Myotonine Tablets 10mg

Each 10mg tablet weighs 400mg; total active ingredient 10mg bethanechol chloride USP.

Each 10mg tablet is white, flat with bevelled edge and with a single score and embossed “MYO10”.

Urinary retention -acute postoperative, postpartum and neurogenic.

Reflux oesophagitis.

Administration orally by tablets.

Adults: 10 mg - 25mg 3-4 times daily. Taken ½ hr before food. Occasionally it may be felt necessary to initiate therapy with a 50mg dose.

Children: The experience with children is limited; therefore no recommended dose is given.

Elderly: Adult dosage administered with caution.

Intestinal or urinary obstruction, recent myocardial infarction, recent intestinal anastomosis.

A severe cholinergic reaction is likely to occur if Bethanechol Chloride is administered IV or IM. This reaction has also rarely occurred in cases of hypersensitivity or overdose.

Pharmacological interactions may occur with the following when bethanechol is administered. Quinidine and procainamide which may antagonise cholinergic effects, cholinergic drugs which may have an additive effect, particularly cholinesterase inhibitors. When administered to patients receiving ganglionic blocking compounds, a critical fall in blood pressure may occur preceded by severe abdominal symptoms.

Should not be used during pregnancy or lactation.

In some cases the ability to drive and operate machinery may be impaired.

Nausea, vomiting, sweating and intestinal colic.

Symptoms: Include nausea, salivation, lachrymation, eructation, involuntary defecation and urination, transient dyspnoea, palpitation, bradycardia and peripheral vasodilation leading to hypertension, transient heart block and a feeling of constriction under the sternum.

Emergency Procedure: The stomach should be emptied by aspiration and lavage.

Give atropine sulphate 1-2mg intravenously, intramuscularly or subcutaneously to control muscarinic effects. This dose may be repeated every 2-4 hours as necessary. Supportive treatment includes intravenous administration of diazepam 5-10mg:muscle twitching may be controlled by small doses of tubocararine (together with assisted respiration): oxygen may be required.

Bethanechol is a synthetic choline ester of carbamic acid which possesses a significant acetylcholine-like activity. It is active after oral administration. As a consequence of the very slow hydrolysation by acetylcholinesterase, bethanechol has a prolonged action as has been demonstrated on the urinary tract. The onset of action after oral administration of bethanechol chloride occurs within one hour.

The major pharmacological effects of bethanechol result from interaction of the drug with muscarinic receptor sites of smooth muscles, especially those of the urinary bladder and gastrointestinal tract. In addition, minor but important nicotinic effects have been noted.

In usual therapeutic doses, bethanechol does not cross the blood brain barrier. Studies addressing pharmacokinetic- pharmacodynamic are not available.

None stated.

Calcium sulphate dihydrate BP;

Maize starch BP;

Purified talc BP

None known.

3 years.

None. Keep out of reach of children.

The container consists of blister strips of PVC/ aluminium foil packed in boxes. Each container holds 100 tablets.

None

Glenwood GmbH

Riedener Weg 23

82319 Starnberg

Germany

PL 22824/0003

4^th December 1973/ 9^th May 1996

25/10/2010