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DESVENLAFAXINE- desvenlafaxine succinate tablet, extended release


  1. Can Cause Serious Side Effects, Including:
  2. How Can I Watch For And Try To Prevent Suicidal Thoughts And Actions?
  3. Call Your Healthcare Provider Right Away If You Have Any Of The Following Symptoms, Especially If They Are New, Worse, Or Worry You:
  4. Desvenlafaxine Can Cause Serious Side Effects, Including:
  5. Active Ingredient:
  6. What Is Desvenlafaxine?
  7. Do Not Take Desvenlafaxine If You:
  8. How Should I Take Desvenlafaxine?
  9. Call Your Healthcare Provider Or Go To The Nearest Hospital Emergency Room Right Away If You Have Any Of The Following Signs And Symptoms Of Serotonin Syndrome:
  10. Inactive Ingredients:
  11. Distributed By:
  12. Manufactured By:
  13. Patient Information

Can Cause Serious Side Effects, Including: 

  • Increased risk of suicidal thoughts or actions in some children and young adults within the first few months of treatment.Desvenlafaxineis not for use in children.
  • Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.

How Can I Watch For And Try To Prevent Suicidal Thoughts And Actions? 

o 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.

o Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.

o 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 Your Healthcare Provider Right Away If You Have Any Of The Following Symptoms, Especially If They Are New, Worse, Or Worry You: 

o thoughts about suicide or dyingo trouble sleeping (insomnia)
o attempts to commit suicideo new or worse irritability
o new or worse depressiono acting aggressive, being angry, or violent
o new or worse anxietyo acting on dangerous impulses
o feeling very agitated or restlesso an extreme increase in activity and talking (mania)
o panic attackso other unusual changes in behavior or mood

What isdesvenlafaxine?

  • Desvenlafaxine is a prescription medicine used to treat adults with a certain type of depression called major depressive disorder (MDD). Desvenlafaxine belongs to a class of medicines known as serotonin and norepinephrine reuptake inhibitors (SNRIs).

Do not takedesvenlafaxineif you:

  • are allergic to desvenlafaxine succinate, venlafaxine hydrochloride, or any of the ingredients in desvenlafaxine extended-release tablets.

    Know the medicines you take. Keep a list of them to show to your healthcare providers when you get a new medicine.

    How should I takedesvenlafaxine?

    • Take desvenlafaxine exactly as your healthcare provider tells you to.
    • Take desvenlafaxine 1 time a day at about the same time each day.
    • Desvenlafaxine may be taken either with or without food.
    • Swallow desvenlafaxine tablets whole, with fluid. Do not divide, crush, chew, or dissolve desvenlafaxine tablets.
    • When you take desvenlafaxine, you may

      • Do not drive a car or operate heavy machinery until you know how desvenlafaxine affects you.
      • You should not drink alcohol while taking desvenlafaxine.

      What are the possible side effects ofdesvenlafaxine?

Desvenlafaxine Can Cause Serious Side Effects, Including: 

  • Serotonin syndrome.Apotentially life-threatening problem called serotonin syndrome can happen when you take desvenlafaxine with certain other medicines. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms of serotonin syndrome:
    o agitationo

    • Store desvenlafaxine at room temperature between 68 F to 77 F (20 C to 25 C).
    • Keep desvenlafaxine and all medicines out of the reach of children.

    General Information about the safe and effective use of desvenlafaxine

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take desvenlafaxine for a condition for which it was not prescribed. Do not give desvenlafaxine to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about desvenlafaxine that is written for healthcare professionals.

Active Ingredient: 

desvenlafaxine

What Is Desvenlafaxine? 

Desvenlafaxine is a prescription medicine used to treat adults with a certain type of depression called major depressive disorder (MDD). Desvenlafaxine belongs to a class of medicines known as serotonin and norepinephrine reuptake inhibitors (SNRIs).

Do Not Take Desvenlafaxine If You: 

are allergic to desvenlafaxine succinate, venlafaxine hydrochloride, or any of the ingredients in desvenlafaxine extended-release tablets.

Know the medicines you take. Keep a list of them to show to your healthcare providers when you get a new medicine.

How Should I Take Desvenlafaxine? 

Take desvenlafaxine exactly as your healthcare provider tells you to.
Take desvenlafaxine 1 time a day at about the same time each day.
Desvenlafaxine may be taken either with or without food.
Swallow desvenlafaxine tablets whole, with fluid. Do not divide, crush, chew, or dissolve desvenlafaxine tablets.
When you take desvenlafaxine, you may

Do not drive a car or operate heavy machinery until you know how desvenlafaxine affects you.
You should not drink alcohol while taking desvenlafaxine.

