Venlafaxine Hydrochloride (Page 13 of 14)

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 MAOls, 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 are available as follows:

25 mg — mottled peach, round, flat beveled tablet, scored on both sides. One side of the tablet has embossing “T” on one side of the score and “V” on the other side of the score. The opposite side of the tablet has embossing “1” on one side of the score and “K” on the other side of the score. It is available in bottles of 100 (NDC 0093-9147-01).

37.5 mg — mottled peach, round, flat beveled tablet, scored on both sides. One side of the tablet has embossing “T” on one side of the score and “V” on the other side of the score. The opposite side of the tablet has embossing “2” on one side of the score and “K” on the other side of the score. It is available in bottles of 100 (NDC 0093-9148-01).

50 mg — mottled peach, round, flat beveled tablet, scored on both sides. One side of the tablet has embossing “T” on one side of the score and “V” on the other side of the score. The opposite side of the tablet has embossing “3” on one side of the score and “K” on the other side of the score. It is available in bottles of 100 (NDC 0093-9149-01).

75 mg — mottled peach, round, flat beveled tablet, scored on both sides. One side of the tablets has embossing “T” on one side of the score and “V” on the other side of the score. The opposite side of the tablet has embossing “4” on one side of the score and “K” on the other side of the score. It is available in bottles of 100 (NDC 0093-9157-01).

100 mg — mottled peach, round, flat beveled tablet, scored on both sides. One side of the tablet has embossing “T” on one side of the score and “V” on the other side of the score. The opposite side of the tablet has embossing “5” on one side of the score and “K” on the other side of the score. It is available in bottles of 100 (NDC 0093-9163-01).

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

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

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

Manufactured In Czech Republic By:
Teva Czech Industries, s.r.o.
Opava-Komarov, Czech Republic

Manufactured For:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454

Rev. R 2/2019

MEDICATION GUIDE

Venlafaxine (ven la fax een) Tablets USP

Read the Medication Guide that comes with venlafaxine tablets before you start taking them 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 are 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 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 tablets 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 breast-feeding or plan to breast-feed. Some venlafaxine hydrochloride may pass into your breast milk. 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.

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