CEVIMELINE 30 mg/1

CEVIMELINE HYDROCHLORIDE · CAPSULE · Bionpharma Inc

1 Recall on Record

Plain English

CEVIMELINE is a capsule containing cevimeline hydrochloride at 30 mg/1, taken oral. Manufactured by Bionpharma Inc.

Key Facts

Brand Name: CEVIMELINE
Generic Name: CEVIMELINE HYDROCHLORIDE
NDC Code (Product): 69452-316
Manufacturer: Bionpharma Inc
Strength: 30 mg/1
Dosage Form: CAPSULE
Route: ORAL
Marketing Status
Application #: ANDA218290
Marketing Start: 01/17/2024

Recall History

1 Recall on Record

Class II08/17/2015

Apotex Inc.

Failed Stability Specifications: product may not meet specification limit for assay test.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective103 reports

nausea88 reports

headache87 reports

fatigue86 reports

diarrhoea74 reports

dyspnoea63 reports

pain61 reports

malaise59 reports

off label use57 reports

product dose omission issue55 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Cevimeline hydrochloride capsules are 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 capsules 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. Cevimeline 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.

Adverse Reactions

ADVERSE REACTIONS Cevimeline was administered to 1,777 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: Adverse Event Cevimeline 30 mg (tid) n n is the total number of patients exposed to the dose at any time during the study. = 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: Adverse Event Cevimeline 30 mg (tid) n n is the total number of patien…

Frequently Asked Questions

What is CEVIMELINE used for?

CEVIMELINE contains CEVIMELINE HYDROCHLORIDE. It is a capsule taken oral. Consult your doctor for specific uses.

Is CEVIMELINE a controlled substance?

CEVIMELINE is not classified as a controlled substance by the DEA.

What is the generic name for CEVIMELINE?

The generic name for CEVIMELINE is CEVIMELINE HYDROCHLORIDE. There are 11 other brand versions of CEVIMELINE HYDROCHLORIDE.

What is the NDC code for CEVIMELINE 30 mg/1?

The NDC (National Drug Code) for CEVIMELINE 30 mg/1 is 69452-316, listed by Bionpharma Inc.

Product NDC

69452-316

Package NDC

69452-316-20

Other Cevimeline Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)