Oxytocin-Ferein^® (Solution) Instructions for Use

Marketing Authorization Holder

Bryntsalov-A, JSC (Russia)

Manufactured By

Bryntsalov-A, JSC (Russia)

Or

Ferein, CJSC (Republic Of Belarus)

Quality Control Release

Bryntsalov-A, JSC (Russia)

ATC Code

H01BB02 (Oxytocin)

Active Substance

Oxytocin (Rec.INN registered by WHO)

Dosage Form

Oxytocin-Ferein®

Solution for intravenous and intramuscular administration 5 IU/1 ml: amp. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular administration transparent, colorless, with the odor of chlorobutanol hemihydrate.

Excipients: chlorobutanol hemihydrate, water for injection, 1M acetic acid.

1 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
1 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
1 ml – ampoules (5) complete with an ampoule knife or scarifier – cardboard packs.
1 ml – ampoules (10) complete with an ampoule knife or scarifier – cardboard packs.

Clinical-Pharmacological Group

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

Pharmacotherapeutic Group

Hypothalamic and pituitary hormones and their analogues; posterior pituitary lobe hormones; oxytocin and its analogues

Pharmacological Action

Oxytocin is a synthetic analogue of the peptide hormone of the posterior pituitary lobe – it stimulates the contraction of the smooth muscles of the uterus (especially the pregnant uterus) and myoepithelial cells of the mammary gland.

Oxytocin has a weak antidiuretic effect and in therapeutic doses does not significantly affect blood pressure.

The effect occurs within 1-2 minutes after subcutaneous and intramuscular administration, lasting 20-30 minutes; after intravenous administration – within 0.5-1 minute.

Pharmacokinetics

T_1/2 is 1-6 minutes (decreases in late pregnancy and during lactation). Plasma protein binding is low (30%).

It is metabolized in the liver and kidneys. During pregnancy, the content of oxytocinase, which inactivates endogenous and exogenous Oxytocin, increases in the plasma, target organs, and placenta. Excretion is mainly by the kidneys unchanged.

Indications

• Induction and stimulation of labor;
• Prevention and treatment of hypotonic uterine bleeding in the early postpartum period;
• Acceleration of postpartum uterine involution;
• Enhancement of uterine contractility during cesarean section (after removal of the placenta).

ICD codes

Dosage Regimen

Oxytocin-Ferein^® is administered intravenously, intramuscularly, into the wall or vaginal portion of the cervix.

For labor induction, 0.5-2.0 IU of oxytocin is administered intramuscularly; if necessary, injections are repeated every 30-60 minutes.

For intravenous drip administration, 1 ml of the drug (5 IU) is diluted in 500 ml of a 5% dextrose solution. Administration begins at 5-8 drops/min, with a subsequent increase in the rate depending on the nature of labor, but not more than 40 drops/min. During the infusion, constant monitoring of uterine activity and fetal heart rate is necessary.

For the prevention of hypotonic uterine bleeding Oxytocin-Ferein^® is administered intramuscularly at 3-5 IU 2-3 times/day daily for 2-3 days, and for the treatment of hypotonic uterine bleeding 5-8 IU is administered 2-3 times a day for 3 days. During a cesarean section operation (after removal of the placenta), it is administered into the uterine wall at a dose of 3-5 IU.

Adverse Reactions

Arrhythmia and bradycardia (in the mother and fetus), decrease or increase in blood pressure, shock, subarachnoid hemorrhage, nausea, vomiting, neonatal jaundice, decrease in fibrinogen levels in the fetus, allergic reactions, bronchospasm, water retention, excessively active labor, which can cause acute fetal hypoxia, premature detachment of a normally located placenta, uterine rupture are possible. If symptoms of these complications appear, the administration of the drug should be stopped immediately.

Contraindications

• Increased individual sensitivity to the drug;
• Arterial hypertension;
• Renal failure;
• Predisposition to uterine rupture;
• Discrepancy between the size of the mother’s pelvis and the fetus (anatomically and clinically narrow pelvis);
• Transverse or oblique position of the fetus;
• Premature birth;
• Threatening uterine rupture;
• Presence of scars after a previous cesarean section or other uterine surgeries;
• Excessive uterine distension, uterus after multiple births;
• Uterine sepsis;
• Invasive cervical carcinoma;
• Uterine hypertonus (not occurring during labor),
• Fetal compression, intrauterine fetal hypoxia;
• Suspected premature placental abruption, placenta previa.

Use in Pregnancy and Lactation

The drug is used during childbirth under strict indications.

Use in Renal Impairment

Contraindicated in renal failure.

Special Precautions

Use only under the supervision of a physician in a hospital setting with monitoring of uterine contractile activity, fetal condition, blood pressure, and the general condition of the woman.

Overdose

Symptoms: uterine hyperstimulation, which can lead to uterine hypertonus and tetanic contractions, which, in turn, can lead to uterine rupture, postpartum hemorrhage, various changes in fetal cardiac activity, hypoxia and fetal death; fetal compression, fetal asphyxia, fetal bradycardia, utero-placental hypoperfusion, hypoxia, hypercapnia, fetal birth trauma, water intoxication, convulsions.

Treatment: the administration of the drug should be stopped immediately, fluid administration should be reduced, diuresis should be forced, symptomatic drugs and hypertonic saline solutions should be administered (to normalize electrolyte balance), barbiturates (with caution). The patient requires careful observation.

Drug Interactions

Use with caution in combination with sympathomimetics (potentiates the pressor effect of sympathomimetics). When combined with monoamine oxidase inhibitors, the risk of increased blood pressure increases. Halothane and cyclopropane increase the risk of arterial hypotension.

Storage Conditions

List B. Store in a place protected from light and out of the reach of children at a temperature from 8 to 20°C (68°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

By prescription.

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.