Effexor XR (Page 15 of 15)

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
  • 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

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

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.

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LAB-0542-1.0

Revised November 2011

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — 37.5 MG — LABEL

Effexor XR®

(venlafaxine HCl)

Extended-Release Capsules

Equivalent to 37.5 mg venlafaxine

SEALED FOR YOUR PROTECTION

Note to authorized dispenser: Each time Effexor XR is dispensed, give the patient the attached Medication Guide.

Rx only

Principal Display Panel -- 37.5 mg Label
(click image for full-size original)

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — 75 MG — LABEL

Effexor XR®

(venlafaxine HCl)

Extended-Release Capsules

Equivalent to 75 mg venlafaxine

SEALED FOR YOUR PROTECTION

Note to authorized dispenser: Each time Effexor XR is dispensed, give the patient the attached Medication Guide.

Rx only

Principal Display Panel -- 75 mg -- Label
(click image for full-size original)

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — 150 MG — LABEL

Effexor XR®

(venlafaxine HCl)

Extended-Release Capsules

Equivalent to 150 mg venlafaxine

SEALED FOR YOUR PROTECTION

Note to authorized dispenser: Each time Effexor XR is dispensed, give the patient the attached Medication Guide.

Rx only

Principal  Display Panel -- 150 mg -- Label
(click image for full-size original)
EFFEXOR XR venlafaxine hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4504(NDC:0008-0837)
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
POWDERED CELLULOSE
GELATIN
FERRIC OXIDE RED
TITANIUM DIOXIDE
ETHYLCELLULOSE (100 MPA.S)
HYPROMELLOSES
HYPROMELLOSE 2910 (6 MPA.S)
Product Characteristics
Color ORANGE (PEACH) , GRAY (GRAY) Score no score
Shape CAPSULE (CAPSULE) Size 16mm
Flavor Imprint Code W;EffexorXR;375
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4504-0 30 CAPSULE, EXTENDED RELEASE (CAPSULE) in 1 BOTTLE, PLASTIC None
2 NDC:54868-4504-1 10 CAPSULE, EXTENDED RELEASE (CAPSULE) in 1 BOTTLE, PLASTIC None
3 NDC:54868-4504-2 60 CAPSULE, EXTENDED RELEASE (CAPSULE) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020699 04/07/2004
EFFEXOR XR venlafaxine hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4253(NDC:0008-0833)
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
POWDERED CELLULOSE
GELATIN
FERRIC OXIDE RED
TITANIUM DIOXIDE
ETHYLCELLULOSE (100 MPA.S)
HYPROMELLOSES
HYPROMELLOSE 2910 (6 MPA.S)
Product Characteristics
Color ORANGE (PEACH) Score no score
Shape CAPSULE (CAPSULE) Size 20mm
Flavor Imprint Code W;EffexorXR;75
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4253-0 30 CAPSULE, EXTENDED RELEASE (CAPSULE) in 1 BOTTLE, PLASTIC None
2 NDC:54868-4253-2 60 CAPSULE, EXTENDED RELEASE (CAPSULE) in 1 BOTTLE, PLASTIC None
3 NDC:54868-4253-3 90 CAPSULE, EXTENDED RELEASE (CAPSULE) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020699 04/25/2003
EFFEXOR XR venlafaxine hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4252(NDC:0008-0836)
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
POWDERED CELLULOSE
GELATIN
FERRIC OXIDE RED
TITANIUM DIOXIDE
ETHYLCELLULOSE (100 MPA.S)
HYPROMELLOSES
HYPROMELLOSE 2910 (6 MPA.S)
Product Characteristics
Color ORANGE (DARK ORANGE) Score no score
Shape CAPSULE (CAPSULE) Size 22mm
Flavor Imprint Code W;EffexorXR;150
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4252-0 30 CAPSULE, EXTENDED RELEASE (CAPSULE) in 1 BOTTLE, PLASTIC None
2 NDC:54868-4252-2 60 CAPSULE, EXTENDED RELEASE (CAPSULE) in 1 BOTTLE, PLASTIC None
3 NDC:54868-4252-4 90 CAPSULE, EXTENDED RELEASE (CAPSULE) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020699 08/28/2001
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel, repack

Revised: 12/2011 Physicians Total Care, Inc.

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