first symptom or sign of liver dysfunction (e.g., pruritus, dark urine, jaundice, right upper quadrant tenderness, or unexplained "flu-like" symptoms). (See also Information for Patients under PRECAUTIONS.)

Allergic Events

Although uncommon, allergic reactions, including angioneurotic edema, urticaria, and rash, have been reported in patients taking STRATTERA.

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Precautions

General

Effects on blood pressure and heart rate - STRATTERA should be used with caution in patients with hypertension, tachycardia, or cardiovascular or cerebrovascular disease because it can increase blood pressure and heart rate. Pulse and blood pressure should be measured at baseline, following STRATTERA dose increases, and periodically while on therapy.

In pediatric placebo-controlled trials, STRATTERA-treated subjects experienced a mean increase in heart rate of about 6 beats/minute compared with placebo subjects. At the final study visit before drug discontinuation, 3.6% (12/335) of STRATTERA-treated subjects had heart rate increases of at least 25 beats/minute and a heart rate of at least 110 beats/minute, compared with 0.5% (1/204) of placebo subjects. No pediatric subject had a heart rate increase of at least 25 beats/minute and a heart rate of at least 110 beats/minute on more than one occasion. Tachycardia was identified as an adverse event for 1.5% (5/340) of these pediatric subjects compared with 0.5% (1/207) of placebo subjects. The mean heart rate increase in extensive metabolizer (EM) patients was 6.7 beats/minute, and in poor metabolizer (PM) patients 10.4 beats/minute.

STRATTERA-treated pediatric subjects experienced mean increases of about 1.5 mm Hg in systolic and diastolic blood pressures compared with placebo. At the final study visit before drug discontinuation, 6.8% (22/324) of STRATTERA-treated pediatric subjects had high systolic blood pressure measurements compared with 3.0% (6/197) of placebo subjects. High systolic blood pressures were measured on 2 or more occasions in 8.6% (28/324) of STRATTERA-treated subjects and 3.6% (7/197) of placebo subjects. At the final study visit before drug discontinuation, 2.8% (9/326) of STRATTERA-treated pediatric subjects had high diastolic blood pressure measurements compared with 0.5% (1/200) of placebo subjects. High diastolic blood pressures were measured on 2 or more occasions in 5.2% (17/326) of STRATTERA-treated subjects and 1.5% (3/200) of placebo subjects. (High systolic and diastolic blood pressure measurements were defined as those exceeding the 95th percentile, stratified by age, gender, and height percentile - National High Blood Pressure Education Working Group on Hypertension Control in Children and Adolescents.)

In adult placebo-controlled trials, STRATTERA-treated subjects experienced a mean increase in heart rate of 5 beats/minute compared with placebo subjects. Tachycardia was identified as an adverse event for 3% (8/269) of these adult atomoxetine subjects compared with 0.8% (2/263) of placebo subjects.

STRATTERA-treated adult subjects experienced mean increases in systolic (about 3 mm Hg) and diastolic (about 1 mm Hg) blood pressures compared with placebo. At the final study visit before drug discontinuation, 1.9% (5/258) of STRATTERA-treated adult subjects had systolic blood pressure measurements ≥150 mm Hg compared with 1.2% (3/256) of placebo subjects. At the final study visit before drug discontinuation, 0.8% (2/257) of STRATTERA-treated adult subjects had diastolic blood pressure measurements ≥100 mm Hg compared with 0.4% (1/257) of placebo subjects. No adult subject had a high systolic or diastolic blood pressure detected on more than one occasion.

Orthostatic hypotension has been reported in subjects taking STRATTERA. In short-term, child- and adolescent-controlled trials, 1.8% (6/340) of STRATTERA-treated subjects experienced symptoms of postural hypotension compared with 0.5% (1/207) of placebo-treated subjects. STRATTERA should be used with caution in any condition that may predispose patients to hypotension.

Effects on urine outflow from the bladder - In adult ADHD controlled trials, the rates of urinary retention (3%, 7/269) and urinary hesitation (3%, 7/269) were increased among atomoxetine subjects compared with placebo subjects (0%, 0/263). Two adult atomoxetine subjects and no placebo subjects discontinued from controlled clinical trials because of urinary retention. A complaint of urinary retention or urinary hesitancy should be considered potentially related to atomoxetine.

Effects on Growth - Data on the long-term effects of STRATTERA on growth come from open-label studies, and weight and height changes are compared to normative population data. In general, the weight and height gain of pediatric patients treated with STRATTERA lags behind that predicted by normative population data for about the first 9-12 months of treatment. Subsequently, weight gain rebounds and at about 3 years of treatment, patients treated with STRATTERA have gained 17.9 kg on average, 0.5 kg more than predicted by their baseline data. After about 12 months, gain in height stabilizes, and at 3 years, patients treated with STRATTERA have gained 19.4 cm on average, 0.4 cm less than predicted by their baseline data (see Figure 1 below).

Figure 1: Mean Weight and Height Percentiles Over Time for Patients With Three Years of STRATTERA Treatment

This growth pattern was generally similar regardless of pubertal status at the time of treatment initiation. Patients who were pre-pubertal at the start of treatment (girls ≤8 years old, boys ≤9 years old) gained an average of 2.1 kg and 1.2 cm less than predicted after three years. Patients who were pubertal (girls >8 to ≤13 years old, boys >9 to ≤14 years old) or late pubertal (girls >13 years old, boys >14 years old) had average weight and height gains that were close to or exceeded those predicted after three years of treatment.

Growth followed a similar pattern in both extensive and poor metabolizers (EMs, PMs). PMs treated for at least two years gained an average of 2.4 kg and 1.1 cm less than predicted, while EMs gained an average of 0.2 kg and 0.4 cm less than predicted.

In short-term controlled studies (up to 9 weeks), STRATTERA-treated patients lost an average of 0.4 kg and gained an average of 0.9 cm, compared to a gain of 1.5 kg and 1.1 cm in the placebo-treated patients. In a fixed-dose controlled trial, 1.3%, 7.1%, 19.3%, and 29.1% of patients lost at least 3.5% of their body weight in the placebo, 0.5, 1.2, and 1.8 mg/kg/day dose groups.

Growth should be monitored during treatment with STRATTERA.

Aggressive Behavior or Hostility - Aggressive behavior or hostility is often observed in children and adolescents with ADHD, and has been reported in clinical trials and the postmarketing experience of some medications indicated for the treatment of ADHD. Although there is no conclusive evidence that STRATTERA causes aggressive behavior or hostility, aggressive behavior or hostility was more frequently observed in clinical trials among children and adolescents treated with STRATTERA compared to placebo (overall risk ratio of 1.33 - not statistically significant). Patients beginning treatment for ADHD should be monitored for the appearance of or worsening of aggressive behavior or hostility.

