DESCRIPTION
id: 6cd05646-c9ca-03ee-e053-2a91aa0a83cb
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Citalopram HBr, USP is an orally administered selective serotonin reuptake inhibitor (SSRI) with a chemical structure unrelated to that of other SSRIs or of tricyclic, tetracyclic, or other available antidepressant agents. Citalopram HBr is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile, HBr with the following structural formula:
The molecular formula is C
20H
22BrFN
2O and its molecular weight is 405.35.
Citalopram HBr, USP occurs as a fine, white to off-white powder.Citalopram HBr is sparingly soluble in water and soluble in ethanol.
Citalopram hydrobromide is available only in tablet dosage form.
Citalopram hydrobromide 10 mg tablets are film-coated, round shaped tablets containing citalopram HBr in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide 20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram HBr in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: copovidone, croscarmellose sodium, ferric oxide red, ferric oxide yellow, glycerin, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, starch, and titanium dioxide.
INDICATIONS AND USAGE
id: 6cd05646-c9cf-03ee-e053-2a91aa0a83cb
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Citalopram HBr is indicated for the treatment of depression.
The efficacy of citalopram HBr in the treatment of depression was established in 4-6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see
CLINICAL PHARMACOLOGY
).
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.The antidepressant action of citalopram in hospitalized depressed patients has not been adequately studied.
The efficacy of citalopram in maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials (see
CLINICAL PHARMACOLOGY
). Nevertheless, the physician who elects to use citalopram for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
CONTRAINDICATIONS
id: 6cd05646-c9d0-03ee-e053-2a91aa0a83cb
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
The use of MAOIs intended to treat psychiatric disorders with citalopram or within 14 days of stopping treatment with citalopram is contraindicated because of an increased risk of serotonin syndrome. The use of citalopram within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see
WARNINGS and DOSAGE and ADMINISTRATION).
Starting citalopram in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see
WARNINGS and DOSAGE AND ADMINISTRATION).
Concomitant use in patients taking pimozide is contraindicated (see
PRECAUTIONS
).
Citalopram HBr is contraindicated in patients with a hypersensitivity to citalopram or any of the inactive ingredients in citalopram HBr tablets.
ADVERSE REACTIONS
id: 6cd05646-c9df-03ee-e053-2a91aa0a83cb
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
The premarketing development program for citalopram included citalopram exposures in patients and/or normal subjects from 3 different groups of studies: 429 normal subjects in clinical pharmacology/pharmacokinetic studies; 4422 exposures from patients in controlled and uncontrolled clinical trials, corresponding to approximately 1370 patient-exposure years. There were, in addition, over 19,000 exposures from mostly open-label, European postmarketing studies. The conditions and duration of treatment with citalopram varied greatly and included (in overlapping categories) open-label and double-blind studies, inpatient and outpatient studies, fixed-dose and dose-titration studies, and short-term and long-term exposure. Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analyses, ECGs, and results of ophthalmologic examinations.
Adverse events during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories. In the tables and tabulations that follow, standard World Health Organization (WHO) terminology has been used to classify reported adverse events.
The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.
DOSAGE AND ADMINISTRATION
id: 6cd05646-c9e9-03ee-e053-2a91aa0a83cb
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Citalopram tablets should be administered once daily, in the morning or evening, with or without food.
HOW SUPPLIED
id: 6cd05646-c9f0-03ee-e053-2a91aa0a83cb
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Citalopram Tablets, USP contain citalopram hydrobromide USP, equivalent to 10, 20 or 40 mg citalopram base.
Citalopram Tablets USP 10 mg
Bottle of 30 NDC 13668-009-30
Bottle of 100 NDC 13668-009-01
Bottle of 500 NDC 13668-009-05
Bottle of 9990 NDC 13668-009-09
10 x 10 Unit Dose NDC 13668-009-74
Tan coloured, round shaped, biconvex film coated tablets with ’10’ debossed on one side and plain on the other side.
Citalopram Tablets, USP 20 mg
Bottle of 30 NDC 13668-010-30
Bottle of 100 NDC 13668-010-01
Bottle of 500 NDC 13668-010-05
Bottle of 5600 NDC 13668-010-06
10 x 10 Unit Dose NDC 13668-010-74
Tan coloured, oval shaped, biconvex film coated tablets with ‘2|0’ debossed (‘2’ on left side and ‘0’ on right side of the break line) on one side and ‘1010’ on the other side.
Citalopram Tablets, USP 40 mg
Bottle of 30 NDC 13668-011-30
Bottle of 100 NDC 13668-011-01
Bottle of 500 NDC 13668-011-05
Bottle of 2800 NDC 13668-011-08
10 x 10 Unit Dose NDC 13668-011-74
Tan coloured, oval shaped, biconvex film coated tablets with ‘4|0’ debossed (‘4’ on left side and ‘0’ on right side of the break line) on one side and ‘1011’ on the other side.
Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].
Principal Display Panel
id: 6cd06f85-81e6-21a1-e053-2a91aa0ae7d6
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
NDC: 70934-090-30
