Citalopram Tablets USP

/Citalopram Tablets USP
Citalopram Tablets USP2018-09-06T09:12:40+00:00

Prescription Drug Name:

Citalopram Tablets USP

ID:

c3edfa0d-2238-4478-afc6-f3af0c43f3eb

Code:

34391-3

DESCRIPTION


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displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Citalopram hydrobromide 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 hydrobromide USP is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran -5-carbonitrile, hydrobromide with the following structural formula: The molecular formula is C20H22BrFN2O and its molecular weight is 405.35. Citalopram hydrobromide USP occurs as a white or almost white crystalline powder, odorless or almost odorless. Citalopram hydrobromide USP is soluble in methanol and sparingly soluble in water. Citalopram hydrobromide is available only in tablet dosage form.  Citalopram 10 mg tablets USP are film-coated, round tablets containing citalopram hydrobromide in strengths equivalent to 10 mg citalopram base. Citalopram 20 mg and 40 mg tablets USP are film-coated, round, scored tablets containing citalopram hydrobromide in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: colloidal silicon dioxide, copovidone, croscarmellose sodium, hypromellose 5 cP, hypromellose 6 cP, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, starch and titanium dioxide. Iron oxides are used as coloring agents in the brown (10 mg) and pink (20 mg) tablets.

INDICATIONS AND USAGE


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displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Citalopram tablets USP are indicated for the treatment of depression. The efficacy of citalopram in the treatment of depression was established in 4-6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-lII and DSM-llI-R category of major depressive disorder (see CLINICAL PHARMACOLOGY ). A major depressive episode (DSM-lV) 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: e0388139-2a1c-4d09-96d6-a7dd00566a77
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 tablets USP are contraindicated in patients with a hypersensitivity to citalopram or any of the inactive ingredients in citalopram tablets USP.

ADVERSE REACTIONS


id: 6e1d6d8f-5c3c-43a4-99d2-723519a3ef5f
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


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displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

Citalopram should be administered once daily, in the morning or evening, with or without food.

HOW SUPPLIED


id: 921c5ed3-9484-43a9-b11f-8887fee6b05d
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Citalopram tablets USP, 10 mg are brown, round, biconvex, film coated tablets embossed “RDY” on one side and “342” on other side and are supplied in bottles of 30. Unit of Use Bottles of 30:  10 mg (NDC 68645-569-54) Citalopram tablets USP, 20 mg are pink, round, biconvex, film coated tablets embossed ‘RDY’                                                                                                                                  343 on one side and scored on other side and are supplied in bottles of 30. Unit of Use Bottles of 30:  20 mg (NDC 68645-570-54) Citalopram tablets USP, 40 mg are white, round, biconvex, film coated tablets embossed ‘RDY’                                                                                                                                                                                   344 on one side and scored on other side and are supplied in bottles of 30. Unit of Use Bottles of 30:  40 mg (NDC 68645-571-54)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION


id: 4bdd0bec-02fe-4957-80d3-2e435e667046
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

10 mg Bottle Label 20 mg Bottle Label 40 mg Bottle Label