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cevimeline hydrochloride

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Overview

What is Evoxac?

Cevimeline is cis -2’-methylspiro{1-azabicyclo [2.2.2] octane-3, 5’-[1,3] oxathiolane} hydrochloride, hydrate (2:1). Its empirical formula is CHNOS.HCl.½ HO, 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 203C. 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, hydroxypropyl cellulose, and magnesium stearate.



What does Evoxac look like?



What are the available doses of Evoxac?

Sorry No records found.

What should I talk to my health care provider before I take Evoxac?

Sorry No records found

How should I use Evoxac?

Cevimeline is indicated for the treatment of symptoms of dry mouth in patients with Sjögren’s Syndrome.

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.


What interacts with Evoxac?

Sorry No Records found


What are the warnings of Evoxac?

Sorry No Records found


What are the precautions of Evoxac?

Sorry No Records found


What are the side effects of Evoxac?

Sorry No records found


What should I look out for while using Evoxac?

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.


What might happen if I take too much Evoxac?

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 medically indicated, atropine, an anti-cholinergic agent, may be of value as an antidote for emergency use in patients who have had an overdose of cevimeline. If medically indicated, epinephrine may also be of value in the presence of severe cardiovascular depression or bronchoconstriction. It is not known if cevimeline is dialyzable.


How should I store and handle Evoxac?

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].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” on the cap and “30 mg” on the body with a black bar above “30 mg”. It is supplied in child resistant bottles of:100 capsules (NDC 63395-201-13).Store at 25°C (77°F) excursion permitted to 15°-30°C (59°-86°F)Rx onlyManufactured for:Daiichi Sankyo, Inc.Basking Ridge, NJ 07920Revised 06/2017 Printed in U.S.A.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” on the cap and “30 mg” on the body with a black bar above “30 mg”. It is supplied in child resistant bottles of:100 capsules (NDC 63395-201-13).Store at 25°C (77°F) excursion permitted to 15°-30°C (59°-86°F)Rx onlyManufactured for:Daiichi Sankyo, Inc.Basking Ridge, NJ 07920Revised 06/2017 Printed in U.S.A.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” on the cap and “30 mg” on the body with a black bar above “30 mg”. It is supplied in child resistant bottles of:100 capsules (NDC 63395-201-13).Store at 25°C (77°F) excursion permitted to 15°-30°C (59°-86°F)Rx onlyManufactured for:Daiichi Sankyo, Inc.Basking Ridge, NJ 07920Revised 06/2017 Printed in U.S.A.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” on the cap and “30 mg” on the body with a black bar above “30 mg”. It is supplied in child resistant bottles of:100 capsules (NDC 63395-201-13).Store at 25°C (77°F) excursion permitted to 15°-30°C (59°-86°F)Rx onlyManufactured for:Daiichi Sankyo, Inc.Basking Ridge, NJ 07920Revised 06/2017 Printed in U.S.A.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” on the cap and “30 mg” on the body with a black bar above “30 mg”. It is supplied in child resistant bottles of:100 capsules (NDC 63395-201-13).Store at 25°C (77°F) excursion permitted to 15°-30°C (59°-86°F)Rx onlyManufactured for:Daiichi Sankyo, Inc.Basking Ridge, NJ 07920Revised 06/2017 Printed in U.S.A.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” on the cap and “30 mg” on the body with a black bar above “30 mg”. It is supplied in child resistant bottles of:100 capsules (NDC 63395-201-13).Store at 25°C (77°F) excursion permitted to 15°-30°C (59°-86°F)Rx onlyManufactured for:Daiichi Sankyo, Inc.Basking Ridge, NJ 07920Revised 06/2017 Printed in U.S.A.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” on the cap and “30 mg” on the body with a black bar above “30 mg”. It is supplied in child resistant bottles of:100 capsules (NDC 63395-201-13).Store at 25°C (77°F) excursion permitted to 15°-30°C (59°-86°F)Rx onlyManufactured for:Daiichi Sankyo, Inc.Basking Ridge, NJ 07920Revised 06/2017 Printed in U.S.A.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” on the cap and “30 mg” on the body with a black bar above “30 mg”. It is supplied in child resistant bottles of:100 capsules (NDC 63395-201-13).Store at 25°C (77°F) excursion permitted to 15°-30°C (59°-86°F)Rx onlyManufactured for:Daiichi Sankyo, Inc.Basking Ridge, NJ 07920Revised 06/2017 Printed in U.S.A.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

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 glands and increase tone of the smooth muscle in the gastrointestinal and urinary tracts.

Non-Clinical Toxicology
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.

Cevimeline should be administered with caution to patients taking beta adrenergic antagonists, because of the possibility of conduction disturbances. Drugs with parasympathomimetic effects administered concurrently with cevimeline can be expected to have additive effects. Cevimeline might interfere with desirable antimuscarinic effects of drugs used concomitantly.