Information for Patients

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with STRATTERA and should counsel them in its appropriate use. A patient Medication Guide about using STRATTERA is available. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.

Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking STRATTERA.

Suicide Risk - Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, depression, and suicidal ideation, especially early during STRATTERA treatment and when the dose is adjusted. Families and caregivers of patients should be advised to observe for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication.

Patients initiating STRATTERA should be cautioned that liver dysfunction may develop rarely. Patients should be instructed to contact their physician immediately should they develop pruritus, dark urine, jaundice, right upper quadrant tenderness, or unexplained "flu-like" symptoms.

Patients should be instructed to call their doctor as soon as possible should they notice an increase in aggression or hostility.

STRATTERA is an ocular irritant. STRATTERA capsules are not intended to be opened. In the event of capsule content coming in contact with the eye, the affected eye should be flushed immediately with water, and medical advice obtained. Hands and any potentially contaminated surfaces should be washed as soon as possible.

Patients should consult a physician if they are taking or plan to take any prescription or over-the-counter medicines, dietary supplements, or herbal remedies.

Patients should consult a physician if they are nursing, pregnant, or thinking of becoming pregnant while taking STRATTERA.

Patients may take STRATTERA with or without food.

If patients miss a dose, they should take it as soon as possible, but should not take more than the prescribed total daily amount of STRATTERA in any 24-hour period.

Patients should use caution when driving a car or operating hazardous machinery until they are reasonably certain that their performance is not affected by atomoxetine.

Laboratory Tests

Routine laboratory tests are not required.

CYP2D6 metabolism - Poor metabolizers (PMs) of CYP2D6 have a 10-fold higher AUC and a 5-fold higher peak concentration to a given dose of STRATTERA compared with extensive metabolizers (EMs). Approximately 7% of a Caucasian population are PMs. Laboratory tests are available to identify CYP2D6 PMs. The blood levels in PMs are similar to those attained by taking strong inhibitors of CYP2D6. The higher blood levels in PMs lead to a higher rate of some adverse effects of STRATTERA (see ADVERSE REACTIONS).

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Drug Interactions

Albuterol - STRATTERA should be administered with caution to patients being treated with systemically-administered (oral or intravenous) albuterol (or other beta2 agonists) because the action of albuterol on the cardiovascular system can be potentiated resulting in increases in heart rate and blood pressure.

CYP2D6 inhibitors - Atomoxetine is primarily metabolized by the CYP2D6 pathway to 4-hydroxyatomoxetine. In EMs, selective inhibitors of CYP2D6 increase atomoxetine steady-state plasma concentrations to exposures similar to those observed in PMs. Dosage adjustment of STRATTERA may be necessary when coadministered with CYP2D6 inhibitors, e.g., paroxetine, fluoxetine, and quinidine (see DOSAGE AND ADMINISTRATION). In EM individuals treated with paroxetine or fluoxetine, the AUC of atomoxetine is approximately 6- to 8-fold and Css,max is about 3- to 4-fold greater than atomoxetine alone.

In vitro studies suggest that coadministration of cytochrome P450 inhibitors to PMs will not increase the plasma concentrations of atomoxetine.

Monoamine oxidase inhibitors - See CONTRAINDICATIONS.

Pressor agents - Because of possible effects on blood pressure, STRATTERA should be used cautiously with pressor agents.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis -Atomoxetine HCl was not carcinogenic in rats and mice when given in the diet for 2 years at time-weighted average doses up to 47 and 458 mg/kg/day, respectively. The highest dose used in rats is approximately 8 and 5 times the maximum human dose in children and adults, respectively, on a mg/m2 basis. Plasma levels (AUC) of atomoxetine at this dose in rats are estimated to be 1.8 times (extensive metabolizers) or 0.2 times (poor metabolizers) those in humans receiving the maximum human dose. The highest dose used in mice is approximately 39 and 26 times the maximum human dose in children and adults, respectively, on a mg/m2 basis.

Mutagenesis - Atomoxetine HCl was negative in a battery of genotoxicity studies that included a reverse point mutation assay (Ames Test), an in vitro mouse lymphoma assay, a chromosomal aberration test in Chinese hamster ovary cells, an unscheduled DNA synthesis test in rat hepatocytes, and an in vivo micronucleus test in mice. However, there was a slight increase in the percentage of Chinese hamster ovary cells with diplochromosomes, suggesting endoreduplication (numerical aberration).

The metabolite N-desmethylatomoxetine HCl was negative in the Ames Test, mouse lymphoma assay, and unscheduled DNA synthesis test.

Impairment of fertility - Atomoxetine HCl did not impair fertility in rats when given in the diet at doses of up to 57 mg/kg/day, which is approximately 6 times the maximum human dose on a mg/m2 basis.

Pregnancy

Pregnancy Category C - Pregnant rabbits were treated with up to 100 mg/kg/day of atomoxetine by gavage throughout the period of organogenesis. At this dose, in 1 of 3 studies, a decrease in live fetuses and an increase in early resorptions was observed. Slight increases in the incidences of atypical origin of carotid artery and absent subclavian artery were observed. These findings were observed at doses that caused slight maternal toxicity. The no-effect dose for these findings was 30 mg/kg/day. The 100-mg/kg dose is approximately 23 times the maximum human dose on a mg/m2 basis; plasma levels (AUC) of atomoxetine at this dose in rabbits are estimated to be 3.3 times (extensive metabolizers) or 0.4 times (poor metabolizers) those in humans receiving the maximum human dose.

Rats were treated with up to approximately 50 mg/kg/day of atomoxetine (approximately 6 times the maximum human dose on a mg/m2 basis) in the diet from 2 weeks (females) or 10 weeks (males) prior to mating through the periods of organogenesis and lactation. In 1 of 2 studies, decreases in pup weight and pup survival were observed. The decreased pup survival was also seen at 25 mg/kg (but not at 13 mg/kg). In a study in which rats were treated with atomoxetine in the diet from 2 weeks (females) or 10 weeks (males) prior to mating throughout the period of organogenesis, a decrease in fetal weight (female only) and an increase in the incidence of incomplete ossification of the vertebral arch in fetuses were observed at 40 mg/kg/day (approximately 5 times the maximum human dose on a mg/m2 basis) but not at 20 mg/kg/day.

No adverse fetal effects were seen when pregnant rats were treated with up to 150 mg/kg/day (approximately 17 times the maximum human dose on a mg/m2 basis) by gavage throughout the period of organogenesis.

No adequate and well-controlled studies have been conducted in pregnant women. STRATTERA should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus.

Labor and Delivery

Parturition in rats was not affected by atomoxetine. The effect of STRATTERA on labor and delivery in humans is unknown.

