Venlafaxine (Page 11 of 12)

Dosage for Patients with Renal Impairment

Given the decrease in clearance for venlafaxine and the increase in elimination half-life for both venlafaxine and ODV that is observed in patients with renal impairment (GFR = 10 to 70 mL/min) compared to normals (see CLINICAL PHARMACOLOGY), it is recommended that the total daily dose be reduced by 25% in patients with mild to moderate renal impairment. It is recommended that the total daily dose be reduced by 50% in patients undergoing hemodialysis. Since there was much individual variability in clearance between patients with renal impairment, individualization of dosing may be desirable in some patients.

Dosage for Elderly Patients

No dose adjustment is recommended for elderly patients on the basis of age. As with any antidepressant, however, caution should be exercised in treating the elderly. When individualizing the dosage, extra care should be taken when increasing the dose.

Maintenance Treatment

It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacological therapy beyond response to the acute episode. In one study, in which patients responding during 8 weeks of acute treatment with venlafaxine hydrochloride extended-release capsules were assigned randomly to placebo or to the same dose of venlafaxine hydrochloride extended-release capsules (75, 150, or 225 mg/day, qAM) during 26 weeks of maintenance treatment as they had received during the acute stabilization phase, longer-term efficacy was demonstrated. A second longer-term study has demonstrated the efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then randomly assigned to placebo or venlafaxine tablets for periods of up to 52 weeks on the same dose (100 to 200 mg/day, on a b.i.d. schedule) (see CLINICAL TRIALS). Based on these limited data, it is not known whether or not the dose of venlafaxine tablets/venlafaxine hydrochloride extended-release capsules needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment.

Discontinuing Venlafaxine Tablets

Symptoms associated with discontinuation of venlafaxine tablets, other SNRIs, and SSRIs, have been reported (see PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.

Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders

At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with venlafaxine tablets. Conversely, at least 7 days should be allowed after stopping venlafaxine tablets before starting an MAOI intended to treat psychiatric disorders (see CONTRAINDICATIONS).

Use of Venlafaxine Tablets With Other MAOIs, Such as Linezolid or Methylene Blue

Do not start venlafaxine tablets in a patient who is being treated with linezolid or intravenous methylene blue because there is increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered (see CONTRAINDICATIONS).

In some cases, a patient already receiving therapy with venlafaxine tablets may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, venlafaxine tablets should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 7 days or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with venlafaxine tablets may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS).

The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with venlafaxine tablets is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see WARNINGS).

HOW SUPPLIED

Venlafaxine Tablets, USP equivalent to 25 mg of venlafaxine are peach-colored, round, flat, beveled-edged tablets with bisect on one side; one side of bisect is debossed with logo of “ZC” and other side is debossed with “64” and other side of tablet is plain and are supplied as follows:
Unit dose packages of 30 (5 x 6) NDC 68084-896-25

Venlafaxine Tablets, USP equivalent to 37.5 mg of venlafaxine are peach-colored, round, flat, beveled-edged tablets with bisect on one side; one side of bisect is debossed with logo of “ZC” and other side is debossed with “65” and other side of tablet is plain and are supplied as follows:
Unit dose packages of 100 (10 x 10) NDC 68084-844-01

Venlafaxine Tablets, USP equivalent to 75 mg of venlafaxine are peach-colored, round, flat, beveled-edged tablets with bisect on one side; one side of the bisect is debossed with logo of “ZC” and other side is debossed with “67” and other side of tablet is plain and are supplied as follows:
Unit dose packages of 100 (10 x 10) NDC 68084-856-01

Storage

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] in a dry place.

KEEP THIS AND ALL MEDICINES OUT OF THE REACH OF CHILDREN.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

PACKAGING INFORMATION

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from BluePoint Laboratories as follows:
(25 mg / 30 UD) NDC 68084-896-25 packaged from NDC 68001-157
(37.5 mg / 100 UD) NDC 68084-844-01 packaged from NDC 68001-158
(75 mg / 100 UD) NDC 68084-856-01 packaged from NDC 68001-160

Distributed by:
American Health Packaging
Columbus, OH 43217

8284401/0219

Medication Guide

8284401/0219

Venlafaxine (VEN-la-fax-een) Tablets, USP
Rx only

Read the Medication Guide that comes with venlafaxine tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk with your healthcare provider if there is something you do not understand or want to learn more about.

