Country: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG)
Camber Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder (MDD). Efficacy was established in three short-term (4, 8, and 12 weeks) and two long-term, maintenance trials. Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Generalized Anxiety Disorder (GAD). Efficacy was established in two 8-week and two 26-week placebo-controlled trials. Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Social Anxiety Disorder (SAD), also known as social phobia. Efficacy was established in four 12-week and one 26-week, placebo-controlled trials. Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Panic Disorder (PD), with or without agoraphobia. Efficacy was established in two 12-week placebo-controlled trials. Hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation The use of MAOIs (intended to treat psychiatri
Venlafaxine hydrochloride extended-release capsules USP are available as follows: Venlafaxine hydrochloride extended-release capsules USP, 37.5 mg are white to off white colored, round to oval shaped pellets filled in size '3' hard Gelatin capsules with grey opaque cap imprinted with 'V' in black color, white opaque body imprinted with '9' in black color. Bottle of 30 capsules NDC 31722-002-30 Bottle of 90 capsules NDC 31722-002-90 Bottle of 500 capsules NDC 31722-002-05 Carton of 100 (10 x 10) unit-dose capsules (Alu-Blister pack) NDC 31722-002-01 Venlafaxine hydrochloride extended-release capsules USP, 75 mg are white to off white colored, round to oval shaped pellets filled in size '1' hard Gelatin capsules with peach opaque cap imprinted with 'V' in black color, white opaque body imprinted with '10' in black color. Bottle of 30 capsules NDC 31722-003-30 Bottle of 90 capsules NDC 31722-003-90 Bottle of 500 capsules NDC 31722-003-05 Carton of 100 (10 x 10) unit-dose capsules (Alu-Blister pack) NDC 31722-003-01 Venlafaxine hydrochloride extended-release capsules USP, 150 mg are white to off white colored, round to oval shaped pellets filled in size '0' hard Gelatin capsules with orange opaque cap imprinted with 'V' in black color, white opaque body imprinted with '11' in black color. Bottle of 30 capsules NDC 31722-004-30 Bottle of 90 capsules NDC 31722-004-90 Bottle of 500 capsules NDC 31722-004-05 Carton of 100 (10 x 10) unit-dose capsules (Alu-Blister pack) NDC 31722-004-01 Store at controlled room temperature, 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature]
Abbreviated New Drug Application
VENLAFAXINE HYDROCHLORIDE - VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE CAMBER PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, FOR ORAL USE INITIAL U.S. APPROVAL: 1997 WARNING: SUICIDAL THOUGHTS AND BEHAVIORS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN, ADOLESCENTS AND YOUNG ADULTS TAKING ANTIDEPRESSANTS ( 5.1) • MONITOR FOR WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS ( 5.1) • VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES ARE NOT APPROVED FOR USE IN PEDIATRIC PATIENTS ( 8.4) INDICATIONS AND USAGE Venlafaxine hydrochloride extended-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of: • Major Depressive Disorder (MDD) • Generalized Anxiety Disorder (GAD) • Social Anxiety Disorder (SAD) • Panic Disorder (PD) (1) DOSAGE AND ADMINISTRATION INDICATION STARTING DOSE TARGET DOSE MAXIMUM DOSE MDD (2.1) 37.5 to 75 mg/day 75 mg/day 225 mg/day GAD (2.2) 37.5 to 75 mg/day 75 mg/day 225 mg/day SAD (2.3) 75 mg/day 75 mg/day 75 mg/day PD (2.4) 37.5 mg/day 75 mg/day 225 mg/day • Take once daily with food ( 2). Capsules should be taken whole; do not divide, crush, chew, or dissolve ( 2). • When discontinuing treatment, reduce the dose gradually ( 2.8, 5.7). • Renal impairment: reduce the total daily dose by 25% to 50% in patients with renal impairment. Reduce the total daily dose by 50% or more in patients undergoing dialysis or with severe renal impairment ( 2.6). • Hepatic impairment: reduce the daily dose by 50% in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment or hepatic cirrhosis, it may be সম্পূর্ণ নথি পড়ুন