Nursing Mothers

Atomoxetine and/or its metabolites were excreted in the milk of rats. It is not known if atomoxetine is excreted in human milk. Caution should be exercised if STRATTERA is administered to a nursing woman.

Pediatric Use

Anyone considering the use of STRATTERA in a child or adolescent must balance the potential risks with the clinical need (see BOX WARNING and WARNINGS, Suicidal Ideation).

The safety and efficacy of STRATTERA in pediatric patients less than 6 years of age have not been established. The efficacy of STRATTERA beyond 9 weeks and safety of STRATTERA beyond 1 year of treatment have not been systematically evaluated.

A study was conducted in young rats to evaluate the effects of atomoxetine on growth and neurobehavioral and sexual development. Rats were treated with 1, 10, or 50 mg/kg/day (approximately 0.2, 2, and 8 times, respectively, the maximum human dose on a mg/m2 basis) of atomoxetine given by gavage from the early postnatal period (Day 10 of age) through adulthood. Slight delays in onset of vaginal patency (all doses) and preputial separation (10 and 50 mg/kg), slight decreases in epididymal weight and sperm number (10 and 50 mg/kg), and a slight decrease in corpora lutea (50 mg/kg) were seen, but there were no effects on fertility or reproductive performance. A slight delay in onset of incisor eruption was seen at 50 mg/kg. A slight increase in motor activity was seen on Day 15 (males at 10 and 50 mg/kg and females at 50 mg/kg) and on Day 30 (females at 50 mg/kg) but not on Day 60 of age. There were no effects on learning and memory tests. The significance of these findings to humans is unknown.

Geriatric Use

The safety and efficacy of STRATTERA in geriatric patients have not been established.

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Adverse Reactions

STRATTERA was administered to 2067 children or adolescent patients with ADHD and 270 adults with ADHD in clinical studies. During the ADHD clinical trials, 169 patients were treated for longer than 1 year and 526 patients were treated for over 6 months.

The data in the following tables and text cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with data obtained from other clinical investigations involving different treatments, uses, or investigators. The cited data provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse event incidence in the population studied.

Child and Adolescent Clinical Trials

Reasons for discontinuation of treatment due to adverse events in child and adolescent clinical trials - In acute child and adolescent placebo-controlled trials, 3.5% (15/427) of atomoxetine subjects and 1.4% (4/294) placebo subjects discontinued for adverse events. For all studies, (including open-label and long-term studies), 5% of extensive metabolizer (EM) patients and 7% of poor metabolizer (PM) patients discontinued because of an adverse event. Among STRATTERA-treated patients, aggression (0.5%, N=2); irritability (0.5%, N=2); somnolence (0.5%, N=2); and vomiting (0.5%, N=2) were the reasons for discontinuation reported by more than 1 patient.

Commonly observed adverse events in acute child and adolescent, placebo-controlled trials- Commonly observed adverse events associated with the use of STRATTERA (incidence of 2% or greater) and not observed at an equivalent incidence among placebo-treated patients (STRATTERA incidence greater than placebo) are listed in Table 1 for the BID trials. Results were similar in the QD trial except as shown in Table 2, which shows both BID and QD results for selected adverse events. The most commonly observed adverse events in patients treated with STRATTERA (incidence of 5% or greater and at least twice the incidence in placebo patients, for either BID or QD dosing) were: dyspepsia, nausea, vomiting, fatigue, appetite decreased, dizziness, and mood swings (see Tables 1 and 2).

¹ Events reported by at least 2% of patients treated with atomoxetine, and greater than placebo. The following events did not meet this criterion but were reported by more atomoxetine-treated patients than placebo-treated patients and are possibly related to atomoxetine treatment: anorexia, blood pressure increased, early morning awakening, flushing, mydriasis, sinus tachycardia, tearfulness. The following events were reported by at least 2% of patients treated with atomoxetine, and equal to or less than placebo: arthralgia, gastroenteritis viral, insomnia, sore throat, nasal congestion, nasopharyngitis, pruritus, sinus congestion, upper respiratory tract infection.

Table 2: Common Treatment-Emergent Adverse Events Associated with the Use of STRATTERA in Acute (up to 9 weeks) Child and Adolescent Trials
Adverse Event	Percentage of Patients Reporting Events from BID Trials					Percentage of Patients Reporting Events from QD Trials
STRATTERA (N=340)		Placebo (N=207)		STRATTERA (N=85)			Placebo (N=85)
Gastrointestinal Disorders
Abdominal pain upper	20		16		16			9
Constipation	3		1		0			0
Diarrhea	3		6		4			1
Dry mouth	1		2		4			1
Dyspepsia	4		2		8			0
Nausea	7		8		12			2
Vomiting	11		9		15			1
General Disorders
Fatigue	4		5		9			1
Psychiatric Disorders
Mood swings	2		0		5			2

The following adverse events occurred in at least 2% of PM patients and were either twice as frequent or statistically significantly more frequent in PM patients compared with EM patients: decreased appetite (23% of PMs, 16% of EMs); insomnia (13% of PMs, 7% of EMs); sedation (4% of PMs, 2% of EMs); depression (6% of PMs, 2% of EMs); tremor (4% of PMs, 1% of EMs); early morning awakening (3% of PMs, 1% of EMs); pruritus (2% of PMs, 1% of EMs); mydriasis (2% of PMs, 1% of EMs).

Adult Clinical Trials

Reasons for discontinuation of treatment due to adverse events in acute adult placebo-controlled trials - In the acute adult placebo-controlled trials, 8.5% (23/270) atomoxetine subjects and 3.4% (9/266) placebo subjects discontinued for adverse events. Among STRATTERA-treated patients, insomnia (1.1%, N=3); chest pain (0.7%, N=2); palpitations (0.7%, N=2); and urinary retention (0.7%, N=2) were the reasons for discontinuation reported by more than 1 patient.

Commonly observed adverse events in acute adult placebo-controlled trials - Commonly observed adverse events associated with the use of STRATTERA (incidence of 2% or greater) and not observed at an equivalent incidence among placebo-treated patients (STRATTERA incidence greater than placebo) are listed in Table 3. The most commonly observed adverse events in patients treated with STRATTERA (incidence of 5% or greater and at least twice the incidence in placebo patients) were: constipation, dry mouth, nausea, appetite decreased, dizziness, insomnia, decreased libido, ejaculatory problems, impotence, urinary hesitation and/or urinary retention and/or difficulty in micturition, and dysmenorrhea (see Table 3).