Drugs which inhibit CYP2D6 and CYP3A3/4 also inhibit the metabolism of cevimeline. Cevimeline should be used with caution in individuals known or suspected to be deficient in CYP2D6 activity, based on previous experience, as they may be at a higher risk of adverse events. In an study, cytochrome P450 isozymes 1A2, 2A6, 2C9, 2C19, 2D6, 2E1, and 3A4 were not inhibited by exposure to cevimeline.

Cevimeline toxicity is characterized by an exaggeration of its parasympathomimetic effects. These may include: headache, visual disturbance, lacrimation, sweating, respiratory distress, gastrointestinal spasm, nausea, vomiting, diarrhea, atrioventricular block, tachycardia, bradycardia, hypotension, hypertension, shock, mental confusion, cardiac arrhythmia, and tremors.

Cevimeline should be administered with caution to patients with a history of nephrolithiasis or cholelithiasis. Contractions of the gallbladder or biliary smooth muscle could precipitate complications such as cholecystitis, cholangitis and biliary obstruction. An increase in the ureteral smooth muscle tone could theoretically precipitate renal colic or ureteral reflux in patients with nephrolithiasis.

Cevimeline was administered to 1777 patients during clinical trials worldwide, including Sjögren’s patients and patients with other conditions. In placebo-controlled Sjögren’s studies in the U.S., 320 patients received cevimeline doses ranging from 15 mg tid to 60 mg tid, of whom 93% were women and 7% were men. Demographic distribution was 90% Caucasian, 5% Hispanic, 3% Black and 2% of other origin. In these studies, 14.6% of patients discontinued treatment with cevimeline due to adverse events.

The following adverse events associated with muscarinic agonism were observed in the clinical trials of cevimeline in Sjögren’s syndrome patients:

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In addition, the following adverse events (≥3% incidence) were reported in the Sjögren’s clinical trials:

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The following events were reported in Sjögren’s patients at incidences of <3% and ≥1%: constipation, tremor, abnormal vision, hypertonia, peripheral edema, chest pain, myalgia, fever, anorexia, eye pain, earache, dry mouth, vertigo, salivary gland pain, pruritus, influenza-like symptoms, eye infection, post operative pain, vaginitis, skin disorder, depression, hiccup, hyporeflexia, infection, fungal infection, sialoadenitis, otitis media, erythematous rash, pneumonia, edema, salivary gland enlargement, allergy, gastroesophageal reflux, eye abnormality, migraine, tooth disorder, epistaxis, flatulence, toothache, ulcerative stomatitis, anemia, hypoesthesia, cystitis, leg cramps, abscess, eructation, moniliasis, palpitation, increased amylase, xerophthalmia, allergic reaction.

The following events were reported rarely in treated Sjögren’s patients (<1%): Causal relation is unknown:

Body as a Whole Disorders

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Cardiovascular Disorders

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Digestive Disorders

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Endocrine Disorders

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Hematologic Disorders

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Liver and Biliary System Disorders

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Metabolic and Nutritional Disorders:

 

Musculoskeletal Disorders

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Neoplasms:

 

Nervous Disorders

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Miscellaneous Disorders

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Resistance Mechanism Disorders:

 

Respiratory Disorders

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Rheumatologic Disorders

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Skin and Appendages Disorders

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Special Senses Disorders:

 

Urogenital Disorders:

 

In one subject with lupus erythematosus receiving concomitant multiple drug therapy, a highly elevated ALT level was noted after the fourth week of cevimeline therapy. In two other subjects receiving cevimeline in the clinical trials, very high AST levels were noted. The significance of these findings is unknown.

Additional adverse events (relationship unknown) which occurred in other clinical studies (patient population different from Sjögren’s patients) are as follows:

cholinergic syndrome, blood pressure fluctuation, cardiomegaly, postural hypotension, aphasia, convulsions, abnormal gait, hyperesthesia, paralysis, abnormal sexual function, enlarged abdomen, change in bowel habits, gum hyperplasia, intestinal obstruction, bundle branch block, increased creatine phosphokinase, electrolyte abnormality, glycosuria, gout, hyperkalemia, hyperproteinemia, increased lactic dehydrogenase (LDH), increased alkaline phosphatase, failure to thrive, abnormal platelets, aggressive reaction, amnesia, apathy, delirium, delusion, dementia, illusion, impotence, neurosis, paranoid reaction, personality disorder, hyperhemoglobinemia, apnea, atelectasis, yawning, oliguria, urinary retention, distended vein, lymphocytosis.

The following adverse reaction has been identified during post-approval use of

EVOXAC

. Because post-marketing adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Post-Marketing Adverse Events

Liver and Biliary

System Disorders: cholecystitis

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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