Oxytocin injection 5IU / ml, 1 ml No. 10
Russian Pharmacy name:
Окситоцин раствор для инъекций 5МЕ/мл, 1 мл №10
For the excitement and stimulation of labor (primary and secondary weakness of labor, the need for early delivery in connection with gestosis, Rh-conflict, intrauterine fetal death; post-term pregnancy, premature discharge of amniotic fluid, management of labor in breech presentation).
For the prevention and treatment of hypotonic uterine bleeding after abortion (including in late pregnancy) in the early postpartum period and to accelerate the postpartum involution of the uterus; to enhance the contractility of the uterus during cesarean section (after removal of the placenta).
Intravenous intramuscular injection.
For the initiation of labor : intramuscularly at 05-2 ME (01-04 ml of the drug); if necessary, repeat the injections every 30-60 minutes.
Stimulation of labor activity : intravenous drip of 10 IU of oxytocin per 1 liter of 5% dextrose solution with the development of excessive contractions of the uterus, slowing down the infusion quickly leads to a decrease in the activity of the myometrium. The introduction begins with 5-8 drops / min, followed by an increase in speed, depending on the nature of labor, but not more than 40 drops / min. During the infusion, constant monitoring of uterine activity and fetal heart rate is necessary.
Treatment of unavoidable or incomplete abortion : intravenous drip of 10 IU (2 ml of the drug) oxytocin per 500 ml of 5% dextrose solution at a rate of 20-40 drops / min.
For the prevention of hypotonic uterine bleeding after abortion, oxytocin is injected intramuscularly at 3-5 IU (06-1 ml) 2-3 times a day every day for 2-3 days, intramuscular administration of 10 IU (2 ml) immediately after separation of the placenta is permissible. For the treatment of hypotonic uterine bleeding after abortion, 5-8 IU is administered 2-3 times a day for 3 days. If necessary, 10-40 ME (2-8 ml) of oxytocin dissolved in 100 ml of donor blood is injected intravenously.
When conducting labor in breech presentation: 2-5 ME (04-1 ml).
To enhance the contractile ability of the uterus during cesarean section (after removal of the placenta), 3-5 ME (06-1 ml) is injected into the uterine wall.
1 ml contains:
active substance : oxytocin (synthetic oxytocin) - 5 ME;
excipients: chlorobutanol hemihydrate (chlorobutanol hydrate) 5.0 mg, water for injection up to 1 ml.
Hypersensitivity;
narrow pelvis (anatomical and clinical) lateral and oblique position of the fetus,
facial presentation of the fetus,
premature birth
threatening rupture of the uterus,
scars on the uterus (after a previous cesarean section of the operation on the uterus)
excessive stretching of the uterus
uterus after multiple births
partial placenta previa
uterine sepsis
invasive cervical cancer
hypertonicity of the uterus (not during childbirth) compression of the fetus arterial hypertension chronic renal failure.
Trade name of the drug
Oxytocin
International non-proprietary name
Oxytocin
Dosage form
solution for intravenous and intramuscular administration
Composition
1 ml contains:
active substance : oxytocin (synthetic oxytocin) 5 ME;
excipients: chlorobutanol hemihydrate (chlorobutanol hydrate) 5.0 mg, water for injection up to 1 ml.
Description
Transparent, colorless liquid with the smell of chlorobutanol hydrate.
Pharmacotherapeutic group
Labor activity stimulant - oxytocin drug
ATX code
H01BB02
Pharmacodynamics:
The hormonal agent is an oligopeptide analogue of the hormone of the posterior lobe of the pituitary gland. Has a uterotonic stimulating labor and lactotropic action. Has a stimulating effect on the smooth muscles of the uterus, increases the contractile activity of the myometrium and, to a lesser extent, tone (especially at the end of pregnancy during labor and immediately during delivery). Under the influence of oxytocin, the permeability of cell membranes for calcium ions increases, the resting potential decreases and their excitability increases (a decrease in the membrane potential leads to an increase in the frequency of the intensity and duration of contractions).In small doses, oxytocin increases the frequency and amplitude of uterine contractions in large doses or, with repeated administration, helps to increase the tone of the uterus, to increase the frequency and increase of its contractions (up to tetanic).
Stimulates the secretion of breast milk by increasing the production of prolactin by the anterior pituitary gland. Shrinks the myoepithelial cells around the alveoli of the mammary gland, stimulates the flow of milk into the large ducts or sinuses, thereby increasing the separation of milk.
It is practically devoid of vasoconstrictor and anti-diuretic effects (it manifests them only in high doses) does not cause contraction of the muscles of the bladder and intestines. The effect occurs in 1-2 minutes with intramuscular injection, lasts 20-30 minutes; with intravenous - after 05-1 minutes.
Pharmacokinetics:
The half-life is 1-6 minutes (decreases in late pregnancy and lactation). The connection with plasma proteins is low (30%).
It is metabolized in the liver and kidneys. During pregnancy, the concentration of oxytocinase inactivating endogenous and exogenous oxytocin increases in the plasma of the target organs of the placenta. Excretion is mainly by the kidneys unchanged.
Indications:
For the excitement and stimulation of labor (primary and secondary weakness of labor, the need for early delivery in connection with gestosis, Rh-conflict, intrauterine fetal death; post-term pregnancy, premature discharge of amniotic fluid, management of labor in breech presentation).
For the prevention and treatment of hypotonic uterine bleeding after abortion (including in late pregnancy) in the early postpartum period and to accelerate the postpartum involution of the uterus; to enhance the contractility of the uterus during cesarean section (after removal of the placenta).