¹ Events reported by at least 2% of patients treated with atomoxetine, and greater than placebo. The following events did not meet this criterion but were reported by more atomoxetine-treated patients than placebo-treated patients and are possibly related to atomoxetine treatment: early morning awakening, peripheral coldness, tachycardia. The following events were reported by at least 2% of patients treated with atomoxetine, and equal to or less than placebo: abdominal pain upper, arthralgia, back pain, cough, diarrhea, influenza, irritability, nasopharyngitis, sore throat, upper respiratory tract infection, vomiting.

² Based on total number of males (STRATTERA, N=174; placebo, N=172).

³ Based on total number of females (STRATTERA, N=95; placebo, N=91).

Male and female sexual dysfunction - Atomoxetine appears to impair sexual function in some patients. Changes in sexual desire, sexual performance, and sexual satisfaction are not well assessed in most clinical trials because they need special attention and because patients and physicians may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in product labeling are likely to underestimate the actual incidence. The table below displays the incidence of sexual side effects reported by at least 2% of adult patients taking STRATTERA in placebo-controlled trials.

¹ Males only.

There are no adequate and well-controlled studies examining sexual dysfunction with STRATTERA treatment. While it is difficult to know the precise risk of sexual dysfunction associated with the use of STRATTERA, physicians should routinely inquire about such possible side effects.

Postmarketing Spontaneous Reports

The following list of undesirable effects (adverse drug reactions) is based on post-marketing spontaneous reports, and corresponding reporting rates have been provided.

Vascular disorders - Very rare (<0.01%): Peripheral vascular instability and/or Raynaud's phenomenon (new onset and exacerbation of preexisting condition).

Drug Abuse and Dependence

Controlled Substance

Class STRATTERA is not a controlled substance.

Physical and Psychological Dependence

In a randomized, double-blind, placebo-controlled, abuse-potential study in adults comparing effects of STRATTERA and placebo, STRATTERA was not associated with a pattern of response that suggested stimulant or euphoriant properties.

Clinical study data in over 2000 children, adolescents, and adults with ADHD and over 1200 adults with depression showed only isolated incidents of drug diversion or inappropriate self-administration associated with STRATTERA. There was no evidence of symptom rebound or adverse events suggesting a drug-discontinuation or withdrawal syndrome.

Animal Experience

Drug discrimination studies in rats and monkeys showed inconsistent stimulus generalization between atomoxetine and cocaine.

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Overdose

Human Experience

There is limited clinical trial experience with STRATTERA overdose and no fatalities were observed. During postmarketing, there have been reports of acute and chronic overdoses of STRATTERA. No fatal overdoses of STRATTERA alone have been reported. The most commonly reported symptoms accompanying acute and chronic overdoses were somnolence, agitation, hyperactivity, abnormal behavior, and gastrointestinal symptoms. Signs and symptoms consistent with sympathetic nervous system activation (e.g., mydriasis, tachycardia, dry mouth) have also been observed.

Management of Overdose

An airway should be established. Monitoring of cardiac and vital signs is recommended, along with appropriate symptomatic and supportive measures. Gastric lavage may be indicated if performed soon after ingestion. Activated charcoal may be useful in limiting absorption. Because atomoxetine is highly protein-bound, dialysis is not likely to be useful in the treatment of overdose.

Dosage and Administration

Initial Treatment

Dosing of children and adolescents up to 70 kg body weight - STRATTERA should be initiated at a total daily dose of approximately 0.5 mg/kg and increased after a minimum of 3 days to a target total daily dose of approximately 1.2 mg/kg administered either as a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening. No additional benefit has been demonstrated for doses higher than 1.2 mg/kg/day (see CLINICAL STUDIES).

The total daily dose in children and adolescents should not exceed 1.4 mg/kg or 100 mg, whichever is less.

Dosing of children and adolescents over 70 kg body weight and adults - STRATTERA should be initiated at a total daily dose of 40 mg and increased after a minimum of 3 days to a target total daily dose of approximately 80 mg administered either as a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening. After 2 to 4 additional weeks, the dose may be increased to a maximum of 100 mg in patients who have not achieved an optimal response. There are no data that support increased effectiveness at higher doses (see CLINICAL STUDIES).

The maximum recommended total daily dose in children and adolescents over 70 kg and adults is 100 mg.

Maintenance/Extended Treatment

There is no evidence available from controlled trials to indicate how long the patient with ADHD should be treated with STRATTERA. It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods. Nevertheless, the physician who elects to use STRATTERA for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.

General Dosing Information

STRATTERA may be taken with or without food. The safety of single doses over 120 mg and total daily doses above 150 mg have not been systematically evaluated.

Dosing adjustment for hepatically impaired patients - For those ADHD patients who have hepatic insufficiency (HI), dosage adjustment is recommended as follows: For patients with moderate HI (Child-Pugh Class B), initial and target doses should be reduced to 50% of the normal dose (for patients without HI). For patients with severe HI (Child-Pugh Class C), initial dose and target doses should be reduced to 25% of normal (see Special Populations under CLINICAL PHARMACOLOGY).

Dosing adjustment for use with a strong CYP2D6 inhibitor - In children and adolescents up to 70 kg body weight administered strong CYP2D6 inhibitors, e.g., paroxetine, fluoxetine, and quinidine, STRATTERA should be initiated at 0.5 mg/kg/day and only increased to the usual target dose of 1.2 mg/kg/day if symptoms fail to improve after 4 weeks and the initial dose is well tolerated.

In children and adolescents over 70 kg body weight and adults administered strong CYP2D6 inhibitors, e.g., paroxetine, fluoxetine, and quinidine, STRATTERA should be initiated at 40 mg/day and only increased to the usual target dose of 80 mg/day if symptoms fail to improve after 4 weeks and the initial dose is well tolerated.

Atomoxetine can be discontinued without being tapered.

Instructions for Use/Handling STRATTERA capsules are not intended to be opened, they should be taken whole. (See also Information for Patients under PRECAUTIONS.)

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How Supplied

STRATTERA® (atomoxetine HCl) capsules are supplied in 10-, 18-, 25-, 40-, 60-, 80-, and 100-mg strengths.

* Atomoxetine base equivalent.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

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Strattera Medication Guide
Strattera Patient Information

Detailed Info on Signs, Symptoms, Causes, Treatments of ADHD

Last updated: 11/2005

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The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse.

Copyright © 2007 Healthyplace Inc. All rights reserved.

back to: Psychiatric Medications Pharmacology Homepage

Read articles about alternative treatments for addiction, including nutrition therapy for alcoholism, hynotherapy, and more.

• Alternative Treatments for Alcoholism and Addiction
• Nutrition Therapy for Treating Alcoholism
• Alternative Treatments for Addiction

 

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next: Alternative Treatments for Alcoholism and Addiction

Parents share stories of how a low phosphate diet and magnet therapy work to help their child's ADHD symptoms.

