VENLAFAXINE HYDROCHLORIDE- venlafaxine hydrochloride capsule, extended release

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG)

Tersedia dari:

Camber Pharmaceuticals, Inc.

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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

Ringkasan produk:

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]

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

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