Methylergometrine maleate Sugar coated tablet, each sugar coated tablet contains : Methylergometrine maleate 0.125 mg.
Methylergometrine maleate contains Methylergometrine maleate as active ingredient available in sugar coated tablet 0.125 mg and injection 0.2 mg/ml.
Active management of the thrid stage of labor (as a means to promote separation of the placenta and to reduce blood loss).
Treatment of uterine atony/hemorrhage occurring.
During and after the third stage of labor.
In association with cesarean section.
Treatment of subinvolution of the uterus, lochiometra, puerperal bleeding.
DOSAGE AND ADMINISTRATIONS :
Active management of the third stage labour :
Intramuscular injection (IM) is the recommended route of administration. When adminsitered intravenously (IV) the dose must be administered slowly over a period of no less than 60 seconds (see WARNINGS AND PRECAUTIONS).
The recommended dosage Methylergometrine maleate is : 1 ml (0.2 mg) IM or 0.5 – 1 ml (0.1 – 0.2 mg) slowly IV following 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 Methylergometrine maleate, should be manually assisted by applying fundal pressure.
For delivery under general anesthesia, the recommended dose is 1 ml (0.2 mg) by slow intravenous injection.
Treatment uterine atony/hemorrhage :
Intramuscular injection (IM) is the recommended route of administration. When administered intravenously (IV) the dose must be administered slowly over a period of no less than 60 seconds (see WARNINGS AND PRECAUTIONS).
The recommended dosage of Methylergometrine maleate is : 1 ml (0.2 mg) IM or 0.5 – 1 ml (0.1 – 0.2 mg) slowly IV. The dose may be repeated as required at intervals of no less than 2 hours.
Treatment of subinvolution, lochiometra, puerperal bleeding :
0.125 – 0.25 mg p.o. (1 – 2 tablets) or 0.5 – 1 ml IM, up to 3 times daily; in lactating women preferably for no longer than 3 days.
Nausea, vomiting, hypertension or hypotension, numbness, tingling and pain in the extremities, respiratory depression, convulsions, coma.
Elimination of orally ingested drug by administration of high doses of activated charcoal.
Symptomatic treatment under close monitoring of the cardiovascular and the respiratory system.
If sedation is required, Benzodiazepines may be used.
In case of severe arteriospasm, vasodilators should be administered, e.g., Sodium nitroprusside, Phentolamine or Dihydralazine. In the event of coronary constriction, appropriate antianginal treatment should be provided (e.g., Nitrates).
First stage of labor.
Second stage of labor before delivery of the anterior shoulder (Methylergometrine maleate must not be used for induction or enhancement of labor).
Severe hypertension, preeclampsia and eclampsia, occlusive vascular disease (including ischemic heart disease).
Known hypersensitivity to Methylergometrine to other ergot alkaloids or to any excipients of Methylergometrine maleate.
WARNINGS AND PRECAUTIONS :
In breech presentation and other abnormal presentations, Methylergometrine maleate should not be given before delivery of the child is completed and in multiple birth not before the last child has been delivered.
Active management of the third stage of labor requires obstetric supervision. Intravenous injections must be given slowly over a period of no less than 60 seconds with careful monitoring of blood pressure. Intra or periarterial injection must be avoided.
Hypertension and impaired hepatic or renal function : Caution should be exercised in the presence of mild or moderate hypertension (severe hypertension is a contraindication) or impaired hepatic or renal function.
Coronary artery disease : Patients with coronary artery disease or with risk factors for coronary artery disease (e.g., smoking, obesity, diabetes, high cholesterol) may be more susceptible to developing myocardial ischemia and infarction associated with Methylergometrine-induced vasospasm (see ADVERSE REACTIONS).
Medications errors : Accidental administration to be newborn infant has been reported. In these accidental neonatal overdosage cases, symptoms such a respiratory depression, convulsions, cyanosis, oliguria, have been reported. Furthermore, encephalopathy has been reported in infants presenting with signs and symptoms such as irritability, agitation and lethargy. Treatment should be symptomatic; in severe cases respiratory and cardiovascular support have been required. Fatal cases have been reported in the absence of adequate treatment (see OVERDOSAGE).
Women of child-bearing potential : Not applicable for Methylergometrine maleate due to the targeted indications.
Pregnancy : The use of Methylergometrine maleate in pregnancy is contraindicated because of its potent uterotonic activity.
