citalopram hydrobromide


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Related to citalopram hydrobromide: Celexa

citalopram hydrobromide

Celexa

Pharmacologic class: Selective serotonin reuptake inhibitor

Therapeutic class: Antidepressant

Pregnancy risk category C

FDA Box Warning

• Drug may increase risk of suicidal thinking and behavior in children and adolescents with major depressive disorder and other psychiatric disorders, especially during first few months of therapy. Risk must be balanced with clinical need, as depression itself increases suicide risk. With patient of any age, observe closely for clinical worsening, suicidality, and unusual behavior changes when therapy begins. Advise family to observe patient closely and communicate with prescriber as needed.

• Drug isn't approved for use in pediatric patients.

Action

Unclear. Thought to potentiate serotonergic activity in CNS by inhibiting neuronal uptake of serotonin.

Availability

Oral solution: 10 mg/5 ml

Tablets: 10 mg, 20 mg, 40 mg

Indications and dosages

Depression

Adults: Initially, 20 mg P.O. daily; may increase to maximum recommended dosage of 40 mg/day at an interval of no less than 1 week.

Dosage adjustment

• Hepatic impairment
• CYP2C19 poor metabolizers or concurrent use of cimetidine or another CYP2C19 inhibitor
• Elderly patients

Off-label uses

• Alcoholism
• Panic disorder
• Premenstrual dysphoria
• Social phobia

Contraindications

• Hypersensitivity to drug or its components
• Concurrent use of MAO inhibitors or pimozide

Precautions

Use cautiously in:
• severe renal impairment, hepatic impairment
• bradycardia, hypokalemia, hypomagnesemia, hyponatremia, recent acute myocardial infarction, congenital long QT syndrome, or uncompensated heart failure (avoid use)
• concurrent use of drugs that prolong QTc interval (avoid use)
• concurrent use of serotonin precursors such as tryptophan (not recommended)
• concurrent use of aspirin, NSAIDs, warfarin, and other anticoagulants
• history of mania or seizure disorder
• elderly patients
• pregnant or breastfeeding patients
• children (safety not established).

Administration

• Administer drug in the morning or evening, with or without food.

Don't give within 14 days of MAO inhibitor; life-threatening interactions may occur.

Be aware that drug shouldn't be given at doses above 40 mg/day because of risk of QTc-interval prolongation.

Gradually reduce dosage rather than abruptly stopping drug.

Adverse reactions

CNS: apathy, confusion, drowsiness, insomnia, migraine, weakness, agitation, amnesia, anxiety, dizziness, fatigue, poor concentration, tremor, paresthesia, deepening of depression, suicide attempt, neuroleptic malignant syndrome-like reactions

CV: orthostatic hypotension, tachycardia, ECG changes

Metabolic: hyponatremia

EENT: abnormal visual accommodation

GI: nausea, vomiting, diarrhea, abdominal pain, dyspepsia, flatulence, increased saliva, dry mouth, increased appetite, anorexia

GU: polyuria, amenorrhea, dysmenorrhea, ejaculatory delay, erectile dysfunction, decreased libido

Musculoskeletal: joint pain, myalgia

Respiratory: cough

Skin: rash, pruritus, diaphoresis, photosensitivity

Other: altered taste, fever, yawning, weight changes, serotonin syndromelike reactions

Interactions

Drug-drug.Aspirin, NSAIDs, warfarin, other anticoagulants: increased risk of bleeding

Anti-infectives (such as gatifloxacin, moxifloxacin), antipsychotics (such as chlorpromazine, thioridazine), Class 1A antiarrhythmics (such as procainamide, quinidine), Class III antiarrhythmics (such as amiodarone, sotalol), CYP2C19 inhibitors (such as cimetidine), methadone, pentamidine: risk of prolonged QTc interval

Carbamazepine: decreased citalopram blood level

Centrally acting drugs (such as antihistamines, opioids, sedative-hypnotics): additive CNS effects

Erythromycin, itraconazole, ketoconazole, omeprazole: increased citalopram blood level

5-hydroxytryptamine1 receptor agonists (such as sumatriptan, zolmitriptan): increased risk of adverse reactions

Lithium: potentiation of serotonergic effects

MAO inhibitors: life-threatening reactions

Tricyclic antidepressants (TCAs): altered TCA pharmacokinetics

Drug-diagnostic tests.Serum sodium: decreased level

Drug-herbs.St. John's wort, S-adenosylmethionine (SAM-e): increased risk of serotonergic reactions, including serotonin syndrome