What is the most important information I should know about venlafaxine tablets?
Venlafaxine tablets and other antidepressant medicines may cause serious side effects, including:

1. Suicidal thoughts or actions:

  • Venlafaxine tablets and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed.
  • Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
  • Watch for these changes and call your healthcare provider right away if you notice:
    • New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.
    • Pay particular attention to such changes when venlafaxine tablets is started or when the dose is changed.
  • Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.
  • Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:
    • attempts to commit suicide
    • acting on dangerous impulses
    • acting aggressive or violent
    • thoughts about suicide or dying
    • new or worse depression
    • new or worse anxiety or panic attacks
    • feeling agitated, restless, angry or irritable
    • trouble sleeping
    • an increase in activity or talking more than what is normal for you
    • other unusual changes in behavior or mood

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. Venlafaxine tablets may be associated with these serious side effects:

2. Serotonin Syndrome
This condition can be life-threatening and may include:

  • agitation, hallucinations, coma or other changes in mental status
  • coordination problems or muscle twitching (overactive reflexes)
  • racing heartbeat, high or low blood pressure
  • sweating or fever
  • nausea, vomiting, or diarrhea
  • muscle rigidity

3. Changes in blood pressure. Venlafaxine tablets may:

  • increase your blood pressure. Control high blood pressure before starting treatment and monitor blood pressure regularly

4. Enlarged pupils (mydriasis).

5. Anxiety and insomnia.

6. Changes in appetite or weight.

  • children and adolescents should have height and weight monitored during treatment

7. Manic/hypomanic episodes:

  • greatly increased energy
  • severe trouble sleeping
  • racing thoughts
  • reckless behavior
  • unusually grand ideas
  • excessive happiness or irritability
  • talking more or faster than usual

8. Low salt (sodium) levels in the blood.
Elderly people may be at greater risk for this. Symptoms may include:

  • headache
  • weakness or feeling unsteady
  • confusion, problems concentrating or thinking or memory problems

9. Seizures or convulsions.

10. Abnormal bleeding: Venlafaxine tablets and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin ® , Jantoven ®), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.

11. Elevated cholesterol.

12. Lung disease and pneumonia:
Venlafaxine tablets may cause rare lung problems. Symptoms include:

  • worsening shortness of breath
  • cough
  • chest discomfort

13. Severe allergic reactions:

  • trouble breathing
  • swelling of the face, tongue, eyes or mouth
  • rash, itchy welts (hives) or blisters, alone or with fever or joint pain.

14. Visual problems.

  • eye pain
  • changes in vision
  • swelling or redness in or around the eye
  • 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.

Do not stop venlafaxine tablets without first talking to your healthcare provider. Stopping venlafaxine tablets too quickly or changing from another antidepressant too quickly may cause serious symptoms including:

  • anxiety, irritability
  • feeling tired, restless or problems sleeping
  • headache, sweating, dizziness
  • electric shock-like sensations, shaking, confusion, nightmares
  • vomiting, nausea, diarrhea

What are venlafaxine tablets?
Venlafaxine tablets are a prescription medicine used to treat depression. It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider.

Talk to your healthcare provider if you do not think that your condition is getting better with venlafaxine tablets treatment.

Who should not take venlafaxine tablets?
Do not take venlafaxine tablets if you:

  • are allergic to venlafaxine hydrochloride or any of the ingredients in venlafaxine tablets. See the end of this Medication Guide for a complete list of ingredients in venlafaxine tablets.
  • have uncontrolled narrow-angle glaucoma
  • 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 tablets unless directed to do so by your physician.
    • Do not start venlafaxine tablets if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.

