Important information about Strattera including risk of suicidal thinking in children and teenagers taking Strattera.

Strattera Prescribing Information
Strattera Patient Information

Read this information carefully before you start taking STRATTERA (Stra-TAIR-a) to learn about the benefits and risks of STRATTERA.

Read the information you get with STRATTERA each time you get more STRATTERA, as there may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.

Parents or guardians need to think about 4 important things when their child or teenager is prescribed STRATTERA:

1. There is a risk of suicidal thinking

2. How to try to prevent suicidal thoughts or actions in your child

3. You should watch for certain signs if your child is taking STRATTERA

4. There are benefits and risks when using STRATTERA

1. There is a Risk of Suicidal Thinking

Children and teenagers sometimes think about suicide, and many report trying to kill themselves.

STRATTERA increased suicidal thinking in some children being treated for ADHD in clinical trials.

A large study combined the results of 12 different studies of children and teenagers with ADHD. In these studies, patients took either a placebo (sugar pill) or STRATTERA for 6 to 18 weeks. No one committed suicide in these studies, but some patients experienced suicidal thinking. On sugar pills, no patients developed suicidal thinking. On STRATTERA, 4 out of every 1000 patients developed suicidal thinking.

For some children and teenagers, the risks of suicidal thinking or behaviors may be especially high.

These include patients with

• Bipolar illness (sometimes called manic-depressive illness)
• A family history of bipolar illness
• A personal or family history of attempting suicide

If any of these are present, make sure you tell your healthcare provider before your child takes STRATTERA.

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2. How to Try to Prevent Suicidal Thoughts and Actions

 

To try to prevent suicidal thoughts and actions in your child, talk with and listen to your child about his or her thoughts and feelings and pay close attention to changes in his or her moods or actions, especially if the changes occur suddenly. Other important people in your child's life can help by paying attention as well (e.g., brothers and sisters, teachers, and other important people). The changes to look out for are listed in Section 3.

Whenever STRATTERA is started or its dose is changed, pay close attention to your child.

After starting STRATTERA, your child should generally see his or her healthcare provider:

• Once a week for the first 4 weeks
• Every 2 weeks for the next 4 weeks
• After taking STRATTERA for 12 weeks
• After 12 weeks, follow your healthcare provider's advice about how often to come back
• More often if problems or questions arise (see Section 3)

You should call your child's healthcare provider between visits if needed.

3. You Should Watch for Certain Signs If Your Child is Taking STRATTERA

Contact your child's healthcare provider right away if your child exhibits any of the following signs for the first time, or if they seem worse, or worry you, your child, or your child's teacher:

• Thoughts about suicide or dying
• Attempts to commit suicide
• New or worse depression
• New or worse anxiety
• Feeling very agitated or restless
• Panic attacks
• Difficulty sleeping (insomnia)
• New or worse irritability
• Acting aggressive, being angry, or violent
• Acting on dangerous impulses
• An extreme increase in activity and talking
• Other unusual changes in behavior

4. There are Benefits and Risks When Using STRATTERA

STRATTERA is a non-stimulant medicine used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). In some children and teenagers who participated in clinical trials, treatment with STRATTERA increased suicidal thinking. It is important to discuss all the risks of treating

ADHD and also the risks of not treating it. As with all treatments for ADHD, you should discuss with your healthcare provider the potential benefits and risks of STRATTERA

What is STRATTERA?

STRATTERA is a non-stimulant medicine used to treat ADHD in children, teenagers and adults. STRATTERA contains atomoxetine hydrochloride, a selective norepinephrine reuptake inhibitor. Your doctor has prescribed this medicine as part of an overall treatment plan to control your symptoms of ADHD.

What is ADHD?

ADHD has 3 main types of symptoms: inattention, hyperactivity, and impulsiveness. Symptoms of inattention include not paying attention, making careless mistakes, not listening, not finishing tasks, not following directions, and being easily distracted. Symptoms of hyperactivity and impulsiveness include fidgeting, talking excessively, running around at inappropriate times, and interrupting others. Some patients have more symptoms of hyperactivity and impulsiveness while others have more symptoms of inattentiveness. Some patients have all 3 types of symptoms.

Symptoms of ADHD in adults may include a lack of organization, problems starting tasks, impulsive actions, daydreaming, daytime drowsiness, slow processing of information, difficulty learning new things, irritability, lack of motivation, sensitivity to criticism, forgetfulness, low self-esteem, and excessive effort to maintain some organization. The symptoms shown by adults who primarily have attention problems but not hyperactivity have been commonly described as Attention-Deficit Disorder (ADD).

Many people have symptoms like these from time to time, but patients with ADHD have these symptoms more than others their age. Symptoms must be present for at least 6 months to be certain of the diagnosis.

Who should NOT take STRATTERA?

Do not take STRATTERA if:

• you took a medicine known as a monoamine oxidase inhibitor (MAOI) in the last 2 weeks. An MAOI is a medicine sometimes used for depression and other mental problems. Some names of MAOI medicines are Nardil® (phenelzine sulfate) and Parnate® (tranylcypromine sulfate). Taking STRATTERA with an MAOI could cause serious side effects or be life-threatening.
• you have an eye disease called narrow angle glaucoma.
• you are allergic to STRATTERA or any of its ingredients. The active ingredient is atomoxetine. The inactive ingredients are listed at the end of this Medication Guide.

What should I tell my doctor before taking STRATTERA?

Talk to your doctor before taking STRATTERA if you:

• have or had suicidal thoughts.
• have or had liver problems. You may need a lower dose.
• have high blood pressure. STRATTERA can increase blood pressure.
• have problems with your heart or an irregular heartbeat. STRATTERA can increase heart rate (pulse).
• have low blood pressure. STRATTERA can cause dizziness or fainting in people with low blood pressure.

Tell your doctor about all the medicines you take or plan to take, including prescription and non-prescription medicines, dietary supplements, and herbal remedies. Your doctor will decide if you can take STRATTERA with your other medicines.

Certain medicines may change the way your body reacts to STRATTERA. These include medicines used to treat depression [like Paxil® (paroxetine hydrochloride) and Prozac® (fluoxetine hydrochloride)], and certain other medicines (like quinidine). Your doctor may need to change your dose of STRATTERA if you are taking it with these medicines.

STRATTERA may change the way your body reacts to oral or intravenous albuterol (or drugs with similar actions), but the effectiveness of these drugs will not be changed. Talk with your doctor before taking STRATTERA if you are taking albuterol.

How should I take STRATTERA?

• Take STRATTERA according to your doctor's instructions. This is usually taken 1 or 2 times a day (morning and late afternoon/early evening).
• You can take STRATTERA with or without food.
• If you miss a dose, take it as soon as possible, but do not take more than your total daily dose in any 24-hour period.
• Taking STRATTERA at the same time each day may help you remember.
• STRATTERA is available in several dosage strengths: 10, 18, 25, 40, 60, 80, and 100 mg.

Call your doctor right away if you take more than your prescribed dose of STRATTERA.

You should not open STRATTERA capsules, but if they are accidentally opened or broken you should avoid contact with the powder and wash away any loose powder as soon as possible with water. If any of the powder gets in your eyes you should rinse them with water immediately and contact your doctor.

Other important safety information about STRATTERA

STRATTERA can cause liver damage in rare cases. Call your doctor right away if you have itching, dark urine, yellow skin/eyes, upper right-sided abdominal tenderness, or unexplained "flu-like" symptoms.

