Cevimeline 30 mg Capsule, 100-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Cholinergic Receptor Agonist class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Cevimeline is used to treat the symptoms of dry mouth in patients with Sjogren's syndrome (a condition that affects the immune system and causes dryness of certain parts of the body such as the eyes and mouth). Cevimeline is in a class of medications called cholinergic agonists. It works by increasing the amount of saliva in the mouth.
Read the full MedlinePlus article ↗- Your Sjögren's Syndrome causes your immune system to damage the glands that make saliva. Cevimeline steps in by directly activating the 'on switches' on those glands — called musca...
- What is cevimeline actually doing for my dry mouth?
- Taking it on an empty stomach gets it into your system a little faster and gives a slightly higher peak level. Food slows things down a bit and lowers the peak level. Either way is...
- Should I take it with food or on an empty stomach?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Cevimeline — tap one for details:
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII RFW2ET671P
Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
3 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.708 | $70.80 / 100 capsules |
| Medicaid paysCMS SDUD · 12 mo | $0.8418 | $84.18 / 100 capsules |
| Medicare drug plans payPart D · Q2 2026 | $1.24 | $124.32 / 100 capsules |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Cevimeline Hydrochloride 30 mg 00054-0334-25 | Hikma | 100 capsules | $0.708 | AB | Availability likely | — |
| cevimeline hydrochloride 30 mg 00713-0937-01 | Cosette | 100 capsules | $0.708 | AB | Availability likely | — |
| Cevimeline Hydrochloride 30 mg 16571-0657-10 | Rising | 100 capsules | $0.708 | AB | Availability likely | — |
| Cevimeline Hydrochloride 30 mg 33342-0216-11 | Macleods | 100 capsules | $0.708 | AB | Availability likely | — |
| Cevimeline Hydrochloride 30 mg 59651-0422-01 | Aurobindo | 100 capsules | $0.708 | — | Availability likely | — |
| Cevimeline 30 mgthis 63304-0479-01 | Sun | 100 capsules | $0.708 | AB | Availability likely | — |
| Cevimeline 30 mg 69452-0316-20 | Bionpharma | 100 capsules | $0.708 | AB | Availability likely | — |
| Cevimeline Hydrochloride 30 mg 72578-0208-01 | Viona | 100 capsules | $0.708 | AB | Availability likely | — |
| Evoxac 30 mg 00713-0883-01 | Cosette | 100 capsules | $8.591 | AB | Availability likely | +1113% |
| cevimeline hydrochloride 30 mg 40032-0999-01 | Novel | 100 capsules | — | AB | FDA listed | — |
| Cevimeline Hydrochloride 30 mg 63629-9863-01 | Bryant | 30 capsules | — | AB | FDA listed | — |
| Cevimeline Hydrochloride 30 mg 70771-1982-01 | Zydus | 100 capsules | — | AB | FDA listed | — |
| Cevimeline Hydrochloride 30 mg 71335-2264-01 | Bryant | 30 capsules | — | AB | FDA listed | — |
| Cevimeline Hydrochloride 30 mg 71335-2326-01 | Bryant | 30 capsules | — | AB | FDA listed | — |
| Cevimeline Hydrochloride 30 mg 72162-2563-01 | Bryant | 100 capsules | — | AB | FDA listed | — |
| Cevimeline Hydrochloride 30 mg 72789-0457-01 | PD-Rx | 100 capsules | — | AB | FDA listed | — |
| Cevimeline Hydrochloride 30 mg 72888-0118-00 | Advagen | 1000 capsules | — | AB | FDA listed | — |
| Cevimeline Hydrochloride 30 mg 87063-0180-01 | ASCLEMED | 100 capsules | — | AB | FDA listed | — |
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⏳ Availability & generic status
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
Where does this data come from?
🗺️ Medicaid utilization & spend
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 63304-0479-01 You're viewing this | 100 CAPSULE in 1 BOTTLE (63304-479-01) | 2016-03-10 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Cevimeline hydrochloride capsules are indicated for the treatment of symptoms of dry mouth in patients with Sjögren’s Syndrome.
