Instruction for use: Gynipral

Active substance Hexoprenaline

ATX Code G02CA Adrenomimetiki, tocolytic drugs

Pharmacotherapeutic group:

Beta2-agonists selective [beta-adrenergic agonist]

Selective beta2-agonists [Tocolytics]

The nosological classification (ICD-10)

O60 Premature birth

Pregnancy prematurity, The birth premature, Preterm labor pains, Premature contractions prehospital, Immobilization of the uterus before the cesarean section, Immobilization of the uterus, Acute tocolysis, Threatening premature labor, Premature discharge of water, Preventing premature births, The threat of premature birth

Structure and Composition

Tablets 1 tab.

hexoprenaline sulfate 0.5 mg

corn starch 27.8 mg

80 mg of lactose hydrate

copovidone 8 mg

edetate disodium dihydrate 0.5 mg

0.8 mg talc

magnesium stearate 0.8 mg

glycerol palmitostearate mg 1.6

in blister PVC / Al. 10 pieces.; In the paper cartons 1 or 2 blisters.

Description

Tablets: white, round, biconvex.

pharmachologic effect

pharmachological effect tocolytic.

pharmacodynamics

It relaxes the muscles of the uterus, reduces the frequency and intensity of contractions, inhibits spontaneous and oxytocin induced labor pains. During labor normalises the strength and regularity of contractions, inhibits (in most cases), premature contractions and prolongs pregnancy until the normal term delivery. Negligible effect on the cardiovascular system and fetal pregnant.

Pharmacokinetics

If ingestion is well absorbed. Is output as a dimethylated derivative with urine and bile - a complex of metabolites.

Ginipral® consists of 2 groups of catecholamine, which humans are exposed to through the methylation of catecholamine-O-methyltransferase. Hexoprenaline becomes biologically inactive only if both of its methylation catecholamine groups. When intrabronchial administration of 3H-labeled hexoprenaline for a relatively long time excreted in urine in the form of a biologically active substance. Part of the administered substance is active at the site of a long time.

Indications

The threat of premature birth (as a continuation of infusion therapy).

Contraindications

hypersensitivity (especially in patients suffering from bronchial asthma and hypersensitivity to sulfites);

hyperthyroidism;

cardiovascular disease, particularly heart rhythm disturbances that occur with tachycardia; myocarditis, malformation of the mitral valve and aortic stenosis;

coronary artery disease;

arterial hypertension;

severe liver and kidney disease;

angle-closure glaucoma;

premature detachment of the placenta, uterine bleeding, intrauterine infection;

pregnancy (I term);

lactation.

Pregnancy and breast-feeding

It contraindicated in I trimester of pregnancy. At the time of treatment should stop breastfeeding.

Side effects

Dizziness, anxiety, slight tremor of fingers, sweating, tachycardia, headache, increase in liver enzymes.

Perhaps the reduction in blood pressure, particularly diastolic. In some cases, nausea and vomiting develops.

In rare cases - premature ventricular beats, pain in the heart (cardialgia). These symptoms disappear rapidly after discontinuation of the drug.

The level of blood sugar rises due glikogenoliticheskogo drug action (especially in diabetics).

Urine output decreases in early treatment. In patients with a tendency to fluid retention in the tissues it can lead to the appearance of edema.

During treatment Ginipralom® may decrease bowel motility rate (necessary to pay attention to the regularity of the chair).

Newborns - hypoglycemia, acidosis, bronchospasm, anaphylactic shock.

Interaction

A number of drugs that lower blood pressure (β-blockers) weaken the effect Giniprala® or neutralize it.

Methylxanthines (such as theophylline) increase the effect Giniprala®.

The action of oral hypoglycemic agents in the background Ginipralom® therapy attenuated.

General anesthetics (halothane) and adrenostimulyatorov (cardiovascular and anti-asthmatic drugs) increase the side effects of the cardiovascular system.

Ginipral® incompatible with ergot alkaloid, MAO inhibitors, tricyclic antidepressants, as well as mineralocorticoids, dihydrotachysterol and preparations containing calcium and vitamin D.

Dosage and Administration

Inside, squeezed a small amount of water.

In the absence of other recommendations should be strictly observe the specified dosage.

The threat of premature birth: for 1-2 hours before the end of the infusion Giniprala® start taking the tablets at a dose of 0.5 mg (1 tab.) Every 3 hours, then - every 4-6 hours (4-8 hours in the Table.).

Overdose

Symptoms: anxiety, tremor, sweating, severe tachycardia, arrhythmia, headaches, false angina, lower blood pressure, shortness of breath.

Treatment: the use Giniprala® antagonists - non-selective β-blockers, completely neutralizing its effects.

special instructions

Blood pressure, pulse and cardiac activity should be under constant medical supervision.

Patients with diabetes should monitor the level of blood sugar.

Under the influence of Giniprala® decreased urine output, so you should carefully observe the symptoms, reflecting the fluid retention in the body (such as leg swelling, shortness of breath). Especially it is important in the case of simultaneous reception or corticosteroids in renal disease.

Strict limitation of excessive fluid intake.

Limit salt intake from food.

During tocolytic treatment is necessary to control bowel movements.

When prolonged tocolytic therapy is necessary to monitor the state of fetoplacental complex. When rupture of membranes and cervical dilatation of more than 2-3 cm the effectiveness of tocolytic therapy is low.

When the need for surgery should inform the anesthesiologist Ginipralom® therapy.

You should always take into account the intake of any other medicines in the event of appointment Ginipralom® therapy.

Coffee and tea may increase the side effects Giniprala®.

the doctor should be informed immediately about contraindications or side effects.

Storage conditions

In a dry, the dark place at a temperature no higher than 25 ° C.

Keep out of the reach of children.

The shelf life

5 years.

Do not use beyond the expiration date printed on the package.

Available with prescription