Contraindications:
Hypersensitivity;
narrow pelvis (anatomical and clinical) lateral and oblique position of the fetus,
facial presentation of the fetus,
premature birth
threatening rupture of the uterus,
scars on the uterus (after a previous cesarean section of the operation on the uterus)
excessive stretching of the uterus
uterus after multiple births
partial placenta previa
uterine sepsis
invasive cervical cancer
hypertonicity of the uterus (not during childbirth) compression of the fetus arterial hypertension chronic renal failure.
Pregnancy and lactation:
In the first trimester of pregnancy, oxytocin is used only for spontaneous or induced abortion.
When using the drug to stop uterine bleeding, breastfeeding can only be started when the course of treatment with oxytocin is completed.
Method of administration and dosage:
Intravenous intramuscular injection.
For the initiation of labor : intramuscularly at 05-2 ME (01-04 ml of the drug); if necessary, repeat the injections every 30-60 minutes.
Stimulation of labor activity : intravenous drip of 10 IU of oxytocin per 1 liter of 5% dextrose solution with the development of excessive contractions of the uterus, slowing down the infusion quickly leads to a decrease in the activity of the myometrium. The introduction begins with 5-8 drops / min, followed by an increase in speed, depending on the nature of labor, but not more than 40 drops / min. During the infusion, constant monitoring of uterine activity and fetal heart rate is necessary.
Treatment of unavoidable or incomplete abortion : intravenous drip of 10 IU (2 ml of the drug) oxytocin per 500 ml of 5% dextrose solution at a rate of 20-40 drops / min.
For the prevention of hypotonic uterine bleeding after abortion, oxytocin is injected intramuscularly at 3-5 IU (06-1 ml) 2-3 times a day every day for 2-3 days, intramuscular administration of 10 IU (2 ml) immediately after separation of the placenta is permissible. For the treatment of hypotonic uterine bleeding after abortion, 5-8 IU is administered 2-3 times a day for 3 days. If necessary, 10-40 ME (2-8 ml) of oxytocin dissolved in 100 ml of donor blood is injected intravenously.
When conducting labor in breech presentation: 2-5 ME (04-1 ml).
To enhance the contractile ability of the uterus during cesarean section (after removal of the placenta), 3-5 ME (06-1 ml) is injected into the uterine wall.
Side effects:
In women in labor:
From the reproductive system at high doses or hypersensitivity: uterine hypertension, tetany spasm, rupture of the uterus; increased bleeding in the postpartum period as a result of oxytocin-induced thrombocytopenia of afibrinogenemia and hypoprothrombinemia, sometimes hemorrhages in the pelvic organs. With close medical supervision of childbirth, the risk of bleeding in the postpartum period is reduced.
From the side of the cardiovascular system : at high doses - arrhythmia; ventricular premature beats; severe hypertension (in the case of the use of vasopressor drugs); hypotension (when used simultaneously with the anesthetic cyclopropane); reflex tachycardia; shock; if administered too quickly: bradycardia, subarachnoid bleeding.
From the digestive system : nausea, vomiting.
On the part of water and electrolyte metabolism: severe overhydration with prolonged intravenous administration (usually at 40-50 IU / min) with a large amount of fluid (antidiuretic effect of oxytocin) proceeding with convulsions and coma is possible with a 24-hour slow infusion of oxytocin; rarely - death.
From the immune system: anaphylaxis and other allergic reactions if administered too quickly - bronchospasm; rarely - death.
In a fetus or newborn :
As a result of the administration of oxytocin to the mother - within 5 minutes, a low Apgar score for neonatal jaundice with too rapid administration - a decrease in fibrinogen in the blood of the fetus; hemorrhage in the retina; as a result of increased contractile activity of the uterus - sinus bradycardia, tachycardia, ventricular premature beats and other arrhythmias, residual changes in the central nervous system, fetal death as a result of asphyxia.
Overdose:
Symptoms : fetal compression fetal asphyxia fetal bradycardia postpartum bleeding tetanus of the uterus rupture of the uterus uteroplacental hypoperfusion hypoxia hypercapnia fetal death birth trauma of the fetus water intoxication; convulsions.
Treatment : drug withdrawal; reduced fluid intake; forced diuresis; hypertonic sodium chloride solution normalization of electrolyte balance barbiturates (with caution) close observation.
Interaction:
Oxytocin enhances the pressor effect of sympathomimetics.
In combination with monoamine oxidase inhibitors, the risk of high blood pressure increases.
Halothane and cyclopropane increase the risk of arterial hypotension.
Special instructions:
Use only under the supervision of a doctor in a hospital under the control of the contractile activity of the uterus, the fetal blood pressure and the general condition of the woman.
Impact on the ability to drive vehicles. Wed and fur .:
Oxytocin does not affect the ability to drive and operate machinery that is associated with an increased risk of injury.
Release form / dosage:
Solution for intravenous and intramuscular administration of 5 IU / ml.
Packaging:
1 ml in neutral glass ampoules.
10 ampoules, together with instructions for use and a knife for opening ampoules or an ampoule scarifier, are placed in a cardboard box.
5 ampoules in a blister strip made of polyvinyl chloride film and printed aluminum foil, varnished or without foil.
1 or 2 blister packs together with instructions for use and a knife for opening ampoules or an ampoule scarifier are placed in a pack of cardboard.
When using ampoules with break points or rings, the ampoule opening knife or ampoule scarifier is not inserted.
Storage conditions:
In a dark place at a temperature of 8 to 15 ? C.
Keep out of the reach of children.
Shelf life:
2 years.
Do not use after the expiration date.
Vacation conditions
On prescription
Manufacturer
JSC 'DALKHIMFARM', 680001, Khabarovsk Territory, Khabarovsk, Tashkent street, 22, Russia
Marketing Authorization Holder / Organization Receiving Consumer Claims:
DALKHIMFARM OJSC