DESCRIPTION
id: 8318bc82-4ae5-4fc3-b49c-3c1eeb4eee74
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Venlafaxine hydrochloride is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below.
Venlafaxine hydrochloride
Venlafaxine hydrochloride is a white crystalline powder. It is freely soluble in water and dilute hydrochloric acid, soluble in ethanol and chloroform and insoluble in ether.
Each venlafaxine hydrochloride tablet intended for oral administration contains venlafaxine hydrochloride equivalent to 25 mg or 37.5 mg or 50 mg or 75 mg or 100 mg of venlafaxine. In addition, each tablet contains the following inactive ingredients: ferric oxide yellow, ferric oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.
INDICATIONS AND USAGE
id: 1cda3dc0-b876-466c-a110-79120a19fd31
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Venlafaxine hydrochloride tablets are indicated for the treatment of major depressive disorder.
The efficacy of venlafaxine hydrochloride tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see
CLINICAL TRIALS).
A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.
The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine hydrochloride tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see
CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine hydrochloride tablets/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
CONTRAINDICATIONS
id: b240f354-9334-4d85-82e2-ade13f7485e0
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Hypersensitivity to venlafaxine hydrochloride or to any excipients in the formulation.
Venlafaxine hydrochloride Tablets must not be used concomitantly in patients taking MAOIs or in patients who have taken MAOIs within the preceding 14 days due to the risk of serious, sometimes fatal, drug interactions with SNRI or SSRI treatment or with other serotonergic drugs. These interactions have been associated with symptoms that include tremor, myoclonus, diaphoresis, nausea, vomiting, flushing, dizziness, hyperthermia with features resembling neuroleptic malignant syndrome, seizures, rigidity, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma. Based on the half-life of venlafaxine, at least 7 days should be allowed after stopping venlafaxine hydrochloride tablets before starting an MAOI (see
DOSAGE AND ADMINISTRATION).
HOW SUPPLIED
id: e9154df0-3a31-4724-b318-20bc95041f37
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Venlafaxine Hydrochloride Tablets equivalent to 25 mg of venlafaxine are peach-colored, round, flat, beveled-edged tablets with bisect on one side; one side of bisect is debossed with logo of “ZC” and other side is debossed with “64” and other side is plain and are supplied as follows:
NDC 68382-018-06 in bottles of 30 tablets
NDC 68382-018-14 in bottles of 60 tablets
NDC 68382-018-16 in bottles of 90 tablets
NDC 68382-018-01 in bottles of 100 tablets
NDC 68382-018-05 in bottles of 500 tablets
NDC 68382-018-10 in bottles of 1000 tablets
Venlafaxine Hydrochloride Tablets equivalent to 37.5 mg of venlafaxine are peach-colored, round, flat, beveled-edged tablets with bisect on one side; one side of bisect is debossed with logo of “ZC” and other side is debossed with “65” and other side is plain and are supplied as follows:
NDC 68382-019-06 in bottles of 30 tablets
NDC 68382-019-14 in bottles of 60 tablets
NDC 68382-019-16 in bottles of 90 tablets
NDC 68382-019-01 in bottles of 100 tablets
NDC 68382-019-05 in bottles of 500 tablets
NDC 68382-019-10 in bottles of 1000 tablets
Venlafaxine Hydrochloride Tablets equivalent to 50 mg of venlafaxine are peach-colored, round, flat, beveled-edged tablets with bisect on one side; one side of the bisect is debossed with logo of “ZC” and other side is debossed with “66” and other side is plain and are supplied as follows:
NDC 68382-020-06 in bottles of 30 tablets
NDC 68382-020-14 in bottles of 60 tablets
NDC 68382-020-16 in bottles of 90 tablets
NDC 68382-020-01 in bottles of 100 tablets
NDC 68382-020-05 in bottles of 500 tablets
NDC 68382-020-10 in bottles of 1000 tablets
Venlafaxine Hydrochloride Tablets equivalent to 75 mg of venlafaxine are peach-colored, round, flat, beveled-edged tablets with bisect on one side; one side of the bisect is debossed with logo of “ZC” and other side is debossed with “67” and other side is plain and are supplied as follows:
NDC 68382-021-06 in bottles of 30 tablets
NDC 68382-021-14 in bottles of 60 tablets
NDC 68382-021-16 in bottles of 90 tablets
NDC 68382-021-01 in bottles of 100 tablets
NDC 68382-021-05 in bottles of 500 tablets
NDC 68382-021-10 in bottles of 1000 tablets
Venlafaxine Hydrochloride Tablets equivalent to 100 mg of venlafaxine are peach-colored, round, flat, beveled-edged tablets with bisect on one side; one side of the bisect is debossed with logo of “ZC” and other side is debossed with “68” and other side is plain and are supplied as follows:
NDC 68382-101-06 in bottles of 30 tablets
NDC 68382-101-14 in bottles of 60 tablets
NDC 68382-101-16 in bottles of 90 tablets
NDC 68382-101-01 in bottles of 100 tablets
NDC 68382-101-05 in bottles of 500 tablets
NDC 68382-101-10 in bottles of 1000 tablets
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
id: 5f5d7244-67d7-4de4-97c8-4fc16e919479
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
NDC 68382-021-01 in bottle of 100 Tablets
Venlafaxine Hydrochloride Tablets, 75 mg
Rx only
100 TABLETS
ZYDUS
