Citalopram Hydrobromide

Brand Name: Celexa

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Description

CITALOPRAM (Celexa ™) is a medicine for depression and other related problems. Celexa is a potent serotonin reuptake inhibitor.

Pharmacology

You may have to take citalopram for up to 4 weeks or longer before you begin to feel better.

Indications and Usage

Citalopram hydrobromide is indicated for the symptomatic relief of depressive illness.

The relapse rate was significantly lower in citalopram-treated patients than in placebo-treated patients in two placebo-controlled studies, that were conducted over a 24-week period in patients who responded to 6 or 8 weeks of acute treatment with citalopram. Nevertheless, the physician who elects to use citalopram for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.

Contraindications

Citalopram hydrobromide (Celexa) is contraindicated in patients with known hypersensitivity to citalopram hydrobromide or the excipients of the drug product.

Monoamine Oxidase Inhibitors
In patients, receiving selective serotonin reuptake inhibitors (SSRIs) in combination with a monoamine oxidase inhibitor (MAOI), 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, including extreme agitation progressing to delirium and coma. These reactions have also been reported in patients who have recently discontinued SSRI treatment and have been started on a MAOI. Some cases presented with features resembling serotonin syndrome. Therefore, it is recommended that citalopram should not be used in combination with a MAOI or within 14 days of discontinuing treatment with a MAOI. Similarly, at least 14 days should elapse after discontinuing citalopram treatment before starting a MAOI.

Warnings

Visit your prescriber or health care professional for regular checks on your progress. Continue to take your tablets even if you do not immediately feel better. It can take about 4 weeks before you feel the full effect of citalopram. If you have suicidal thoughts, call your prescriber or health care professional at once. If you are going to have surgery, tell your prescriber or health care professional that you are taking citalopram.

If you have been taking citalopram regularly for some time, do not suddenly stop taking it. You must gradually reduce the dose, or your symptoms may get worse. Ask your prescriber or health care professional for advice.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how citalopram affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of citalopram. Avoid alcoholic drinks.

Do not treat yourself for coughs, colds, or allergies without asking your prescriber or health care professional for advice. Some ingredients can increase possible side effects.

Precautions

Suicide: The possibility of a suicide attempt is inherent in depression and may persist until remission occurs. Therefore, high risk patients should be closely supervised throughout therapy with Citalopram hydrobromide and consideration should be given to the possible need for hospitalization. In order to minimize the opportunity for overdosage, prescription for citalopram should be written for the smallest quantity of drug consistent with good patient management.

Activation of Mania/Hypomania: In placebo-controlled trials with citalopram, some of which included patients with bipolar disorder, mania/hypomania was reported in 0.1% of 1027 patents treated with citalopram versus none of the 426 patients treated with placebo. Activation of mania/hypomania has also been reported in a small proportion of patients with major affective disorders treated with other marketed antidepressants. If a patient enters a manic phase, citalopram should be discontinued.

Seizures: Citalopram has not been systematically evaluated in patients with a seizure disorder. These patients were excluded from clinical studies during the premarketing testing of citalopram. In clinical trials, seizures occurred in 0.25% of patients treated with citalopram and in 0.23% patients treated with placebo. Like other antidepressants, citalopram should be used with caution in patients with a history of seizure disorder.

Serotonin Syndrome: Rarely, the occurrence of serotonin syndrome has been reported in patients receiving SSRIs. A combination of symptoms, possibly including agitation, confusion, tremor, myoclonus and hyperthermia, may indicate the development of this condition.

5-HT1 Agonists: There have been rare postmarketing reports describing patients with weakness, hyperreflexia and incoordination, following the concomitant use of a SSRI and the antimigraine drug sumatriptan, a 5-HT1 agonist. Such interaction should be considered if citalopram is to be used in combination with a 5-HT1 agonist.

Hyponatremia: Hyponatremia and SIADH (syndrome of inappropriate antidiuretic hormone secretion) have been reported with citalopram use as a rare adverse event.

Hepatic Impairment: The use of citalopram in hepatically impaired patients should be approached with caution and a lower maximum dosage is recommended.

