Prescription Drug Information: VENLAFAXINE HYDROCHLORIDE (Page 9 of 9)

Medication Guide

Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions

Read the Medication Guide that comes with your or your family member’s antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, or your family member’s,healthcare provider about:

  • all risks and benefits of treatment with antidepressant medicines
  • all treatment choices for depression or other serious mental illness

Who should not take venlafaxine extendedrelease tablets?

  • take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
  • Do not take an MAOI within 7 days of stopping venlafaxine extended-release tablets unless directed to do so by your physician.
  • Do not start venlafaxine extended-release tablets if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.

What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?

1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.

2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.

3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?

  • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
  • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
  • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

  • thoughts about suicide or dying
  • trouble sleeping (insomnia)
  • attempts to commit suicide
  • new or worse irritability
  • new or worse depression
  • acting aggressive, being angry, or violent
  • new or worse anxiety
  • acting on dangerous impulses
  • feeling very agitated or restless
  • an extreme increase in activity and talking (mania)
  • panic attacks
  • other unusual changes in behavior or mood
  • Visual Problems: Eye pain, change in vision, swelling or redness around eye

What else do I need to know about antidepressant medicines?

  • Never stop an antidepressant medicine without first talking to a healthcare provider.

Stopping an antidepressant medicine suddenly can cause other symptoms.

  • Visual Problems. Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.
  • Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
  • Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
  • Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
  • Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child’s healthcare provider for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Trademarks are the properties of their respective owners.

This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants.

Manufactured by:
Cadila Pharmaceuticals Limited
1389, Dholka, District — Ahmedabad,
Gujarat State, INDIA.

Manufactured for:
Nivagen Pharmaceuticals, Inc.
Sacramento, CA 95827
Toll free number: 1-877-977-0687

Rev. 09/2019

PRINCIPAL DISPLAY PANEL — 75 mg Tablet Bottle Label

NDC 75834-217-00

Venlafaxine
Extended-Release
Tablets

75 mg

1000 Tablets

Pharmacist: Dispense the accompanying Medication Guide to each patient.

NIVAGEN

Rx only

PRINCIPAL DISPLAY PANEL -- 75 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 150 mg Tablet Bottle Label

NDC 75834-218-00

Venlafaxine
Extended-Release
Tablets

150 mg

1000 Tablets

Pharmacist: Dispense the accompanying Medication Guide to each patient.

NIVAGEN

Rx only

PRINCIPAL DISPLAY PANEL -- 150 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 225 mg Tablet Bottle Label

NDC 75834-219-00

Venlafaxine
Extended-Release
Tablets

225 mg

1000 Tablets

Pharmacist: Dispense the accompanying Medication Guide to each patient.

NIVAGEN

Rx only

PRINCIPAL DISPLAY PANEL -- 225 mg Tablet Bottle Label
(click image for full-size original)
VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:75834-217
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE) VENLAFAXINE 75 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE 2208 (100 MPA.S)
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
TALC
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
SHELLAC
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
AMMONIA
MEDIUM-CHAIN TRIGLYCERIDES
HYPROMELLOSE 2910 (5 MPA.S)
ETHYLCELLULOSE (20 MPA.S)
POLYETHYLENE GLYCOL 8000
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code C46
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75834-217-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:75834-217-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:75834-217-00 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211323 09/06/2019
VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:75834-218
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE) VENLAFAXINE 150 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
TALC
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
SHELLAC
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
AMMONIA
MEDIUM-CHAIN TRIGLYCERIDES
HYPROMELLOSE 2208 (100 MPA.S)
ETHYLCELLULOSE (20 MPA.S)
POLYETHYLENE GLYCOL 8000
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code C34
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75834-218-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:75834-218-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:75834-218-00 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211323 09/06/2019
VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:75834-219
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE) VENLAFAXINE 225 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
TALC
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
SHELLAC
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
AMMONIA
MEDIUM-CHAIN TRIGLYCERIDES
HYPROMELLOSE 2208 (100 MPA.S)
ETHYLCELLULOSE (20 MPA.S)
POLYETHYLENE GLYCOL 8000
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 12mm
Flavor Imprint Code C49
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75834-219-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:75834-219-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:75834-219-00 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211323 09/06/2019
Labeler — Nivagen Pharmaceuticals, Inc. (052032418)

Revised: 01/2021 Nivagen Pharmaceuticals, Inc.

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