Syntocinon

SYNTOCINON- oxytocin injection, solution
Sandoz Pharmaceuticals Corporation

Syntocinon®

(oxytocin) injection, USP

Caution: Federal law prohibits dispensing without prescription.

DESCRIPTION

Syntocinon® (oxytocin) is a synthetic, (1-6) cyclic nonapeptide. Chemically, oxytocin is designated as Glycinamide, L-cysteinyl-L-tyrosyl-L-isoleucyl-L-glutaminyl-L-asparaginyl-L-cysteinyl-L-prolyl- L-leucy1-, cyclic (1-6)-disulfide.

The structural formula is:

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Syntocinon® (oxytocin) injection is provided as a sterile solution for intravenous or intramuscular administration. Each 1 mL of solution contains 10 USP or International Units of oxytocin and the following inactive ingredients:

acetic acid, NF, qs to ………………….. pH 4 ± 0.3

alcohol, USP………………………. 0.61 % by vol.

chlorobutanol, NF ……….,………………. 0.5%

sodium acetate, USP …,…………………… 1 mg

sodium chloride, USP …………………… 0.017 mg

water for injection, USP, qs to ………………… 1 mL

CLINICAL PHARMACOLOGY

The pharmacologic and clinical properties of Syntocinon® (oxytocin) are identical with the naturally occurring oxytocic principle of the posterior lobe of the pituitary. Syntocinon® (oxytocin) injection does not contain the amino acids characteristic of vasopressin, and therefore has fewer and less severe cardiovascular effects. Syntocinon® (oxytocin) exerts a selective action on the smooth musculature of the uterus, particularly toward the end of pregnancy, during labor and immediately following delivery. Oxytocin stimulates rhythmic contractions of the uterus, increases the frequency of existing contractions, and raises the tone of the uterine musculature.

Syntocinon® (oxytocin), when given in appropriate doses during pregnancy, is capable of eliciting graded increases in uterine motility from a moderate increase in the rate and force of spontaneous motor activity to sustained tetanic contraction.

Syntocinon® (oxytocin) is promptly effective after parenteral administration. Following intramuscular injection, the myotonic effect on the uterus appears in 3-7 minutes, and persists for 30-60 minutes. With intravenous injection, the uterine effect appears within 1 minute and is of more brief duration.

Syntocinon Indications and Usage

Important Notice

Syntocinon® (oxytocin) injection is indicated for the medical rather than the elective induction of labor. Available data and information are inadequate to define the benefits to risk considerations in the use of the drug product for elective induction. Elective induction of labor is defined as the initiation of labor for convenience in an individual with a term pregnancy who is free of medical indications.

Antepartum

Syntocinon® (oxytocin) is indicated for the initiation or improvement of uterine contractions, where this is desirable and considered suitable, in order to achieve early vaginal delivery for fetal or maternal reasons. It is indicated for (1) induction of labor in patients with a medical indication for the initiation of labor, such as Rh problems, maternal diabetes, pre-eclampsia at or near term, when delivery is in the best interest of mother and fetus or when membranes are prematurely ruptured and delivery is indicated; (2) stimulation or reinforcement of labor, as in selected cases of uterine inertia; (3) as adjunctive therapy in the management of incomplete or inevitable abortion. In the first trimester, curettage is generally considered primary therapy. In the second trimester abortion, oxytocin infusion will often be successful in emptying the uterus. Other means of therapy, however, may be required in such cases.

Postpartum

Syntocinon® (oxytocin) injection is indicated to produce uterine contractions during the third stage of labor and to control postpartum bleeding or hemorrhage.

CONTRAINDICATIONS

Syntocinon® (oxytocin) injection is contraindicated in any of the following conditions: Significant cephalopelvic disproportion; unfavorable fetal positions or presentations which are undeliverable without conversion prior to delivery (transverse lies); i.e., in obstetrical emergencies where the benefit-to-risk ratio for either the fetus or the mother favors surgical intervention; in cases of fetal distress where delivery is not imminent; prolonged use in uterine inertia or severe toxemia; hypertonic uterine patterns; patients with hypersensitivity to the drug; induction or augmentation of labor in those cases where vaginal delivery is contraindicated, such as cord presentation or prolapse, total placental previa, and vasa previa.

WARNINGS

Syntocinon® (oxytocin), when given for induction or stimulation of labor, must be administered only by the intravenous route and with adequate medical supervision in a hospital.

PRECAUTIONS

General

All patients receiving intravenous oxytocin must he under continuous observation by trained personnel with a thorough knowledge of the drug and qualified to identify complications. A physician qualified to manage any complications should be immediately available.

When properly administered, oxytocin should stimulate uterine contractions similar to those seen in normal labor. Overstimulation of the uterus by improper administration can be hazardous to both mother and fetus. Even with proper administration and adequate supervision, hypertonic contractions can occur in patients whose uteri are hypersensitive to oxytocin.

Except in unusual circumstances, oxytocin should not be administered in the following conditions: prematurity, borderline cephalopelvic disproportion, previous major surgery on the cervix or uterus including cesarean section, over-distention of the uterus, grand multiparity, or invasive cervical carcinoma. Because of the variability of the combinations of factors which may be present in the conditions listed above, the definition of “unusual circumstances” must be left to the judgment of the physician. The decision can only be made by carefully weighing the potential benefits which oxytocin can provide in a given case against rare but definite potential for the drug to produce hypertonicity or tetanic spasm.

Maternal deaths due to hypertensive episodes, subarachnoid hemorrhage, rupture of the uterus, and fetal deaths due to various causes have been reported associated with the use of parenteral oxytocic drugs for induction of labor or for augmentation in the first and second stages of labor.

Oxytocin has been shown to have an intrinsic antidiuretic effect, acting to increase water reabsorption from the glomerular filtrate. Consideration should, therefore, be given to the possibility of water intoxication, particularly when oxytocin is administered continuously by infusion and the patient is receiving fluids by mouth.

Drug Interactions

Severe hypertension has been reported when oxytocin was given 3-4 hours following prophylactic administration of a vasoconstrictor in conjunction with caudal block anesthesia. Cyclopropane anesthesia may modify oxytocin’s cardiovascular effects, so as to produce unexpected results such as hypotension. Maternal sinus bradycardia with abnormal atrioventricular rhythms has also been noted when oxytocin was used concomitantly with cyclopropane anesthesia.

Carcinogenesis, Mutagenesis, Impairment of Fertility

There are no animal or human studies on the carcinogenicity and mutagenicity of this drug, nor is there any information on its effect on fertility.

Pregnancy

Teratogenic Effects:

Animal reproduction studies have not been conducted with oxytocin. There are no known indications for use in the first trimester of pregnancy other than in relation to spontaneous or induced abortion. Based on the wide experience with this drug and its chemical structure and pharmacological properties, it would not be expected to present a risk of fetal abnormalities when used as indicated.

Nonteratogenic Effects:

See ADVERSE REACTIONS in the fetus or infant.

Labor and Delivery

See INDICATIONS AND USAGE.

Nursing Mothers

Syntocinon® (oxytocin) may be found in small quantities in mother’s milk. If a patient requires the drug postpartum to control severe bleeding, she should not commence nursing until the day after Syntocinon® (oxytocin) has been discontinued.

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