Protocin

Protocin

oxytocin

Manufacturer:

Meprofarm

Marketer:

Meprofarm
Full Prescribing Info
Contents
Oxytocin.
Description
Oxytocin solution equal to Oxytocin 10 IU.
Action
Pharmacology: Oxytocin is a cyclic nonapeptide obtained by chemical synthesis. The synthetic form is identical to the natural hormone stored in the posterior pituitary and released into the systemic circulation during lactation and childbirth. Oxytocin stimulating contraction of smooth muscles of the uterus stronger towards the end of pregnancy, during labor and immediately after childbirth. At this time oxytocin receptors in the myometrium is increased. Oxytocin raises regular contractions on the surface of the uterus, with similar strength, frequency and duration to contractions that is observed during labor. The synthetic form of Oxytocin does not contain vasopressin, but in its pure form, oxytocin has the form of a weak vasopressin, such as antidiuretic work. Long-term use of oxytocin have been reported to cause desensitization of the oxytocin receptor may be caused by decreasing order of bonding oxytocin, oxytocin receptor mRNA destabilization and oxytocin receptor internalization.
Indications/Uses
Antepartum: Labor induction for medical reasons, for example in overtime pregnancy, premature membranes rupture, hypertension caused by pregnancy (pre-eclampsia).
Labor stimulation in certain cases of uterine inertia.
Oxytocin may also be indicated in the early stages of pregnancy as adjunctive therapy in an incomplete and unavoidable miscarriage.
Postpartum: During caesarean section, after the baby is delivered.
Prevention and treatment of postpartum uterine atony and bleeding.
Prevention and treatment of uterine bleeding after childbirth.
Dosage/Direction for Use
Labor induction or stimulation: Oxytocin is given by IV infusion or even better by using an infusion pump which can set for the speed. For drip infusion, it is recommended to add 5 IU Oxytocin in 500 ml physiological electrolyte solution (such as 0.9% NaCl). For patients who should not be given NaCl, NaCl can be replaced with 5% dextrose solution (See Precautions). To ensure the solution was mixed well, infusion bottles should be turned upside down several times before use.
Initial infusion rate should be 1-4 mU/min (2-8 drops/minute). This speed is increased gradually at intervals not shorter than 20 minutes, until a contraction pattern similar to a normal delivery is achieved. In pregnancy closer to the date, this can be achieved with the infusion rate of less than 10 mU/min (20 drops/min), and the maximum recommended speed is 20 mU/min (40 drops/min).
In some unusual events whereas the higher speeds are required, such as the death of the fetus in the uterus or for the stimulation of labor in early pregnancy, when the uterus is less sensitive to oxytocin, it is recommended to use a more concentrated Oxytocin solution, for example 10 IU in 500 ml.
When using a motor-controlled infusion pump in which the volume of the solution that is delivered is less than that in drip infusion, the recommended dose should be recalculated in accordance with the specifications of the pump. Frequency, strength and duration of contractions and the baby's heart rate should be monitored closely during infusion. When the right uterus activity level is reached, the infusion rate may be reduced. In the case of uterine hyperactivity happened and/or in a state of fetal distress, the infusion should be discontinued immediately.
For women who is near delivery time, if the regular contraction has not been reached yet after oxytocin 5 IU infused, it is recommended to stop the stimulation activities; the stimulation can be repeated in the next day, initially start on 1-4 mU/minute.
Caesarean section: 5 IU dose is given by intravenous infusion (5 IU is diluted with physiological electrolyte solution and even better if it is given by intravenous drops infusion with variety infusion rate for more than 5 minutes), immediately after delivery.
Prevention of uterine bleeding after childbirth: The prevalent dose is 5 IU Oxytocin given by intravenous infusion (5 IU is diluted with physiological electrolyte solution and even better if it is given by intravenous drops infusion with variety infusion rate for more than 5 minutes) or 5-10 IU given by IM injection after placenta delivery. In women given oxytocin to stimulate labor, the infusion should be continued at a pace that improved during the third stage of labor and for the next several hours.
Treatment of uterine bleeding after childbirth: The prevalent dose is 5 IU Oxytocin given by intravenous infusion (5 IU is diluted with physiological electrolyte solution and even better if it is given by intravenous drops infusion with variety infusion rate for more than 5 minutes) or 5-10 IU given by I.M injection, for more severe cases the medication is followed by an IV infusion with a solution containing 5-20 IU of oxytocin in 500 mL of electrolyte solution, in sufficient rate to monitor the uterus atony.