Low Phosphate Diet

Richard from Australia wrote saying:
"My colleague and I have recently launched an important new ADD web site. It is about German research into ADD which goes back some twenty years but has until now been almost completely unknown in the English-speaking world.

The information has benefited thousands of families in Europe. Very many have found it makes the use of stimulant medication unnecessary and gives better results. More than 70,000 copies of the book we introduce have been sold in German - which makes it a 'best seller' many times over.

Full and carefully targeted information is available on our new web site at: http://www.phosadd.com/."

Here is an extract from the site:

"We describe the important discovery of German research pharmacist Hertha Hafer, largely unknown in the English-speaking world. She discovered that excess dietary phosphate triggered her son's ADD. Phosphate is a very common and versatile food additive today; its use by food manufacturers and processors has increased enormously over the last fifty years, in parallel with the explosion of ADD/ADHD in the developed countries.

A low phosphate diet led to dramatic improvements in her son's behaviour, well-being and school performance, making medication unnecessary. Her family's ADD problem was resolved and her son had no further problems as long as he avoided high phosphate foods.

For over twenty years thousands of families in Europe have been following her recommendations and have been rewarded with normal, manageable, lovable, sometimes highly performing children. This site is for adults affected by ADD/ADHD too."

Magnets and Far Infar Red

Simone from Florida USA wrote saying....
"Dear Simon,

I have got an ADHD child 9 years of age. I've read through your article and I have to say that I agree with you that not a lot is known about the side effects of these drugs given to these kids. My experience with them are limited to Ritalin and Adderall. I have to tell you I was not impressed with either.

Against the wishes of my husband, to the point of having very HEATED arguments with him, I got our son these meds hoping they would work. I was desparate to try anything to have my son function at "normal" level. While my son is not destructive, he was being disruptive to his peers because he was always moving and wanting to play. I found these drugs did no more than just what they are; drug him. This, while calming his physical symptoms, had no effect on his ability to focus. I took him off the meds and was to the point of home schooling. I was fortunate enough to have been directed to a charter school in his school district that teaches only children with ADHD.

Since being there, our son was chosen as one of 3 kids to participate in an experiment involving Magnets and Far Infar Red. We were so pleased with the results, my husband and I have become distributors and are busy telling all who are willing to listen about these non-invasive and drugless products that can help others. While we are not claiming these products to be medical devices, we believe them to be an alternative to these drugs.

As you stated in your article, sleep deprivation has been shown to have an effect and even more pronouncement of these symptoms expressed by these children.

One of these magnetic products I mentioned is a sleep system. It is a mattress pad with magnets that are dispersed and secured. There is also a comforter that is made with the FIR ceramics which is floated into the fabric of the comforter. It was to my delight that I found these products had a very positive effect on my son.

My objective is to introduce you to a product that has been my experience and that of others to be helpful to those children.

E-mail:SimoneC777@aol.com

Ed. Note: Please remember, we do not endorse any treatments and strongly advise you to check with your doctor before using, stopping or changing any treatment

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Journal Articles and Book Chapters

• Peele, S. (1996), Assumptions about drugs and the marketing of drug policies. In W.K. Bickel & R.J. DeGrandpre (Eds.), Drug policy and human nature. New York: Plenum, pp. 199-220.
• Peele, S. (1998), The results for drug reform goals of shifting from interdiction/punishment to treatment. International Journal of Drug Policy,9, 43-56.
• Peele, S. & Brodsky, A. (1998), Gateway to nowhere: How alcohol came to be scapegoated for drug abuse. Addiction Research, 5, 419-426.
• Husak, D., & Peele, S. (1998), "One of the major problems of our society": Symbolism and evidence of drug harms in U.S. Supreme Court decisions. Contemporary Drug Problems, 25, 191-233.
• Peele, S. (1999), The fix is in. A Commentary on "The Fix" (Massing, 1998) and "An Informed Approach to Substance Abuse" (Kleiman, 1998). International Journal of Drug Policy, 10, 9-16.
• Peele, S. (2000), The road to hell. Review of 'Mental Hygiene: Classroom Films — 1945-1970'. International Journal of Drug Policy, 11, 245-250.
• Peele, S. (2001), Court-ordered treatment for drug offenders is much better than prison: Or is it? Reconsider Quarterly, Winter 2000-1001, pp. 20-23.
• Peele, S. (2001), The new consensus—"Treat 'em or jail 'em" —is worse than the old. DPFT News (newsletter of the Drug Policy Forum of Texas), February, pp. 1; 3-4.
• Peele, S. (2001), Whose spirits have been broken anyway? Review of 'Broken Spirits: Power and Ideas in Nordic Alcohol Control'. Nordisk alkohol- & narkotikatidskrift, 18(1), 2001, 106-110.
• Peele, S. (2001), Will the Internet encourage or combat addiction? Review of 'Telematic Drug and Alcohol Prevention: Guidelines and Experience from Prevnet Euro'. Nordisk alkohol- & narkotikatidskrift, 18(1), 2001, 114-118.
• Peele, S. (2001, July/August), The world as addict. Review of "Forces of Habit: Drugs and the Making of the Modern World," by David E. Courtwright. Psychology Today, p. 72.

Magazine Articles

• Peele, S. (2001, May), Drunk with power. The case against court-imposed 12-step treatments. Reason, pp. 34-38.
• Peele, S. (2003, Spring), The best and the worst of 2002. SMART Recovery News & Views, Vol. 9, pp. 6-8.

Newspaper Articles

• Peele, S. (1990, March 14), Cures depend on attitudes, not programs. Los Angeles Times.
• Peele, S. (1997, April 14), Should we continue to wage the drug war? Chasing the dragon. New York Times (Letters), p. A16.
• Peele, S. (1998, August 9), A drug-users' advocate. Washington Post (Letters), p. C6.
• Peele, S. (2000, February 14), McCain has two standards on drug abuse. The GOP candidate is a hawk in the drug war, yet his wife got no penalty. Los Angeles Times, p. B5.

Internet Publications

• Peele, S., & Brodsky, A. (1997), The Great Zinberg/McCaffrey Debate. The Stanton Peele Addiction Website.
• Peele, S. (2000), On being Jewish, a communist, and a drug legalizer. The Stanton Peele Addiction Website.
• Peele, S. (2000), Little drunken rats. The Stanton Peele Addiction Website.
• Peele, S. (2000), Eliminate bad crops — rent hell. The Stanton Peele Addiction Website.
• Peele, S. (2000), The drug reform movement is doing the wrong thing. The Stanton Peele Addiction Website.
• Peele, S., & Archie Brodsky (2000), Guidelines for sensible cannabis use. Prepared for, and with the assistance of, Cannabis Action Network, Berkeley, CA. Morristown, NJ: The Stanton Peele Addiction Website.
• Peele, S. (2006), Marijuana Is Addictive - So What? The Stanton Peele Addiction Website.
• Peele, S. (2006, March), I Know - Let's Really Scare Kids About Drugs! The Stanton Peele Addiction Website.

next: How Do I Get My Boyfriend To Quit Drugs/Drinking?
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Find out why Campral is prescribed, side effects of Campral, and Campral's role in helping people who are alcohol-dependent - in plain English.