Breastfeeding : Methylergometrine maleate has been reported to reduce milk secretion and to be excreted in the breast milk. There have been isolated reports of intoxication in breast-fed infants whose mothers were receiving the drug for several days. One or more of the following symptoms were observed (and disappeared upon withdrawal of the medication) : Elevated blood pressure, bradycardia or tachycardia, vomiting, diarrhea, restlessness, convulsion. In view of the possible side effects for the child and the reduction of the milk yield Methylergometrine maleate is not recommended for use during breastfeeding. Women should not breast-feed during treatment with Methylergometrine maleate and at least 12 hours after administration of the last dose. Milk secreted during this period should be discarded.
Fertility : Not applicable for Methylergometrine maleate due to the targeted indications.
Driving and using machines : Methylergometrine may cause dizziness and convulsions. Therefore, caution should be exercised when driving or operating machines.
DRUG INTERACTIONS :
CYP3A4 inhibitors : Ergot alkaloids are substrates of CYP3A4. The concomitant use of Methylergometrine maleate with potent CYP3A4 inhibitors such as Macrolide antibiotics (e.g., Troleandomycin, Erythromycin, Clarithromycin), HIV protease or reverse transcriptase inhibitors (e.g., Ritonavir, Indinavir, Nelfinavir, Delavirdine) or Azole antifungals (e.g., Ketoconazole, Itraconazole, Voriconazole) should be avoided, since this can result in an elevated exposure to Methylergometrine and ergot toxicity (vasospasm and ischemia of the extremities and other tissues).
Bromocriptine : The concomitant use of Bromocriptine and Methylergometrine maleate in the puerperium is not recommended as Methylergometrine may enhance the vasoconstrictor effect of other ergot alkaloids. No adverse interactions are known to occur with the concurrent administration of Methylergometrine maleate and Oxytocin.
Prostaglandins : Prostaglandins (e.g., Sulprostone, Dinoprostone, Misoprostol) facilitate contraction of the myometrium hence, Methylergometrine maleate can potentiate the uterine action of prostaglandins and vice versa. Concomitant use with these drugs is not recommended.
Less potent CYP3A4 inhibitors : Caution is required for the concomitant use of Methylergometrine maleate with less potent CYP3A4 inhibitors (e.g., Cimetidine, Delavirdine, Grapefruit juice, Quinupristin, Dalfopristin).
Vasoconstrictors, Triptans, sympathomimetics and other ergot alkaloids : Caution should be exercised when Methylergometrine maleate is used concurrently with other vasoconstrictors or other ergot alkaloids. Methylergometrine may enhance the vasoconstrictor/vasopressor effects of other drugs such as Triptans (5HT1B/1D receptor agonists), sympathomimetics (including those in local anesthetics) or other ergot alkaloids.
β-blocker : Caution should be exercised when Methylergometrine maleate is used concurrently with β-blocker. Concomitant administration with β-blocker may enhance the vasoconstrictive action of ergot alkaloids.
Anesthetics : Anesthetics like Halothan and Methoxyfluran may reduce the oxytocic potency of Methylergometrine maleate.
CYP3A4 inducers : Drugs (e.g., Nevirapine, Rifampicin) that are strong inducers of CYP3A4 are likely to decrease the pharmacological action of Methylergometrine maleate.
Glyceryl trinitrate and other antianginal drugs : Methylergometrine produces vasoconstriction and can be expected to reduce the effect of Glyceryl trinitrate and other antianginal drugs.
ADVERSE REACTIONS :
Immune system disorders :
Anaphylactic reactions (very rare)
Nervous system disorders :
Dizziness, convulsions (uncommon)
Hallucinations (very rare)
Cerebrovascular accident, paraesthesia
Ear and labyrinth disorders :
Tinnitus (very rare)
Cardiac disorders :
Chest pain (uncommon)
Bradycardia, tachycardia, palpitations (rare)
Myocardial infarction, arteriospasm coronary (very rare)
Ventricular fibrillation, ventricular tachycardia, angina pectoris, atrioventricular block
Vascular disorders :
Vasoconstriction, vasospasm, arterial spasm (rare)
Thrombophlebitis (very rare)
Respiratory, thoracic and mediastinal disorders :
Nasal congestion (very rare)
Gastrointestinal disorders :
Nausea, vomiting (uncommon)
Diarrhea (very rare)
Skin and sub-cutaneous tissue disorders :
Skin eruptions (common)
Musculoskeletal and connective tissue disorders :
Muscle spasms (very rare)
Pregnancy, puerperium and perinatal conditions :
Abdominal pain (caused by uterine contractions) (common)
Methylergometrine maleate Sugar coated tablet Box, 3 strips @ 10 sugar coated tablets
Reg. No. GKL1902359716A1
Methylergometrine maleate Sugar coated tablet :
STORE BELOW 25°C AND DRY PLACE, PROTECT FROM LIGHT.
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
Sidoarjo – Indonesia