EVOXAC® (cevimeline HCl) Important Safety Information
Cevimeline HCI is indicated for the treatment of symptoms of dry mouth in patients with Sjögren’s syndrome.
- Cevimeline HCl is contraindicated in patients with uncontrolled asthma, known hypersensitivity to the drug, and when miosis is undesirable, e.g., in acute iritis and narrow-angle (angle-closure) glaucoma
- Cevimeline HCl can potentially alter cardiac conduction and heart rate and produce transient changes in hemodynamics. Cevimeline HCl should be administered with caution and under close medical supervision to patients with a history of cardiac disease, controlled asthma, chronic bronchitis, or chronic obstructive pulmonary disease
- Cevimeline HCl should be administered with caution to patients taking beta-adrenergic antagonists because of the possibility of conduction disturbances and to patients with a history of nephrolithiasis or cholelithiasis
- If a patient sweats excessively while taking cevimeline HCl, dehydration may develop
- Caution should be advised while driving at night or performing hazardous activities in reduced lighting
- Safety and effectiveness in pediatric patients have not been established
- Cevimeline HCl is metabolized by the P-450 isozymes CYP2D6 and CYP3A3/4. Thus, there may be potential for interaction between cevimeline HCl and other compounds
- Special care should be exercised when cevimeline HCl is taken by geriatric patients, considering the greater frequency of decreased hepatic, renal, or cardiac function
- The most frequently reported adverse events associated with the pharmacologic action of a muscarinic agonist (>10% incidence) in clinical trials of cevimeline HCl were: excessive sweating, nausea, rhinitis, and diarrhea. Consult the full prescribing information for other adverse events
Please click here for full Prescribing Information for EVOXAC.
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