Use in Patients with Cardiac Disease: Citalopram has not been systematically evaluated in patients with a recent history of myocardial infarction or unstable heart disease. Patients with these diagnoses were generally excluded from clinical trials during the drugs premarketing assessment. However, the electrocardiograms of patients, who received citalopram in clinical trials, indicate that citalopram was not associated with the development of clinically significant ECG abnormalities.

In clinical trials, citalopram caused small but statistically significant decreases in heart rate. Consequently, caution should be observed when citalopram is initiated in patients with pre-existing slow heart rate.

Use in Diabetic Patients: Citalopram has not been systematically evaluated in diabetic patients since diabetes constituted an exclusion criterion. Although 13 patients did receive insulin during the studies, this number is too small to determine whether citalopram affects the response to insulin. Rare events of hypoglycemia were reported. Citalopram should be used with caution in diabetic patients on insulin or other antidiabetic drugs.

Interference with Cognitive and Motor Performance: In studies in normal volunteers, citalopram in doses of 40 mg/day did not impair cognitive function or psychomotor performance. However, psychotropic medications may impair judgement, thinking or motor skills. Consequently, patients should be cautioned against driving a car or operating hazardous machinery until they are reasonably certain that citalopram does not affect them adversely.

Pregnancy and Nursing Mothers: The safety of citalopram during pregnancy and lactation has not been established. Therefore, citalopram should not be used during pregnancy, unless, in the opinion of the physician, the expected benefits to the patient markedly outweigh the possible hazards to the fetus. Citalopram is excreted in human milk. Citalopram should not be administered to nursing mothers unless, in the opinion of the treating physician, the expected benefits to the patient markedly outweigh the possible hazards to the child.

Pediatric Use
Safety and effectiveness in children below the age of 18 years have not been established.

Geriatric Use:
Geriatric Use in premarketing clinical trials, 800 elderly patients (>=65 years of age) have been treated with citalopram. Of these patients 298 were >=75 years old. In a pharmacokinetic study (n=11, age 73 to 90 years), clearance was substantially decreased and half-life prolonged. In a 6-week placebo-controlled study, approximately equal numbers of patients received citalopram at 20 or 30 mg per day, as the final dose. In about 5% of patients, the final dose was 10 mg per day. Consequently, elderly patients should be administered lower doses and a lower maximum dose.

Drug Interactions

Monoamine Oxidase Inhibitors (MAOI)

Do not take citalopram with any of the following medications: •medicines called MAO inhibitors-phenelzine (Nardil®), tranylcypromine (Parnate®), isocarboxazid (Marplan®), selegiline (Eldepryl®)

Also: alprazolam, amphetamine, buspirone; certain diet drugs (dexfenfluramine, fenfluramine, sibutramine); certain medicines for blood pressure or heart problems (bisoprolol, diltiazem, encainide, flecainide, metoprolol, mexiletine, mibefridil, nicardipine, penbutolol, pindolol, propafenone, propranolol, verapamil); certain steroids (dexamethasone, methylprednisolone, prednisone); cimetidine, cyproheptadine, dextromethorphan, dextroamphetamine, diazepam, fluvastatin, grapefruit juice, kava kava, linezolid, lithium, medicines that treat HIV infection or AIDS, migraine headache medicines (naratriptan, rizatriptan, sumatriptan, zolmitriptan), certain seizure medicines (carbamazepine, ethosuximide, phenobarbital, phenytoin, primidone, topiramate), medicines for mental problems and psychotic disturbances (clozapine, haloperidol, phenothiazines, risperidone, thiothixene), modafinil, nefazodone, omeprazole, prescription pain relievers (codeine, hydrocodone, meperidine, morphine, oxycodone), procarbazine, quinine, some medicines for infections (clarithromycin, clotrimazole, erythromycin, fluconazole, furazolidone, isoniazid, INH, itraconazole, ketoconazole, metronidazole, norfloxacin, rifabutin, rifampin, troleandomycin), St. John's Wort, trazodone, tricyclic antidepressant medications, like amitriptyline or imipramine, troglitazone, tryptophan, valerian, venlafaxine, zafirlukast.

