Finished product reference
Cevimeline Hydrochloride
Capsule · Oral · 30 mg
- List code
- 52427
Indications
INDICATIONS AND USAGE Cevimeline hydrochloride capsules are indicated for the treatment of symptoms of dry mouth in patients with Sjögren’s Syndrome.
Dosage and administration (summary)
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.
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.
Warnings and precautions
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.
Storage and supply
HOW SUPPLIED Cevimeline hydrochloride capsules are available as white, hard gelatin capsules with white opaque cap and white opaque body filled with white to off-white powder blend. The capsule is printed with CH in black ink on the body.
Source: Cevimeline Hydrochloride (Cevimeline) — US FDA prescribing information, 2024-02-08, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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