Ambenonium

U.S. BRAND NAMES — Mytelase®

PHARMACOLOGIC CATEGORY
Cholinergic Agonist

DOSING: ADULTS — Myasthenia gravis: Oral: 5-25 mg 3-4 times/day

DOSING: ELDERLY — Refer to adult dosing.

DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Caplet, as chloride [scored]:
Mytelase®: 10 mg

DOSAGE FORMS: CONCISE
Caplet [scored]:
Mytelase®: 10 mg

GENERIC EQUIVALENT AVAILABLE — No

USE — Treatment of myasthenia gravis

ADVERSE REACTIONS SIGNIFICANT — Frequency not defined.

Cardiovascular: Arrhythmias (especially bradycardia), hypotension, carbon monoxide decreased, tachycardia, AV block, nodal rhythm, ECG changes (nonspecific), cardiac arrest, syncope, flushing

Central nervous system: Convulsions, dysarthria, dysphonia, dizziness, loss of consciousness, drowsiness, headache

Dermatologic: Skin rash, thrombophlebitis (I.V.), urticaria

Gastrointestinal: Hyperperistalsis, nausea, vomiting, salivation, diarrhea, stomach cramps, dysphagia, flatulence

Genitourinary: Urinary urgency

Neuromuscular & skeletal: Weakness, fasciculations, muscle cramps, spasms, arthralgia

Ocular: Small pupils, lacrimation

Respiratory: Bronchial secretions increased, laryngospasm, bronchiolar constriction, respiratory muscle paralysis, dyspnea, respiratory depression, respiratory arrest, bronchospasm

Miscellaneous: Diaphoresis increased, anaphylaxis, allergic reactions

CONTRAINDICATIONS — Routine administration of atropine or other belladonna alkaloids with ambenonium is contraindicated because they may suppress the muscarinic symptoms of excessive gastrointestinal stimulation, leaving only the more serious symptoms of muscle fasciculations and paralysis as signs of overdosage; should not be administered to patients receiving mecamylamine

WARNINGS / PRECAUTIONS
Concerns related to adverse effects: Anticholinergic insensitivity: May develop for brief or prolonged periods; reduce or withhold dosages until the patient becomes sensitive again. May require respiratory support.

Disease-related concerns: Asthma: Use with caution in patients with asthma. Bradycardia: Use with caution in patients with bradycardia. Hyperthyroidism: Use with caution in patients with hyperthyroidism. Parkinson's disease: Use with caution in patients with Parkinson's disease. Peptic ulcer disease: Use with caution in patients with peptic ulcer disease. Seizures: Use with caution in patients with a history of seizures. Urinary tract obstruction: Use with caution in patients with urinary obstruction.

Special populations: Pediatrics: Safety and efficacy have not been established in children.

Other warnings/precautions: Appropriate use: Differentiation of cholinergic/myasthenia crisis is critical; use edrophonium and clinical judgment. Prolonged action after cholinergics; drug should be discontinued until the patient is stabilized.

DRUG INTERACTIONS
Acetylcholinesterase Inhibitors: May enhance the adverse/toxic effect of Cholinergic Agonists. Risk C: Monitor therapy

PREGNANCY RISK FACTOR — C (show table)

LACTATION — Excretion in breast milk unknown/not recommended

PRICING — (data from drugstore.com)
Tablets (Mytelase)
10 mg (100): $172.65

CANADIAN BRAND NAMES — Mytelase®

INTERNATIONAL BRAND NAMES — Mytelase (FI, HU, PL); Mytelase Chloride (BE, CZ, FR, HN, SE)