EVOXAC is a cholinergic agonist indicated for the treatment of symptoms of dry mouth in adults with Sjögren’s disease.
INDICATIONS AND USAGE
EVOXAC (capsules and oral solution) is a cholinergic agonist indicated for the treatment of symptoms of dry mouth in patients with Sjögren’s disease.
CONTRAINDICATIONS
EVOXAC is contraindicated in patients with:
• Known hypersensitivity to cevimeline.
• Uncontrolled asthma.
• Conditions in which miosis is undesirable, e.g., acute iritis and narrow-angle (angle-closure) glaucoma.
WARNINGS AND PRECAUTIONS
Cardiovascular Disease. Cevimeline can potentially alter cardiac conduction and/or heart rate. Patients with significant cardiovascular disease may be unable to compensate for transient changes in hemodynamics or rhythm induced by cevimeline. Use with caution and under close medical supervision in patients with a history of cardiovascular disease evidenced by angina pectoris or myocardial infarction
Pulmonary Disease. Cevimeline can potentially increase airway resistance, bronchial smooth muscle tone, and bronchial secretions. Administer with caution and close medical supervision to patients with controlled asthma, chronic bronchitis, or chronic obstructive pulmonary disease.
Ocular Effects. Muscarinic agonists may cause visual blurring, decreased visual acuity, especially at night and in patients with central lens changes, and impaired depth perception. Advise caution while driving at night or performing hazardous activities in reduced lighting.
ADVERSE REACTIONS
In placebo-controlled Sjögren’s studies, the most common adverse events with cevimeline 30 mg three times daily that occurred at an incidence of at least 10% and at an incidence equal to or greater than placebo were excessive sweating, nausea, rhinitis, diarrhea, sinusitis, and upper respiratory tract infection.
DRUG INTERACTIONS
• Use caution with beta-adrenergic antagonists because of the possibility of conduction disturbances.
• Drugs with parasympathomimetic effects may have additive effects when used with cevimeline. Cevimeline may interfere with desirable antimuscarinic effects of concomitant drugs.
• Drugs that inhibit CYP2D6 and CYP3A3/4 also inhibit cevimeline metabolism. Use caution in patients known or suspected to be deficient in CYP2D6 activity because they may be at higher risk of adverse events.
USE IN SPECIFIC POPULATIONS
EVOXAC is not recommended during pregnancy or breastfeeding, and in pediatric patients.
REPORTING SUSPECTED ADVERSE REACTIONS
To report suspected adverse reactions, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or to the FDA at1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information for EVOXAC