Cevimeline Hydrochloride
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Questions & Answers
Side Effects & Adverse Reactions
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 hydrochloride capsules. Cevimeline hydrochloride capsules 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.
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.
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Cevimeline is indicated for the treatment of symptoms of dry mouth in patients with Sjögren’s Syndrome.
History
There is currently no drug history available for this drug.
Other Information
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.½ H2O, and its structural formula is:
Cevimeline has a molecular weight of 244.79. It is a white to off white crystalline powder with a melting point range of 201 to 203°C. It is freely soluble in alcohol and chloroform, very soluble in water, and virtually insoluble in ether. The pH of a 1% solution ranges from 4.6 to 5.6. Inactive ingredients include lactose monohydrate and magnesium stearate.
Sources
Cevimeline Hydrochloride Manufacturers
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Apotex Corp.
![Cevimeline Hydrochloride Capsule [Apotex Corp. ]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Cevimeline Hydrochloride | Apotex Corp.
The recommended dose of cevimeline hydrochloride is 30 mg taken three times a day. There is insufficient safety information to support doses greater than 30 mg t.i.d. There is also insufficient evidence for additional efficacy of cevimeline hydrochloride at doses greater than 30 mg t.i.d.
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Roxane Laboratories, Inc.
Cevimeline Hydrochloride | Roxane Laboratories, Inc.
The recommended dose of cevimeline hydrochloride 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.
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Pack Pharmaceuticals, Llc
Cevimeline Hydrochloride | Pack Pharmaceuticals, Llc
The recommended dose of Cevimeline Hydrochloride 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.
![Cevimeline Hydrochloride Capsule [Roxane Laboratories, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1167360c-7e0f-4619-9d1a-ad4ee56cab71&name=1167360c-7e0f-4619-9d1a-ad4ee56cab71-02.jpg)
![Cevimeline Hydrochloride Capsule [Pack Pharmaceuticals, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d4bd942a-1339-40c5-8fd4-850da5a69635&name=product-label.jpg)
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