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Pregnancy Category: UK
ClassificationTherapeutic: xerostomia therapy adjuncts
Treatment of the symptoms of dry mouth associated with Sjögren's syndrome.
Direct cholinergic (muscarinic) effects result on increased secretion of exocrine glands including salivary and sweat glands, and increased smooth muscle tone in the gastrointestinal and urinary tracts.
Improved symptoms of dry mouth in patients with Sjögren's syndrome.
Absorption: Rapidly absorbed following oral administration.
Distribution: Extensively bound to tissues.
Metabolism and Excretion: genetic implication Mostly metabolized by the liver (CYP2D6 and CYP3A3/4 isoenzymes) (the CYP2D6 enzyme system exhibits genetic polymorphism; ~7% of population may be poor metabolizers and may have significantly ↑ cevimeline concentrations and an ↑ risk of adverse effects); 16% excreted unchanged in urine.
Half-life: 5 hr.
Time/action profile (blood levels)
Contraindicated in: Hypersensitivity; When miosis is undesirable (acute iritis, angle-closure glaucoma); Lactation: Discontinue or bottle feed.
Use Cautiously in: Cardiovascular disease including angina pectoris or history of MI; Pulmonary disease including asthma, chronic bronchitis, or chronic obstructive pulmonary disease; Nephrolithiasis or cholelithiasis; Geriatric: May be more sensitive to toxicity; Obstetric: Use only if potential benefit justifies potential risk to the fetus; Pediatric: Safety not established.
Adverse Reactions/Side Effects
Central nervous system
Ear, Eye, Nose, Throat
- rhinitis (most frequent)
- visual disturbances
- nausea (most frequent)
- excessive salivation
- excessive sweating (most frequent)
- hot flashes
Drug-Drug interactionConcurrent beta blocker therapy may ↑ the risk of cardiac conduction disturbances.Additive parasympathetic and muscarinic effects may occur with drugs that have parasympathetic or muscarinic properties.Drugs that inhibit CYP2D6 and CYP3A3/4 liver enzymes may inhibit the metabolism of cevimeline and ↑ its effects and risk of toxicity.St. John's wort may ↑ the metabolism of cevimeline and ↓ its levels.Angel's trumpet, jimson weed, and scopolia may antagonize cholinergic effects.
Oral (Adults) 30 mg 3 times daily.
Availability (generic available)
Capsules: 30 mg
- Assess patient for dry mouth prior to and periodically during therapy.
- Lab Test Considerations: May cause ↑ GGT, AST, and ALT.
Potential Nursing DiagnosesImpairedoral mucous membrane, altered (Indications)
Deficient knowledge, related to medication regimen (Patient/Family Teaching)
- Oral: Administer 30 mg three times daily.
- Instruct patient to take cevimeline as directed.
- May cause visual disturbances, especially at night, that could impair ability to drive safely.
- Advise patient to drink extra water if sweating excessively. May cause dehydration.
- Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
- Advise female patients to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
- Decrease in dry mouth in patients with Sjögren's disease.
cevimeline/cev·i·mel·ine/ (sĕ-vim´ah-lēn) a cholinergic agonist used as the hydrochloride salt in the treatment of xerostomia associated with Sjögren's syndrome.
a cholinergic agonist used as the hydrochloride salt in the treatment of xerostomia associated with Sjögren's syndrome, administered orally.