Venlafaxine (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 Mydriasis

Mydriasis (prolonged dilation of the pupils of the eye) has been reported with venlafaxine. Patients should be advised to notify their physician if they have a history of glaucoma or a history of increased intraocular pressure [see Warnings and Precautions (5.5) ].

17.9 FDA-Approved Medication Guide

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

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
  • attempts to commit suicide
  • new or worse depression
  • new or worse anxiety
  • feeling very agitated or restless
  • panic attacks
  • trouble sleeping (insomnia)
  • new or worse irritability
  • acting aggressive, being angry, or violent
  • acting on dangerous impulses
  • an extreme increase in activity and talking (mania)
  • other unusual changes in behavior or mood

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.
  • 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.

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

Manufactured for:

Osmotica Pharmaceutical Corp.Wilmington, NC 28405, USA

VENLAFAXINE venlafaxine hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42843-301
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
povidone
microcrystalline cellulose
polyethylene glycol
colloidal silicon dioxide
magnesium stearate
cellulose acetate
hypromellose
lactose
titanium dioxide
triacetin
black iron oxide
propylene glycol
Product Characteristics
Color white Score no score
Shape ROUND (round biconvex) Size 0mm
Flavor Imprint Code OS;301
Contains
Coating true Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42843-301-10 100 TABLET, EXTENDED RELEASE (100 TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:42843-301-11 10 BLISTER PACK (10 BLISTER PACK) in 1 CARTON contains a BLISTER PACK
2 10 TABLET, EXTENDED RELEASE (10 TABLET) in 1 BLISTER PACK This package is contained within the CARTON (42843-301-11)
VENLAFAXINE venlafaxine hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42843-302
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
povidone
microcrystalline cellulose
polyethylene glycol
colloidal silicon dioxide
magnesium stearate
cellulose acetate
hypromellose
lactose
titanium dioxide
triacetin
black iron oxide
propylene glycol
Product Characteristics
Color white Score no score
Shape ROUND (round biconvex) Size 0mm
Flavor Imprint Code OS;302
Contains
Coating true Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42843-302-10 100 TABLET, EXTENDED RELEASE (100 TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:42843-302-11 10 BLISTER PACK (10 BLISTER PACK) in 1 CARTON contains a BLISTER PACK
2 10 TABLET, EXTENDED RELEASE (10 TABLET) in 1 BLISTER PACK This package is contained within the CARTON (42843-302-11)
VENLAFAXINE venlafaxine hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42843-303
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
povidone
microcrystalline cellulose
polyethylene glycol
colloidal silicon dioxide
magnesium stearate
cellulose acetate
hypromellose
lactose
titanium dioxide
triacetin
black iron oxide
propylene glycol
Product Characteristics
Color white Score no score
Shape ROUND (round biconvex) Size 0mm
Flavor Imprint Code OS;303
Contains
Coating true Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42843-303-10 100 TABLET, EXTENDED RELEASE (100 TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:42843-303-11 10 BLISTER PACK (10 BLISTER PACK) in 1 CARTON contains a BLISTER PACK
2 10 TABLET, EXTENDED RELEASE (10 TABLET) in 1 BLISTER PACK This package is contained within the CARTON (42843-303-11)
VENLAFAXINE venlafaxine hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42843-304
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
povidone
microcrystalline cellulose
polyethylene glycol
colloidal silicon dioxide
magnesium stearate
cellulose acetate
hypromellose
lactose
titanium dioxide
triacetin
black iron oxide
propylene glycol
Product Characteristics
Color white Score no score
Shape ROUND (round biconvex) Size 0mm
Flavor Imprint Code OS;304
Contains
Coating true Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42843-304-10 100 TABLET, EXTENDED RELEASE (100 TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:42843-304-11 10 BLISTER PACK (10 BLISTER PACK) in 1 CARTON contains a BLISTER PACK
2 10 TABLET, EXTENDED RELEASE (10 TABLET) in 1 BLISTER PACK This package is contained within the CARTON (42843-304-11)
Labeler — Osmotica Pharmaceutical Corp.

Revised: 06/2008 Osmotica Pharmaceutical Corp.

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