Use caution when driving a car or operating heavy machinery until you know how STRATTERA affects you.

If you notice an increase in aggression or hostility since taking this medication, you should call your doctor as soon as possible.

Talk to your doctor if you are:

• pregnant or planning to become pregnant
• breast-feeding. We do not know if STRATTERA can pass into your breast milk.

What are the common side effects of STRATTERA?

The most common side effects of STRATTERA used in teenagers and children over 6 years old are:

• upset stomach
• decreased appetite
• nausea or vomiting
• dizziness
• tiredness
• mood swings

Weight loss may occur after starting STRATTERA. Treatment data up to 3 years indicates minimal, if any, long-term effects of STRATTERA on weight and height. Your doctor will watch your weight and height. If you are not growing or gaining weight as expected, your doctor may change your treatment with STRATTERA.

The most common side effects of STRATTERA used in adults are:

• constipation
• dry mouth
• nausea
• decreased appetite
• dizziness
• problems sleeping
• sexual side effects
• problems urinating
• menstrual cramps

Stop taking STRATTERA and call your doctor right away if you get swelling or hives. STRATTERA can cause a serious allergic reaction in rare cases.

This is not a complete list of side effects. Talk to your doctor if you develop any symptoms that concern you.

See also "What is the most important information I should know about STRATTERA?" and "Other important safety information about STRATTERA".

General advice about STRATTERA

STRATTERA has not been studied in children under 6 years old.

Medicines are sometimes prescribed for conditions that are not mentioned in Medication Guides. Do not use STRATTERA for a condition for which it was not prescribed. Do not give STRATTERA to other people, even if they have the same symptoms you have.

This Medication Guide summarizes the most important information about STRATTERA. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information on STRATTERA that is written for health professionals. You can also call 1-800-Lilly-Rx (1-800-545-5979) or visit our website at www.strattera.com.

What are the ingredients in STRATTERA?

Active ingredient: atomoxetine.

Inactive ingredients: pregelatinized starch, dimethicone, gelatin, sodium lauryl sulfate, FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide, and edible black ink.

Store STRATTERA at room temperature.

 

This Medication Guide has been approved by the US Food and Drug Administration.

 

Eli Lilly and Company
Indianapolis, IN 46285, USA
www.strattera.com

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Strattera Prescribing Information
Strattera Patient Information

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

back to: Psychiatric Medications Pharmacology Homepage

Generic name: Naproxen
Other brand name: EC-Naprosyn

Pronounced: NA-proh-sinn

• Non-Steroidal AntiInflammatory Drugs (NSAIDs)
• Naprosyn Full Prescription Information

 

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What is the most important information I should know about medicines called Non-Steroidal AntiInflammatory Drugs (NSAIDs)?

NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases: · with longer use of NSAID medicines · in people who have heart disease

NSAID medicines should never be used right before or after a heart surgery called a ìcoronary artery bypass graft (CABG)."

NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding: · can happen without warning symptoms · may cause death

The chance of a person getting an ulcer or bleeding increases with: · taking medicines called ìcorticosteroidsî and ìanticoagulantsî · longer use · smoking · drinking alcohol · older age · having poor health

NSAID medicines should only be used: · exactly as prescribed · at the lowest dose possible for your treatment · for the shortest time needed

What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAID medicines are use to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as: · different types of arthritis · menstrual cramps and other types of short-term pain

 

Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine: · if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine · for pain right before or after heart bypass surgery Tell your healthcare provider: · about all of your medical conditions. · about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist. · if you are pregnant. NSAID medicines should not be used by pregnant women late in their pregnancy. · if you are breastfeeding. Talk to your doctor.

What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

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Seriousside effects include:

• heart attack
• stroke
• high blood pressure
• heart failure from body swelling (fluid retention)
• kidney problems including kidney failure
• bleeding and ulcers in the stomach and intestine
• low red blood cells (anemia)
• life-threatening skin reactions
• life-threatening allergic reactions
• liver problems including liver failure
• asthma attacks in people who have asthma

Otherside effects include:

• stomach pain
• constipation
• diarrhea
• gas
• heartburn  
• nausea
• vomiting
• dizziness

Get emergency help right away if you have any of the following symptoms:

• shortnes s of breath or trouble breathing body
• chest pain
• slurred speech
• weakness in one part or side of your
• swelling of the face or throat

Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:

• nausea
• vomit blood
• more tired or weaker than usual
• there is blood in your bowel
• itching movement or it is black and
• your skin or eyes look yellow sticky like tar
• stomach pain
• skin rash or blisters with fever
• flu-like symptoms
• unusual weight gain
• swelling of the arms and legs, hands and feet

These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines.

Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

• Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
• Some of these NSAID medicines are sold in lower doses without a prescription (over ñthe ñcounter). Talk to your healthcare provider before using over ñthe ñcounter NSAIDs for more than 10 days.

 

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Why is Naprosyn prescribed?

Naprosyn, a nonsteroidal anti-inflammatory drug, is used to relieve the inflammation, swelling, stiffness, and joint pain associated with rheumatoid arthritis, osteoarthritis (the most common form of arthritis), juvenile arthritis, ankylosing spondylitis (spinal arthritis), tendinitis, bursitis, and acute gout; it is also used to relieve menstrual cramps and other types of mild to moderate pain.

Most important fact about Naprosyn

You should have frequent checkups with your doctor if you take Naprosyn regularly. Ulcers or internal bleeding can occur without warning.

How should you take Naprosyn?

Naprosyn may be taken with food or an antacid, and with a full glass of water to avoid stomach upset. Avoid taking it on an empty stomach.

If you are using Naprosyn for arthritis, it should be taken regularly; take it exactly as prescribed.

Do not break, crush, or chew an EC-Naprosyn tablet.

--If you miss a dose...

And you take the drug on a regular schedule, take the dose as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Do not take 2 doses at once.

--Storage instructions...

Store at room temperature in a well-closed container. Protect from light and extreme heat.

What side effects may occur using Naprosyn?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Naprosyn.

• More common side effects may include: Abdominal pain, bruising, constipation, difficult or labored breathing, dizziness, drowsiness, headache, heartburn, itching, nausea, ringing in ears, skin eruptions, swelling due to fluid retention

Why should this drug not be prescribed?

If you are sensitive to or have ever had an allergic reaction to Naprosyn, EC-Naprosyn, Anaprox, Anaprox DS, or Aleve, you should not take this drug. Also, if aspirin or other nonsteroidal anti-inflammatory drugs have ever given you asthma or nasal inflammation or tumors, you should not take this medication. Make sure your doctor is aware of any drug reactions you have experienced.

Special warnings about Naprosyn

Remember that peptic ulcers and bleeding can occur without warning. Call your doctor immediately if you suspect a problem.

Use this drug with caution if you have kidney or liver disease; it can cause liver or kidney problems in some people.

Naprosyn may prolong bleeding time. If you are taking blood-thinning medication, your doctor will prescribe Naprosyn with caution.

By reducing fever and inflammation, Naprosyn may hide an underlying condition.

This medication may cause vision problems. If you experience any changes in your vision, inform your doctor.

This drug can increase water retention. It will be prescribed with caution if you have heart disease or high blood pressure. Naprosyn suspension contains a significant amount of sodium. If you are on a low-sodium diet, discuss this with your doctor.

Naprosyn may cause you to become drowsy or less alert; therefore, avoid driving, operating dangerous machinery, or participating in any hazardous activity that requires full mental alertness until you are sure of the drug's effect on you.

