Venlafaxine Hydrochloride description, usages, side effects, indications, overdosage, supplying and lots more!

Venlafaxine Hydrochloride

Torrent Pharmaceuticals Limited
Torrent Pharma, Inc.

Venlafaxine Hydrochloride Extended-Release Capsules, USPRx Only

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Suicidality and Antidepressant Drugs

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of venlafaxine hydrochloride extended-release capsules or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Venlafaxine hydrochloride extended-release capsules are not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use)   

DESCRIPTION

Venlafaxine hydrochloride extended-release capsules, USP for oral administration contain venlafaxine hydrochloride, a structurally novel antidepressant. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below.

DESCRIPTION

CLINICAL PHARMACOLOGY

INDICATIONS AND USAGE

CONTRAINDICATIONS

Hypersensitivity to venlafaxine hydrochloride or to any excipients in the formulation.

The use of MAOIs intended to treat psychiatric disorders with venlafaxine hydrochloride extended-release capsules or within 7 days of stopping treatment with venlafaxine hydrochloride extended-release capsules are contraindicated because of an increased risk of serotonin syndrome. The use of venlafaxine hydrochloride extended-release capsules within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see WARNINGS and DOSAGE AND ADMINISTRATION).

Starting venlafaxine hydrochloride extended-release capsules in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see WARNINGS and DOSAGE AND ADMINISTRATION).

WARNINGS

PRECAUTIONS

The 75 mg and 150 mg capsules contain FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.    

Carcinogenesis, Mutagenesis, Impairment of Fertility

ADVERSE REACTIONS

DRUG ABUSE AND DEPENDENCE

OVERDOSAGE

DOSAGE AND ADMINISTRATION

HOW SUPPLIED

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Venlafaxine Hydrochloride Extended-Release Capsules, 37.5 mg  

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Venlafaxine Hydrochloride Extended-Release Capsules, 75 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Venlafaxine Hydrochloride Extended-Release Capsules, 150 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Venlafaxine Hydrochloride

Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:13668-018
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE 37.5 mg

Inactive Ingredients

Ingredient Name Strength
COLLOIDAL SILICON DIOXIDE
ETHYLCELLULOSES
ferric oxide red
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
GELATIN
HYPROMELLOSES
SODIUM LAURYL SULFATE
SUCROSE
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
GRAY (grey cap and peach body) 15 mm 37;5;1018 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13668-018-30 30 in 1 BOTTLE
2 NDC:13668-018-90 90 in 1 BOTTLE
3 NDC:13668-018-01 100 in 1 BOTTLE
4 NDC:13668-018-05 500 in 1 BOTTLE
5 NDC:13668-018-45 2600 in 1 BOTTLE
6 NDC:13668-018-74 100 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090899 2011-06-01


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