Venlafaxine Extended-Release Tablets 112.5 mg

Important Safety Information

Indication for Use

VENLAFAXINE EXTENDED-RELEASE TABLETS are indicated in adults for the treatment of Major Depressive Disorder and Generalized Anxiety Disorder.

Contraindications

Venlafaxine Extended-Release Tablets is contraindicated in patients

• With known hypersensitivity to venlafaxine besylate, venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation.
• Taking, or within 14 days of stopping, monoamine oxidase inhibitors (MAOIs) because of an increased risk of serotonin syndrome.

Warnings and Precautions

Serotonin Syndrome

• Serotonin and norepinephrine reuptake inhibitors (SNRIs), including Venlafaxine Extended-Release Tablets, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs and with drugs that impair metabolism of serotonin.

Elevations in Blood Pressure

• In controlled trials, there were dose-related increases in systolic and diastolic blood pressure, as well as cases of sustained hypertension. Monitor blood pressure before initiating treatment with Venlafaxine Extended-Release Tablets and regularly during treatment. Control pre-existing hypertension before initiating treatment with Venlafaxine Extended-Release Tablets.

Abnormal Bleeding

• Venlafaxine Extended-Release Tablets may increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may add to this risk. There is an association between drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding. Exposure to SNRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage.

Angle-Closure Glaucoma

• Venlafaxine Extended-Release Tablets may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.

Activation of Mania or Hypomania

• In patients with bipolar disorder, treating a depressive episode with Venlafaxine Extended-Release Tablets may precipitate a mixed/manic episode. Prior to initiating treatment, screen for any personal or family history of bipolar, mania, or hypomania.

Discontinuation Syndrome

• Abrupt discontinuation or dose reduction of venlafaxine at various doses has been found to be associated with the appearance of new symptoms, the frequency of which increased with increased dose level and with longer duration of treatment. Reported symptoms include agitation, anorexia, anxiety, confusion, impaired coordination and balance, diarrhea, dizziness, dry mouth, dysphoric mood, fasciculation, fatigue, flu-like symptoms, headaches, hypomania, insomnia, nausea, nervousness, nightmares, sensory disturbances (including shock-like electrical sensations), somnolence, sweating, tremor, vertigo, and vomiting. There have been post marketing reports of serious discontinuation symptoms which can be protracted and severe. Completed suicide, suicidal thoughts, aggression, and violent behavior have been observed. Patients should be monitored when discontinuing treatment. A gradual reduction in dosage rather than abrupt cessation is recommended.

Seizures

• Cases of seizures have occurred with venlafaxine therapy. Venlafaxine Extended-Release Tablets, like many antidepressants, should be used cautiously in patients with a history of seizures and should be discontinued in any patient who develops seizures.

Hyponatremia

• Hyponatremia may occur with Venlafaxine Extended-Release Tablets. Elderly patients, patients taking diuretics, and those who are volume-depleted may be at greater risk.

Interstitial Lung Disease and Eosinophilic Pneumonia

• Interstitial lung disease and eosinophilic pneumonia associated with venlafaxine therapy have been rarely reported. The possibility of these events should be considered in Venlafaxine Extended-Release Tablets patients who present with progressive dyspnea, cough, or chest discomfort. Such patients should undergo a prompt medical evaluation, and discontinuation of Venlafaxine Extended-Release Tablets should be considered.

Sexual Dysfunction

• Use of Venlafaxine Extended-Release Tablets may cause symptoms of sexual dysfunction. In male patients, use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction. In female patients, use may result in decreased libido and delayed or absent orgasm.

Adverse reactions

• Most common adverse reactions (incidence ≥ 5% and at least twice the rate of placebo): nausea (30.0%), somnolence (15.3%), dry mouth (14.8%), sweating (11.4%), abnormal ejaculation (9.9%), anorexia (9.8%), constipation (9.3%), impotence (5.3%) and decreased libido (5.1%).

Drug interactions

• Caution is advised when Venlafaxine Extended-Release Tablets is taken in combination with other CNS-active drugs.
• Alcohol increases the release rate of Venlafaxine Extended-Release Tablets. Concomitant alcohol use should be avoided.
• Concomitant use of Venlafaxine Extended-Release Tablets with CYP3A inhibitors may increase the risk of toxicity of venlafaxine.
• Concomitant use of Venlafaxine Extended-Release Tablets with CYP2D6 substrates may increase the risk of toxicity of the CYP2D6 substrate.
• Concomitant use of Venlafaxine Extended-Release Tablets with an antiplatelet or anticoagulant drug may potentiate the risk of bleeding.

Use in specific populations

Pregnancy

• Exposure to Venlafaxine Extended-Release Tablets in mid to late pregnancy may increase the risk for preeclampsia, and exposure to Venlafaxine Extended-Release Tablets in the month before delivery may increase the risk of postpartum hemorrhage.
• Neonates exposed to SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Monitor neonates who were exposed to Venlafaxine Extended-Release Tablets in the third trimester of pregnancy for drug discontinuation syndrome.

For additional safety information about Venlafaxine Extended-Release Tablets, see the Venlafaxine Extended-Release Tablets Full Prescribing Information, including Boxed Warning, and Medication Guide.

You are encouraged to report negative side effects of prescription drugs to Almatica at 1-877-447-7979 or the FDA at www.fda.gov/medwatch, or call 1-800-FDA-1088.