Switching from Celexa to MAOI or vice versa: At least 14 days should elapse between discontinuation of a MAOI and initiation of therapy with citalopram. Similarly, at least 14 days should be allowed after stopping citalopram before starting a MAOI.

Alcohol:
Although citalopram did not potentiate the cognitive and psychomotor effects of alcohol in volunteers, the concomitant use of alcohol and citalopram should be avoided.

BEFORE USING THIS MEDICINE: INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. Also tell your prescriber or health care professional if you are a frequent user of grapefruit juice, drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

Adverse Reactions

Side effects that you should report to your prescriber or health care professional as soon as possible:

Rare or uncommon:

confusion, dizziness or lightheadedness, skin rash, itching (hives), fast talking and excited feelings or actions that are out of control, suicidal thoughts, vomiting.

Other Side Effects:

The following additional adverse reactions have been reported: agitation or restlessness, blurred vision, diarrhea, difficulty sleeping, drowsiness, dry mouth, fever, frequent urination, headache, indigestion, nausea, increased or decreased appetite, increased sweating, sexual difficulties (decreased sexual ability or desire), taste alterations, tremor (shaking), weight changes.

Overdose

Signs and Symptoms

Citalopram hydrobromide has a wide margin of safety in overdose. Cases of overdoses involved the ingestion of citalopram either alone or in combination with other drugs and/or alcohol. In clinical trials, with overdoses of citalopram ranging from 180 mg to 2000 mg, all patients recovered.

Symptoms most often accompanying citalopram overdose included dizziness, sweating, nausea, vomiting, tremor, and somnolence. In more rare cases, observed symptoms included confusion, loss of consciousness, convulsions, coma, sinus tachycardia, cyanosis, hyperventilation and rhabdomyolysis.

Treatment

Establish and maintain an airway to ensure adequate ventilation and oxygenation. Gastric lavage and use of activated charcoal should be considered. Cardiac and vital sign monitoring are recommended, along with general symptomatic and supportive measures. There are no specific antidotes for citalopram.

Dosage

HOW TO USE THIS MEDICINE:

DO NOT EXCEED THE RECOMMENDED DOSE or take this medicine for longer than prescribed.

Follow the directions for using this medicine provided by your doctor.
Take this medicine with water.
Citalopram hydrobromide (Celexa) should be administered once daily, in the morning or evening, with or without food. Follow the directions on the prescription label.
Store this medicine at room temperature, away from heat and light.
If you miss a dose of this medicine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Follow your prescriber or health care professional's advice on missed doses. Do not take double or extra doses.
Do not stop taking this medicine without first checking with your doctor.

Adults: Citalopram (Celexa) should be administered as a single oral dose of 20 mg/day. In patients who do not respond adequately, an increase of dosage to 40 mg/day should be considered. Certain patients may require 60 mg/day. However, in a dose response study, the 60 mg/day dose did not demonstrate an advantage regarding effectiveness over the 40 mg/day dose. Dose increases should usually occur in increments of 20 mg, at intervals of no less than one week.

Elderly: A single oral dose of 20 mg/day is the recommended dose for most elderly patients. Some patients may respond to a 10 mg/day dose.

Hepatic Impairment: Patients with reduced hepatic function should receive dosages of no more than 30 mg/day.

Additional Information: Do not share this medicine with others for whom it was not prescribed. Do not use this medicine for other health conditions. Keep this medicine out of the reach of children.

IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.

How Supplied

20 mg tablets: Each oval, white, scored, film-coated tablet, marked "C" and "N", symmetrically around the score contains 20 mg citalopram (as citalopram hydrobromide). Blister packages of 30 tablets and bottles of 100 tablets.

40 mg tablets: Each oval, white, scored, film-coated tablet, marked "C" and "R", symmetrically around the score contains 40 mg citalopram (as citalopram hydrobromide). Blister packages of 30 tablets.

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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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.