MERGOTRINE (tab)
-
Chemical Name:
Methylergometrine maleate -
Therapeutic Category:
Gynecological drugs -
Pharmacologic Category:
Uterine stimulant -
Pharmaceutical Form:
Tablets -
Composition:
Methylergometrine maleate 0.125mg
MERGOTRINE
F.C.Tablets, Injection (Ampoule)
Methylergometrine Maleate
1. PHARMACOLOGY:
Methylergometrine, a semisynthetic derivative of the naturally occurring alkaloid ergometrine, is a potent and specific uterotonic agent, compared with the alkaloids of the ergotamine group its effect on peripheral vessels.
2. PHARMACOKINETICS:
The absorption of MERGOTRINE following both oral and intramuscular administration is rapid, the maximum plasma concentration being reached after 30 minutes. In the puerperium gastrointestinal absorption is slower, and the maximum plasma concentration is reached after 3 hours. Only about 3% of an oral dose is eliminated as parent drug in the urine, indicating extensive metabolism. The drug is mainly eliminated with the bile into the faeces.
The onset of action of MERGOTRINE occurs in 30 - 60 seconds after i.v, (2 - 5) minutes after i.m, and 5 - 10 minutes after oral administration and lasts for 4 - 6 hours.
3. INDICATIONS:
- Active management of the third stage of labour.
- Treatment of uterine atony/haemorrhage occurring:
- during and after the third stage of labour.
- in association with caesarean section.
- following abortion.
- Treatment of subinvolution of the uterus, lochiometra, puerperal bleeding
4. CONTRAINDICATIONS:
Pregnancy, first stage of labour, second stage of labour before crowning of the head (MERGOTRINE must not be used for induction or enhancement of labour), severe hypertension, hypertensive toxaemia (pre-eclampsia, eclampsia), occlusive vascular disease (incl. ischemic heart disease), sepsis, hypersensitivity to ergot alkaloids.
5. PRECAUTIONS:
MERGOTRINE passes into the milk but, the doses which reach the newborn is very small. By any case the patient must consult his physcian.
Care should be taken if it is prescribed in patients with renal or hepatic failure.
Intravenous injection should be given slowly over a period of not less than 60 seconds.
6. DRUG INTERACTIONS:
MERGOTRINE may enhance the vasconstrictor/vasopressor effects of other drugs such as sympathomimetics (e.g. used with local anaesthetics) or ergotamine.
No adverse interactions are known to occur with the concurrent administration of MERGOTRINE and oxytocin.
7. SIDE EFFECTS:
In few cases: Abdominal pain (caused by uterine contractions); nausea, vomiting, sweating, dizziness, headache, skin eruptions.
Very rarely hypertension, bradycardia or tachycardia.
In very few cases anaphylactic reactions (dyspnoea, hypotension, shock) occurred.
8. DOSAGE & ADMINISTRATION:
Tablets:
Subinvolution, lochiometra, puerperal bleeding: 0,125 to 0,250 mg p.o. (1-2 tablets daily). Preferably for no longer than 3 days in lactating women. The dosage may reach to 3 times daily.
Ampoules:
Active management of the third stage of labour. 0.1 to 0.2 mg slowly i.v. following the delivery of the anterior shoulder or, at the latest, immediately after delivery of the child. Expulsion of the placenta-usually separated by the first strong contraction following MERGOTRINE – should be manually assisted.
For delivery under general anaesthesia the recommended dose is (0.2 mg).
9. PACKAGING & COMPOSITION:
- MERGOTRINE – F.C.Tablets: A pack of 20 film coated tablets. Each f.c.tablet contains Methylergometrine Maleate 0.125 mg.
- MERGOTRINE – Injection: A pack of 5 or 100 ampoules of 1 mL. Each ampoule (1 mL) contains Methylergometrine Maleate 0.2 mg.