DailyMed Label: Citalopram Hydrobromide

DailyMed Label: Citalopram Hydrobromide

2024

DailyMed Prescription

Citalopram Hydrobromide

Citalopram Hydrobromide

REMEDYREPACK INC.

NDC: 70518-3502

NDC: 70518-3502

Citalopram tablets, USP contains citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3­-dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula: The molecular formula is C 20 H 22 BrFN 2 O and its molecular weight is 405.35. Citalopram hydrobromide USP occurs as a white or almost white crystalline powder. Citalopram hydrobromide USP is soluble in methanol and sparingly soluble in water. Citalopram tablets USP, 10 mg are film-coated, round tablets containing citalopram hydrobromide in strengths equivalent to 10 mg of citalopram base. Citalopram tablets USP, 20 mg and 40 mg are film-coated, round, scored tablets containing citalopram hydrobromide in strengths equivalent to 20 mg or 40 mg of citalopram base. 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.

Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14 )] .

Citalopram tablets are available as:  Citalopram tablets USP, 10 mg are brown, round, biconvex, film-coated tablets embossed “RDY” on one side and “342” on other side. Citalopram tablets USP, 20 mg are pink, round, biconvex, film-coated tablets embossed ‘RDY’/343 on one side and scored on other side. Citalopram tablets USP, 40 mg are white, round, biconvex, film-coated tablets embossed ‘RDY’/344 on one side and scored on other side.

Citalopram tablets are contraindicated in patients: taking, or within 14 days of stopping, MAOIs (including MAOIs such as linezolid or intravenous methylene blue) because of an increased risk of serotonin syndrome [see Warnings and Precautions ( 5.3 ), Drug Interactions ( 7 )]. taking pimozide because of risk of QT prolongation  [see Drug Interactions ( 7 ) ] . with known hypersensitivity to citalopram or any of the inactive ingredients in citalopram tablets. Reactions have included angioedema and anaphylaxis [see Adverse Reactions ( 6.2 )].

The following adverse reactions are discussed in greater detail in other sections of the labeling:

Table 5 presents clinically important drug interactions with citalopram tablets. Table 5: Clinically Important Drug Interactions with Citalopram Tablets Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact Concomitant use of SSRIs, including citalopram tablets, and MAOIs increases the risk of serotonin syndrome. Intervention Citalopram tablets are contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Dosage and Administration ( 2.5 ), Contraindications ( 4 ), Warnings and Precautions ( 5.3 )]. Pimozide Clinical Impact: Concomitant use of citalopram tablets with pimozide increases plasma concentrations of pimozide, a drug with a narrow therapeutic index, and may increase the risk of QT prolongation and/or ventricular arrhythmias compared to use of citalopram alone  [see Clinical Pharmacology ( 12.2 )] . Intervention: Citalopram tablets are contraindicated in patients taking pimozide [see Contraindications ( 4 ), Warnings and Precautions ( 5.2 )]. Drugs thatProlong the QTc Interval Clinical Impact: Concomitant use of citalopram with drugs that prolong QT can cause additional QT prolongation compared to the use of citalopram alone [see Clinical Pharmacology ( 12.2 )]. Intervention: Avoid concomitant use of citalopram tablets with drugs that prolong the QT interval (Citalopram tablets are contraindicated in patients taking pimozide) [see Contraindications ( 4 ), Warnings and Precautions ( 5.2 )]. CYP2C19 Inhibitors Clinical Impact: Concomitant use of citalopram with CYP2C19 inhibitors increases the risk of QT prolongation and/or ventricular arrhythmias compared to the use of citalopram alone  [see Clinical Pharmacology ( 12.2 )]. Intervention: The maximum recommended dosage of citalopram tablets is 20 mg daily when used concomitantly with a CYP2C19 inhibitor [see Dosage and Administration ( 2.4 ), Warnings and Precautions ( 5.2 )]. Serotonergic Drugs Clinical Impact: Concomitant use of citalopram tablets and other serotonergic drugs increases the risk of serotonin syndrome. Intervention: Monitor patients for signs and symptoms of serotonin syndrome, particularly during citalopram initiation and dosage increases. If serotonin syndrome occurs, consider discontinuation of citalopram tablets and/or concomitant serotonergic drugs  [see Warningand Precautions ( 5.3 )]. Drugs ThatInterfere With Hemostasis (antiplatelet agents andanticoagulants) Clinical Impact: Concomitant use of citalopram tablets and an antiplatelet or anticoagulant may potentiate the risk of bleeding. Intervention: Inform patients of the increased risk of bleeding associated with the concomitant use of citalopram tablets and antiplatelet agents and anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio [see Warning and Precautions ( 5.4 )].