Drug-behaviors.Alcohol use: additive CNS depression

Sun exposure: photosensitivity

Patient monitoring

• If patient is receiving lithium concurrently, watch closely for potentiation of serotonergic effects.
• Monitor patient for signs of mania or hypomania, bleeding, serotonin syndrome-like reactions (including mental status changes, such as agitation, hallucinations, coma), autonomic instability (such as tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (such as hyperreflexia, incoordination), GI symptoms (such as nausea, vomiting, diarrhea) or neuroleptic malignant syndrome-like reactions (fever, muscle rigidity, mental status changes, irregular pulse or blood pressure, rapid heartbeats, excessive sweating).
• Monitor ECG and electrolyte levels in patients with cardiac conditions that may lead to QT-interval prolongation. Discontinue drug in patients with persistent QTc measurements of more than 500 ms.
• Be aware that drug should be discontinued in patients with symptomatic hyponatremia (headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness). Signs and symptoms associated with more severe or acute cases have included hallucinations, syncope, seizures, coma, respiratory arrest, and death).
• When discontinuing drug, monitor patient for dysphoria, irritability, agitation, dizziness, sensory disturbances, anxiety, confusion, headache, lethargy, emotional lability, insomnia, and hypomania.

Patient teaching

• Instruct patient to take drug with full glass of water with or without food at same time every day.

Advise patient or caregiver (especially if drug is given to a child or adolescent) to immediately report suicidal thoughts or extreme depression.
• Instruct patient to move slowly when sitting up or standing, to avoid dizziness or light-headedness caused by sudden blood pressure decrease.
• Tell patient several weeks may pass before he starts to feel better.
• Instruct patient to immediately report irregular or rapid heartbeats, dizziness, fainting, palpitations, agitation, hallucinations, incoordination, nausea, vomiting, diarrhea, fever, muscle rigidity, altered mental status (including catatonic signs), excessive sweating, headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness.
• Tell patient about risk of bleeding associated with concomitant use of this drug and NSAIDs, aspirin, or other drugs that affect coagulation; tell patient to report bruising or other signs or symptoms of bleeding.
• Caution patient to avoid driving and other hazardous activities until drug's effects on concentration and alertness are known.
• Advise patient to avoid alcohol during therapy.
• Tell male patient he may experience inadequate filling of penile erectile tissue. Advise him to consult prescriber if he experiences adverse sexual effects.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, herbs, and behaviors mentioned above.

Citalopram hydrobromide

Celexa; a SSRI that is highly specific for serotonin reuptake.
References in periodicals archive ?
In the first phase, patients with a diagnosis of Major Depressive Disorder (n=450) were given open label citalopram hydrobromide over six weeks and evaluated based on their improvement on two scales -- HAM-D and the Clinical Global Impression subscale for severity of illness (CGI-SI) -- to determine the extent of any response.
This press release includes statements that constitute "forward-looking statements," including with regard to the immediate shipment of Citalopram Hydrobromide.
Citalopram hydrobromide tablets are the generic version of Forest Laboratories' Celexa(R), which is indicated for the treatment of depression.
NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR Therapeutics[TM], today announced the presentation of data from its recently completed Phase 2b clinical trial of TC-5214 as an augmentation (add-on) treatment in subjects with major depressive disorder, or MDD, who did not respond adequately to first-line treatment with the representative SSRI citalopram hydrobromide.
In the first phase, 579 subjects with MDD received first-line treatment with citalopram hydrobromide for eight weeks, 20mg daily for the first four weeks and 40mg daily for the next four weeks.
In a Phase 2 trial in patients who did not respond adequately to first-line treatment with citalopram hydrobromide that Targacept completed in 2006, patients whose citalopram regimen was augmented with mecamylamine showed greater improvement on symptoms of depression and irritability than patients who received citalopram and a placebo.
The Targacept study included an open label citalopram hydrobromide phase and a subsequent double blind, placebo controlled phase in which the effects of mecamylamine taken with citalopram, a treatment combination known as TRIDMAC(TM), were evaluated in patients who did not respond adequately to citalopram alone.
TORONTO -- Biovail Corporation (NYSE:BVF)(TSX:BVF) announced today that it has received an Approval Letter from the United States Food and Drug Administration (FDA) for its New Drug Application for an orally disintegrating tablet formulation of citalopram hydrobromide (HBr) for the treatment of depression.
Citalopram hydrobromide is a highly selective and potent serotonin (5-hydroxytryptamine 5-HT) reuptake inhibitor with minimal effects on the neuronal reuptake of norepinephrine and dopamine.
L) received final approval from the Federal Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for citalopram hydrobromide tablets in 10, 20, and 40 mg dosages.
Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Citalopram hydrobromide tablets 10 mg, 20 mg and 40 mg.