Drug Catalog - Product Detail
TRAZODONE HCL 50MG TB 500
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68382-0805-05 | ZYDUS PHARMACEUTICALS (USA) | 500 | 50MG | TABLET |
PACKAGE FILES
Generic Name
TRAZODONE HYDROCHLORIDE
Substance Name
TRAZODONE HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA205253
Description
11 DESCRIPTION Trazodone hydrochloride is a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride, USP is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]- 1,2,4-triazolo[4, 3-a]pyridin-3(2H)-one hydrochloride. It is a white to off-white, crystalline powder which is sparingly soluble in chloroform and in water. The structural formula is represented as follows: Molecular Formula: C 19 H 22 C l N 5O •HCl Molecular Weight: 408.33 Each trazodone hydrochloride tablet, USP for oral administration contains 50 mg, 100 mg, 150 mg or 300 mg of trazodone hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, and sodium starch glycolate. The USP Dissolution Test is pending. Trazodone Hydrochloride Tablets USP
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Trazodone Hydrochloride Tablets USP, 50 mg are white to off-white, round-shape, biconvex beveled tablets, bisect on one side and plain on other side. The bisected side of tablet is debossed with '8' on upper side of bisect and '05' on lower side of bisect and are supplied as follows: NDC 68382-805-06 in bottle of 30 tablets with child-resistant closure NDC 68382-805-16 in bottle of 90 tablets with child-resistant closure NDC 68382-805-01 in bottle of 100 tablets NDC 68382-805-05 in bottle of 500 tablets NDC 68382-805-10 in bottle of 1,000 tablets NDC 68382-805-77 in unit-dose blister carton of 100 (10 x 10) unit-dose tablets Trazodone Hydrochloride Tablets USP, 100 mg are white to off-white, round-shape, biconvex beveled tablets, bisect on one side and plain on other side. The bisected side of tablet is debossed with '8' on upper side of bisect and '06' on lower side of bisect and are supplied as follows: NDC 68382-806-06 in bottle of 30 tablets with child-resistant closure NDC 68382-806-16 in bottle of 90 tablets with child-resistant closure NDC 68382-806-01 in bottle of 100 tablets NDC 68382-806-05 in bottle of 500 tablets NDC 68382-806-10 in bottle of 1,000 tablets NDC 68382-806-77 in unit-dose blister carton of 100 (10 x 10) unit-dose tablets Trazodone Hydrochloride Tablets USP, 150 mg are white to off-white, oval-shape, flat faced beveled tablets having one full bisect and two trisect notches on one side and two trisects on other side. The full bisected side of tablet is debossed with '8' on one side of bisect and '07' on other bisect segments and are supplied as follows: NDC 68382-807-06 in bottle of 30 tablets with child-resistant closure NDC 68382-807-16 in bottle of 90 tablets with child-resistant closure NDC 68382-807-01 in bottle of 100 tablets NDC 68382-807-05 in bottle of 500 tablets NDC 68382-807-10 in bottle of 1,000 tablets NDC 68382-807-77 in unit-dose blister carton of 100 (10 x 10) unit-dose tablets Directions for using the correct score when breaking the tablet, please refer to the following: -For 50 mg, break the score on either the left or right side of the tablet (one-third of a tablet). -For 75 mg, break the score down the middle of the tablet (one-half of a tablet). -For 100 mg, break the score on either the left or right side of the tablet (two-thirds of a tablet). -For 150 mg, use the entire tablet. Trazodone Hydrochloride Tablets USP, 300 mg are white to off-white, oval-shape, flat faced beveled tablets having one full bisect and two trisect notches on one side and two trisects on other side. The full bisected side of tablet is debossed with '8' on one side of bisect and '08' on other bisect segment and are supplied as follows: NDC 68382-808-06 in bottle of 30 tablets with child-resistant closure NDC 68382-808-16 in bottle of 90 tablets with child-resistant closure NDC 68382-808-01 in bottle of 100 tablets NDC 68382-808-05 in bottle of 500 tablets NDC 68382-808-10 in bottle of 1,000 tablets NDC 68382-808-77 in unit-dose blister carton of 100 (10 x 10) unit-dose tablets Directions for using the correct score when breaking the tablet, please refer to the following: -For 100 mg, break the score on either the left or right side of the tablet (one-third of a tablet). -For 150 mg, break the score down the middle of the tablet (one-half of a tablet). -For 200 mg, break the score on either the left or right side of the tablet (two-thirds of a tablet). -For 300 mg, use the entire tablet. Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Dispense with a child-resistant closure in a tight, light-resistant container. Trazodone Hydrochloride Tablets USP Trazodone Hydrochloride Tablets USP Trazodone Hydrochloride Tablets USP Trazodone Hydrochloride Tablets USP Trazodone Hydrochloride Tablets USP Trazodone Hydrochloride Tablets USP Trazodone Hydrochloride Tablets USP Trazodone Hydrochloride Tablets USP
Indications & Usage
1 INDICATIONS AND USAGE Trazodone is a selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) ( 1 ). Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.
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 ). Trazodone hydrochloride tablets should be taken shortly after a meal or light snack ( 2 ). Tablets should be swallowed whole or broken in half along the score line, and should not be chewed or crushed ( 2 ). When discontinued, gradual dose reduction is recommended ( 2 ). 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 Improtant 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 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 Switchning 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 dose based on tolerability when trazodone is coadministered with a strong CYP3A4 inhibitor [see Drug Interactions ( 7.1 )]. Coadministration with Strong CYP3A4 Inducers Consider increasing trazodone dose based on therapeutic response when trazodone is coadministered with a strong CYP3A4 inducer [see Drug Interactions ( 7.1 )]. 2.6 Discontinuation of Treatment with Trazodone Adverse reactions may occur upon discontinuation of trazodone [See Warnings and Precautions ( 5.8 )]. Gradually reduce the dosage rather than stopping trazodone abruptly whenever possible.