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Cevimeline Hydrochloride (Cevimeline Hydrochloride)

Trade Name : Cevimeline Hydrochloride

West-Ward Pharmaceuticals Corp.

CAPSULE

Strength 30 mg/1

CEVIMELINE HYDROCHLORIDE Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Cevimeline Hydrochloride (Cevimeline Hydrochloride) which is also known as Cevimeline Hydrochloride and Manufactured by West-Ward Pharmaceuticals Corp.. It is available in strength of 30 mg/1 per ml. Read more

Cevimeline Hydrochloride (Cevimeline Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Rx only
  • Cevimeline is cis-2u2019-methylspiro {1-azabicyclo [2.2.2] octane-3, 5u2019 -[1,3] oxathiolane} hydrochloride, hydrate (2:1). Its molecular formula is CHNOS.HCl.1/2 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 203u00b0C. 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 hydroxypropyl cellulose, lactose monohydrate, and magnesium stearate. Gelatin capsule shells contain: gelatin, monogramming ink, purified water, sodium lauryl sulfate and titanium dioxide. The monogramming ink contains: ammonium hydroxide, iron oxide, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac.
  • No data
  • Cevimeline hydrochloride is indicated for the treatment of symptoms of dry mouth in patients with Sju00f6grenu2019s Syndrome.
  • Cevimeline hydrochloride 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.
  • No data
  • No data
  • Cevimeline was administered to 1777 patients during clinical trials worldwide, including Sju00f6grenu2019s patients and patients with other conditions. In placebo-controlled Sju00f6grenu2019s 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 Sju00f6grenu2019s syndrome patients:
  • In addition, the following adverse events (u22653% incidence) were reported in the Sju00f6grenu2019s clinical trials:
  • The following events were reported in Sju00f6grenu2019s patients at incidences of <3% and u22651%: 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 Sju00f6grenu2019s patients (<1%): Causal relation is unknown:
  • Body as a Whole Disorders:
  • Cardiovascular Disorders:
  • Digestive Disorders:
  • Endocrine Disorders:
  • Hematologic Disorders:
  • Liver and Biliary System Disorders:
  • Metabolic and Nutritional Disorders:
  • Musculoskeletal Disorders:
  • Neoplasms:
  • Nervous Disorders:
  • Miscellaneous Disorders:
  • Resistance Mechanism Disorders:
  • Respiratory Disorders:
  • Rheumatologic Disorders:
  • Skin and Appendages Disorders:
  • 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 Sju00f6grenu2019s 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 cevimeline. 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.
  • 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.
  • 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 Capsules
  • 30 mg capsules is supplied as a white opaque cap and white opaque body with u201c54 190u201d printed on the cap and body, containing a white powder.
  • NDC 0054-0334-25: Bottle of 100 Capsules
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]
  • Distr. by:n
  • Pharmaceuticals Corp.
  • Eatontown, NJ 07724
  • 10006322/02
  • Revised April 2016
  • No data

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