Ginipral

Ginipral – the drug promoting decrease in a tone and sokratitelny activity of a myometrium.

Form of release and structure

Ginipral release in the following dosage forms:

• Tablets: white, biconvex, round (on 10 pieces in blisters, on 2 blisters in a cardboard pack);
• Solution for intravenous administration: colourless, transparent (in ampoules on 2 ml, on 5 ampoules in plastic pallets, on 1 or 5 pallets in a cardboard pack).

Is a part of 1 tablet:

• Active agent: a geksoprenalina sulfate – 0,5 mg;
• Auxiliary components: talc, corn starch, коповидон, hydrate of lactose, dinatrium эдетат dihydrate, magnesium stearate, glitserola of palmitate stearate.

Is a part of 1 ml:

• Active agent: a geksoprenalina sulfate – 0,005 mg;
• Auxiliary components: dinatrium эдетат a dihydrate, sulphuric acid 2N (for maintenance of level рН), sodium pyrosulphite, sodium chloride, water for injections.

Indications to use

Ginipral in the form of solution for injections appoint in the following cases:

• Massive tocolysis: for braking of premature labor pains at disclosure of a pharynx of a uterus and/or existence of a smoothed neck of uterus;
• Acute tocolysis: as an emergency measure at premature births before delivery of the pregnant woman in hospital; for braking of labor pains at the time of delivery at a uterus immobilization before Caesarian section, acute intrauterine asphyxia, the complicated patrimonial activity, an umbilical cord prolapse, and also before version from cross situation;
• Long tocolysis: for prevention of premature births at the speeded-up or strengthened pains without disclosure of a pharynx of a uterus or smoothing of a neck; at a uterus immobilization to, in time and after a cervical cerclage.

Ginipral in the form of tablets apply at threat of premature births (most often as continuation of infusional therapy).

Contraindications

• Tachyarrhythmias;
• Thyrotoxicosis;
• Aortal stenosis and defect of the mitral valve;
• Myocarditis;
• Serious illness of kidneys and liver;
• Arterial hypertension;
• Coronary heart disease;
• Premature placental detachment, uterine bleedings;
• Intrauterine infections;
• Closed-angle glaucoma;
• First trimester of pregnancy and period of a lactation (breastfeeding);
• Hypersensitivity to drug components (especially at patients with bronchial asthma and hypersensitivity to sulfites in the anamnesis).

Route of administration and dosage

Ginipral's solution is entered intravenously slowly for 5-10 minutes. The doctor selects a dose individually. It is necessary to drive drug after cultivation to 10 ml isotonic solution of sodium of chloride, using automatically dosing infuzomata or usual infusional systems.

The scheme of use of drug is defined by indications:

• Massive tocolysis: Ginipral's introduction is begun with 0,01 mg (1 ampoule on 2 ml) with the subsequent infusion with a speed of 0,0003 mg a minute. Also perhaps infusional use of drug without preliminary bolyusny introduction;
• Acute tocolysis: drug is used in a dose 0,01 mg. In need of further therapy can be continued by means of infusions;
• Long tocolysis: Ginipral appoint in the form of long drop infusion with a speed of 0,000075 mg a minute.

If resuming of pains does not happen within 48 hours, treatment is continued Ginipral in the form of tablets.

Pill is taken orally, washing down with a small amount of water.

At threat of premature births Ginipral appoint in a dose 0,5 mg (1 tablet) in 1-2 hours prior to the end of infusion.

At first accept on 1 tablet each 3 hours, then each 4-6 hours. A daily dose – from 4 to 8 tablets (2-4 mg).

Side effects

• Central and peripheral nervous system: dizziness, headache, easy tremor of fingers, uneasiness;
• Alimentary system: seldom – vomiting, nausea, oppression of motility of intestines, temporary increase in level of transaminases, intestinal impassability (it is recommended to control a chair regularity);
• Cardiovascular system: tachycardia at mother (in most cases heart rate at a fruit remains invariable), arterial hypotension (diastolic is more often); seldom – cardialgias (usually after drug withdrawal quickly disappear), disturbances of a rhythm (ventricular premature ventricular contraction);
• Laboratory indicators: a hypocalcemia in an initiation of treatment, a hypopotassemia, increase in level of glucose in a blood plasma;
• Allergic reactions: a bronchospasm, breath difficulty, disturbance of consciousness up to a coma, an acute anaphylaxis (at patients with bronchial asthma or hypersensitivity to sulfites);
• Others: an oliguria, the increased sweating, hypostases (especially at patients with diseases of kidneys).

