Version May 2024
Xerostomia (associated with Sjögren disease): Oral: 30 mg 3 times/day.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults.
>10%:
Dermatologic: Diaphoresis (19%)
Gastrointestinal: Nausea (14%)
Respiratory: Rhinitis (11%), sinusitis (12%), upper respiratory tract infection (11%)
1% to 10%:
Cardiovascular: Chest pain (1% to 3%), edema (1% to 3%), palpitations (1% to 3%), peripheral edema (1% to 3%)
Dermatologic: Erythematous rash (1% to 3%), pruritus (1% to 3%)
Endocrine & metabolic: Hot flash (2%)
Gastrointestinal: Abdominal pain (8%), anorexia (1% to 3%), aphthous stomatitis (1% to 3%), constipation (1% to 3%), enlargement of salivary glands (1% to 3%), eructation (1% to 3%), flatulence (1% to 3%), gastroesophageal reflux disease (1% to 3%), hiccups (1% to 3%), increased serum amylase (1% to 3%), salivary gland pain (1% to 3%), sialadenitis (1% to 3%), sialorrhea (2%), vomiting (5%)
Genitourinary: Cystitis (1% to 3%), urinary tract infection (6%), vaginitis (1% to 3%)
Hematologic & oncologic: Anemia (1% to 3%)
Hypersensitivity: Hypersensitivity reaction (1% to 3%)
Infection: Abscess (1% to 3%), fungal infection (1% to 3%), infection (1% to 3%)
Nervous system: Depression (1% to 3%), fatigue (3%), hypertonia (1% to 3%), hypoesthesia (1% to 3%), hyporeflexia (1% to 3%), insomnia (2%), migraine (1% to 3%), tremor (1% to 3%), vertigo (1% to 3%)
Neuromuscular & skeletal: Arthralgia (4%), back pain (5%), lower limb cramp (1% to 3%), myalgia (1% to 3%), skeletal pain (3%)
Ophthalmic: Eye infection (1% to 3%), eye pain (1% to 3%), visual disturbance (1% to 3%)
Otic: Otalgia (1% to 3%)
Respiratory: Bronchitis (4%), cough (6%), epistaxis (1% to 3%), flu-like symptoms (1% to 3%), pneumonia (1% to 3%)
Miscellaneous: Fever (1% to 3%)
<1%: Nervous system: Asthenia
Postmarketing:
Cardiovascular: Cardiac arrhythmia (Petrone 2002), ECG abnormality (Petrone 2002), hypotension (Petrone 2002)
Dermatologic: Urticaria (Petrone 2002)
Gastrointestinal: Cholecystitis, diarrhea (Petrone 2002), dyspepsia (Fife 2002), dysphagia (Petrone 2002), parotid gland enlargement (Noaiseh 2014)
Genitourinary: Breast swelling (Noaiseh 2014), urinary frequency (Fife 2002)
Hypersensitivity: Mouth edema (Petrone 2002)
Nervous system: Dizziness (Petrone 2002), headache (Petrone 2002), paranoid ideation (Petrone 2002)
Hypersensitivity to cevimeline or any component of the formulation; uncontrolled asthma; when miosis is undesirable (eg, narrow-angle glaucoma, acute iritis)
Concerns related to adverse effects:
• Parasympathomimetic effects: Toxicity is characterized by an exaggeration of parasympathomimetic effects (eg, atrioventricular block, bradycardia, cardiac arrhythmia, hypotension, lacrimation, sweating, respiratory distress, tachycardia, tremors, vomiting); excessive sweating may lead to dehydration in some patients.
• Visual effects: May cause blurred vision, decreased visual acuity (particularly at night and in patients with central lens changes) and impaired depth perception. Patients should be cautioned about driving at night or performing hazardous activities in reduced lighting.
Disease-related concerns:
• Cardiovascular disease: Use with caution in patients with significant cardiovascular disease (including angina, myocardial infarction); may alter cardiac conduction and/or heart rate.
• Cholelithiasis: Use with caution in patients with a history of cholelithiasis; may induce contractions of the gallbladder or biliary smooth muscle, precipitating complications such as cholangitis, cholecystitis, or biliary obstruction.
• Nephrolithiasis: Use with caution in patients with a history of nephrolithiasis; may induce smooth muscle spasms, precipitating renal colic or ureteral reflux in patients with nephrolithiasis.
• Respiratory disease: Use with caution in patients with controlled asthma, COPD, or chronic bronchitis; may increase bronchial smooth muscle tone, airway resistance, and bronchial secretions.
Special populations:
• Patients with CYP2D6 deficiency: Patients with a known or suspected deficiency of CYP2D6 may be at higher risk of adverse effects.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Oral, as hydrochloride:
Evoxac: 30 mg
Generic: 30 mg
Yes
Capsules (Cevimeline HCl Oral)
30 mg (per each): $3.48 - $3.49
Capsules (Evoxac Oral)
30 mg (per each): $9.77
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Xerostomia (associated with Sjögren disease): Treatment of symptoms of dry mouth in patients with Sjögren disease.
Cevimeline may be confused with Savella
Evoxac may be confused with Eurax
Substrate of CYP2D6 (minor), CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Acetylcholinesterase Inhibitors: May enhance the adverse/toxic effect of Cholinergic Agonists. Specifically, cholinergic effects may be enhanced or increased. Risk C: Monitor therapy
Beta-Blockers: May enhance the adverse/toxic effect of Cholinergic Agonists. Of particular concern are the potential for cardiac conduction abnormalities and bronchoconstriction. Risk C: Monitor therapy
Cimetropium: Cholinergic Agonists may diminish the anticholinergic effect of Cimetropium. Risk C: Monitor therapy
Rivastigmine: Cholinergic Agonists may enhance the adverse/toxic effect of Rivastigmine. Specifically, cholinergic effects may be enhanced or increased. Rivastigmine may enhance the adverse/toxic effect of Cholinergic Agonists. Management: Use of rivastigmine with a cholinergic agonist is not recommended unless clinically necessary. If the combination is necessary, monitor for increased cholinergic effects. Risk D: Consider therapy modification
Sincalide: Drugs that Affect Gallbladder Function may diminish the therapeutic effect of Sincalide. Management: Consider discontinuing drugs that may affect gallbladder motility prior to the use of sincalide to stimulate gallbladder contraction. Risk D: Consider therapy modification
Adverse effects were observed in animal reproduction studies.
It is not known if cevimeline is excreted in breast milk. Due to the potential for serious adverse reactions in the nursing infant, the manufacturer recommends a decision be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of treatment to the mother.
Binds to muscarinic (cholinergic) receptors, causing an increase in secretion of exocrine glands (such as salivary and sweat glands) and increase tone of smooth muscle in gastrointestinal and urinary tracts
Absorption: Rapid; food decreases rate of absorption.
Distribution: Vd: 6 L/kg.
Protein binding: <20%.
Metabolism: Hepatic via CYP2D6, CYP3A3, and CYP3A4; metabolites: cis and trans-sulfoxide, glucuronic acid conjugate, N-oxide metabolite.
Half-life elimination: 5 ± 1 hours.
Time to peak: 1.5 to 2.9 hours.
Excretion: Urine (84% in 24 hours, 97% in 7 days); feces (0.5% in 7 days).
آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟
