VENLAFAXINE HYDROCHLORIDE (Page 11 of 11)

17.4 Alcohol

Although venlafaxine has not been shown to increase the impairment of mental and motor skills caused by alcohol, patients should be advised to avoid alcohol while taking venlafaxine.

17.5 Allergic Reactions

Patients should be advised to notify their physician if they develop a rash, hives, or a related allergic phenomenon.

17.6 Pregnancy

Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy.

17.7 Nursing

Patients should be advised to notify their physician if they are breast-feeding an infant.

17.8 Angle Closure Glaucoma

Patients should be advised that taking venlafaxine can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible. [see Warnings and Precautions (5.4)]

17.9 FDA-Approved Medication Guide

Manufactured by:

Ascent Pharmaceuticals, Inc.

Central Islip, NY 11722

For:

Blue Point Laboratories

RevIsion: 03/21

MEDICATION GUIDE

Venlafaxine Extended-Release Tablets

(ven-luh-fak-seen)

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 extended-release 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:

Symptoms Table
(click image for full-size original)

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.

Medication Guide available at http://camberpharma.com/medication-guides

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

Manufactured by:

Ascent Pharmaceuticals, Inc.

Central Islip, NY 11722

Manufactured for:

Blue Point Laboratories

Rev: 03/21

37.5 mg 30 count

37.5 mg 30 count
(click image for full-size original)

75 mg 30 count

75mg 30 count
(click image for full-size original)

150 mg 30 count

150mg 30 count
(click image for full-size original)

225 mg 30 count

225mg 30 count
(click image for full-size original)
VENLAFAXINE HYDROCHLORIDE
venlafaxine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-496
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE) VENLAFAXINE 37.5 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
MICROCRYSTALLINE CELLULOSE
POVIDONE
POLYETHYLENE GLYCOL 400
POLYETHYLENE GLYCOL 8000
POLYETHYLENE GLYCOL 3350
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE ACETATE
HYPROMELLOSES
TITANIUM DIOXIDE
TALC
PROPYLENE GLYCOL
FERROSOFERRIC OXIDE
Product Characteristics
Color white Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 392
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-496-04 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:68001-496-05 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214419 04/30/2021
VENLAFAXINE HYDROCHLORIDE
venlafaxine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-497
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
MANNITOL
MICROCRYSTALLINE CELLULOSE
POVIDONE
POLYETHYLENE GLYCOL 400
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE ACETATE
HYPROMELLOSES
POLYETHYLENE GLYCOL 3350
TITANIUM DIOXIDE
TALC
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
POLYETHYLENE GLYCOL 8000
Product Characteristics
Color white Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 393
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-497-04 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:68001-497-05 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214419 04/30/2021
VENLAFAXINE HYDROCHLORIDE
venlafaxine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-498
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
MANNITOL
MICROCRYSTALLINE CELLULOSE
POVIDONE
POLYETHYLENE GLYCOL 400
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE ACETATE
HYPROMELLOSES
POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 8000
TITANIUM DIOXIDE
TALC
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
Product Characteristics
Color white Score no score
Shape ROUND Size 9mm
Flavor Imprint Code 394
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-498-04 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:68001-498-05 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214419 04/30/2021
VENLAFAXINE HYDROCHLORIDE
venlafaxine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-499
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
MANNITOL
MICROCRYSTALLINE CELLULOSE
POVIDONE
POLYETHYLENE GLYCOL 400
POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 8000
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE ACETATE
HYPROMELLOSES
TITANIUM DIOXIDE
TALC
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
Product Characteristics
Color white Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 395
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-499-04 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:68001-499-05 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214419 04/30/2021
Labeler — BluePoint Laboratories (985523874)
Establishment
Name Address ID/FEI Operations
Ascent Pharmaceuticals, Inc. 080938961 analysis (68001-496), analysis (68001-497), analysis (68001-498), analysis (68001-499), manufacture (68001-496), manufacture (68001-497), manufacture (68001-498), manufacture (68001-499), pack (68001-496), pack (68001-497), pack (68001-498), pack (68001-499), label (68001-496), label (68001-497), label (68001-498), label (68001-499)

Revised: 05/2021 BluePoint Laboratories

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