Venlafaxine Tablets USP

/Venlafaxine Tablets USP
Venlafaxine Tablets USP2018-09-06T09:12:40+00:00

Prescription Drug Name:

Venlafaxine Tablets USP

ID:

d23adbf8-2c6a-76ae-c7e7-4dfa626a560d

Code:

34391-3

Suicidality and Antidepressant Drugs


id: 0471aea8-ccb8-5229-65e2-4894745d4b5f
displayName: BOXED WARNING SECTION
FDA Article Code: 34066-1

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 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 is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use)

DESCRIPTION


id: 45da43a8-7ec7-2ce2-30ed-e4bda223877c
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Venlafaxine hydrochloride USP 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 USP is an off-white to white crystalline powder and soluble in methanol. Compressed tablets contain venlafaxine hydrochloride USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate.

CLINICAL TRIALS


id: 1bbad24e-61a7-63bf-0a57-05a36e30ceec
displayName: CLINICAL STUDIES SECTION
FDA Article Code: 34092-7

The efficacy of venlafaxine hydrochloride as a treatment for major depressive disorder was established in 5 placebo-controlled, short-term trials. Four of these were 6-week trials in adult outpatients meeting DSM-III or DSM-III-R criteria for major depression: two involving dose titration with venlafaxine hydrochloride in a range of 75 to 225 mg/day (t.i.d. schedule), the third involving fixed venlafaxine hydrochloride doses of 75, 225, and 375 mg/day (t.i.d. schedule), and the fourth involving doses of 25, 75, and 200 mg/day (b.i.d. schedule). The fifth was a 4-week study of adult inpatients meeting DSM-III-R criteria for major depression with melancholia whose venlafaxine hydrochloride doses were titrated in a range of 150 to 375 mg/day (t.i.d. schedule). In these 5 studies, venlafaxine hydrochloride was shown to be significantly superior to placebo on at least 2 of the following 3 measures: Hamilton Depression Rating Scale (total score), Hamilton depressed mood item, and Clinical Global Impression-Severity of Illness rating. Doses from 75 to 225 mg/day were superior to placebo in outpatient studies and a mean dose of about 350 mg/day was effective in inpatients. Data from the 2 fixed-dose outpatient studies were suggestive of a dose-response relationship in the range of 75 to 225 mg/day. There was no suggestion of increased response with doses greater than 225 mg/day. While there were no efficacy studies focusing specifically on an elderly population, elderly patients were included among the patients studied. Overall, approximately 2/3 of all patients in these trials were women. Exploratory analyses for age and gender effects on outcome did not suggest any differential responsiveness on the basis of age or sex. In one longer-term study, adult outpatients meeting DSM-IV criteria for major depressive disorder who had responded during an 8-week open trial on venlafaxine extended-release capsules (75, 150, or 225 mg, qAM) were randomized to continuation of their same venlafaxine extended-release capsules dose or to placebo, for up to 26 weeks of observation for relapse. Response during the open phase was defined as a CGI Severity of Illness item score of ≤ 3 and a HAM-D-21 total score of ≤ 10 at the day 56 evaluation. Relapse during the double-blind phase was defined as follows: (1) a reappearance of major depressive disorder as defined by DSM-IV criteria and a CGI Severity of Illness item score of ≥ 4 (moderately ill), (2) 2 consecutive CGI Severity of Illness item scores of ≥ 4, or (3) a final CGI Severity of Illness item score of ≥ 4 for any patient who withdrew from the study for any reason. Patients receiving continued venlafaxine extended-release capsules treatment experienced significantly lower relapse rates over the subsequent 26 weeks compared with those receiving placebo. In a second longer-term trial, adult outpatients meeting DSM-III-R criteria for major depression, recurrent type, who had responded (HAM-D-21 total score ≤ 12 at the day 56 evaluation) and continued to be improved [defined as the following criteria being met for days 56 through 180: (1) no HAM-D-21 total score ≥ 20; (2) no more than 2 HAM-D-21 total scores > 10; and (3) no single CGI Severity of Illness item score ≥ 4 (moderately ill)] during an initial 26 weeks of treatment on venlafaxine hydrochloride (100 to 200 mg/day, on a b.i.d. schedule) were randomized to continuation of their same venlafaxine hydrochloride dose or to placebo. The follow-up period to observe patients for relapse, defined as a CGI Severity of Illness item score ≥ 4, was for up to 52 weeks. Patients receiving continued venlafaxine hydrochloride treatment experienced significantly lower relapse rates over the subsequent 52 weeks compared with those receiving placebo.

