VENLAFAXINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cadila Pharmaceuticals Limited

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Venlafaxine tablets are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine 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 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 (seeCLINICAL 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. 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 DOSAGE AND ADMINISTRATION ). Starting venlafaxine hydrochloride 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 ). Venlafaxine hydrochloride is not a controlled substance. In vitro studies revealed that venlafaxine has virtually no affinity for opiate, benzodiazepine, phencyclidine (PCP), or N-methyl-D- aspartic acid (NMDA) receptors. Venlafaxine was not found to have any significant CNS stimulant activity in rodents. In primate drug discrimination studies, venlafaxine showed no significant stimulant or depressant abuse liability. Discontinuation effects have been reported in patients receiving venlafaxine (seeDOSAGE AND ADMINISTRATION ). While venlafaxine hydrochloride has not been systematically studied in clinical trials for its potential for abuse, there was no indication of drug-seeking behavior in the clinical trials. However, it is not possible to predict on the basis of premarketing experience the extent to which a CNS active drug will be misused, diverted, and/or abused once marketed. Consequently, physicians should carefully evaluate patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of venlafaxine hydrochloride (e.g., development of tolerance, incrementation of dose, drug-seeking behavior).

Product summary:

Venlafaxine Tablets USP are available as follows: Venlafaxine Tablets USP 25 mg is supplied as mottled peach, round, flat bevelled tablet, on one side scored and debossed "1" on one side of the score and "1"on the other side of the score. Debossed with "C" on the opposite side of the tablet NDC Number                                     Size NDC 71209-025-05                            bottle of 100 Venlafaxine Tablets USP 37.5 mg is supplied as mottled peach, round, flat bevelled tablet, on one side scored and debossed "1" on one side of the score and "2"on the other side of the score. Debossed with "C" on the opposite side of the tablet NDC Number                                     Size NDC 71209-026-05                            bottle of 100 Venlafaxine Tablets USP 50 mg is supplied as mottled peach, round, flat bevelled tablet, on one side scored and debossed "1" on one side of the score and "3"on the other side of the score. Debossed with "C" on the opposite side of the tablet NDC Number                                     Size NDC 71209-027-05                            bottle of 100 Venlafaxine Tablets USP 75 mg is supplied as mottled peach, round, flat bevelled tablet, on one side scored and debossed "1" on one side of the score and "5"on the other side of the score. Debossed with "C" on the opposite side of the tablet NDC Number                                     Size NDC 71209-028-05                            bottle of 100 Venlafaxine Tablets USP 100 mg is supplied as mottled peach, round, flat bevelled tablet, on one side scored and debossed "1" on one side of the score and "7"on the other side of the score. Debossed with "C" on the opposite side of the tablet NDC Number                                     Size NDC 71209-029-05                            bottle of 100 Venlafaxine tablets, USP 25 mg, 37.5 mg, 50 mg, 75 mg and 100 mg meet the requirements for functional scoring. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] in a dry place. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured By: Cadila Pharmaceuticals Limited 1389 Trasad Road, Dholka – 382225, District - Ahmedabad, Gujarat, INDIA August, 2023

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

VENLAFAXINE - VENLAFAXINE TABLET
Cadila Pharmaceuticals Limited
----------
MEDICATION GUIDE
VENLAFAXINE (ven la fax een) TABLETS, USP
Read the Medication Guide that comes with venlafaxine tablets before
you start taking them and each
time you get a refill. There may be new information. This Medication
Guide does not take the place of
talking to your healthcare provider about your medical condition or
treatment. Talk with your healthcare
provider if there is something you do not understand or want to learn
more about.
What is the most important information I should know about venlafaxine
tablets?
Venlafaxine tablets and other antidepressant medicines may cause
serious side effects, including:
1. Suicidal thoughts or actions:
•Venlafaxine tablets and other antidepressant medicines may increase
suicidal thoughts or actions in some
children, teenagers, or young adults within the first few months of
treatment or when the dose is changed.
•Depression or other serious mental illnesses are the most important
causes of suicidal thoughts or
actions.
•Watch for these changes and call your healthcare provider right
away if you notice:
■ New or sudden changes in mood, behavior, actions, thoughts, or
feelings, especially if severe.
■ Pay particular attention to such changes when venlafaxine tablets
are started or when the dose is
changed.
Keep all follow-up visits with your healthcare provider and call
between visits if you are worried about
symptoms.
Call your healthcare provider right away if you have any of the
following symptoms, or call 911 if an
emergency, especially if they are new, worse, or worry you:
•attempts to commit suicide
•acting on dangerous impulses
•acting aggressive or violent
•thoughts about suicide or dying
•new or worse depression
•new or worse anxiety or panic attacks
•feeling agitated, restless, angry or irritable
•trouble sleeping
•an increase in activity or talking more than what is normal for you
•other unusual changes in behavior or mood
Call your healthcare provider r

Summary of Product characteristics

VENLAFAXINE - VENLAFAXINE TABLET
CADILA PHARMACEUTICALS LIMITED
----------
VENLAFAXINE TABLETS, USP
RX ONLY
BOXED WARNING
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
TABLETS 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 TABLETS 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, 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-[(dimethylamino)methyl]-_p-_
methoxybenzyl]cyclohexanol hydrochloride. The structural formula is
shown below.
C
H
NO •HCl M.W. 313.87
Venlafaxine hydrochloride, USP is a white to off-white crystalline
solid with a solubility of
17
27
2
572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium
chloride). Its
octanol: water (0.2 M sodium chloride) partition coefficient is 0.43.
Compressed tablets contain venla