Possible food and drug interactions when taking Naprosyn

If Naprosyn is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Naprosyn with the following:

ACE inhibitors such as the blood-pressure drug Zestril Aspirin Beta blockers such as the blood-pressure drug Tenormin Blood-thinning drugs such as Coumadin Furosemide (Lasix) Lithium (Eskalith, Lithobid) Methotrexate Naproxen sodium (Aleve, Anaprox) Oral diabetes drugs such as Diabinese and Micronase Phenytoin (Dilantin) Probenecid (Benemid) Sulfa drugs such as the antibiotics Bactrim and Septra

EC-Naprosyn should not be used with antacids, H 2 blockers such as Tagamet, or sucralfate (Carafate).

Special information if you are pregnant or breastfeeding

The effects of Naprosyn during pregnancy have not been adequately studied. If you are pregnant or plan to become pregnant, inform your doctor immediately. Naprosyn appears in breast milk and could affect a nursing infant. If this medication is essential to your health, your doctor may advise you to discontinue breastfeeding until your treatment with this medication is finished.

Recommended dosage

Naprosyn is available in tablet and liquid form. When taking the liquid, use a teaspoon or the measuring cup, marked in one-half teaspoon and 2.5 milliliter increments, that comes with Naprosyn suspension.

ADULTS

Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis

The usual dose of Naprosyn is 250 milligrams (10 milliliters or 2 teaspoons of suspension), 375 milligrams (15 milliliters or 3 teaspoons), or 500 milligrams (20 milliliters or 4 teaspoons) 2 times a day (morning and evening). EC-Naprosyn is taken in doses of 375 or 500 milligrams twice a day. Your dose may be adjusted by your doctor over your period of treatment. Improvement of symptoms should be seen in 2 to 4 weeks.

Acute Gout

Starting dose of Naprosyn is 750 milligrams (30 milliliters or 6 teaspoons), followed by 250 milligrams (10 milliliters or 2 teaspoons) every 8 hours until the symptoms are relieved. EC-Naprosyn should not be used to treat gout.

Mild to Moderate Pain, Menstrual Cramps, Acute Tendinitis, and Bursitis

Starting dose is 500 milligrams (20 milliliters or 4 teaspoons of suspension), followed by 250 milligrams (10 milliliters or 2 teaspoons) every 6 to 8 hours as needed. The most you should take in a day is 1,250 milligrams (50 milliliters or 10 teaspoons). Do not take EC-Naprosyn for these problems.

CHILDREN

Juvenile Arthritis

The usual daily dose is 10 milligrams per 2.2 pounds of body weight, divided into 2 doses. Follow your doctor's directions carefully when giving a child this medicine.

The safety and effectiveness of Naprosyn have not been established in children under 2 years of age.

OLDER ADULTS

Your doctor will probably have you take a reduced dose.

Overdosage

Any medication taken in excess can have serious consequences. If you suspect an overdose, seek medical attention immediately.

• Symptoms of Naprosyn overdose may include: Drowsiness, heartburn, indigestion, nausea, vomiting

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Full Naprosyn prescribing information

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About Using Antidepressants in Children and Teenagers

See Effexor XR Full Prescribing Information

What is the most important information I should know if my child is being prescribed an antidepressant?

Parents or guardians need to think about 4 important things when their child is prescribed an antidepressant:

1. There is a risk of suicidal thoughts or actions.
2. How to try to prevent suicidal thoughts or actions in your child.
3. You should watch for certain signs if your child is taking an antidepressant.
4. There are benefits and risks when using antidepressants.

1. There is a Risk of Suicidal Thoughts or Actions

Children and teenagers sometimes think about suicide, and many report trying to kill themselves.

Antidepressants increase suicidal thoughts and actions in some children and teenagers. But suicidal thoughts and actions can also be caused by depression, a serious medical condition that is commonly treated with antidepressants. Thinking about killing yourself or trying to kill yourself is called suicidality or being suicidal.

A large study combined the results of 24 different studies of children and teenagers with depression or other illnesses. In these studies, patients took either a placebo (sugar pill) or an antidepressant for 1 to 4 months. No one committed suicide in these studies, but some patients became suicidal. On sugar pills, 2 out of every 100 became suicidal. On the antidepressants, 4 out of every 100 patients became suicidal.

For some children and teenagers, the risks of suicidal actions may be especially high. These include patients with:

- Bipolar illness (sometimes called manic-depressive illness)
- A family history of bipolar illness
- A personal or family history of attempting suicide

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continue story below

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If any of these are present, make sure you tell your healthcare provider before your child takes an antidepressant.

2. How to Try to Prevent Suicidal Thoughts and Actions

To try to prevent suicidal thoughts and actions in your child, pay close attention to changes in her or his moods or actions, especially if the changes occur suddenly. Other important people in your child's life can help by paying attention as well (e.g., your child, brothers and sisters, teachers, and other important people). The changes to look out for are listed in Section 3, on what to watch for.

Whenever an antidepressant is started or its dose is changed, pay close attention to your child.

After starting an antidepressant, your child should generally see his or her healthcare provider:

- Once a week for the first 4 weeks
- Every 2 weeks for the next 4 weeks
- After taking the antidepressant for 12 weeks
- After 12 weeks, follow your healthcare provider's advice about how often to come back
- More often if problems or questions arise (see Section 3)

You should call your child's healthcare provider between visits if needed.

3. You Should Watch for Certain Signs If Your Child is Taking an Antidepressant

Contact your child's healthcare provider right away if your child exhibits any of the following signs for the first time, or if they seem worse, or worry you, your child, or your child's teacher:

- Thoughts about suicide or dying
- Attempts to commit suicide
- New or worse depression
- New or worse anxiety
- Feeling very agitated or restless
- Panic attacks
- Difficulty sleeping (insomnia)
- New or worse irritability
- Acting aggressive, being angry, or violent
- Acting on dangerous impulses
- An extreme increase in activity and talking
- Other unusual changes in behavior or mood

Never let your child stop taking an antidepressant without first talking to his or her healthcare provider. Stopping an antidepressant suddenly can cause other symptoms.

4. There are Benefits and Risks When Using Antidepressants

Antidepressants are used to treat depression and other illnesses. Depression and other illnesses can lead to suicide. In some children and teenagers, treatment with an antidepressant increases suicidal thinking or actions. It is important to discuss all the risks of treating depression and also the risks of not treating it. You and your child should discuss all treatment choices with your healthcare provider, not just the use of antidepressants.

Other side effects can occur with antidepressants (see section below).

Of all the antidepressants, only fluoxetine (Prozac®) has been FDA approved to treat pediatric depression.

For obsessive compulsive disorder in children and teenagers, FDA has approved only fluoxetine (Prozac®), sertraline (Zoloft®), fluvoxamine, and clomipramine (Anafranil®).*

Your healthcare provider may suggest other antidepressants based on the past experience of your child or other family members.

Is this all I need to know if my child is being prescribed an antidepressant?

No. This is a warning about the risk for suicidality. Other side effects can occur with antidepressants. Be sure to ask your healthcare provider to explain all the side effects of the particular drug he or she is prescribing. Also ask about drugs to avoid when taking an antidepressant. Ask your healthcare provider or pharmacist where to find more information.

* Prozac® is a registered trademark of Eli Lilly and Company
Zoloft® is a registered trademark of Pfizer Pharmaceuticals
Anafranil® is a registered trademark of Mallinckrodt Inc.

