Viatrin® Injection, each ampoule contains : Methylergometrine maleate 0.2 mg/ml.
Viatrin® contains Methylergometrine maleate as active ingredient available in sugar coated tablet 0.125 mg and injection 0.2 mg/ml.
- Active management of the third 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.
- Following abortion.
- 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 Viatrin® 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 Viatrin®, 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 Viatrin® 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 Viatrin®.
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.
Viatrin® Injection Box, 5 ampoules @ 1 ml
Reg. No. DKL2002361543A1
KEEP IN REFRIGERATOR (2 – 8)ºC, PROTECT FROM LIGHT AND NO FREEZING. PLEASE STORE THE PRODUCT ON THE BOX BEFORE USED.
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
Sidoarjo – Indonesia