Myotonine Tablets 10mg
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Myotonine Tablets 10mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10mg tablet weighs 400mg; total active ingredient 10mg bethanechol chloride USP.
3 PHARMACEUTICAL FORM
Each 10mg tablet is white, flat with bevelled edge and with a single score and embossed “MYO10”.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Urinary retention -acute postoperative, postpartum and neurogenic.
Reflux oesophagitis.
4.2 Posology and method of administration
Administration orally by tablets.
Adults: 10 mg - 25mg 3-4 times daily. Taken 'A 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.
4.3 Contraindications
Intestinal or urinary obstruction, recent myocardial infarction, recent intestinal anastomosis.
4.4 Special warnings and precautions for use
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.
4.5 Interaction with other medicinal products and other forms of interaction
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.
4.6 Fertility, Pregnancy and lactation
Should not be used during pregnancy or lactation.
4.7 Effects on ability to drive and use machines
In some cases the ability to drive and operate machinery may be impaired.
4.8 Undesirable effects
Nausea, vomiting, sweating and intestinal colic.
Overdose
4.9
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.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
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.
5.2 Pharmacokinetic properties
In usual therapeutic doses, bethanechol does not cross the blood brain barrier. Studies addressing pharmacokinetic- pharmacodynamic are not available.
5.3
Preclinical safety data
None stated.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Calcium dihydrate BP;
Maize starch BP;
Purified talc BP
6.2 Incompatibilities
None known.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
None.
Keep out of reach of children.
6.5 Nature and contents of container
The container consists of blister strips of PVC/aluminium foil packed in boxes.
Each container holds 100 tablets.
6.6 Special precautions for disposal
None
MARKETING AUTHORISATION HOLDER
7
Glenwood GmbH Jensenstr. 6 81679 Munchen Germany
8 MARKETING AUTHORISATION NUMBER(S)
PL 22824/0005
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
04.12.1973 / 01.06.2014
10 DATE OF REVISION OF THE TEXT
20/03/2015