Campral (acamprosate calcium) Full Prescribing Information

Campral Patient FAQs

Q - Is there a difference between alcohol dependence and alcohol abuse?

A -Yes. The difference is in the degree of symptoms. People who are alcohol-dependent may have a physical addiction and have lost the ability to control their drinking. With physical dependence, their bodies need alcohol and without it, they go into withdrawal. People who abuse alcohol are able to control the amount of alcohol they consume, are not physically dependent on it, and will not experience withdrawal symptoms when they do not drink.

Q - Is there a difference between alcoholism and alcohol dependence?

A - Alcohol dependence is the medical term for alcoholism.

Q - How can I tell if I or someone I'm close to is alcohol dependent?

A - That is not always a simple thing to do. But, on this Campral website, you will find a questionnaire that can help you answer this question. Download the questionnaire, fill it out, and discuss it with your doctor or the person you are trying to help.

Q - What is the best way to bring up the subject of drinking with a friend or family member?

A - There's no easy answer to this question because every situation is different. Begin by discussing the problem with your family physician. Your physician can steer you to local resources that you and your family member or friend may want to explore together.

Q - How do I know if I am a candidate for Campral (acamprosate calcium) Delayed-Release Tablets?

A - Campral is for people who are alcohol-dependent, not for those who abuse alcohol. Candidates must be committed to abstaining from alcohol and abstinent when they begin treatment with Campral. Campral must be prescribed by a physician. If you think you or someone you know is a candidate for Campral, speak to your physician.

 

Q - How is Campral different from other medicines for alcohol dependence?

A - Campral is the first new medical treatment approved for alcoholism in in a decade. It works differently from other treatments. Antabuse (disulfiram) works by making you nauseous when you drink. ReVia (naltrexone) reduces the pleasure of drinking. Campral helps reduce both the physical and emotional discomfort (e.g. sweating, anxiety, sleep disturbances) many people feel in the weeks and months after they've stopped drinking. This makes it easier for them not to drink after the immediate withdrawal period. It is the first medication thought to impact the biological and medical processes of the disease.

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Q - Is Campral addictive?

A - No. Campral is not addictive and is not listed by the FDA as a controlled substance.

Q - Will Campral make me stop drinking?

A - Campral will not prevent you from drinking. Only you can do that. But it will make it easier for you to resist drinking and get yourself moving along the road to recovery. Campral works best when it is part of a comprehensive treatment program that includes counseling and support.

Q - How does Campral help me maintain abstinence?

A - As is true of many medicines, we do not know exactly how Campral works. Currently, researchers believe that Campral acts on the complex processes of the nervous system by restoring a balance that was altered by continued alcohol consumption.

Q - Does Campral prevent withdrawal symptoms?

A - No. None of the alcohol dependence therapies will prevent acute withdrawal symptoms. Speak to your doctor about what to expect during withdrawal and how to deal with it.

Q - Does Campral have side effects?

A - Campral is well tolerated. As is often the case with many medications, Campral does have side effects but does not pose any serious safety problems. In clinical trials patients reported a range of side effects, including asthenia, diarrhea, flatulence, nausea, and itching. Side effects were generally mild and few patients discontinued treatment due to them. In fact, in trials lasting longer than 6 months, the same percentage of patients discontinued treatment due to side effects in both the Campral and placebo groups.

Q - How do I take Campral?

A - Campral is a tablet. The recommended dose is two 333 mg tablets 3 times per day.

Q - Can I take Campral with food?

A - Yes. You can take your Campral dose with food. Some people find that coordinating their Campral with meals makes it easier to keep on schedule.

Q - If I relapse while I'm taking Campral, does that mean Campral is not for me?

A - Not necessarily. If you relapse, you should continue taking your Campral as prescribed by your doctor. Speak to your doctor about relapse problems.

Q - How long do I need to take Campral?

A - Clinical trials have shown Campral is effective and safe for one year. You and your doctor will decide the best course of treatment for you.

Q - What is a "Standard Drink"?

A - While alcohol dependence is not defined by how much alcohol a person consumes, it may be useful to estimate alcohol consumption to determine health risks and other potential problems. Currently, there is no universally accepted definition of a standard drink. However, the National Institute on Alcohol Abuse and Alcoholism (NIAAA, NIH) has published a guideline that establishes the relative amounts of alcohol in different drinks (Dawson, 2003).

12 oz. of beer or cooler	8-9 oz. of malt liquor	5 oz. of table wine	3-4 oz. of fortified wine (such as sherry or port) 3.5oz.	2-3 oz. of cordial liqueur or aperitif	1.5 oz. of brandy (a single jigger)	1.5 oz. of spirits (a single jigger of 80-proof gin, vodka, whisky, etc.
Note: People buy many of these drinks in containers that hold multiple standard drinks. For example, malt liquor is often sold in 16, 22 or 40 oz. containers that hold between two and five standard drinks, and table wine is typically sold in 25 oz. (750ml.) bottles that hold five standard drinks.

Q - What is "At Risk" drinking?

A - Physicians use terms such as "heavy," "chronic heavy," "harmful," "hazardous," and "at risk" drinking interchangeably to describe alcohol consumption that meets or exceeds the following limits:

• For men: more than 14 drinks per week or more than 4 drinks per occasion
• For women: more than 7 drinks per week or more than 3 drinks per occasion

People whose drinking exceeds these levels should be assessed for alcohol-related problems.

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Campral (acamprosate calcium) Full Prescribing Information

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How to tell if your child is using drugs or alcohol. Here are the signs of alcohol and drug abuse.

Parents sometimes tell me they had no idea that their teenagers were drinking or using drugs. That's usually because they've been oblivious to the telltale hints all around them. Don't let this happen to you. Here are the signs you should be on the lookout for.

The Nose Knows

Your teenage son breezes into the house on a Saturday night after a night out with the guys. How do you know if he was drinking or smoking? Make a point of having a conversation with him -- not a yelled conversation through various rooms and closed doors, but a real, face-to-face conversation. If your child has been drinking alcohol, smoking cigarettes, or smoking marijuana, the smell will be on his breath. Any smoke he's been around will also soak into his clothing and hair. That's not necessarily a sign of personal guilt, but if it's pot smoke you smell, you have the right to be alarmed; even if he wasn't smoking it himself, he was with peers who were. You should also be suspicious if your teen enters the house chomping on a fresh wad of spearmint gum or a handful of Altoids, or smelling of freshly applied lotion or perfume. He's probably trying to cover up a telltale odor.