At newborns side effects can be shown as acidosis and a hypoglycemia.

Special instructions

At Ginipral's use it is recommended to control carefully function of cardiovascular system (arterial pressure, heart rate) of a fruit and mother. Also it is necessary to register an ECG to and during treatment.

Patients with hypersensitivity to sympathomimetics are recommended to appoint small doses of Ginipral which the doctor selects individually. Also such patients need constant medical observation.

At considerable increase of heart rate at mother (it is more than 130 beats per minute) or/and at the expressed lowering of arterial pressure the dose of drug needs to be lowered.

At emergence of symptoms of heart failure, pains in heart and the complicated breath Ginipral's use needs to be stopped immediately.

During therapy, especially during an initial stage, increase in glucose in a blood plasma in this connection at mothers with a diabetes mellitus it is necessary to control indicators of carbohydrate metabolism is possible. If childbirth happens right after carrying out a course of treatment, it is necessary to consider a possibility of development in newborn acidosis and a hypoglycemia that it is connected with transplacental penetration of ketonic and lactic acids.

At Ginipral's use the diuresis therefore it is necessary to watch closely liquid delay signs in an organism goes down.

During Ginipral's infusions can sometimes lead simultaneous use of glucocorticosteroids to a fluid lungs. Therefore at infusional therapy constant control of a condition of patients is necessary. It is especially important at the combined treatment by glucocorticosteroids at patients with diseases of kidneys. It is necessary to limit excess reception of liquid strictly. Because of risk of possible edematization of lungs it is necessary as far as it is possible, to limit the volume of infusions. Also it is recommended to limit the use of salt in a diet.

During use of drug it is necessary to watch a regularity of activity of intestines.

Before tokolitichesky treatment it is necessary to accept potassium drugs as action of sympathomimetics on a myocardium at a hypopotassemia amplifies.

Simultaneous use of sympathomimetics and means for the general anesthesia (halothane) can cause disturbances of a heart rhythm. Therefore before use of a halothane therapy by Ginipral should be stopped.

At long tokolitichesky therapy it is necessary to watch a condition of a fetoplacental complex. It is also necessary to be convinced of lack of placental detachment which clinical symptoms against the background of tokolitichesky therapy can be maleficiated. At disclosure of a neck of uterus it is more than on 2-3 cm and a rupture of a bag of waters Ginipral's use is inefficient.

When performing tokolitichesky treatment using beta-adrenergic agonists strengthening of symptoms of the accompanying dystrophic myatonia is possible. In these cases use of drugs of diphenylhydantoin (Phenytoinum) is recommended.

Strengthening of side effects of Ginipral at its use in the form of tablets with coffee or tea is possible.

Medicinal interaction

At simultaneous use of Ginipral with some medicines there can be undesirable effects:

• Beta adrenoblockers: easing or neutralization of action of Ginipral;
• Peroral hypoglycemic drugs: weakening of their action;
• Methylxanthines (including theophylline): strengthening of efficiency of Ginipral;
• Glucocorticosteroids: decrease in intensity of accumulation in a glycogen liver;
• Other medicines with sympathomimetic activity (broncholitic and cardiovascular drugs): emergence of symptoms of overdose and strengthening of effect of these drugs on cardiovascular system;
• Ftorotanum and beta адреностимуляторы: strengthening of side effects of Ginipral from cardiovascular system.

Ginipral is incompatible with tricyclic antidepressants, monoamine oxidase inhibitors (MAO), ergot alkaloids, and also with the medicines containing vitamin D and calcium, mineralokortikoida and Dihydrotachysterolum.

Sulfite – a highly active component therefore it is not necessary to mix Ginipral with any other solutions, except 5% of solution of glucose (dextrose) and isotonic solution of sodium of chloride.

Terms and storage conditions

To store at a temperature of 18-25 °C in protected from light, the place, unavailable to children.

Period of validity:

• Solution for intravenous administration – 3 years;
• Tablets – 5 years.