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 NDC: 70518-3502-00 PACKAGING: 30 in 1 BLISTER PACK Storage and HandlingStore at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

The efficacy of citalopram as a treatment for major depressive disorder was established in two placebo-controlled studies (of 4 to 6 weeks duration) in adult outpatients (ages 18 to 66) meeting DSM-III or DSM-III-R criteria for major depressive disorder (MDD) (Studies 1 and 2). Study 1, a 6-week trial in which patients received fixed citalopram doses of 10 mg, 20 mg, 40 mg, and 60 mg daily, showed that citalopram 40 daily and 60 mg daily (1.5 times the maximum recommended daily dosage) was effective as measured by the Hamilton Depression Rating Scale (HAMD) total score, the primary efficacy endpoint. The HAMD-17 is a 17-item, clinician-rated scale used to assess severity of depressive symptoms. Scores on the HAMD-17 range from 0 to 52, with higher scores indicating more severe depression. This study showed no clear effect of the 10 mg and 20 mg daily doses, and the 60 mg daily dose was not more effective than the 40 mg daily dose. Due to the risk of QTc prolongation and ventricular arrhythmias, the maximum recommended dosage of citalopram is 40 mg once daily. In study 2, a 4-week, placebo-controlled trial in patients with MDD, the initial dose was 20 mg daily, followed by titration to the maximum tolerated dose or a maximum dose of 80 mg daily (2 times the maximum recommended daily dosage). Patients treated with citalopram showed statistically significantly greater improvement than placebo patients on the HAMD total score, the primary efficacy endpoint. In three additional placebo-controlled trials in patients with MDD, the difference in response to treatment between patients receiving citalopram and patients receiving placebo was not statistically significant. In two long-term studies, patients with MDD who had responded to citalopram during an initial 6 or 8 weeks of acute treatment were randomized to continuation of citalopram or placebo. In one study, patients received fixed doses of citalopram 20 mg or 40 mg daily and in the second study, patients received flexible doses of citalopram 20 mg daily to 60 mg daily (1.5 times the maximum recommended daily dosage). In both studies, patients receiving continued citalopram treatment experienced statistically significantly lower relapse rates over the subsequent 6 months compared to those receiving placebo. In the fixed-dose study, the decreased rate of depression relapse was similar in patients receiving 20 mg or 40 mg daily of citalopram. Due to the risk of QTc prolongation and ventricular arrhythmias, the maximum recommended dosage of citalopram is 40 mg once daily. Analyses of the relationship between treatment outcome and age, gender, and race did not suggest any differential responsiveness on the basis of these patient characteristics.

DRUG: Citalopram Hydrobromide GENERIC: Citalopram Hydrobromide DOSAGE: TABLET, FILM COATED ADMINSTRATION: ORAL NDC: 70518-3502-0 COLOR: brown SHAPE: ROUND SCORE: No score SIZE: 6 mm IMPRINT: RDY;342 PACKAGING: 30 in 1 BLISTER PACK ACTIVE INGREDIENT(S): CITALOPRAM HYDROBROMIDE 10mg in 1 INACTIVE INGREDIENT(S): SILICON DIOXIDE COPOVIDONE K25-31 CROSCARMELLOSE SODIUM HYPROMELLOSE 2910 (5 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE polyethylene glycol 400 STARCH, CORN TITANIUM DIOXIDE FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE