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GYNOTOCIN:

 
 
 
   
   
   
 
 



 
   
 
     
     
 
  Composition
   
  Each ampoule of GYNOTOCIN contains:
Oxytocin (synthetic). . .5 IU
Chlorbutol (as preservative). . .0.5% w/v
   
   
  Therapeutic Indications & Usage
   
  GYNOTOCIN is indicated for:

9. Induction of labor when medically indicated.
10. Augmentation of spontaneous labor.
11. Management of incomplete, missed or inevitable abortion.
12. Prevention or treatment of postpartum or post-abortal uterine atony and postpartum hemorrhage.
13. To facilitate the milk-ejection reflex.
14. Cesarean section, immediately after delivery.
15. Assessing fetal well-being in the oxytocin challenge test.
   
   
  Contraindications
   
  GYNOTOCIN is contraindicated in:
Any obstetrical condition in which spontaneous normal labor is not in the best interests of the mother and / or fetus and surgical intervention offers better risk : benefit ratio such as:
   
 
  • Cephalopelvic disproportion.
  • Mechanical obstruction to delivery.
  • Fetal malpresentation.
  • Fetal distress.
  • Placenta previa, vasa previa.
  • Impaired strength of the uterus as in placental abruption, polyhydramnios, grand multiparity, or prior uterine surgery where the cavity of the uterus has been entered.
  • Conditions wherein the vaginal delivery is contraindicated such as cord prolapse, cord resentation, or invasive cancer of cervix.
  • Uterine hyperactivity, especially with elevation of basal uterine tone as in placental abruption.
  • Hypersensitivity to oxytocin.
  • Severe pre-eclamptic toxemia.
   
  Precautions
 
  GYNOTOCIN must be advocated for prolonged periods with due precaution in presence of severe cardiovascular disorders and in oxytocin-resistant uterine inertia.
   
   
  Warnings
   
  Oxytocin (GYNOTOCIN) must be coadministered with due precaution along with prostaglandins, inhalation anesthetics and sympathomimetic vasoconstrictive agents.
   
   
  Adverse Reactions
   
  Nausea, vomiting and cardiac arrhythmias can occasionally occur due to GYNOTOCIN. The oxytocin-stimulated uterine contractions could be more difficult to tolerate. Rarely skin rashes and anaphylactoid reactions associated with dyspnea, hypotension and shock can be caused by oxytocin (GYNOTOCIN).

When used for labor induction (and not for augmentation of labor), oxytocin (GYNOTOCIN) can increase incidence of neonatal jaundice. Rapid administration of high doses of GYNOTOCIN
   
   
  Drug Interactions:
   
  Oxytocin (GYNOTOCIN) in combination with prostaglandins can increase the risk of uterine rupture and cervical lacerations. Some inhalation agents such as cyclopropane and halothane may enhance the hypotensive action of oxytocin (GYNOTOCIN), may reduce its oxytoxic effects and / or cause cardiac rhythm disturbances if used concomitantly. Oxytocin (GYNOTOCIN) may potentiate the pressor effect of sympathomimetics vasoconstrictive agents when given during or after a caudal block.
   
  Recommended Dosage & Administration
   
  1. Induction / Augmentation of Labor

A solution containing 5 units (or 10-30 units as necessary) of oxytocin in 500 ml of a physiological electrolyte solution such as sodium chloride 0.9% has been recommended. Intravenous (IV) infusion is begun at a recommended initial rate of 1-2 milliunits/minute and then gradually increased at intervals of at least 30 minutes, until a maximum of 3 or 4 contractions are occurring every 10 minutes. A rate of upto 6 milliunits/minute is reported to produce plasma concentrations comparable to those in natural labor, and 12 milliunits/minute is usually the most that is needed but doses of up to 20 milliunits/minute or more may be required. The maximum limits are 32 milliunits/minute and not more than 5 units per day. Fetal heart rate and uterine contractions should be monitored continuously. Once labor is progressing, GYNOTOCIN infusion may be gradually withdrawn.
   
  2. Postpartum Hemorrhage

GYNOTOCIN may be given by slow IV injection in a dose of 5 units; this may be followed in severe case by IV infusion of 5-20 units (maximum 30 units) in 500 ml of a suitable non-hydrating diluent at a rate of 20-40 milliunits/minute. Alternatively, for postpartum hemorrhage prophylaxis in routine management for third stage of labor, 5 units of oxytocin intramuscular (IM) injection along with ergometrine maleate 500 mcg with or after delivery of the baby's shoulders.

3.Missed Abortion

GYNOTOCIN 5 units by slow IV followed, if necessary, by IV infusion as a rate of 20-40 milliunits/minute or higher is recommended.

4. Oxytocin Challenge Test (OCT)

Oxytocin 1 milliunit/minute is given by infusion pump and increased every 5-10 minutes until a contraction rate of 3 per 10 minutes is achieved. Less than 10% of late or variable decelerations of fetal heart rate is judged negative; 10-29% is judged equivocal; and 30% or more is judged positive. The finding of a positive or equivocal response to the OCT is considered a predilection of decelerations of the fetal heart rate during parturition, though the type of risk may vary.
   
   
  Presentations
   
  GYNOTOCIN Injections: 1 ml ampoules (cold chain supply).
   
  fulera md
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
   
 
         
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