Take a Closer Look

If your teenager is using or abusing an illegal substance, there's probably visual evidence to support it too. While you're chatting with her after she gets back from going out with her friends, take a close look. Pay attention to her eyes -- they tend to reveal any substance use. If she's been smoking marijuana, her eyes will be red and heavy lidded, with constricted pupils. If she's been drinking alcohol, her pupils will be dilated, and she may have difficulty focusing on you. In addition, some alcohol effects are red, flushed color to the face and cheeks. There are also telltale signs of more serious drug use. Intravenous drug use leaves track marks, usually on the arms, but occasionally other places like the legs. Long sleeves in scorching hot summer weather may be an attempt to hide something. Cocaine use effects are nosebleeds and eventually eats away at the septum inside the nose. Finally, if there are strange burns on her lips or fingers, she may be smoking a substance through a hot glass or metal pipe. Sores or spots around the mouth along with paint stains on the body or clothing, a chemical odor or a runny nose can also indicate inhalant use, the practice of inhaling the fumes from household chemicals for a high. Ecstasy causes involuntary teeth clenching, increased affection and a loss of inhibitions. Also look for a fascination with sights and sounds, excessive water consumption and child-like toys.

Mood Changes

Okay, the scenario is the same as above; it's Saturday night, and your son has just gotten back from a night out with his friends. How is he acting? Is he loud and obnoxious, or laughing hysterically at nothing? Is he unusually clumsy to the point where he's stumbling into furniture and walls, tripping over his own feet and knocking things over? Is he sullen, withdrawn, and unusually tired and slack-eyed for the hour of night? Does he look queasy and stumble into the bathroom? These are all signs that he could have just been using some kind of illegal substance: alcohol, marijuana, or something else. You shouldn't read too much into a slight mood change after he gets home from being with his friends, but you should be on the lookout for unusual or extreme behavior. You should also pay attention to your teenager's behavior over time. If your teenager has become silent, angry, withdrawn, and uncommunicative, and this has lasted for at least a few weeks, something else is going on. He may get angry if you try to reach out to him, and insist that you leave him alone, but you need to find out what's going on. While there are a number of reasons for a child to be moody, you should certainly consider the possibility that he has formed a habit of substance use.

Car Accidents

For many older teens, their cars are their lives. If you suspect your teenager has been using illicit substances recently, see if the car has any clues to offer. Maybe her driving is noticeably more reckless when she's coming home after being with her friends. She might whip into the driveway at eighty miles per hour, run over sections of lawn, hit things, or park carelessly. Or maybe there's a new dent in the front of the car and she claims she knows nothing about it. If you're suspicious, examine the inside of the car too; most teens are pretty sloppy about cleaning the inside of their car. Does it smell like marijuana smoke or alcohol fumes? Are there any bottles, pipes, bongs, or other drug paraphernalia rolling around on the floor or hidden in the glove box? If you find anything, challenge her on it immediately: be forthright, and tell her exactly what you've discovered and why you're concerned.

Deceit or Secretiveness

Suddenly you find your normally honest child lying to you all the time. Her evening and weekend plans are starting to sound a little fishy; she's either vague about where she's going or her alibis don't work (she can't describe the movie she supposedly just saw; or the friend she's supposed to be out with just called looking for her). She says that parents will be at the parties she's going to but can't give you a phone number, and comes home acting intoxicated. She gets in way past her curfew or estimated time, and she's got a seemingly endless string of excuses to justify her behavior. Even if you find evidence of substance use -- drunken or high behavior, a beer can or a marijuana rolling paper in her room -- she's got someone or something else to place the blame on. When excuses fail, she'll respond to your inquiries and concern by telling you that it's none of your business. Something is wrong, and you need to figure out what she's really up to.

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Decreased Motivation

Your child's grades start falling and there's no obvious reason for it. He gives you a weak explanation and assures you he can handle the situation, but he doesn't. He may be skipping school and spending less and less time on his homework. And he appears to be losing interest in other activities as well. You're getting calls from teachers, coaches, principals, all saying the same thing: that your teenager has been skipping his classes, activities, or practices, and when he's there he's not putting forth any effort. This could be a sign of a real drug abuse problem, where the desire to get drunk or high has taken top priority in his life.

Missing Alcohol, Cigarettes, Money or Valuables

 For the teen who's looking to get drunk or buy drugs, their parents' house can be a gold mine of resources. Nearly all parents keep some sort of alcohol in the house, whether it's six-packs of beer, a rack of wine bottles, or a cabinet featuring an assortment of liquor. Teens will start stealing this alcohol, hoping their parents won't miss it, or filling liquor bottles back up with water to bring them to the original level. If one or both of their parents smokes cigarettes, they can always take some from the pack (or take the whole pack). If they need money to buy drugs, then they'll start going through their parents' wallets, stealing bills, or else will steal valuables like jewelry and heirlooms to pawn for money.
You should always keep track of the alcohol in the house. If you notice anything missing or your liquor tastes suspiciously watery, you should lock it up so your teen can't get to it. If your child is stealing cigarettes and you don't approve of him smoking, don't leave packs out where he can get to them. And in all these instances, particularly when money or valuables are being stolen, you need to confront him immediately. Let him know that you're aware of what goes on and that you won't tolerate him stealing from you.

Cash Flow Problems

You know something is going on when your money starts disappearing. There are other money-related ways to detect this sort of problem too. Obviously, drugs and alcohol cost money, and even seemingly inexpensive substances add up over time. Your child may work a part-time job after school, but he's probably not earning much more than minimum wage. So if you find that he is increasingly concerned about getting more money but volunteers no explanation as to why, you should wonder what he's spending it on, especially if he doesn't turn up with any new clothes, CDs, or other material items. It may be that he's using his money -- allowance, wages, handouts, whatever -- to support his substance use. On the other hand, if he suddenly seems to have a whole lot more money for clothing, CDs, or other coveted items, way beyond what he reasonably should in his circumstances, consider that he could be dealing drugs. Under these circumstances, a room search may be justified.

Change in Friends

You notice that your teenager is hanging out with a different peer group. Sure, it's normal for teenagers to make new friends, but these friends worry you for some reason. Perhaps these new friends are older and seem to be more promiscuous and independent, with less parental supervision and less interest in school. They might be making poor choices and getting involved in questionable activities. Maybe you've even suspected they were high or drunk when you were talking to them. Whatever the case, your teen will probably defend her new choice in friends, saying her new friends are more fun and understanding. But if you've got a feeling they're up to no good, keep your eyes and ears open, and go with your instincts.