This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants.

Wyeth Pharmaceuticals Inc.
Philadelphia, PA 19101

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See Effexor XR Full Prescribing Information

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

Extensive Information on Suicide and Suicidal Thoughts

back to: Psychiatric Medications Pharmacology Homepage

About Using Antidepressants in Children and Teenagers

Full Symbax Prescribing Information
Symbyax Patient Information

What is the most important information I should know if my child is being prescribed an antidepressant?

Parents or guardians need to think about 4 important things when their child is prescribed an antidepressant:

1. There is a risk of suicidal thoughts or actions
2. How to try to prevent suicidal thoughts or actions in your child
3. You should watch for certain signs if your child is taking an antidepressant 4. There are benefits and risks when using antidepressants

1. There is a Risk of Suicidal Thoughts or Actions

Children and teenagers sometimes think about suicide, and many report trying to kill themselves.

Antidepressants increase suicidal thoughts and actions in some children and teenagers. But suicidal thoughts and actions can also be caused by depression, a serious medical condition that is commonly treated with antidepressants. Thinking about killing yourself or trying to kill yourself is called suicidality or being suicidal.

A large study combined the results of 24 different studies of children and teenagers with depression or other illnesses. In these studies, patients took either a placebo (sugar pill) or an antidepressant for 1 to 4 months. No one committed suicide in these studies, but some patients became suicidal. On sugar pills, 2 out of every 100 became suicidal. On the antidepressants, 4 out of every 100 patients became suicidal.

For some children and teenagers, the risks of suicidal actions may be especially high. These include patients with

• Bipolar illness (sometimes called manic-depressive illness)
• A family history of bipolar illness
• A personal or family history of attempting suicide

If any of these are present, make sure you tell your health care provider before your child takes an antidepressant.

2. How to Try to Prevent Suicidal Thoughts and Actions

To try to prevent suicidal thoughts and actions in your child, pay close attention to changes in her or his moods or actions, especially if the changes occur suddenly. Other important people in your child's life can help by paying attention as well (e.g., your child, brothers and sisters, teachers, and other important people). The changes to look out for are listed in Section 3, on what to watch for

Whenever an antidepressant is started or its dose is changed, pay close attention to your child.

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continue story below

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After starting an antidepressant, your child should generally see his or her health care provider

• Once a week for the first 4 weeks
• Every 2 weeks for the next 4 weeks
• After taking the antidepressant for 12 weeks
• After 12 weeks, follow your health care provider's advice about how often to come back
• More often if problems or questions arise (see Section 3)

You should call your child's health care provider between visits if needed.

3. You Should Watch for Certain Signs If Your Child is Taking an Antidepressant

Contact your child's health care provider right away if your child exhibits any of the following signs for the first time, or if they seem worse, or worry you, your child, or your child's teacher:

• Thoughts about suicide or dying
• Attempts to commit suicide - New or worse depression
• New or worse anxiety - Feeling very agitated or restless
• Panic attacks - Difficulty sleeping (insomnia)
• New or worse irritability
• Acting aggressive, being angry, or violent
• Acting on dangerous impulses
• An extreme increase in activity and talking
• Other unusual changes in behavior or mood

Never let your child stop taking an antidepressant without first talking to his or her health care provider. Stopping an antidepressant suddenly can cause other symptoms.

4. There are Benefits and Risks When Using Antidepressants

Antidepressants are used to treat depression and other illnesses. Depression and other illnesses can lead to suicide. In some children and teenagers, treatment with an antidepressant increases suicidal thinking or actions. It is important to discuss all the risks of treating depression and also the risks of not treating it. You and your child should discuss all treatment choices with your health care provider, not just the use of antidepressants.

Other side effects can occur with antidepressants (see section below).

Of all the antidepressants, only fluoxetine (Prozac®) has been FDA approved to treat pediatric depression.

For obsessive compulsive disorder in children and teenagers, FDA has approved only fluoxetine (Prozac®), sertraline (Zoloft®), fluvoxamine, and clomipramine (Anafranil®).

Your health care provider may suggest other antidepressants based on the past experience of your child or other family members.

Is this all I need to know if my child is being prescribed an antidepressant?

No. This is a warning about the risk for suicidality. Other side effects can occur with antidepressants. Be sure to ask your health care provider to explain all the side effects of the particular drug he or she is prescribing. Also ask about drugs to avoid when taking an antidepressant. Ask your health care provider or pharmacist where to find more information.

Prozac^® is a registered trademark of Eli Lilly and Company.

Zoloft^® is a registered trademark of Pfizer Pharmaceuticals.

Anafranil^® is a registered trademark of Mallinckrodt Inc.

This Medication Guide has been approved by the US Food and Drug Administration for all antidepressants.

Eli Lilly and Company
Indianapolis, IN 46285
www.SYMBYAX.com

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Full Symbax Prescribing Information
Symbyax Patient Information

back to: Psychiatric Medications Pharmacology Homepage

About Using Antidepressants in Children and Teenagers

What is the most important information I should know if my child is being prescribed an antidepressant?

Parents or guardians need to think about 4 important things when their child is prescribed an antidepressant:

1. There is a risk of suicidal thoughts or actions
2. How to try to prevent suicidal thoughts or actions in your child
3. You should watch for certain signs if your child is taking an antidepressant
4. There are benefits and risks when using antidepressants

1. There is a Risk of Suicidal Thoughts or Actions

Children and teenagers sometimes think about suicide, and many report trying to kill themselves.

Antidepressants increase suicidal thoughts and actions in some children and teenagers. But suicidal thoughts and actions can also be caused by depression, a serious medical condition that is commonly treated with antidepressants. Thinking about killing yourself or trying to kill yourself is called suicidality or being suicidal .

A large study combined the results of 24 different studies of children and teenagers with depression or other illnesses. In these studies, patients took either a placebo (sugar pill) or an antidepressant for 1 to 4 months. No one committed suicide in these studies, but some patients became suicidal. On sugar pills, 2 out of every 100 became suicidal. On the antidepressants, 4 out of every 100 patients became suicidal.

For some children and teenagers, the risks of suicidal actions may be especially high. These include patients with

• Bipolar illness (sometimes called manic-depressive illness)
• A family history of bipolar illness
• A personal or family history of attempting suicide

If any of these are present, make sure you tell your healthcare provider before your child takes an antidepressant.

2. How to Try to Prevent Suicidal Thoughts and Actions

 

To try to prevent suicidal thoughts and actions in your child, pay close attention to changes in her or his moods or actions, especially if the changes occur suddenly. Other important people in your child's life can help by paying attention as well (e.g., your child, brothers and sisters, teachers, and other important people). The changes to look out for are listed in Section 3, on what to watch for.

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Whenever an antidepressant is started or its dose is changed, pay close attention to your child.

After starting an antidepressant, your child should generally see his or her healthcare provider:

• Once a week for the first 4 weeks
• Every 2 weeks for the next 4 weeks
• After taking the antidepressant for 12 weeks
• After 12 weeks, follow your healthcare provider's advice about how often to come back
• More often if problems or questions arise (see Section 3)

You should call your child's healthcare provider between visits if needed.