People who take venlafaxine tablets close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:

  • high fever
  • uncontrolled muscle spasms
  • stiff muscles
  • rapid changes in heart rate or blood pressure
  • confusion
  • loss of consciousness (pass out)

What should I tell my healthcare provider before taking venlafaxine tablets? Ask if you are not sure. Before starting venlafaxine tablets, tell your healthcare provider if you:

  • Are taking certain drugs such as:
    • Amphetamines
    • Medicines used to treat migraine headaches such as:
      • triptans
    • Medicines used to treat mood, anxiety, psychotic or thought disorders, such as:
      • tricyclic antidepressants
      • lithium
      • SSRIs
      • SNRIs
      • antipsychotic drugs
    • Medicines used to treat pain such as:
      • tramadol
    • Medicines used to thin your blood such as:
      • warfarin
    • Medicines used to treat heartburn such as:
      • Cimetidine
    • Over-the-counter medicines or supplements such as:
      • Aspirin or other NSAIDs
      • Tryptophan
      • St. John’s Wort
  • have heart problems
  • have diabetes
  • have liver problems
  • have kidney problems
  • have thyroid problems
  • have glaucoma
  • have or had seizures or convulsions
  • have bipolar disorder or mania
  • have low sodium levels in your blood
  • have high blood pressure
  • have high cholesterol
  • have or had bleeding problems
  • are pregnant or plan to become pregnant. It is not known if venlafaxine tablets will harm your unborn baby. Talk to your healthcare provider about the benefits and risks of treating depression during pregnancy
  • are breastfeeding or plan to breastfeed. Some venlafaxine hydrochloride may pass into your breastmilk. Talk to your healthcare provider about the best way to feed your baby while taking venlafaxine tablets.

Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Venlafaxine tablets and some medicines may interact with each other, may not work as well, or may cause serious side effects.

Your healthcare provider or pharmacist can tell you if it is safe to take venlafaxine tablets with your other medicines. Do not start or stop any medicine while taking venlafaxine tablets without talking to your healthcare provider first.

If you take venlafaxine tablets, you should not take any other medicines that contain (venlafaxine) including: venlafaxine HCl.

How should I take venlafaxine tablets?

  • Take venlafaxine tablets exactly as prescribed. Your healthcare provider may need to change the dose of venlafaxine tablets until it is the right dose for you.
  • Venlafaxine tablets are to be taken with food.
  • If you miss a dose of venlafaxine tablets, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of venlafaxine tablets at the same time.
  • If you take too much venlafaxine tablets, call your healthcare provider or poison control center right away, or get emergency treatment.
  • When switching from another antidepressant to venlafaxine tablets your doctor may want to lower the dose of the initial antidepressant first to avoid side effects

What should I avoid while taking venlafaxine tablets?
Venlafaxine tablets can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how venlafaxine tablets affect you. Do not drink alcohol while using venlafaxine tablets.

What are the possible side effects of venlafaxine tablets?
Venlafaxine tablets may cause serious side effects, including:

  • See “What is the most important information I should know about venlafaxine tablets?”
  • Increased cholesterol- have your cholesterol checked regularly
  • Newborns whose mothers take venlafaxine tablets in the third trimester may have problems right after birth including:
    • problems feeding and breathing
    • seizures
    • shaking, jitteriness or constant crying
  • Narrow-angle glaucoma/enlarged pupils. Check eye pressure regularly if you:
    • have a history of increased eye pressure
    • are at risk for certain types of glaucoma

Common possible side effects in people who take venlafaxine tablets include:

  • unusual dreams
  • sexual problems
  • loss of appetite, constipation, diarrhea, nausea or vomiting, or dry mouth
  • feeling tired, fatigued or overly sleepy
  • change in sleep habits, problems sleeping
  • yawning
  • tremor or shaking
  • dizziness, blurred vision
  • sweating
  • feeling anxious, nervous or jittery
  • headache
  • increase in heart rate

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of venlafaxine tablets. For more information, ask your healthcare provider or pharmacist.

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

How should I store venlafaxine tablets?

  • Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
  • Keep venlafaxine tablets in a dry place.

Keep venlafaxine tablets and all medicines out of the reach of children.

General information about venlafaxine tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use venlafaxine tablets for a condition for which it was not prescribed. Do not give venlafaxine tablets to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about venlafaxine tablets. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about venlafaxine tablets that is written for healthcare professionals.

Please address medical inquiries to (MedicalAffairs@zydususa.com) Tel.: 1-877-993-8779.

What are the ingredients in venlafaxine tablets, USP?
Active ingredient: Venlafaxine hydrochloride, USP
Inactive ingredients: ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

The brands listed are the registered trademarks of their respective owners.

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

This product’s labeling may have been updated. For current package inert, please call American Health Packaging at 1-800-707-4621.

Distributed by:
American Health Packaging Columbus, OH 43217

8284401/0219

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