Gynipral ampoules 10mkg 2ml №5

Mechanism of action

The drug that reduces the tone and contractile activity of the myometrium, [b] 2-sympathomimetic. Hinipral reduces the frequency and intensity of contractions of the uterus. Suppresses spontaneous, as well as labor pains caused by oxytocin. During labor normalizes excessively strong or irregular contractions.
Under the action of Giniprala, premature contractions in most cases are terminated, which makes it possible to prolong the pregnancy to the normal term of labor. Due to its selectivity for [b] 2-adrenergic receptors, Gynipral has a negligible effect on the cardiac activity and blood flow of the pregnant woman and the fetus.

After ingestion, hexoprenaline is well absorbed from the gastrointestinal tract.
Metabolism
It is metabolized by methylation of the catecholamine groups to form monomethylderivate, dimethylderivate, and also glucuronide and sulfate.
Excretion:
In experimental studies, it was shown that 4 hours after i.v. administration, 80% of unchanged hexaprenaline and its monomethylderivate are excreted in the urine.
A small portion is excreted in the bile in the form of complex metabolites.
After ingestion, part of the dose is excreted by the urine as a dimethylating metabolite.

Indications and usage

For IV injection and infusion
Acute tocolysis:
inhibition of labor contractions during labor with acute intrauterine asphyxia, immobilization of the uterus before a cesarean section, before the fetus rotates from the transverse position, with umbilical cord prolapse, with complicated labor activity;
as an emergency measure for preterm birth before the delivery of the pregnant woman to the hospital.
Massive tocolysis:
inhibition of premature labor contractions in the presence of a flattened cervix and / or disclosure of the uterine opening.
Long tocolysis:
prevention of preterm labor with increased or more frequent contractions without smoothing the cervix or disclosure of the uterine opening; immobilization of the uterus before, during and after Cerclage-operation.
For ingestion - the threat of premature birth (primarily as a continuation of infusion therapy).

Gynipral is administered in / in the form of injections and infusions.
The indicated doses can be used only as approximate, during the tocolysis they must be adjusted individually.
When conducting acute tocolysis at the beginning of treatment, Gynipral is administered with a bolus of 10 μg. If necessary, further use of the drug is administered by intravenous infusion at a rate of 0.3 mcg / min.
When a massive tocolysis is performed at the beginning of treatment, Gynipral is injected into a / in a bolus at a dose of 10 mcg, followed by a IV infusion at a speed of 0.3 mcg / min.
As an alternative treatment, only an infusion of Gynipral at a speed of 0.3 mcg / min is possible, without prior bolus administration.
When conducting a prolonged tocolysis, Gynipral is administered by continuous drip infusion at a rate of 0.075 mcg / min.
Excess dose of 430 mcg / day is possible only in exceptional cases.
If within 48 hours there is no resumption of contractions Gynipral can be administered orally in the form of tablets, a single dose - 500 mcg.
With the threat of premature birth for 1-2 hours before the end of the infusion, the drug is administered orally, first 500 μg (1 tablet) every 3 hours, and then every 4-6 hours (4-8 pills / day).
Terms of preparation and / in the introduction of solutions
When preparing an injection solution for bolus administration, the contents of the ampoule 10 mg are diluted in 10 ml of isotonic sodium chloride solution or 5% glucose solution and injected IV slowly over 5-10 minutes.
When preparing an infusion solution for administration at a rate of 0.3 mcg / min, the concentrate for infusions is diluted in 500 ml of isotonic sodium chloride solution or 5% glucose solution. The prepared solution is injected into / in the drip, 20 drops = 1 ml.
The calculation of a dose of 0.3 mcg / min corresponds to:
The number of concentrate vials for infusionSpeed ​​on / in the introduction
1 (25 mcg) 120 drops / min
2 (50 mcg) 60 drops / min
3 (75 mcg) 40 drops / min
4 (100 mcg) 30 drops / min
When using dosing infusomats, 75 μg of concentrate for infusions (3 ampoules) is diluted to 50 ml with isotonic sodium chloride solution or 5% glucose solution; infusion rate 0.3 mcg / min.
When preparing an infusion solution for long-term drip, at a rate of 0.075 mcg / min, the concentrate for infusion is diluted in 500 ml of isotonic sodium chloride solution or 5% glucose solution.
The calculation of the dose of 0.075 mcg / min corresponds to:
The number of concentrate vials for infusionSpeed ​​on / in the introduction
1 (25 mcg) 30 drops / min
2 (50 mcg) 15 drops / min
When using automatically dosing infusomats, 75 μg of concentrate for infusions (3 ampoules) is diluted to 50 ml with isotonic sodium chloride solution or 5% glucose solution; infusion rate 0.075 mcg / min.