3. You Should Watch for Certain Signs If Your Child is Taking an Antidepressant

Contact your child's healthcare provider right away if your child exhibits any of the following signs for the first time, or if they seem worse, or worry you, your child, or your child's teacher:

• Thoughts about suicide or dying
• Attempts to commit suicide
• New or worse depression
• New or worse anxiety
• Feeling very agitated or restless
• Panic attacks
• Difficulty sleeping (insomnia)
• New or worse irritability
• Acting aggressive, being angry, or violent
• Acting on dangerous impulses
• An extreme increase in activity and talking
• Other unusual changes in behavior or mood

Never let your child stop taking an antidepressant without first talking to his or her healthcare provider. Stopping an antidepressant suddenly can cause other symptoms.

4. There are Benefits and Risks When Using Antidepressants

Antidepressants are used to treat depression and other illnesses. Depression and other illnesses can lead to suicide. In some children and teenagers, treatment with an antidepressant increases suicidal thinking or actions. It is important to discuss all the risks of treating depression and also the risks of not treating it. You and your child should discuss all treatment choices with your healthcare provider, not just the use of antidepressants.

Other side effects can occur with antdepressants (see section below).

Of all the antidepressants, only fluoxetine (Prozac ® ) has been FDA approved to treat pediatric depression.

For obsessive compulsive disorder in children and teenagers, FDA has approved only fluoxetine (Prozac ® ), sertraline (Zoloft ® ), fluvoxamine, and clomipramine (Anafranil ® ).

Your healthcare provider may suggest other antidepressants based on the past experience of your child or other family members.

Is this all I need to know if my child is being prescribed an antidepressant?

No. This is a warning about the risk for suicidality. Other side effects can occur with antidepressants. Be sure to ask your healthcare provider to explain all the side effects of the particular drug he or she is prescribing. Also ask about drugs to avoid when taking an antidepressant. Ask your healthcare provider or pharmacist where to find more information.

*Prozac ® is a registered trademark of Eli Lilly and Company
*Zoloft ® is a registered trademark of Pfizer Pharmaceuticals
*Anafranil ® is a registered trademark of Mallinckrodt Inc.

This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants.

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PAXIL® (PAX-il) (paroxetine hydrochloride) Tablets and Oral Solution

About Using Antidepressants in Children and Teenagers

What is the most important information I should know if my child is being prescribed an antidepressant?

Parents or guardians need to think about 4 important things when their child is prescribed an antidepressant:

1. There is a risk of suicidal thoughts or actions
2. How to try to prevent suicidal thoughts or actions in your child
3. You should watch for certain signs if your child is taking an antidepressant
4. There are benefits and risks when using antidepressants

1. There is a Risk of Suicidal Thoughts or Actions

Children and teenagers sometimes think about suicide, and many report trying to kill themselves.

Antidepressants increase suicidal thoughts and actions in some children and teenagers. But suicidal thoughts and actions can also be caused by depression, a serious medical condition that is commonly treated with antidepressants. Thinking about killing yourself or trying to kill yourself is called suicidality or being suicidal.

A large study combined the results of 24 different studies of children and teenagers with depression or other illnesses. In these studies, patients took either a placebo (sugar pill) or an antidepressant for 1 to 4 months. No one committed suicide in these studies, but some patients became suicidal. On sugar pills, 2 out of every 100 became suicidal. On the antidepressants, 4 out of every 100 patients became suicidal.

For some children and teenagers, the risks of suicidal actions may be especially high. These include patients with

• Bipolar illness (sometimes called manic-depressive illness)
• A family history of bipolar illness
• A personal or family history of attempting suicide

If any of these are present, make sure you tell your healthcare provider before your child takes an antidepressant.

 

2. How to Try to Prevent Suicidal Thoughts and Actions

To try to prevent suicidal thoughts and actions in your child, pay close attention to changes in her or his moods or actions, especially if the changes occur suddenly. Other important people in your child's life can help by paying attention as well (e.g., your child, brothers and sisters, teachers, and other important people). The changes to look out for are listed in Section 3, on what to watch for.

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continue story below

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Whenever an antidepressant is started or its dose is changed, pay close attention to your child.

After starting an antidepressant, your child should generally see his or her healthcare provider:

• Once a week for the first 4 weeks
• Every 2 weeks for the next 4 weeks
• After taking the antidepressant for 12 weeks
• After 12 weeks, follow your healthcare provider's advice about how often to come back
• More often if problems or questions arise (see Section 3)

You should call your child's healthcare provider between visits if needed.

3. You Should Watch for Certain Signs If Your Child is Taking an Antidepressant

Contact your child's healthcare provider right away if your child exhibits any of the following signs for the first time, or if they seem worse, or worry you, your child, or your child's teacher:

• Thoughts about suicide or dying
• Attempts to commit suicide
• New or worse depression
• New or worse anxiety
• Feeling very agitated or restless
• Panic attacks
• Difficulty sleeping (insomnia)
• New or worse irritability
• Acting aggressive, being angry, or violent
• Acting on dangerous impulses
• An extreme increase in activity and talking
• Other unusual changes in behavior or mood

Never let your child stop taking an antidepressant without first talking to his or her healthcare provider. Stopping an antidepressant suddenly can cause other symptoms.

4. There are Benefits and Risks When Using Antidepressants

Antidepressants are used to treat depression and other illnesses. Depression and other illnesses can lead to suicide. In some children and teenagers, treatment with an antidepressant increases suicidal thinking or actions. It is important to discuss all the risks of treating depression and also the risks of not treating it. You and your child should discuss all treatment choices with your healthcare provider, not just the use of antidepressants.

Other side effects can occur with antidepressants (see section below).

Of all the antidepressants, only fluoxetine (Prozac®)* has been FDA approved to treat pediatric depression.

For obsessive compulsive disorder in children and teenagers, FDA has approved only fluoxetine (Prozac®)*, sertraline (Zoloft®)*, fluvoxamine, and clomipramine (Anafranil®)*.

Your healthcare provider may suggest other antidepressants based on the past experience of your child or other family members.

Is this all I need to know if my child is being prescribed an antidepressant?

No. This is a warning about the risk for suicidality. Other side effects can occur with antidepressants. Be sure to ask your healthcare provider to explain all the side effects of the particular drug he or she is prescribing. Also ask about drugs to avoid when taking an antidepressant. Ask your healthcare provider or pharmacist where to find more information.

*The following are registered trademarks of their respective manufacturers: Prozac®^/Eli Lilly and Company; Zoloft®^/Pfizer Pharmaceuticals; Anafranil®/Mallinckrodt Inc.

This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants.

PAXIL is a registered trademark of GlaxoSmithKline.

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Full Paxil Prescribing Information
Paxil Patient Information

GlaxoSmithKline
Research Triangle Park, NC 27709

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Lexapro® (escitalopram oxalate) Tablets/Oral Solution

Lexapro Prescribing Information
Lexapro Patient Information

Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions

Read the Medication Guide that comes with you or your family member's antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, or your family member's, healthcare provider about:

• all risks and benefits of treatment with antidepressant medicines
• all treatment choices for depression or other serious mental illness

What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?

1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.
3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
   • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
   • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
   • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

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Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

• thoughts about suicide or dying
• attempts to commit suicide
• new or worse depression
• new or worse anxiety
• feeling very agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worse irritability
• acting aggressive, being angry, or violent
• acting on dangerous impulses
• an extreme increase in activity and talking (mania)
• other unusual changes in behavior or mood

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

What else do I need to know about antidepressant medicines?

• Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.
• Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
• Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
• Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
• Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child's healthcare provider for more information.

This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants.