⏱️ Dosage and Administration ▾
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 evidence for additional efficacy of cevimeline hydrochloride at doses greater than 30 mg tid.
⛔ Contraindications ▾
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.
⚠️ Warnings ▾
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 in hemodynamics or rhythm induced by cevimeline. Cevimeline 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.
Pulmonary Disease: 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. Ocular: 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.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS 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: Adverse Event Cevimeline 30 mg (tid) n*=533 Placebo (tid) n=164 Excessive Sweating 18.7% 2.4% Nausea 13.8% 7.9% Rhinitis 11.2% 5.4% Diarrhea 10.3% 10.3% Excessive Salivation 2.2% 0.6% Urinary Frequency 0.9% 1.8% Asthenia 0.5% 0.0% Flushing 0.3% 0.6% Polyuria 0.1% 0.6% * n Is the total number of patients exposed to the dose at any time during the study.
In addition, the following adverse events (≥3% incidence) were reported in the Sjögren’s clinical trials: Adverse Event Cevimeline 30 mg (tid) n*=533 Placebo (tid) n=164 Headache 14.4% 20.1% Sinusitis 12.3% 10.9% Upper Respiratory Tract Infection 11.4% 9.1% Dyspepsia 7.8% 8.5% Abdominal Pain 7.6% 6.7% Urinary Tract Infection 6.1% 3.0% Coughing 6.1% 3.0% Pharyngitis 5.2% 5.4% Vomiting 4.6% 2.4% Injury 4.5% 2.4% Back Pain 4.5% 4.2% Rash 4.3% 6.0% Conjunctivitis 4.3% 3.6% Dizziness 4.1% 7.3% Bronchitis 4.1% 1.2% Arthralgia 3.7% 1.8% Surgical Intervention 3.3% 3.0% Fatigue 3.3% 1.2% Pain 3.3% 3.0% Skeletal Pain 2.8% 1.8% Insomnia 2.4% 1.2% Hot Flushes 2.4% 0.0% Rigors 1.3% 1.2% Anxiety 1.3% 1.2% * n is the total number of patients exposed to the dose at any time during the study.
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 : aggravated allergy, precordial chest pain, abnormal crying, hematoma, leg pain, edema, periorbital edema, activated pain trauma, pallor, changed sensation temperature, weight decrease, weight increase, choking, mouth edema, syncope, malaise, face edema, substernal chest pain Cardiovascular Disorders : abnormal ECG, heart disorder, heart murmur, aggravated hypertension, hypotension, arrhythmia, extrasystoles, t wave inversion, tachycardia, supraventricular tachycardia, angina pectoris, myocardial infarction, pericarditis, pulmonary embolism, peripheral ischemia, superficial phlebitis, purpura, deep thrombophlebitis, vascular disorder, vasculitis, hypertension Digestive Disorders : appendicitis, increased appetite, ulcerative colitis, diverticulitis, duodenitis, dysphagia, enterocolitis, gastric ulcer, gastritis, gastroenteritis, gastrointestinal hemorrhage, gingivitis, glossitis, rectum hemorrhage, hemorrhoids, ileus, irritable bowel syndrome, melena, mucositis, esophageal stricture, esophagitis, oral hemorrhage, peptic ulcer, periodontal destruction, rectal disorder, stomatitis, tenesmus, tongue discoloration, tongue disorder, geographic tongue, tongue ulceration, dental caries Endocrine Disorders : increased glucocorticoids, goiter, hypothyroidism Hem…
🆘 Overdosage ▾
MANAGEMENT OF OVERDOSE 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.
🧬 Clinical Pharmacology ▾
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 glands and increase tone of the smooth muscle in the gastrointestinal and urinary tracts. Pharmacokine tics Absorption: After administration of a single 30 mg capsule, cevimeline was rapidly absorbed with a mean time to peak concentration of 1.5 to 2 hours.
