Therapeutic Index

Oxytocin binds to G-protein coupled receptors. In human myometrium these receptors couple to Gq and G11 receptors. This will activate Phospholipase -C hydrolysis and generate Inositol triphosphate (IP3) and Diacyl glycerol. These will mobilizes calcium ion from calcium deposits and also enhances voltage sensitive Ca2+ channels. This Ca2+ produces contraction.

1. Induction of labour
2. Augmentation of labour
3. Reduction of postpartum bleeding
4. Induce abortion
5. Oxytocin challenge test

Copyright © 2004-2007 Taj Pharmaceuticals Ltd. All rights reserved.This information is intended only for residents of the India. Litocin (Trademark Of Taj Pharmaceuticals Ltd., India)

Litocin (oxytocin injection,USP) is a sterile,clear,colorless aqueous solution of synthetic oxytocin, for intravenous infusion or intramuscular injection.Litocin is a nonapeptide found in pituitary extracts from mammals. It is standardized to contain 10 units of oxytocic hormone/mL and contains 0.5% Chlorobutanol,a chloroform derivative as a preservative,with the pH adjusted with acetic acid. Litocin may contain up to 16% of total impurities.The hormone is prepared synthetically to avoid possible contamination with vasopressin (ADH) and other small polypeptides with biologic activity. Litocin has the empirical formula C43H66N12O12S2 (molecular weight 1007.19).

IMPORTANT NOTICE :
Elective induction of labor is defined as the initiation of labor in a pregnant individual who has no medical indications for induction. Since the available data are inadequate to evaluate the enefits-to-risks considerations, Litocin is not indicated for elective induction of labor.
                           
                            
Litocin is indicated for the initiation or improvement of uterine contractions,where this is desirable and considered suitable for reasons of fetal or maternal concern, in order to achieve vaginal delivery. 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, preeclampsia at or near term, when delivery is in the best interests 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 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: Litocin is indicated to produce uterine contractions during the third stage of labor and to control postpartum bleeding or hemorrhage.

 Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

The dosage of oxytocin is determined by the uterine response and must therefore be individualized and initiated at a very low level. The following dosage information is based upon various regimens and indications in general use.

A. Induction or Stimulation of Labor :
Intravenous infusion (drip method) is the only acceptable method of parenteral administration of Pitocin for the induction or stimulation of labor. Accurate control of the rate of infusion is essential and is best accomplished by an infusion pump. It is convenient to piggyback the Pitocin infusion on a physiologic electrolyte solution,permitting the Pitocin infusion to be stopped abruptly without interrupting the electrolyte infusion.This is done in the following way.

1. Preparation :

a. The standard solution for infusion of Litocin is prepared by adding the contents of one 1-mL ampoule containing 10 units of oxytocin to 1000 mL of 0.9% aqueous sodium chloride or Ringer’s lactate. The combined solution containing 10 milliunits (mU) of oxytocin/mL is rotated in the infusion bottle for thorough mixing.

b. Establish the infusion with a separate bottle of physiologic electrolyte solution not containing Litocin.

c. Attach (piggyback) the Litocin-containing bottle with the infusion pump to the infusion line as close to the infusion site as possible.

2. Administration :

The initial dose should be 0.5–1 mU/min (equal to 3–6 mL of the dilute oxytocin solution per hour). At 30–60 minute intervals the dose should be gradually increased in increments of 1–2 mU/min until the desired contraction pattern has been established.Once the desired frequency of contractions has been reached and labor has progressed to 5–6 cm dilation, the dose may be reduced by similar increments.
Studies of the concentrations of oxytocin in the maternal plasma during Litocin infusion have shown that infusion rates up to 6 mU/min give the same oxytocin levels that are found in spontaneous labor.At term, higher infusion rates should be given with great care,and rates exceeding 9–10 mU/min are rarely required. Before term, when the sensitivity of the uterus is lower because of a lower concentration of oxytocin receptors, a higher infusion rate may be required.

3. Monitoring :

a. Electronically monitor the uterine activity and the fetal heart rate throughout the infusion of Litocin.Attention should be given to tonus, amplitude and frequency of contractions, and to the fetal heart rate in relation to uterine contractions. If uterine contractions become too powerful,the infusion can be abruptly stopped,and oxytocic stimulation of the uterine musculature will soon wane (see PRECAUTIONS section).

b. Discontinue the infusion of Litocin immediately in the event of uterine hyperactivity and/or fetal distress.
Administer oxygen to the mother, who preferably should be put in a lateral position. The condition of mother and fetus should immediately be evaluated by the responsible physician and appropriate steps taken.

B. Control of Postpartum Uterine Bleeding :

1. Intravenous infusion (drip method).If the patient has an intravenous infusion running,10 to 40 units of oxytocin may be added to the bottle,depending on the amount of electrolyte or dextrose solution remaining (maximum 40 units to 1000 mL). Adjust the infusion rate to sustain uterine contraction and control uterine atony.

2. Intramuscular administration.(One mL) Ten (10) units of Litocin can be given after the delivery of the placenta.

C. Treatment of Incomplete,Inevitable,or Elective Abortion  :

Intravenous infusion of 10 units of Litocin added to 500 mL of a physiologic saline solution or 5% dextrose-in-water solution may help the uterus contract after a suction or sharp curettage for an incomplete, inevitable, or elective abortion.
Subsequent to intra-amniotic injection of hypertonic saline, prostaglandins,urea,etc.,for midtrimester elective abortion, the injection-to-abortion time may be shortened by infusion of Litocin at the rate of 10 to 20 milliunits (20 to 40 drops) per minute.The total dose should not exceed 30 units in a 12-hour period due to the risk of water intoxication.

HOW SUPPLIED :
Litocin (Oxytocin Injection,USP) Synthetic is available as follows:
LPT 61570-416-01 Packages of ten 1-mL ampoules, each containing 10 units of oxytocin.
LPT 61570-416-05 Packages of twenty-five oversized 1-mL Steri-Vials, each containing 10 units of oxytocin.

Intravenous or intramuscular Adult: 1. Induction of labour: Initial dose: 0.5- 1 milliunits /minute as IV infusion and if needed rate can be gradually increased by 1 - 2 milliunits/minute until sufficient response is obtained. 2. Augmentation of labour: Initial dose: 2milliunits/minute as intravenous infusion and then gradually increase the dose maximum up to 20milliunits/minute 3. Reduction of postpartum bleeding after expulsion of placenta: 20 - 40 milliunits/minute as intravenous infusion after delivery of placenta. 4. Induce abortion: 10 - 100 milliunits/minutes 5. Oxytocin challenge test to assess fetal distress in high risk pregnancies greater than 31 weeks` gestation: Initial dose: 0.5milliunits/minute followed by gradual increase in infusion rate every 15 minutes up to 20milliunits/minute. When 3 moderate uterine contractions occur in a 10 minute interval then stop the use of medicament.

Store at 2 - 8 degree C.

Manufactured and Distributed by:
Taj Pharmaceuticals Ltd, India.,Mumbai,TN 37620 Reaserched by: Parkedale Pharmaceuticals,Inc.,Rochester,MI 48307

PACKAGING INFORMATION :
Injection 0.5 ml 0.5ml
Injection 1 ml 1ml
                                
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