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Lexapro Prescribing Information
Lexapro Patient Information

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

Forest Pharmaceuticals, Inc.
Subsidiary of Forest Laboratories, Inc.
St. Louis, MO 63045 USA
Licensed from H. Lundbeck A/S

NOTE: This information is not intended to cover all possible uses, precautions, interactions, or adverse effects for this drug. If you have questions about the drug(s) you are taking, check with your health care professional.

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About Using Antidepressants in Children and Teenagers

Full Prozac Prescribing Information
Prozac Patient Information

What is the most important information I should know if my child is being prescribed an antidepressant?

Parents or guardians need to think about 4 important things when their child is prescribed an antidepressant:

1. There is a risk of suicidal thoughts or actions
2. How to try to prevent suicidal thoughts or actions in your child
3. You should watch for certain signs if your child is taking an antidepressant
4. There are benefits and risks when using antidepressants

1. There is a Risk of Suicidal Thoughts or Actions

Children and teenagers sometimes think about suicide, and many report trying to kill themselves.

Antidepressants increase suicidal thoughts and actions in some children and teenagers. But suicidal thoughts and actions can also be caused by depression, a serious medical condition that is commonly treated with antidepressants. Thinking about killing yourself or trying to kill yourself is called suicidality or being suicidal.

A large study combined the results of 24 different studies of children and teenagers with depression or other illnesses. In these studies, patients took either a placebo (sugar pill) or an antidepressant for 1 to 4 months. No one committed suicide in these studies, but some patients became suicidal. On sugar pills, 2 out of every 100 became suicidal. On the antidepressants, 4 out of every 100 patients became suicidal.

For some children and teenagers, the risks of suicidal actions may be especially high. These include patients with

-Bipolar illness (sometimes called manic-depressive illness)

-A family history of bipolar illness

-A personal or family history of attempting suicide

If any of these are present, make sure you tell your health care provider before your child takes an antidepressant.

2. How to Try to Prevent Suicidal Thoughts and Actions

To try to prevent suicidal thoughts and actions in your child, pay close attention to changes in her or his moods or actions, especially if the changes occur suddenly. Other important people in your child's life can help by paying attention as well (e.g., your child, brothers and sisters, teachers, and other important people). The changes to look out for are listed in Section 3, on what to watch for.

 

Whenever an antidepressant is started or its dose is changed, pay close attention to your child.

After starting an antidepressant, your child should generally see his or her health care provider

-Once a week for the first 4 weeks

-Every 2 weeks for the next 4 weeks

-After taking the antidepressant for 12 weeks

-After 12 weeks, follow your health care provider's advice about how often to come back

-More often if problems or questions arise (see Section 3)

You should call your child's health care provider between visits if needed.

3. You Should Watch for Certain Signs If Your Child is Taking an Antidepressant

Contact your child's health care provider right away if your child exhibits any of the following signs for the first time, or if they seem worse, or worry you, your child, or your child's teacher:

-Thoughts about suicide or dying

-Attempts to commit suicide

-New or worse depression

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continue story below

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-New or worse anxiety

-Feeling very agitated or restless

-Panic attacks

-Difficulty sleeping (insomnia)

-New or worse irritability

-Acting aggressive, being angry, or violent

-Acting on dangerous impulses

-An extreme increase in activity and talking

-Other unusual changes in behavior or mood

Never let your child stop taking an antidepressant without first talking to his or her health care provider. Stopping an antidepressant suddenly can cause other symptoms.

4. There are Benefits and Risks When Using Antidepressants

Antidepressants are used to treat depression and other illnesses. Depression and other illnesses can lead to suicide. In some children and teenagers, treatment with an antidepressant increases suicidal thinking or actions. It is important to discuss all the risks of treating depression and also the risks of not treating it. You and your child should discuss all treatment choices with your health care provider, not just the use of antidepressants.

Other side effects can occur with antidepressants (see section below).

Of all the antidepressants, only fluoxetine (Prozac®) has been FDA approved to treat pediatric depression.

For obsessive compulsive disorder in children and teenagers, FDA has approved only fluoxetine (Prozac®), sertraline (Zoloft®), fluvoxamine, and clomipramine (Anafranil®).

Your health care provider may suggest other antidepressants based on the past experience of your child or other family members.

Is this all I need to know if my child is being prescribed an antidepressant?

No. This is a warning about the risk for suicidality. Other side effects can occur with antidepressants. Be sure to ask your health care provider to explain all the side effects of the particular drug he or she is prescribing. Also ask about drugs to avoid when taking an antidepressant. Ask your health care provider or pharmacist where to find more information.

Prozac® is a registered trademark of Eli Lilly and Company.

Zoloft® is a registered trademark of Pfizer Pharmaceuticals.

Anafranil® is a registered trademark of Mallinckrodt Inc.

This Medication Guide has been approved by the US Food and Drug Administration for all antidepressants.

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Full Prozac Prescribing Information
Prozac Patient Information

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

Extensive information on Suicide and Suicide Thoughts

Last revised January 26, 2005

Eli Lilly and Company
Indianapolis, IN 46285, USA
www.lilly.com

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Find out why Geodon is prescribed, side effects of Geodon, Geodon warnings, effects of Geodon during pregnancy, more - in plain English.

Generic name: Ziprasidone hydrochloride
Brand name: Geodon

Pronounced: GEE-oh-dahn

Geodon Prescribing Information

Why is this drug prescribed?

Geodon is used in the treatment of the crippling mental disorder known as schizophrenia. Researchers believe that it works by opposing the action of serotonin and dopamine, two of the brain's major chemical messengers. Because of its potentially serious side effects, Geodon is typically prescribed only after other medications have proved inadequate.

Geodon is usually taken in capsule form. An injectable version is available for quick relief of agitated patients. Injectable Geodon is generally used for no more than a few days.

Most important fact about this drug

In some people with heart problems or a slow heartbeat, Geodon can cause serious and potentially fatal heartbeat irregularities. The chance of a problem is greater if you are taking a water pill (diuretic) or a medication that prolongs a part of the heartbeat known as the QT interval. Many of the drugs prescribed for heartbeat irregularities prolong the QT interval and should never be combined with Geodon. Other drugs to avoid when taking Geodon include Anzemet, Avelox, Halfan, Inapsine, Lariam, Mellaril, Nebupent, Orap, Orlaam, Pentam, Probucol, Prograf, Serentil, Tequin, Thorazine, Trisenox, and Zagam. If you're uncertain about the risks of any drug you're taking, be sure to check with your doctor before combining it with Geodon.

How should you take this medication?

Geodon capsules should be taken twice a day with food.

--If you miss a dose...

Why is this drug prescribed?

Geodon is used in the treatment of the crippling mental disorder known as schizophrenia. Researchers believe that it works by opposing the action of serotonin and dopamine, two of the brain's major chemical messengers. Because of its potentially serious side effects, Geodon is typically prescribed only after other medications have proved inadequate.

 

Geodon is usually taken in capsule form. An injectable version is available for quick relief of agitated patients. Injectable Geodon is generally used for no more than a few days.

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Most important fact about this drug

In some people with heart problems or a slow heartbeat, Geodon can cause serious and potentially fatal heartbeat irregularities. The chance of a problem is greater if you are taking a water pill (diuretic) or a medication that prolongs a part of the heartbeat known as the QT interval. Many of the drugs prescribed for heartbeat irregularities prolong the QT interval and should never be combined with Geodon. Other drugs to avoid when taking Geodon include Anzemet, Avelox, Halfan, Inapsine, Lariam, Mellaril, Nebupent, Orap, Orlaam, Pentam, Probucol, Prograf, Serentil, Tequin, Thorazine, Trisenox, and Zagam. If you're uncertain about the risks of any drug you're taking, be sure to check with your doctor before combining it with Geodon.