INDICATIONS AND USAGE


id: 13a05e9c-c50a-c491-2fa1-d2948d620e6f
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Venlafaxine tablets are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine hydrochloride 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 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 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 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: 471bb751-8688-7ed5-4eba-12b9cc5d7bee
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Hypersensitivity to venlafaxine hydrochloride or to any excipients in the formulation. The use of MAOIs intended to treat psychiatric disorders with venlafaxine hydrochloride or within 7 days of stopping treatment with venlafaxine hydrochloride is contraindicated because of an increased risk of serotonin syndrome. The use of venlafaxine hydrochloride within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see WARNINGS and DOSGE AND ADMINISTRATION )

HOW SUPPLIED


id: 449c70d2-eb91-d0cf-0812-7282230965c1
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Venlafaxine tablets USP are available containing 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg of venlafaxine. The 25 mg are peach colored, round biconvex, uncoated tablets debossed with R and DY separated with a breakline on one side and “545” on the other side. They are supplied in bottles of 30, 60, 90, 100, 500 and unit dose package of 10 (1 x 10). Bottles of 30                                            NDC 55111-545-30
Bottles of 60                                            NDC 55111-545-60
Bottles of 90                                            NDC 55111-545-90
Bottles of 100                                          NDC 55111-545-01
Bottles of 500                                          NDC 55111-545-05
Unit dose package of 10 (1 × 10)            NDC 55111-545-79
The 37.5 mg are peach colored, round biconvex, uncoated, tablets debossed with R and DY separated with a breakline on one side and “546” on the other side. They are supplied in bottles of 30, 60, 90, 100, 500 and unit dose package of 10 (1 x 10). Bottles of 30                                            NDC 55111-546-30
Bottles of 60                                            NDC 55111-546-60
Bottles of 90                                            NDC 55111-546-90
Bottles of 100                                          NDC 55111-546-01
Bottles of 500                                          NDC 55111-546-05
Unit dose package of 10 (1 × 10)            NDC 55111-546-79
The 50 mg are peach colored, round biconvex, uncoated, tablets debossed with R and DY separated with a breakline on one side and “547” on the other side. They are supplied in bottles of 30, 60, 90, 100, 500 and unit dose package of 10 (1 x 10). Bottles of 30                                            NDC 55111-547-30
Bottles of 60                                            NDC 55111-547-60
Bottles of 90                                            NDC 55111-547-90
Bottles of 100                                          NDC 55111-547-01
Bottles of 500                                          NDC 55111-547-05
Unit dose package of 10 (1 × 10)            NDC 55111-547-79
The 75 mg are peach colored, round biconvex, uncoated, tablets debossed with R and DY separated with a breakline on one side and “548” on the other side. They are supplied in bottles of 30, 60, 90, 100, 500 and unit dose package of 10 (1 x 10). Bottles of 30                                            NDC 55111-548-30
Bottles of 60                                            NDC 55111-548-60
Bottles of 90                                            NDC 55111-548-90
Bottles of 100                                          NDC 55111-548-01
Bottles of 500                                          NDC 55111-548-05
Unit dose package of 10 (1 × 10)            NDC 55111-548-79
The 100 mg are peach colored, round, flat bevel edged, uncoated tablets debossed with R and DY separated with a breakline on one side and “549” on the other side. They are supplied in bottles of 30, 60, 90, 100, 500 and unit dose package of 10 (1 x 10). Bottles of 30                                            NDC 55111-549-30
Bottles of 60                                            NDC 55111-549-60
Bottles of 90                                            NDC 55111-549-90
Bottles of 100                                          NDC 55111-549-01
Bottles of 500                                          NDC 55111-549-05
Unit dose package of 10 (1 × 10)            NDC 55111-549-79
Store at 20°-25°C (68°-77°F); in a dry place; excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Dispense in a well-closed container as defined in the USP. The unit of use package is intended to be dispensed as a unit.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION


id: f8c7b895-f711-0006-84d2-ab851bebb5b3
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Venlafaxine Tablets USP, 25 mg – container label