Adult Dosing

Myasthenia gravis

• Start 5 mg PO tid-qid; may increase gradually at intervals of 1-2 days up to 50-75 mg PO tid-qid
• For moderately severe myasthenia, 5-25 mg PO tid-qid is an effective dose
• Max: 200 mg/day; dosage >200 mg requires close supervision of a physician well aware of the signs and treatment of overdosage with cholinergic drugs

• Individualize therapy as per patient's response and tolerance to side-effects
• Use edrophonium to evaluate sufficiency of maintenance dose of ambenonium. Transient increase in strength occurring 30 seconds later and lasting 3-5 minutes indicates inadequate maintenance dose; no change or a transient decrease in strength indicates sufficient or excessive dose

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of myasthenia gravis

• Hypersensitivity to any of the ingredients of the product
• Concomitant use of atropine
• Concurrent administration with mecamylamine or other ganglionic blockers

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• Due to its prolonged action, concurrent administration of ambenonium with other cholinergics is contraindicated in the absence of strict medical supervision
• Suspend use of any other cholinergics until the patient has been stabilized; in most cases, symptoms of myasthenia gravis are effectively controlled by ambenonium monotherapy
• Therapy must be supervised by a qualified physician to avoid the risk of overdosage. Dose titration should be done cautiously, as there is a narrow margin between initial appearance of side effects and serious toxic effects
• Use cautiously in patients with asthma, Parkinson's disease, and those with mechanical intestinal or urinary obstruction

Caution: Use cautiously in

• Elderly patients

Pregnancy Category:NR

Breastfeeding: Safety unknown. Due of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, analyzing the importance of the drug to the mother.

• CNS: Vertigo
• PSYCHIATRIC: Anxiety
• GI: Excessive salivation, abdominal cramps, diarrhea, nausea, vomiting
• GU: Urinary urgency
• DERM: Sweating
• EENT: Miosis, increased lachrymal secretions
• RESP: Increased bronchial secretions
• MUSC: Muscle cramps, fasciculation of voluntary muscles
• MISC: Malaise

• Cholinesterase inhibitor; reversibly inhibits acetylcholinesterase, thereby preventing hydrolysis of acetylcholine and enhancing cholinergic activity through the accumulation of acetylcholine at cholinergic synapses
• Poorly absorbed from GI tract
• Metabolism: Unknown
• Excretion: Unknown
• Half-life: Unknown

US Trade Name(s)

• Mytelase

US Availability

Mytelase

• CAPLETS: 10 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Neurologic

Muscle Stimulant

Anticholinesterase

Pricing data from www.DrugStore.com in U.S.A.

• Mytelase 10 MG TABS [Bottle] (SANOFI-AVENTIS U.S.)
  100 mg = $185.99
  300 mg = $529.96

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Mytelase 10 MG Oral Tablet

Ingredient(s): Ambenonium

Imprint: W;M;87

Color(s): White

Shape: Oval

Size (mm): 10.00

Score: 2

Inactive Ingredient(s): acacia / dibasic calcium phosphate / gelatin / lactose / magnesium stearate / starch / sucrose

Drug Label Author:
sanofi-aventis U.S. LLC

DEA Schedule:
Non-Scheduled