How should you take this medication?

Geodon capsules should be taken twice a day with food.

--If you miss a dose...

Take it as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Do not take 2 doses at once.

--Storage instructions...

Store at room temperature.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Geodon.

• More common side effects may include: Accidental injury, cold symptoms, constipation, cough, diarrhea, dizziness, drowsiness, dry mouth, indigestion, muscle tightness, nausea, rash, stuffy and runny nose, upper respiratory infection, vision problems, weakness

• Other side effects may include: Abdominal pain, abnormal body movements, abnormal ejaculation, abnormal secretion of milk, abnormal walk, abnormally low cholesterol, agitation, amnesia, anemia, bleeding gums, bleeding in the eye, blood clots, blood disorders, blood in urine, body spasms, breast development in males, bruising or purple spots, cataracts, chest pain, chills, clogged bowels, confusion, conjunctivitis (pinkeye), coordination problems, decreased blood flow to the heart, delirium, difficulty breathing, difficulty swallowing, difficulty with orgasm, double vision, dry eyes, enlarged heart, eyelid inflammation, female sexual problems, fever, flank pain, flu-like symptoms, fungal infections, gout, hair loss, heavy menstruation, heavy uterine or vaginal bleeding, high blood pressure, high blood sugar, hives, hostility, impotence, increased reflexes, increased sensitivity to touch or sound, inflammation of the cornea, inflammation of the heart, involuntary or jerky movements, irregular heartbeat, liver problems, lockjaw, loss of appetite, loss of menstruation, low blood sugar, low blood pressure, low body temperature, lymph disorders, male sexual problems, muscle disorders, muscle pain, muscle weakness, nighttime urination, nosebleed, pneumonia, prickling or tingling sensation, rapid heartbeat, rectal bleeding, rigid muscle movement, ringing in ears, rolling of the eyeballs, sensitivity to sunlight, skin problems, slow heartbeat, slowed movement, speech problems, stroke, sudden drop in blood pressure upon standing up, swelling in the arms and legs, swelling in the face, swollen lymph nodes, swollen tongue, tarry stools, tendon inflammation, thirst, throat spasms, thyroid disorders, tremor, twitching, uncontrolled eye movement, urination decrease or increase, vaginal bleeding, vein inflammation, vertigo, vision disorders, vomiting, vomiting or spitting blood, yellowed skin and eyes, weight gain, white spots in the mouth

Why should this drug not be prescribed?

Do not take Geodon if you have the heartbeat irregularity known as QT prolongation, have had a recent heart attack, or suffer from heart failure. You'll also need to avoid this drug if it gives you an allergic reaction.

Special warnings about this medication

Remember that Geodon can cause dangerous--even fatal--heartbeat irregularities. Warning signs include dizziness, palpitations, and fainting. Tell your doctor immediately if you experience any of these symptoms. Be careful to avoid drugs that prolong the QT interval of the heartbeat. Check with your doctor before combining any other medication with Geodon.

Particularly during the first few days of therapy, Geodon can cause low blood pressure, with accompanying dizziness, fainting, and rapid heartbeat. Tell your doctor if you experience any of these side effects. To minimize such problems, your doctor will increase your dose gradually. If you are prone to low blood pressure, take blood pressure medicine, become dehydrated, or have heart disease or poor circulation in the brain, use Geodon with caution.

Geodon may cause drowsiness and can impair your judgment, thinking, and motor skills. Use caution while driving and don't operate potentially dangerous machinery until you know how this drug affects you.

Geodon poses a very slight risk of seizures, especially if you are over age 65, have a history of seizures, or have Alzheimer's disease.

Drugs such as Geodon sometimes cause a condition called Neuroleptic Malignant Syndrome. Symptoms include high fever, muscle rigidity, irregular pulse or blood pressure, rapid heartbeat, excessive perspiration, and changes in heart rhythm. If these symptoms appear, tell your doctor immediately. You'll need to stop taking Geodon while the condition is under treatment.

There also is the risk of developing tardive dyskinesia, a condition marked by slow, rhythmical, involuntary movements. This problem is more likely to occur in mature adults, especially older women. When it does, use of Geodon is usually stopped.

Geodon can suppress the cough reflex; you may have trouble clearing your airway. Some people taking Geodon also develop a rash. Tell your doctor when this happens. If the rash doesn't clear up with treatment, you may have to discontinue the drug.

Other antipsychotic medications have been known to interfere with the body's temperature-regulating mechanism, causing the body to overheat. Although this problem has not occurred with Geodon, caution is still advisable. Avoid exposure to extreme heat, strenuous exercise, and dehydration. There also is a remote chance that this medication may cause abnormal, prolonged and painful erections.

Possible food and drug interactions when taking this medication

Remember that you must never combine Geodon with any drug that prolongs the part of the heartbeat known as the QT interval (see "Most important fact about this drug"). Check with your doctor or pharmacist if you have any doubts about a drug you're taking.

If Geodon is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Geodon with the following: Carbamazepine (Tegretol) Certain blood pressure medications Drugs that boost the effects of dopamine such as Mirapex, Parlodel, Permax, and Requip Drugs that affect the brain and nervous system, such as sedatives, tranquilizers, and antidepressants Ketoconazole (Nizoral) Levodopa (Larodopa, Sinemet)

Special information if you are pregnant or breastfeeding

Geodon has caused fetal harm when tested in animals. It should be taken during pregnancy only if the benefits outweigh the potential risk. Notify your doctor as soon as you become pregnant or plan to become pregnant.

It is not known whether Geodon appears in breast milk, and breastfeeding is not recommended.

Recommended dosage

GEODON CAPSULES

The usual starting dose is 20 milligrams twice a day. If needed, the dosage may be increased at several-week intervals up to a maximum of 80 milligrams twice a day.

Overdosage

Any medication taken in excess can have serious consequences. If you suspect an overdose, seek medical help immediately.

Symptoms of Geodon overdose may include: Drowsiness, slurred speech, high blood pressure

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Geodon Prescribing Information

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

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Find out why Anafranil, Clomipramine is prescribed, side effects using Anafranil, Anafranil warnings, effects of Anafranil during pregnancy, more - in plain English.

Pronounced: an-AF-ran-il
Generic name: Clomipramine hydrochloride

Anafranil (clomipramine) full prescribing information

Why is Anafranil prescribed?

Anafranil, a chemical cousin of tricyclic antidepressant medications such as Tofranil and Elavil, is used to treat people who suffer from obsessions and compulsions.

An obsession is a persistent, disturbing idea, image, or urge that keeps coming to mind despite the person's efforts to ignore or forget it---for example, a preoccupation with avoiding contamination.

A compulsion is an irrational action that the person knows is senseless but feels driven to repeat again and again---for example, hand-washing perhaps dozens or even scores of times throughout the day.

Most important fact about Anafranil

Serious, even fatal, reactions have been known to occur when drugs such as Anafranil are taken along with drugs known as MAO inhibitors. Drugs in this category include the antidepressants Nardil and Parnate. Never take Anafranil with one of these drugs.

All antidepressants can increase the risk of suicidal thoughts or behaviors. Read this FDA warning.

