Description
Release form
Solution for iv administration.
Packing
5 pcs. 2 ml each.
Pharmacological action
Selective beta2-adrenergic agonist, reduces the tone and contractile activity of the myometrium. Reduces the frequency and intensity of uterine contractions, inhibits spontaneous, as well as labor pains caused by oxytocin. During childbirth, normalizes excessively strong or irregular contractions.
Under the influence of the drug, premature contractions in most cases stop, which allows you to extend the pregnancy to the normal term of delivery.
Due to its beta2 selectivity, the drug has little effect on the cardiac activity and blood flow of the pregnant woman and the fetus.
Indications
Acute tocolysis: Inhibition of labor during labor during acute intrauterine asphyxiation, when the uterus is immobilized before cesarean section, before the fetus rotates from the transverse position, when the umbilical cord prolapse, and complicated labor.
An emergency measure for premature birth before a pregnant woman is taken to hospital.
Massive tocolysis: Inhibition of premature labor in the presence of a smoothed cervix and / or opening of the uterus.
Prolonged tocolysis: Prevention of preterm labor in increased or rapid contractions without smoothing the cervix or opening of the uterus.
Uterine immobilization before, during, and after cervical cerclage.
Contraindications
Thyrotoxicosis.
Tachyarrhythmias.
Myocarditis.
Mitral valve disease and aortic stenosis.
ischemic heart disease.
Arterial hypertension.
Severe liver and kidney disease.
Angle-closure glaucoma.
Uterine bleeding, premature placental abruption.
Intrauterine infections.
I trimester of pregnancy.
Lactation (breastfeeding).
Hypersensitivity to the components of the drug (especially in patients with a history of bronchial asthma and hypersensitivity to sulfites).
Special instructions
During the use of Ginipral, it is recommended to carefully monitor the functions of the cardiovascular system (heart rate, blood pressure) of the mother and fetus. It is recommended to record an ECG before and during treatment.
Patients with hypersensitivity to sympathomimetics should be prescribed Ginipral in small doses, individually selected, under the constant supervision of a physician.
With a significant increase in heart rate in the mother (more than 130 beats / min) or / and with a marked decrease in blood pressure, the dose of the drug should be reduced.
If you experience difficulty breathing, pain in the heart, signs of heart failure, Ginipral should be discontinued immediately.
The use of Ginipral can cause an increase in plasma glucose (especially in the initial period of treatment), therefore, carbohydrate metabolism in mothers with diabetes should be monitored. If childbirth occurs immediately after treatment with Ginipral, it is necessary to take into account the possibility of hypoglycemia and acidosis in newborns due to transplacental penetration of lactic and ketonic acids.
When applying Ginipral, diuresis is reduced, so you should carefully monitor the symptoms associated with fluid retention in the body.
In some cases, the simultaneous use of corticosteroids during Ginipral infusions can cause pulmonary edema. Therefore, with infusion therapy, constant careful clinical monitoring of patients is necessary. This is especially important in the combined treatment of corticosteroids in patients with kidney disease. Strict restriction of excess fluid intake is necessary. The risk of possible development of pulmonary edema requires og associated with fluid retention in the body.
In some cases, the simultaneous use of corticosteroids during Ginipral infusions can cause pulmonary edema. Therefore, with infusion therapy, constant careful clinical monitoring of patients is necessary. This is especially important in the combined treatment of corticosteroids in patients with kidney disease. Strict restriction of excess fluid intake is necessary. The risk of possible development of pulmonary edema requires og associated with fluid retention in the body.
In some cases, the simultaneous use of corticosteroids during Ginipral infusions can cause pulmonary edema. Therefore, with infusion therapy, constant careful clinical monitoring of patients is necessary. This is especially important in the combined treatment of corticosteroids in patients with kidney disease. Strict restriction of excess fluid intake is necessary. The risk of possible development of pulmonary edema requires oglimiting the infusion volume as much as possible, as well as using dilution solutions that do not contain electrolytes. Limit salt intake with food.
It is recommended to monitor the regularity of intestinal activity during the period of use of the drug.
Before starting tocolytic therapy, it is necessary to take potassium preparations, as with hypokalemia, the effect of sympathomimetics on the myocardium is enhanced.
The simultaneous use of funds for general anesthesia (halothane) and sympathomimetics can lead to heart rhythm disturbances. Ginipral should be discontinued before using halotane.
