EVOXAC Capsule (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Daiichi Sankyo, Inc.

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1. Description

Cevimeline is cis -2'-methylspiro{1-azabicyclo [2.2.2] octane-3, 5'-[1,3] oxathiolane} hydrochloride, hydrate (2:1). Its empirical formula is C10H17NOS.HCl.½H2O, and its ...

2. Clinical Pharmacology

Pharmacodynamics Cevimeline is a cholinergic agonist which binds to muscarinic receptors. Muscarinic agonists in sufficient dosage can increase secretion of exocrine glands, such as salivary and sweat ...

3. Indications and Usage

Cevimeline is indicated for the treatment of symptoms of dry mouth in patients with Sjögrens Syndrome.

4. 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. ...

5. 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 ...

6.1. General

Cevimeline toxicity is characterized by an exaggeration of its parasympathomimetic effects. These may include: headache, visual disturbance, lacrimation, sweating, respiratory distress, gastrointestinal ...

6.2. Information for Patients

Patients should be informed that cevimeline may cause visual disturbances, especially at night, that could impair their ability to drive safely. If a patient sweats excessively while taking cevimeline, ...

6.4. 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 ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Lifetime carcinogenicity studies were conducted in CD-1 mice and F-344 rats. A statistically significant increase in the incidence of adenocarcinomas of the uterus was observed in female rats that received ...

6.7. Pregnancy

Cevimeline was associated with a reduction in the mean number of implantations when given to pregnant Sprague-Dawley rats from 14 days prior to mating through day seven of gestation at a dosage of 45 mg/kg/day ...

6.9. Nursing Mothers

It is not known whether this drug is secreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from EVOXAC, a ...

6.10. Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

6.11. Geriatric Use

Although clinical studies of cevimeline included subjects over the age of 65, the numbers were not sufficient to determine whether they respond differently from younger subjects. Special care should be ...

7. Adverse Reactions

Cevimeline was administered to 1777 patients during clinical trials worldwide, including Sjögrens patients and patients with other conditions. In placebo-controlled Sjögrens studies in the U.S., 320 patients ...

9. Overdosage

Management of the signs and symptoms of acute overdosage should be handled in a manner consistent with that indicated for other muscarinic agonists: general supportive measures should be instituted. If ...

10. 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 ...

11. How Supplied

EVOXAC is available as white, hard gelatin capsules containing 30 mg of cevimeline hydrochloride. EVOXAC capsules have a white opaque cap and a white opaque body. The capsules are imprinted with EVOXAC ...

12. Storage and Handling

Store at 25°C (77°F) excursion permitted to 15°-30°C (59°-86°F).