Drug Catalog - Product Detail
TRAZODONE HCL TB 150MG 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 53489-0517-01 | SUN PHARMACEUTICALS | 100 | 150MG | TABLET |
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Description
11 DESCRIPTION Trazodone hydrochloride tablets, USP for oral administration contain trazodone hydrochloride, a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-1,2,4-triazolo[4,3-a]pyridin-3(2 H )-one hydrochloride. It is a white, odorless crystalline powder which is freely soluble in water. The structural formula is represented as follows: Molecular Formula: C 19 H 22 ClN 5 O ∙ HCl Molecular Weight: 408.33 Each tablet, for oral administration, contains 50 mg, 100 mg or 150 mg of trazodone hydrochloride, USP. Trazodone hydrochloride tablets, USP, 50 mg and 100 mg, contain the following inactive ingredients: anhydrous lactose, carnauba wax, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, and titanium dioxide. Trazodone hydrochloride tablets, USP, 150 mg, contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, magnesium stearate, and microcrystalline cellulose. structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Trazodone hydrochloride tablets, USP are available as follows: Trazodone hydrochloride tablets, USP 50 mg are scored, white, film coated, round, debossed MP 118 Bottles of 30 NDC 53489-510-07 Bottles of 100 NDC 53489-510-01 Trazodone hydrochloride tablets, USP 100 mg are scored, white, film coated, round, debossed MP 114 Bottles of 30 NDC 53489-511-07 Bottles of 100 NDC 53489-511-01 Trazodone hydrochloride tablets, USP 150 mg are scored in the divided dose design, white, round, debossed on one side and MP 168 on the reverse side. Bottles of 30 NDC 53489-517-07 Bottles of 100 NDC 53489-517-01 figure 2 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.
Indications & Usage
1 INDICATIONS AND USAGE Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults. Trazodone hydrochloride tablets are a selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) ( 1 ).
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Starting dose: 150 mg in divided doses daily. May be increased by 50 mg per day every three to four days. Maximum dose: 400 mg per day in divided doses ( 2.1 ). Trazodone hydrochloride tablets should be taken shortly after a meal or light snack ( 2.2 ). Tablets should be swallowed whole or broken in half along the score line ( 2.2 ). When discontinued, gradual dose reduction is recommended ( 2.6 ). 2.1 Dose Selection An initial dose of 150 mg/day in divided doses is suggested. The dosage should be initiated at a low-dose and increased gradually, noting the clinical response and any evidence of intolerance. Occurrence of drowsiness may require the administration of a major portion of the daily dose at bedtime or a reduction of dosage. The dose may be increased by 50 mg/day every 3 to 4 days. The maximum dose for outpatients usually should not exceed 400 mg/day in divided doses. Inpatients (i.e., more severely depressed patients) may be given up to but not in excess of 600 mg/day in divided doses. Once an adequate response has been achieved, dosage may be gradually reduced, with subsequent adjustment depending on therapeutic response. 2.2 Important Administration Instructions Trazodone hydrochloride tablets can be swallowed whole or administered as a half tablet by breaking the tablet along the score line. Trazodone hydrochloride tablets should be taken shortly after a meal or light snack. 2.3 Screen for Bipolar Disorder Prior to Starting Trazodone Hydrochloride Tablets Prior to initiating treatment with trazodone hydrochloride tablets or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions (5.7) ]. 2.4 Switching to or from Monoamine Oxidase Inhibitor Antidepressant At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of trazodone hydrochloride tablets. In addition, at least 14 days must elapse after stopping trazodone hydrochloride tablets before starting an MAOI antidepressant [see Contraindications (4) , Warnings and Precautions (5.2) ]. 2.5 Dosage Recommendations for Concomitant Use with Strong CYP3A4 Inhibitors or Inducers Coadministration with Strong CYP3A4 Inhibitors Consider reducing trazodone hydrochloride tablets dose based on tolerability when trazodone hydrochloride tablets is coadministered with a strong CYP3A4 inhibitor [see Drug Interactions (7.1) ]. Coadministration with Strong CYP3A4 Inducers Consider increasing trazodone hydrochloride tablets dose based on therapeutic response when trazodone hydrochloride tablets is coadministered with a strong CYP3A4 inducer [see Drug Interactions (7.1) ]. 2.6 Discontinuation of Treatment with Trazodone Hydrochloride Tablets Adverse reactions may occur upon discontinuation of trazodone hydrochloride tablets [see Warnings and Precautions (5.8) ]. Gradually reduce the dosage rather than stopping trazodone hydrochloride tablets abruptly whenever possible.