Cevimeline Hydrochloride 30 mg/1
Cevimeline Hydrochloride · CAPSULE · Zydus Lifesciences Limited
Cevimeline Hydrochloride is a capsule containing cevimeline hydrochloride at 30 mg/1, taken oral. Manufactured by Zydus Lifesciences Limited.
Key Facts
- Brand Name
- Cevimeline Hydrochloride
- Generic Name
- Cevimeline Hydrochloride
- NDC Code (Product)
70771-1982- Manufacturer
- Zydus Lifesciences Limited
- Strength
- 30 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA220267
- Marketing Start
- 04/15/2026
Recall History
Apotex Inc.
Failed Stability Specifications: product may not meet specification limit for assay test.
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Cevimeline is indicated for the treatment of symptoms of dry mouth in patients with SjÖgren's Syndrome.
Dosage & Administration
DOSAGE AND ADMINISTRATION The recommended dose of cevimeline hydrochloride is 30 mg taken three times a day. There is insufficient safety information to support doses greater than 30 mg tid. There is also insufficient evidence for additional efficacy of cevimeline hydrochloride at doses greater than 30 mg tid.
Warnings
WARNINGS Cardiovascular Disease: Cevimeline can potentially alter cardiac conduction and/or heart rate. Patients with significant cardiovascular disease may potentially be unable to compensate for transient changes in hemodynamics or rhythm induced by Cevimeline Hydrochloride Capsules. Cevimeline Hydrochloride Capsules should be used 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. Cevimeline should be administered with caution and with close medical supervision to patients with controlled asthma, chronic bronchitis, or chronic obstructive pulmonary disease. Ocular: Ophthalmic formulations of muscarinic agonists have been reported to cause visual blurring which may result in decreased visual acuity, especially at night and in patients with central lens changes, and to cause impairment of depth perception. Caution should be advised while driving at night or performing hazardous activities in reduced lighting.
Contraindications
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.
Drug Interactions
Drug Interactions Cevimeline should be administered with caution to patients taking beta adrenergic antagonists, because of the possibility of conduction disturbances. Drugs with parasympathomimetic effects administered concurrently with cevimeline can be expected to have additive effects. Cevimeline might interfere with desirable antimuscarinic effects of drugs used concomitantly. Drugs which inhibit CYP2D6 and CYP3A3/4 also inhibit the metabolism of cevimeline. Cevimeline should be used with caution in individuals known or suspected to be deficient in CYP2D6 activity, based on previous experience, as they may be at a higher risk of adverse events. In an in vitro study, cytochrome P450 isozymes 1A2, 2A6, 2C9, 2C19, 2D6, 2E1, and 3A4 were not inhibited by exposure to cevimeline.
Adverse Reactions
ADVERSE REACTIONS 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. In these studies, 14.6% of patients discontinued treatment with cevimeline due to adverse events. The following adverse events associated with muscarinic agonism were observed in the clinical trials of cevimeline in SjÖgren's syndrome patients: *n is the total number of patients exposed to the dose at any time during the study. Adverse Event Cevimeline 30 mg (tid) n *= 533 Placebo (tid) n = 164 Excessive Sweating 18.7% 2.4% Nausea 13.8% 7.9% Rhinitis 11.2% 5.4% Diarrhea 10.3% 10.3% Excessive Salivation 2.2% 0.6% Urinary Frequency 0.9% 1.8% Asthenia 0.5% 0.0% Flushing 0.3% 0.6% Polyuria 0.1% 0.6% In addition, the following adverse events (≥3% incidence) were reported in the SjÖgren's clinical trials: *n is the total number of patients exposed to the dose at any time dur…
Frequently Asked Questions
What is Cevimeline Hydrochloride used for?
Cevimeline Hydrochloride contains Cevimeline Hydrochloride. It is a capsule taken oral. Consult your doctor for specific uses.
Is Cevimeline Hydrochloride a controlled substance?
Cevimeline Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Cevimeline Hydrochloride?
The generic name for Cevimeline Hydrochloride is Cevimeline Hydrochloride. There are 5 other brand versions of Cevimeline Hydrochloride.
What is the NDC code for Cevimeline Hydrochloride 30 mg/1?
The NDC (National Drug Code) for Cevimeline Hydrochloride 30 mg/1 is 70771-1982, listed by Zydus Lifesciences Limited.