With prolonged tocolytic therapy, it is necessary to monitor the status of the placental complex, to make sure that there is no detachment of the placenta. Clinical symptoms of premature placental abruption can be alleviated against the background of tocolytic therapy. With rupture of the fetal bladder and with the opening of the cervix by more than 2-3 cm, the effectiveness of tocolytic therapy is small.
Symptoms of concomitant dystrophic myotonia may intensify during tocolytic therapy with beta-adrenergic agonists. In such cases, the use of diphenylhydantoin (phenytoin) preparations is recommended.
When using the drug in the form of tablets with tea or coffee, it is possible to increase the side effects of Ginipral.
Composition
1 ml of the solution contains:
Active substances: hexoprenaline sulfate – 5 mcg.
Excipients: sodium pyrosulfite, disodium edetate dihydrate, sodium chloride, sulfuric acid 2N (to maintain pH), water d / i.
Dosage and administration
The contents of the ampoule must be administered intravenously slowly for 5-10 minutes using automatically dosing infusomats or using conventional infusion systems – after dilution with isotonic sodium chloride solution to 10 ml. The dose of the drug should be selected individually.
In acute tocolysis: the drug is prescribed in a dose of 10 μg (1 amp. in 2 ml). In the future, if necessary, treatment can be continued with the help of infusions.
In case of massive tocolysis: the administration of the drug begins with 10 μg (1 amp. in 2 ml), followed by infusion of Ginipral at a rate of 0.3 μg / min. As an alternative treatment, it is possible to use only infusions of the drug at a rate of 0.3 μg / min without prior bolus administration of the drug.
With prolonged tocolysis: the drug is prescribed as a long drip infusion at a rate of 0.075 mcg / min.
If resumption of contractions does not occur within 48 hours, continue treatment with 500 mcg Ginipral tablets.
Side effects of
From the central nervous system and peripheral nervous system: headache, dizziness, anxiety, slight tremor of the fingers.
From the cardiovascular system: tachycardia in the mother (heart rate in the fetus in most cases remains unchanged), arterial hypotension (mainly diastolic) rarely – rhythm disturbances (ventricular extrasystole), cardialgia (quickly disappear after drug withdrawal).
From the digestive system: rarely – nausea, vomiting, inhibition of intestinal motility, intestinal obstruction (it is recommended to monitor the regularity of stool), a temporary increase in transaminases.
Allergic reactions: difficulty breathing, bronchospasm, impaired consciousness up to coma, anaphylactic shock (in patients with bronchial asthma or patients with hypersensitivity to sulfites).
On the part of laboratory parameters: hypokalemia, hypocalcemia at the beginning of therapy, increased plasma glucose.
Other: increased sweating, oliguria, edema (especially in patients with kidney disease). Side effects in newborns: hypoglycemia, acidosis.
Drug interaction
When combined with beta-blockers, the effect of Ginipral is weakened or neutralized.
When combined with methylxanthines (including with theophylline), the effectiveness of Ginipral is enhanced.
With the combined use of Ginipral with GCS, the rate of glycogen accumulation in the liver decreases.
When used together, Ginipral weakens the effects of oral hypoglycemic drugs.
With the combined use of Ginipral with other drugs with sympathomimetic activity (cardiovascular and bronchodilator drugs), the effect of the drugs on the cardiovascular system and the appearance of symptoms of an overdose are possible.
When combined with fluorotan and beta-adrenostimulants, the side effects of Ginipral from the cardiovascular system are enhanced.
Ginipral is incompatible with ergot alkaloids, MAO inhibitors, tricyclic antidepressants, as well as with preparations containing calcium and vitamin D, dihydrotachysterol and mineralocorticoids.
Sulfite is a highly active component, so you should refrain from mixing Ginipral with other solutions, except for isotonic sodium chloride solution and 5% dextrose (glucose) solution.
Overdose
Symptoms: severe maternal tachycardia, arrhythmia, finger tremor, headaches, sweating, anxiety, cardialgia, decreased blood pressure, shortness of breath.
Treatment: The use of ginipral antagonists – non-selective beta-blockers that completely neutralize the action of the drug.
Storage conditions
Store in a dark place, out of the reach of children, between 18 ° and 25 ° C.
Shelf life
3 years.
Deystvuyushtee substance
Geksoprenalin
Dosage form
solution for infusion
Prescription
Prescription
Pregnant women II and III trimester as prescribed by a doctor
Nycomed, Norway