Drug Catalog - Product Detail
CITALOPRAM HBR 10MG TB 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 13668-0009-01 | TORRENT PHARMACEUTICALS | 100 | 10MG | TABLET |
PACKAGE FILES
Generic Name
CITALOPRAM
Substance Name
CITALOPRAM HYDROBROMIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA078216
Description
11 DESCRIPTION Citalopram tablets, USP contain citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3dihydroisobenzofuran-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 fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram, USP 10 mg tablets are film-coated, round shaped tablets containing citalopram hydrobromide in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide, USP 20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram hydrobromide, in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: copovidone, corn starch, croscarmellose sodium, ferric oxide red, ferric oxide yellow, glycerin, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. image description
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 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 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 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 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. Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Indications & Usage
1 INDICATIONS AND USAGE Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14 )] . Citalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of major depressive disorder (MDD) in adults ( 1 ) .
Dosage and Administration
2 DOSAGE AND ADMINISTRATION • Administer once daily with or without food ( 2 ) . • Initial dosage is 20 mg once daily; after one week may increase to maximum dosage of 40 mg once daily ( 2.1 ) . • Patients greater than 60 years of age, patients with hepatic impairment, and CYP2C19 poor metabolizers: maximum recommended dosage is 20 mg once daily ( 2.2 ) . • When discontinuing citalopram tablets, reduce dosage gradually ( 2.4 , 5.6 ) . 2.1 Recommended Dosage Administer citalopram tablets once daily, with or without food, at an initial dosage of 20 mg once daily, with an increase to a maximum dosage of 40 mg once daily at an interval of no less than one week. Dosages above 40 mg once daily are not recommended due to the risk of QT prolongation [see Warnings and Precautions ( 5.2 )] . 2.2 Screen for Bipolar Disorder Prior to Starting Citalopram Tablets Prior to initiating treatment with citalopram tablets or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions ( 5.5 )] . 2.3 Recommended Dosage for Specific Populations The maximum recommended dosage of citalopram tablets for patients who are greater than 60 years of age, patients with hepatic impairment, and for CYP2C19 poor metabolizers is 20 mg once daily [see Warnings and Precautions ( 5.2 ), Clinical Pharmacology ( 12.3 )] . 2.4 Dosage Modifications with Concomitant Use of CYP2C19 Inhibitors The maximum recommended dosage of citalopram tablets when used concomitantly with a CYP2C19 inhibitor is 20 mg once daily [see Warnings and Precautions ( 5.2 ), Drug Interactions ( 7 )] . 2.5 Switching Patients to or from a Monoamine Oxidase Inhibitor Antidepressant At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of therapy with citalopram tablets. Conversely, at least 14 days must elapse after stopping citalopram tablets before starting an MAOI antidepressant [see Contraindications ( 4 ) and Warnings and Precautions ( 5.3 )] . 2.6 Discontinuing Treatment with Citalopram Tablets Adverse reactions may occur upon discontinuation of citalopram tablets [see Warnings and Precautions ( 5.6 )] . Gradually reduce the dosage rather than stopping citalopram tablets abruptly whenever possible.