Ergometrine (Tablets) Instructions for Use

Marketing Authorization Holder

Pharmtsentr Vilar JSC (Russia)

ATC Code

G02AB03 (Ergometrine)

Active Substance

Ergometrine (Rec.INN WHO registered)

Dosage Form

Ergometrine

Tablets 200 mcg: 20 pcs.

Dosage Form, Packaging, and Composition

20 pcs. – dark glass jars (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.

Clinical-Pharmacological Group

A drug that increases the tone and contractile activity of the myometrium

Pharmacotherapeutic Group

Uterotonic agent

Pharmacological Action

Ergot alkaloid. Increases the tone and contractile activity of the myometrium. Increases the amplitude and frequency of uterine contractions, increases cervical contractions.

After administration in average therapeutic doses, it causes intense contractions followed by normal periods of relaxation. In high doses, it causes constant strong uterine contractions with shortened or absent periods of relaxation.

Contraction of the uterine wall around bleeding vessels at the placental attachment site causes hemostasis.

Causes vasoconstriction mainly of capacitance vessels, increases central venous pressure and blood pressure. Arterial vasoconstriction is due to stimulation of α-adrenergic and serotonin receptors and inhibition of the release of the relaxation factor produced in the endothelium. Has slight alpha-adrenergic blocking activity, so vasoconstrictor effects are less pronounced than those of ergotamine.

Inhibits prolactin production and milk secretion.

Pharmacokinetics

Ergometrine is rapidly absorbed after oral administration or intramuscular injection. The effect on the uterus occurs within 5-15 minutes after oral administration and within 2-3 minutes after intramuscular injection. Metabolized in the liver.

Indications

Prevention and treatment of hypotonic bleeding in the early postpartum period; postoperative (cesarean section, myomectomy) and post-abortion uterine bleeding; uterine subinvolution in the postpartum period.

ICD codes

Dosage Regimen

Determine the regimen individually based on clinical indication and patient response.

For oral administration, administer a single dose of 200-400 mcg.

Repeat the oral dose 2-3 times per day as required for uterine tone.

For intramuscular or intravenous administration, administer a single dose of 200-500 mcg.

Do not exceed the maximum daily dose of 1 mg for parenteral routes.

Combine parenteral and oral administration sequentially if clinically indicated.

Initiate therapy immediately postpartum for hemorrhage prevention.

For treatment of active bleeding, use the parenteral route for rapid onset of action.

Monitor uterine tone and bleeding response closely after each administration.

Adjust frequency based on therapeutic effect and tolerability.

Discontinue upon achievement of sustained uterine contraction and hemostasis.

Adverse Reactions

From the central nervous system: headache, dizziness, tinnitus are possible; rarely – hallucinations.

From the cardiovascular system: increased blood pressure, tachycardia are possible; sometimes bradycardia.

From the digestive system: nausea, vomiting, diarrhea are possible; rarely – abdominal pain.

Other: dyspnea is possible.

Contraindications

Pregnancy, first stage of labor, second stage of labor before the birth of the head, nephropathy, hyperthyroidism, impaired liver or kidney function, eclampsia and preeclampsia, occlusive diseases of coronary and peripheral vessels, severe Raynaud’s syndrome, hypersensitivity to ergometrine.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy, in the first stage of labor, and in the second stage of labor before the birth of the fetal head.

Not recommended for use during lactation (breastfeeding).

Use in Hepatic Impairment

Contraindicated in impaired liver function.

Use in Renal Impairment

Contraindicated in nephropathy, impaired kidney function.

Special Precautions

Use only in a specialized inpatient setting under strict medical supervision.

Use with extreme caution in the third stage of labor and early postpartum period due to the risk of arterial hypertension.

With prolonged use, ergotism may develop.

Drug Interactions

Ergometrine may enhance the vasoconstrictive effects of sympathomimetics.

Concomitant use with oxytocin may lead to a hypertensive crisis.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.