Incomplete, unavoidable miscarriage or abortion failure: The prevalent dose is 5 IU Oxytocin given by intravenous infusion (5 IU is diluted with physiological electrolyte solution and even better if it is given by intravenous drops infusion with variety infusion rate for more than 5 minutes) or 5-10 IU given by I.M injection, if necessary the medication can be followed by giving an IV infusion in the rate of 20-40 mU or faster.
Overdosage
The symptoms and outcomes of oxytocin overdose has been described on the Adverse Reaction. In addition, as a result of excessive uterine induction, it is been reported the occurrence of placental abruption and/or amniotic fluid embolism.
Treatment: If the signs or symptoms of overdosage occur during intravenous administration of oxytocin in progress, the infusion should be discontinued immediately and the mother had to be given oxygen as the first aid.
In case of water intoxication, it is necessary not to give fluids to the patient, increase the diuresis, improve the electrolyte imbalance, and control the convulsions that sometimes occurs with administration of diazepam.
Contraindications
Hypersensitivity to any components of the drug.
Special Precautions
Oxytocin should not be used for long periods in patients with severe cardiovascular disorders. Oxytocin should not be given as a bolus IV injection. This can lead to short-term acute hypotension accompanied by "flushing" and tachycardia.
Cardiovascular impairment: oxytocin should be used with caution in patients who have myocardial ischemia pre-disposition due to cardiovascular disease (such as hypertrophic cardiomyopathy, valvular heart disease and/or ischemic heart disease includes vasopasme coronary arteries), in order to avoid significant changes in blood pressure and heart rate in patients.
QT Syndrome: oxytocin given with caution in patients known to have "long QT syndrome" or related symptoms and patients taking drugs that prolong the QTc interval (see Interactions).
Effects on ability to drive: It should be cautious when it comes to driving or operating machinery.
Use In Pregnancy & Lactation
Oxytocin is contraindicated in: Hypertonic uterine contractions, fetal distress at premature childbirth.
In conditions in order to ensure safety to the fetus or the mother where normal childbirth is not recommended and/or vaginal delivery is contraindicated due to things such as disproportion cephalopelvic, abnormal fetal position, placenta previa, placenta abruption, umbilical cord position or prolapse, the strain of excessive or impairment of the uterine wall as in a twin pregnancy, polyhydramnions, frequent childbirth, scarred uterus due to major surgery including classical caesarean section.
Labor induction: labor induction using oxytocin is indicated for medical reasons only not to ease childbirth. Oxytocin use must be under the supervision of the hospital and professional medical staff.
Breastfeeding mothers: Oxytocin may be found in small quantities in breast milk.
Oxytocin should not be used for long periods in patients with oxytocin resistance, uterine inertia, toxemia, or pre-eclampsia.
Oxytocin can induce labor. Women who are experiencing contractions should not drive or operate machinery.
Adverse Reactions
Immune system disorders: Rare: anaphylactic reactions associated with dyspnea and hypotension, anaphylactoid shock.
Nervous system disorders: Common: headache.
Heart problems: Common: tachycardia, bradycardia. Rare: arrhythmia. Unknown incidence: myocardial ischemia, electrocardiogram QTc prolongation.
Vascular disorders: Unknown incidence: hypotension.
GI Disorders: Common: nausea.
Skin and subcutaneous tissue disorders: Uncommon: rash.
In condition of pregnant, postpartum and perinatal: Unknown incidence: uterus hypertonic, tetanic contractions of uterus, uterine rupture.
Metabolism and nutrition disorders: Unknown incidence: water intoxication, hyponatraemia
Respiratory, chest and mediastinum disorders: Unknown incidence: acute pulmonary edema
General disorders and condition on the injection site: Unknown incidence: Flushing
Blood and lymphatic system disorders: Unknown incidence: dissemination of intravascular coagulation.
Drug Interactions
Several inhalation anesthetics, such as cyclopropane or halothane, may stimulate the hypotensive effect of oxytocin and reduce its oxytocic. Concomitant use with oxytocin can cause heart rate disturbance.
When given during or after caudal block anesthesia: Oxytocin can amplify the effect of the pressure of sympathomimetic vasoconstrictor agents.
Prostaglandins and analogues: prostaglandins and analogs facilitate contraction in the myometrium, thereby increases the effects of oxytocin and prostaglandin analogs on the uterus.
Drugs that prolong the QT interval: Oxytocin is potentially arrhythmogenic, especially in patients with other risk factors for "torsade de pointes" such as drugs that prolong QT interval or patients with long QT syndrome (see Precautions).
Storage
Store in 2-8°C.
Protect from light exposure.
MIMS Class
Drugs Acting on the Uterus
ATC Classification
H01BB02 - oxytocin ; Belongs to the class of oxytocin and analogues. Used in posterior pituitary lobe hormone preparations.
Presentation/Packing
Form
Protocin inj 10 IU/mL
Packing/Price
10 × 1's (Rp72,000/boks)
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