Evoxac®
GoodRxCevimeline · oral capsule
Dry Eye/OSD
Approved uses
Dry mouth in Sjögren's syndrome
30 mg orally three times daily; there is insufficient safety information to support doses above 30 mg three times daily
Contraindicated in narrow angles and acute iritis, which is the reason an eye examination belongs before it is started
Contraindications
Cevimeline is contraindicated in patients with uncontrolled asthma, known hypersensitivity to cevimeline, and when miosis is undesirable, e.g., in acute iritis and in narrow-angle (angle-closure) glaucoma.
Available FormsCevimeline hydrochloride 30 mg capsules.
Mechanism of ActionCevimeline is a cholinergic agonist that binds muscarinic receptors, with an apparent affinity for the M3 receptors on lacrimal and salivary gland epithelium, increasing secretion from the exocrine glands.
Warnings & Precautions
- Contraindicated when miosis is undesirable, such as in acute iritis and in narrow-angle glaucoma.
- May cause blurred vision, particularly at night and in reduced light; advise caution with driving.
- Use with caution in controlled asthma, chronic bronchitis, chronic obstructive pulmonary disease, and in cardiovascular disease, where changes in heart rate or rhythm may be poorly tolerated.
- May cause excessive sweating and dehydration.
Common Side Effects
Cevimeline was administered to 1777 patients during clinical trials worldwide, including SjÖgren's patients and patients with other conditions. In placebo-controlled SjÖgren's studies in the U.S., 320 patients received cevimeline doses ranging from 15 mg tid to 60 mg tid, of whom 93% were women and 7% were men. Demographic distribution was 90% Caucasian, 5% Hispanic, 3% Black and 2% of other origin.
Pregnancy & LactationPregnancy: No adequate and well-controlled studies in pregnant women; use only if the potential benefit justifies the potential risk.
Lactation: Unknown whether cevimeline is present in human milk; a decision should weigh the mother's clinical need.
Pediatric UseSafety and effectiveness in pediatric patients have not been established.