Adverse reactions

On the part of the central nervous system and peripheral nervous system: possible headache, anxiety, tremor, dizziness.
From the side of the cardiovascular system: a slight tachycardia is possible, a decrease in blood pressure (especially diastolic); rarely - ventricular extrasystoles, pain in the heart area (these symptoms quickly disappear after stopping the use of the drug.
Heart rate in the fetus in most cases remains unchanged or varies slightly.
On the part of the digestive system: possible inhibition of intestinal peristalsis, a temporary increase in the concentration of transaminases in the blood serum; rarely - nausea, vomiting, intestinal atony.
On the part of the urinary system: possible reduction of diuresis (especially at the beginning of treatment).
On the part of the metabolism: an increase in the sugar content in the blood is possible (in diabetes mellitus, this effect is more pronounced), an increase in sweating; in the first days of treatment, a decrease in the concentration of potassium in the blood (in the course of further treatment, normalization).
Allergic reactions: with concomitant bronchial asthma and in patients with hypersensitivity to sulfites, diarrhea, difficulty breathing, impairment and loss of consciousness, bronchospasm, and anaphylactic shock are possible.
Gynipral is usually well tolerated.

Contraindications

Hyperthyroidism; cardiovascular diseases (cardiac rhythm disturbances occurring with tachycardia, myocarditis, mitral valve disease, aortic stenosis); severe liver and kidney disease; angle-closure glaucoma; uterine bleeding (premature detachment of the placenta); intrauterine infections; lactation;
Hypersensitivity to the components of the drug (especially with concomitant bronchial asthma and hypersensitivity to sulfites).

Pregnancy and breastfeeding

If childbirth occurs immediately after a course of treatment with Gynipral, it is necessary to take into account the possibility of hypoglycemia and acidosis in newborns due to transplacental penetration of acidic metabolic products (lactic and ketonic acids).

Special notes

When applying Gynipral, you should monitor the pulse and blood pressure of the mother, as well as the fetal heartbeat. ECG monitoring is recommended before and during treatment.
In patients with hypersensitivity to sympathomimetics, Gynipral should be used in small doses, selected individually, under the constant supervision of a physician.
With a significant increase in the mother's heart rate (more than 130 beats / min) and / or a pronounced decrease in blood pressure, the dose should be reduced; If there are complaints of shortness of breath, pain in the heart area and when signs of heart failure appear, use of Gynipral should be stopped immediately.
Before the start of tocolytic therapy, it is necessary to prescribe potassium preparations, since with hypokalemia, the effect of sympathomimetics on the myocardium is enhanced.
Against the background of the use of the drug should limit the intake of salt with food.
When conducting tocolytic therapy it is necessary to monitor the regularity of the chair.
In pregnant women with diabetes, should be controlled blood sugar concentration, because Gynipral use, especially at the beginning of treatment, may cause an increase in glycemia.
In some cases, the use of corticosteroids during the administration of Gynipral may develop pulmonary edema. Therefore, with infusion therapy, constant careful clinical monitoring of patients is necessary. This is especially important when it comes to combination therapy with corticosteroids and Gynipral in patients with concomitant diseases accompanied by fluid retention (including kidney disease).
Since there is a risk of pulmonary edema with the introduction of Gynipral, it is necessary to limit the volume of fluid introduced during the infusion, in addition, it is preferable to use solutions not containing electrolytes to dilute the drug.
With prolonged tocolytic therapy, it is necessary to ensure that there is no detachment of the placenta. Clinical symptoms of premature detachment of the placenta can be smoothed against the background of tocolytic therapy.When the ruptured membranes and disclosure of the cervix more than 2-3 cm, the effectiveness of tocolytic therapy is low.
When conducting tocolytic therapy with beta-adrenomimetic therapy, the symptoms of concomitant dystrophic myotonia may increase. In such cases, the use of drugs diphenylhydantoin (phenytoin) is recommended.
Before applying halothane, Gynipral should be abolished.
It is necessary to avoid simultaneous use of Gynipral with other sympathomimetics (means for normalizing blood circulation, anti-asthma drugs).
Gynipral is not recommended to be prescribed simultaneously with ergot alkaloids, as well as with drugs containing Calcium and vitamin D, dihydrotachysterol or mineralocorticoids.

Symptoms: marked increase in mother's heart rate, tremor, headache, increased sweating.
Treatment. Moderate symptoms of overdose usually disappear after reducing the dose of the drug. To eliminate the more severe manifestations, Gynipral antagonists should be used - non-selective beta-blockers - drugs that completely neutralize Ginipral's action.

Non-selective beta-blockers weaken or neutralize Ginipral’s action.
Methylxanthines, incl. theophylline, enhance the action of Gynipral.
The intensity of glycogen accumulation in the liver, caused by the use of corticosteroids, is reduced by the action of Gynipral.
Gynipral weakens the hypoglycemic effect of antidiabetic agents.
With simultaneous use of Gynipral with other sympathomimetics (means for normalizing blood circulation, anti-asthma drugs), it is possible to increase the stimulating effect on the cardiovascular system and the onset of overdose symptoms.
With the simultaneous use of sympathomimetics and halothane may develop heart rhythm disorders.
Pharmaceutical Interaction
Sulfite contained in the injection form of the drug is a highly active component, so you should refrain from mixing Gynipral with other solutions (except for isotonic sodium chloride solution and 5% glucose solution).

The drug should be stored in a dark place at room temperature no higher than 25 [0] C. Shelf life is 60 months.
Pharmacy sales terms
The drug is available on prescription.