Pitocin

Pitocin Manufacturers

• Watson Laboratories, Inc.
  

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  Pitocin | Watson Laboratories, Inc.

  

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  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.

  Induction or Stimulation of Labor
  Intravenous infusion (drip method) is the only acceptable method of parenteral administration of oxytocin 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 ocytocin infusion on a physiologic electrolyte solution, permitting the oxytocin infusion to be stopped abruptly without interrupting the electrolyte infusion. This is done in the following way. Preparation The standard solution for infusion of oxytocin is prepared by adding the contents of one 1-mL vial 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. Establish the infusion with a separate bottle of physiologic electrolyte solution not cotaining oxytocin. Attach (piggyback) the oxytocin-containing bottle with the infusion pump to the infusion line as close to the infusion site as possible. 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 oxytocin 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. Monitoring Electronically monitor the uterine activity and the fetal heart rate throughout the infusion of oxytocin. 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). Discontinue the infusion of oxytocin 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. Control of Postpartum Uterine Bleeding 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. Intramuscular administration. (One mL) Ten (10) units of oxytocin can be given after the delivery of the placenta. Treatment of Incomplete, Inevitable, or Elective Abortion
  Intravenous infusion of 10 units of oxytocin 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 curettagefor an incomplete, inevitable, or elective abortion. Subsequent to intra-amniotic injection of hypertonic saline, prostaglandins, urea, etc., for midtrimester elective abortion, the injection-toabortion time may be shortened by infusion of oxytocin 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.

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• Jhp Pharmaceuticals Llc
  

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  Pitocin | Kle 2, Inc.

  

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  For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets is 5 mg three times a day. Based on individual patient response, the dose may be increased to either 7.5 or 10 mg three times a day. Use of cyclobenzaprine hydrochloride tablets for periods longer than two or three weeks is not recommended. (see INDICATIONS AND USAGE).

  Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).

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• Jhp Pharmaceuticals Llc
  

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  Pitocin | Jhp Pharmaceuticals Llc

  

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  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 Pitocin is prepared by adding 1 mL (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 Pitocin. c. Attach (piggyback) the Pitocin-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 Pitocin 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 Pitocin. 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 Pitocin 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. 1 mL (10 units) of Pitocin can be given after the delivery of the placenta. C. Treatment of Incomplete, Inevitable, or Elective Abortion

  Intravenous infusion of 10 units of Pitocin 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 Pitocin 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.

  Directions for Dispensing Pharmacy Bulk Package – Not for Direct Infusion

  The pharmacy bulk package is for use in a pharmacy admixture service only in a suitable work area, such as a laminar flow hood. The closure should be penetrated only once utilizing an appropriate sterile transfer device, which allows measured distribution of the contents. The transfer device should be inserted into the Pharmacy Bulk Package using aseptic technique.

  Contents should be used as soon as possible following initial closure puncture. Discard any unused portion within 24 hours of first entry. Following closure puncture, container should be maintained under labeled storage conditions between 20° to 25°C (68° to 77°F) under a laminar flow hood until contents are dispensed.

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