How should you take Anafranil?

Take Anafranil with meals, at first, to avoid stomach upset. After your regular dosage has been established, you can take 1 dose at bedtime to avoid sleepiness during the day. Always take it exactly as prescribed.

This medicine may cause dry mouth. Hard candy, chewing gum, or bits of ice may relieve this problem.

---If you miss a dose...

If you take 1 dose at bedtime, consult your doctor. Do not take the missed dose in the morning. If you take 2 or more doses a day, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Do not take 2 doses at the same time.

---Storage instructions...

Store at room temperature in a tightly closed container, away from moisture.

 

What side effects may occur from taking Anafranil?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Anafranil.

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The most significant risk is that of seizures (convulsions). Headache, fatigue, and nausea can be a problem. Men are likely to experience problems with sexual function. Unwanted weight gain is a potential problem for many people who take Anafranil, although a small number actually lose weight.

• More common side effects may include: Abdominal pain, abnormal dreaming, abnormal tearing, abnormal milk secretion, agitation, allergy, anxiety, appetite loss, back pain, chest pain, confusion, constipation, coughing, depression, diarrhea, dizziness, dry mouth, extreme sleepiness, failure to ejaculate, fast heartbeat, fatigue, fever, flushing, fluttery heartbeat, frequent urination, gas, headache, hot flushes, impotence, inability to concentrate, increased appetite, increased sweating, indigestion, inflamed lining of nose or sinuses, itching, joint pain, light-headedness on standing up, memory problems, menstrual pain and disorders, middle ear infection (children), migraine, muscle pain or tension, nausea, nervousness, pain, rash, red or purple areas on the skin, ringing in the ears, sex-drive changes, sleeplessness, sleep disturbances, sore throat, speech disturbances, taste changes, tingling or pins and needles, tooth disorder, tremor, twitching, urinary problems, urinary tract infection, vision problems, vomiting, weight gain, weight loss (children), yawning

• Less common side effects may include: Abnormal skin odor (children), acne, aggression (children), eye allergy (children), anemia (children), bad breath (children), belching (children), breast enlargement, breast pain, chills, conjunctivitis (pinkeye), difficult or labored breathing (children), difficulty swallowing, difficulty or pain in urinating, dilated pupils, dry skin, emotional instability, eye twitching (children), fainting (children), hearing disorder (children), hives, irritability, lack of menstruation, loss of sense of identity, mouth inflammation (children), muscle weakness, nosebleed, panic, paralysis (children), skin inflammation, sore throat (children), stomach and intestinal problems, swelling due to fluid retention, thirst, unequal size of pupils of the eye (children), vaginal inflammation, weakness (children), wheezing, white or yellow vaginal discharge

Why should this drug not be prescribed?

Do not take this medication if you are sensitive to or have ever had an allergic reaction to a tricyclic antidepressant such as Tofranil, Elavil, or Tegretol.

Be sure to avoid Anafranil if you are taking, or have taken within the past 14 days, an MAO inhibitor such as the antidepressants Parnate or Nardil. Combining Anafranil with one of these medications could lead to fever, seizures, coma, and even death.

Do not take Anafranil if you have recently had a heart attack.

Special warnings about Anafranil

If you have narrow-angle glaucoma (increased pressure in the eye) or are having difficulty urinating, Anafranil could make these conditions worse. Use Anafranil with caution if your kidney function is not normal.

If you have a tumor of the adrenal gland, this medication could cause your blood pressure to rise suddenly and dangerously.

Because Anafranil poses a possible risk of seizures, and because it may impair mental or physical ability to perform complicated tasks, your doctor will probably warn you to take special precautions if you need to drive a car, operate complicated machinery, or take part in activities such as swimming or climbing, in which suddenly losing consciousness could be dangerous. Note that your risk of seizures is increased:

• If you have ever had a seizure

• If you have a history of brain damage or alcoholism

• If you are taking another medication that might predispose you to seizures

As with Tofranil, Elavil, and other tricyclic antidepressants, an overdose of Anafranil can be fatal. Do not be surprised if your doctor prescribes only a small quantity of Anafranil at a time. This is standard procedure to minimize the risk of overdose.

Anafranil may cause your skin to become more sensitive to sunlight. Avoid prolonged exposure to sunlight.

Before having any kind of surgery involving the use of general anesthesia, tell your doctor or dentist that you are taking Anafranil. You may be advised to discontinue the drug temporarily.

When it is time to stop taking Anafranil, do not stop abruptly. Your doctor will have you taper off gradually to avoid withdrawal symptoms such as dizziness, fever, general feeling of illness, headache, high fever, irritability or worsening emotional or mental problems, nausea, sleep problems, vomiting.

Possible food and drug interactions when taking Anafranil

Avoid alcoholic beverages while taking Anafranil.

If Anafranil is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Anafranil with the following:

Barbiturates such as phenobarbital
Certain blood pressure drugs such as Ismelin and
Catapres-TTS
Cimetidine (Tagamet)
Digoxin (Lanoxin)
Drugs that ease spasms, such as Donnatal, Cogentin, and Bentyl
Flecainide (Tambocor)
Methylphenidate (Ritalin)
Major tranquilizers such as Haldol and Thorazine
MAO inhibitors such as Nardil and Parnate
Phenytoin (Dilantin)
Propafenone (Rythmol)
Quinidine (Quinidex)
Serotonin-boosting drugs such as the antidepressants
Luvox, Paxil, Prozac and Zoloft
Thyroid medications such as Synthroid
Tranquilizers such as Xanax and Valium
Warfarin (Coumadin)

Special information if you are pregnant or breastfeeding

If you are pregnant or plan to become pregnant, inform your doctor immediately. Anafranil should not be used during pregnancy unless absolutely necessary; some babies born to women who took Anafranil have had withdrawal symptoms such as jitteriness, tremors, and seizures. Anafranil appears in breast milk. Your doctor may advise you to stop breastfeeding while you are taking Anafranil.

Recommended dosage for Anafranil

ADULTS

The usual recommended initial dose is 25 milligrams daily. Your doctor may gradually increase this dosage to 100 milligrams during the first 2 weeks. During this period you will be asked to take this drug, divided into smaller doses, with meals. The maximum daily dosage is 250 milligrams. After the dose has been determined, your doctor may direct you to take a single dose at bedtime, to avoid sleepiness during the day.

CHILDREN

The usual recommended initial dose is 25 milligrams daily, divided into smaller doses and taken with meals. Your doctor may gradually increase the dose to a maximum of 100 milligrams or 3 milligrams per 2.2 pounds of body weight per day, whichever is smaller. The maximum dose is 200 milligrams or 3 milligrams per 2.2 pounds of body weight, whichever is smaller. Once the dose has been determined, the child can take it in a single dose at bedtime.

Overdosage

An overdose of Anafranil can be fatal. If you suspect an overdose, seek medical attention immediately.

• Critical signs and symptoms of Anafranil overdose may include:
  Impaired brain activity (including coma), irregular heartbeat, seizures, severely low blood pressure

• Other signs and symptoms of overdosage may include:
  Agitation, bluish skin color, breathing difficulty, delirium, dilated pupils, drowsiness, high fever, incoordination, little or no urine output, muscle rigidity, overactive reflexes, rapid heartbeat, restlessness, severe perspiration, shock, stupor, twitching or twisting movements, vomiting

There is a danger of heart malfunction and even, in rare cases, cardiac arrest.

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