© 2001 by Neil I. Bernstein. From "How to Keep Your Teenager Out of Trouble and What to Do if You Can't" by Dr. Neil I. Bernstein (2001, Workman Publishing, New York).

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Find out why Exubera is prescribed, side effects of Exubera, Exubera warnings, Exurbera drug interactions more - in plain English.

Exubera (insulin inhalation) Full Prescribing Information

Brand Names: Exubera
Generic Name: insulin inhalation

Pronunciation: (IN soo lin in hel AY shun)

What is Exubera?

Exubera is a rapid-acting form of human insulin that is inhaled through the mouth. It works by lowering levels of glucose (sugar) in the blood.

Exubera is used to treat type 1 (insulin dependent) or type 2 (non-insulin dependent) diabetes in adults.

Exubera may also be used for purposes other than those listed here.

Most important fact about Exubera

Do not use Exubera if you smoke, or if you have recently quit smoking (within the past 6 months). If you start smoking while using Exubera, you will have to stop using this medication and switch to another form of insulin to control your blood sugar. Before using Exubera, tell your doctor if you have kidney disease, liver disease, or lung disorders such as asthma or COPD (chronic obstructive pulmonary disease).

You should not Exubera if you have a lung disease that is not well controlled with medication or other treatments. There are many other drugs that can potentially interfere with the glucose-lowering effects of Exubera. It is extremely important that you tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

If there are any changes in the brand, strength, or type of insulin you use, your dosage needs may change. Always check your medicine when it is refilled to make sure you have received the correct brand and type as prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine given to you at the pharmacy.

If you use Exubera as a meal-time insulin, use it no more than 10 minutes before eating the meal.

Exubera is only part of a complete program of treatment that may also include diet, exercise, weight control, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

 

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Take care to keep your blood sugar from getting too low, causing hypoglycemia. Know the signs and symptoms of hypoglycemia, which include headache, confusion, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, and nausea. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.

Before taking Exubera

Before using Exubera, tell your doctor if you have kidney disease, liver disease, or lung disorders such as asthma or COPD (chronic obstructive pulmonary disease).

You should not use Exubera if you have a lung disease that is not well controlled with medication or other treatments. If you have type 1 diabetes, you should use Exubera in addition to another long-acting type of insulin.

If you have type 2 diabetes, this may be the only medication you use to control your blood sugar, or your doctor may prescribe another long-acting insulin or diabetes medicine you take by mouth.

Exubera is only part of a complete program of treatment that may also include diet, exercise, weight control, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

If there are any changes in the brand, strength, or type of insulin you use, your dosage needs may change. Always check your medicine when it is refilled to make sure you have received the correct brand and type as prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine given to you at the pharmacy.

FDA pregnancy category C. Exubera may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Exubera can pass into breast milk and may harm a nursing baby. Do not use Exubera without telling your doctor if you are breast-feeding a baby.

How should you take Exubera?

Use Exubera exactly as it was prescribed for you. Do not use it in larger doses or for longer than recommended by your doctor.

Your doctor may occasionally change your dose to make sure you get the best results from Exubera.

If you use Exubera as a meal-time insulin, use it no more than 10 minutes before eating the meal.

To be sure Exubera is not causing certain side effects, your lung function will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor.

Continue using Exubera if you have a cold or flu virus that causes upper respiratory symptoms (cough, sore throat, nasal congestion). Check your blood sugar carefully during a time of stress or illness, since this can also affect your glucose levels.

Exubera is a powder that is supplied in "dose blisters" on cards that are packaged in a clear plastic tray. This tray is sealed inside a foil pouch that also contains a moisture-absorbing preservative packet. The 1-milligram (mg) dose blisters are supplied on a card printed with green ink. The 3-mg dose blisters are supplied on a card printed with blue ink.

Each 1-milligram dose blister of Exubera powder is equal to 3 units of injectable insulin and each 3-milligram dose blister is equal to 8 units of injectable insulin. Using three of the 1-mg dose blisters will not give you the same amount of medicine as one 3-mg dose blister. You may receive too much insulin when using three 1-mg dose blisters together, which could result in hypoglycemia.

If you are combining 1-mg and 3-mg dose blisters to get your correct dose of insulin, always use the least number of blisters possible. For example, if your dose is 4 mg, use a 1-mg blister and a 3-mg blister (a total of two blisters). Do not use four 1-mg blisters or you may receive too much Exubera. The inhaler unit supplied with Exubera includes a base, a chamber, and a release unit. Each release unit may be used for up to 2 weeks before replacing. You may use the inhaler for up to 1 year before replacing it.

Store the medication at room temperature, away from moisture and heat. Do not refrigerate or freeze. Protect the medicine from moisture and humidity at all times. Do not store the medicine in a bathroom where you shower. Once you have opened the foil pouch, keep the unused dose blisters in the pouch and use them within 3 months after opening the pouch. Keep the moisture-absorbing preservative packet contained in the foil pouch and do not open the packet or use its contents.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

If you use Exubera as meal-time insulin and you forget to use your dose before a meal, use the insulin when you remember and wait 10 minutes before eating.

Overdosage

In case of an overdosage, seek emergency medical attention if you think you have used too much of this medicine. Symptoms of an Exubera overdose may be the same as signs of low blood sugar: confusion, drowsiness, weakness, fast heartbeat, sweating, tremor, and nausea.

What should I avoid while taking Exubera?

Do not smoke while using Exubera. You should not use this medication if you have smoked within the past 6 months. If you start smoking while using Exubera, you will have to stop using the medication and switch to another form of insulin to control your blood sugar. Avoid letting your blood sugar get too low, causing hypoglycemia. Know the signs and symptoms of hypoglycemia, which include headache, confusion, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, and nausea. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.

What side effects may occur using Exubera?

Hypoglycemia (low blood sugar) is the most common side effect of Exubera. Watch for signs of low blood sugar, which include headache, confusion, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, and nausea. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.

Get emergency medical help if you have any of these signs of an allergic reaction: rash, hives, or itching; wheezing, gasping for breath; fast heartbeat; sweating; feeling light-headed or fainting. Other less serious side effects are more likely to occur, such as:

• cough, sore throat;
• runny or stuffy nose;
• dry mouth; or
• ear pain.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Possible drug interactions when taking Exubera

There are many other drugs that can potentially interfere with the glucose-lowering effects of Exubera. It is extremely important that you tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

If you use other inhaled medications, use them before using Exubera.

Where can I get more information?

Exubera (insulin inhalation) Full Prescribing Information

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Last revised 01/07

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