No accumulation of active drug or its metabolites was observed following multiple dose administration. When administered with food, there is a decrease in the rate of absorption, with a fasting t MAX of 1.53 hours and a t MAX of 2.86 hours after a meal; the peak concentration is reduced by 17.3%. Single oral doses across the clinical dose range are dose proportional.
Distribution: Cevimeline has a volume of distribution of approximately 6L/kg and is <20% bound to human plasma proteins. This suggests that cevimeline is extensively bound to tissues; however, the specific binding sites are unknown. Metabolism: Isozymes CYP2D6 and CYP3A3/4 are responsible for the metabolism of cevimeline.
After 24 hours, 86.7% of the dose was recovered (16.0% unchanged, 44.5% as cis and trans-sulfoxide, 22.3% of the dose as glucuronic acid conjugate and 4% of the dose as N-oxide of cevimeline). Approximately 8% of the trans-sulfoxide metabolite is then converted into the corresponding glucuronic acid conjugate and eliminated. Cevimeline did not inhibit cytochrome P450 isozymes 1A2, 2A6, 2C9, 2C19, 2D6, 2E1, and 3A4.
Excretion: The mean half-life of cevimeline is 5+ /-1 hours. After 24 hours, 84% of a 30 mg dose of cevimeline was excreted in urine. After seven days, 97% of the dose was recovered in the urine and 0.5% was recovered in the feces.
Special Populations: The effects of renal impairment, hepatic impairment, or ethnicity on the pharmacokinetics of cevimeline have not been investigated. Clinical Studies Cevimeline has been shown to improve the symptoms of dry mouth in patients with Sjögren’s Syndrome. A 6-week, randomized, double blind, placebo-controlled study was conducted in 75 patients (10 men, 65 women) with a mean age of 53.6 years (range 33-75).
The racial distribution was Caucasian 92%, Black 1 % and other 7%. The effects of cevimeline at 30 mg tid (90 mg/day) and 60 mg tid (180 mg/day) were compared to those of placebo. Patients were evaluated by a measure called global improvement, which is defined as a response of "better" to the question, "Please rate the overall condition of your dry mouth now compared with how you felt before starting treatment in this study." Patients also had the option of selecting "worse" or "no change" as answers.
Seventy-six percent of the patients in the 30 mg tid group reported a global improvement in their dry mouth symptoms compared to 35% of the patients in the placebo group. This difference was statistically significant at p=0.0043. There was no evidence that patients in the 60 mg tid group had better global evaluation scores than the patients in the 30 mg tid group.
A 12-week, randomized, double-blind, placebo-controlled study was conducted in 197 patients (10 men, 187 women) with a mean age of 54.5 years (range 23-74). The racial distribution was Caucasian 91.4%, Black 3% and other 5.6%. The effects of cevimeline at 15 mg tid (45 mg/day) and 30 mg tid (90 mg/day) were compared to those of placebo.
Statistically significant global improvement in the symptoms of dry mouth (p=0.0004) was seen for the 30 mg tid group compared to placebo, but not for the 15 mg group compared to placebo. Salivary flow showed statistically significant increases at both doses of cevimeline during the study compared to placebo. A second 12-week, randomized, double-blind, placebo-controlled study was conducted in 212 patients (11 men, 201 women) with a mean age of 55.3 years (range 24-75).
The racial distribution was Caucasian 88.7%, Black 1.9% and ot…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Cevimeline is available as white, hard gelatin capsules containing 30 mg of cevimeline hydrochloride. Cevimeline hydrochloride 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 63304-479-01). Store at 25°C (77°F); excursion permitted to 15° to 30°C (59° to 86°F). Rx only Distributed by: Sun Pharmaceutical Industries , Inc.
Cranbury, NJ 08512 Revised 05/2018 Printed in U.S.A. USPI-CEV-0518-r100
📋 Description ▾
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 C 10 H 17 NOS.HCl.½ H 2 O, 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 o 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, hydroxypropyl cellulose, and magnesium stearate.
The structural formula for 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 203oC. 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.