Call Your Healthcare Provider Or Go To The Nearest Hospital Emergency Room Right Away If You Have Any Of The Following Signs And Symptoms Of Serotonin Syndrome: 

o agitation

o

Store desvenlafaxine at room temperature between 68 F to 77 F (20 C to 25 C).
Keep desvenlafaxine and all medicines out of the reach of children.

General Information about the safe and effective use of desvenlafaxine

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take desvenlafaxine for a condition for which it was not prescribed. Do not give desvenlafaxine to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about desvenlafaxine that is written for healthcare professionals.

For more information call Breckenridge Pharmaceutical, Inc. at 1-800-367-3395 or go to www.bpirx.com.

Inactive Ingredients: 

For the 25 mg tablet, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, talc and film coating, which consists of hypromellose, iron oxide yellow, iron oxide red, iron oxide black, polyethylene glycol, talc, and titanium dioxide.

For the 50 mg tablet, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, talc and film coating, which consists of hypromellose, iron oxide red, polyethylene glycol, talc, and titanium dioxide.

For the 100 mg tablet, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, talc and film coating, which consists of hypromellose, iron oxide black, iron oxide red, polyethylene glycol, talc, and titanium dioxide.

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

Distributed By: 

Breckenridge Pharmaceutical, Inc.

Boca Raton, FL 33487

Manufactured By: 

Alembic Pharmaceuticals Limited(Formulation Division),

Village Panelav, P. O. Tajpura, Near Baska,

Taluka-Halol, Panchmahal, Gujarat, India.

Revised: 07/2018

Repackaged By: Preferred Pharmaceuticals Inc.

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Suicidal Thoughts and Behaviors

Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dose is adjusted up or down, and instruct them to report such symptoms to the healthcare provider[see Boxed Warning and Warnings and Precautions (5.1)].

Concomitant Medication

Advise patients taking desvenlafaxine not to use concomitantly other products containing desvenlafaxine or venlafaxine. Healthcare professionals should instruct patients not to take desvenlafaxine with an MAOI or within 14 days of stopping an MAOI and to allow 7 days after stopping desvenlafaxine before starting an MAOI[see Contraindications (4)].

Serotonin Syndrome

Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of desvenlafaxine with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John s Wort supplements)[see Warnings and Precautions (5.2)].

Elevated Blood Pressure

Advise patients that they should have regular monitoring of blood pressure when taking desvenlafaxine[see Warnings and Precautions (5.3)].

Increased Risk of Bleeding

Inform patients about the concomitant use of desvenlafaxine with NSAIDs, aspirin, other antiplatelet drugs, warfarin, or other coagulants because the combined use of has been associated with an increased risk of bleeding. Advise patients to inform their health care providers if they are taking or planning to take any prescription or over-the-counter medications that increase the risk of bleeding[see Warnings and Precautions (5.4)].

Activation of Mania/Hypomania

Advise patients, their families, and caregivers to observe for signs of activation of mania/hypomania[see Warnings and Precautions (5.6)].

Discontinuation

Advise patients not to abruptly stop taking desvenlafaxine without talking first with their healthcare professional. Patients should be aware that discontinuation effects may occur when stopping desvenlafaxine, and a dose of 25 mg per day is available for discontinuing therapy[see Warnings and Precautions (5.7) and Adverse Reactions (6.1)].

Switching Patients From Other Antidepressants to Desvenlafaxine

Discontinuation symptoms have been reported when switching patients from other antidepressants, including venlafaxine, to desvenlafaxine. Tapering of the initial antidepressant may be necessary to minimize discontinuation symptoms.

Interference with Cognitive and Motor Performance

Caution patients about operating hazardous machinery, including automobiles, until they are reasonably certain that desvenlafaxine therapy does not adversely affect their ability to engage in such activities.

Alcohol

Advise patients to avoid alcohol while taking desvenlafaxine[see Drug Interactions (7.3)].

Allergic Reactions

Advise patients to notify their physician if they develop allergic phenomena such as rash, hives, swelling, or difficulty breathing.

Pregnancy

Advise patients to notify their physician if they become pregnant or intend to become pregnant during therapy. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to desvenlafaxine during pregnancy[see Use in Specific Populations (8.1)].

Residual Inert Matrix Tablet

Patients receiving desvenlafaxine may notice an inert matrix tablet passing in the stool or via colostomy. Patients should be informed that the active medication has already been absorbed by the time the patient sees the inert matrix tablet.

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