Cevimeline Hcl (cevimeline HCl)
Systemic Xerostomia Agents Oral Capsule
Last reviewed · Source: First Databank (FDB) drug data
Overview
Cevimeline hydrochloride is a cholinergic agonist that binds to muscarinic receptors.
Cevimeline hydrochloride, a quinuclidine derivative of acetylcholine, is a cholinergic agonist that binds to muscarinic receptors. In sufficient dosages, muscarinic agonists can increase exocrine (e.g., salivary, sweat) gland secretion and increase GI and urinary tract smooth muscle tone.
Cevimeline is pharmacologically similar to pilocarpine, another oral cholinergic agonist that exerts predominantly muscarinic action. Both drugs stimulate residual salivary gland tissues and have been shown to substantially increase salivary flow. However, the adverse effect profile of the drugs may differ based on differences in selectivity and affinity for specific muscarinic receptor subtypes.
Cevimeline is a more selective muscarinic agonist than pilocarpine and exhibits a 40-fold greater affinity for M3 muscarinic receptors in the lacrimal and salivary glands than for M2 receptors in cardiac tissue.
Cevimeline is rapidly absorbed following oral administration; peak plasma concentrations are reached in approximately 1.5-2 hours. Cevimeline is metabolized by cytochrome P-450 (CYP) isoenzymes 2D6, 3A3, and 3A4. In an in vitro study, CYP isoenzymes 1A2, 2A6, 2C9, 2C19, 2D6, 2E1, and 3A4 were not inhibited by cevimeline.
The drug is excreted principally in urine, with 97 and 0.5% of a 30-mg dose recovered in urine and feces, respectively, after 7 days.
USES: This medication is used to treat symptoms of dry mouth due to a certain immune disease (Sjogren's syndrome). Cevimeline belongs to a class of drugs known as cholinergic agonists. It works by stimulating certain nerves to increase the amount of saliva you produce, making it easier and more comfortable to speak and swallow.
Generic name: cevimeline HCl
Pronunciation: (seh-VIMM-eh-leen)
Drug class: Systemic Xerostomia Agents
Therapeutic class: Mouth-Throat-Dental - Preparations
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Cevimeline Hcl
Indications
The following indications are listed for Cevimeline Hcl:
- Xerostomia Secondary To Sjogren's Syndrome
Also known as: Xerostomia Secondary To Gougerot-Sjogren Disease, Xerostomia Secondary To Sicca Syndrome, Xerostomia Secondary To Sjogren's Disease.
Dosing
Dosage of cevimeline hydrochloride is expressed in terms of cevimeline.
The recommended adult dosage of cevimeline for treatment of dry mouth secondary to Sjogren syndrome is 30 mg 3 times daily. Safety and efficacy of dosages exceeding 90 mg daily have not been established.
No dosing information is available for this tab.
| Drug label | Dosing type | Instructions |
|---|---|---|
| Cevimeline Hcl 30 Mg Capsule | Maintenance | Take 1 capsule (30 mg) by oral route 3 times per day. |
| Drug label | Dosing type | Instructions |
|---|---|---|
| Cevimeline Hcl 30 Mg Capsule | Maintenance | Take 1 capsule (30 mg) by oral route 3 times per day. |
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
Moderate Interaction: Assess the risk to the patient and take action as needed.
Cholinergics/Quinidine
SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.
MECHANISM OF ACTION: The anticholinergic properties of quinidine may oppose cholinergic drug effects.
CLINICAL EFFECTS: Quinidine may antagonize the effects of cholinergic drugs in the treatment of myasthenia gravis. Cardiac slowing secondary to cholinergic drugs would tend to be prevented by quinidine.
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: If both drugs are administered, observe the myasthenic patient for signs and symptoms of the disease.
DISCUSSION: Caution is warranted in co-administration of these drugs due to their opposing pharmacologic properties.
Contraindications
Known hypersensitivity to cevimeline hydrochloride, uncontrolled asthma, and when miosis is undesirable (e.g., acute iritis, angle-closure glaucoma).
- Angle-closure glaucoma
- Iritis
- Severe persistent asthma
- Acute myocardial infarction
- Angina
- Asthma
- Cardiac arrhythmia
- Chronic obstructive pulmonary disease
- Night blindness
- Non q-wave myocardial infarction
- Reduced visual acuity
- Biliary calculus
- Cholangitis
- Cholecystitis
- CYp2d6 poor metabolizer
- Kidney stone
- Renal colic
Adverse reactions
Adverse effects occurring in 3% or more of patients receiving cevimeline include excessive sweating, headache, nausea, sinusitis, upper respiratory tract infection, rhinitis, diarrhea, dyspepsia, abdominal pain, urinary tract infection, cough, pharyngitis, vomiting, injury, back pain, rash, conjunctivitis, dizziness, bronchitis, arthralgia, surgical intervention, fatigue, and pain.
Less Frequent
- Abscess
- Acute bacterial otitis media
- Aphthous stomatitis
- Candidiasis
- Cystitis
- Dry eye
- Dyspnea
- Erythema
- Fungal infection
- Hypertonia
- Parotitis
- Peripheral edema
- Pneumonia
- Pruritus of skin
- Sialoadenitis
- Skin rash
- Superficial ocular infection
- Tachycardia
- Urinary tract infection
- Vaginitis
- Vertigo
Rare or Very Rare
- Abnormal hepatic function tests
- Chest pain
- Cholecystitis
- Circumoral edema
- Syncope
More Frequent
- Cough
- Hyperhidrosis
- Nausea
- Rhinitis
- Sinusitis
- Upper respiratory infection
Less Frequent
- Abdominal pain with cramps
- Accidental injury
- Anemia
- Anorexia
- Arthralgia
- Bone pain
- Bronchitis
- Conjunctivitis
- Constipation
- Cramps in legs
- Depression
- Earache
- Edema
- Epistaxis
- Eructation
- Fatigue
- Fever
- Flu-like symptoms
- Flushing
- Gastroesophageal reflux disease
- Hiccups
- Hypoesthesia
- Insomnia
- Migraine
- Muscle weakness
- Myalgia
- Ocular disorders
- Ocular pain
- Pain
- Palpitations
- Sialorrhea
- Tooth disorder
- Toothache
- Tremor
- Visual changes
- Vomiting
- Xerostomia
Rare or Very Rare
- Facial edema
- Hematoma
- Weight gain
- Weight loss
Precautions
No enhanced messaging available.
Safety and efficacy of cevimeline have not been established in children.
There are no adequate and well-controlled studies of cevimeline in pregnant women; in animal studies, a reduced number of implantations, possibly due to maternal toxicity was observed when the drug was administered to pregnant rats.
Cevimeline should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether cevimeline is distributed into milk; a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.
Response in patients 65 years of age and older does not appear to differ from that of younger adults. However, the greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy observed in the elderly should be considered.
ICD codes
| Code | Type | Description |
|---|---|---|
| Xerostomia secondary to sjogren's syndrome | ||
| M35.00 | ICD10CM | Sjogren syndrome, unspecified |
| M35.0C | ICD10CM | Sjogren syndrome with dental involvement |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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