GINIPRAL

Active material: Geksoprenalin
When ATH: R03CC05
CCF: Preparation, lowers tone and oxytocics activity oxytocics
ICD-10 codes (testimony): O60, O62
When CSF: 23.02.01
Manufacturer: NYCOMED AUSTRIA GmbH (Austria)

Pharmaceutical form, composition and packaging

Pills white, round, lenticular.

Excipients: corn starch, lactose hydrate (80 mg), kopovydon, disodium эdetat digidrat, talc, magnesium stearate, palymitata glycerol stearate.

10 PC. – blisters (2) – cardboard boxes.

The solution for the on / in the clear, colorless.

Excipients: sodium pyrosulfite, disodium эdetat digidrat, sodium chloride, 2N sulphuric acid (to maintain pH), water d / and.

2 ml – ampoule (5) – trays, plastic (1) – cardboard boxes.

Pharmacological action

Selective beta₂-adrenomimetik, lowers tone and oxytocics activity oxytocics. It reduces the frequency and intensity of uterine contractions, inhibits spontaneous, and oxytocin induced labor pains. During labor normalises excessively strong or irregular contractions.

Under the influence of the drug to premature contractions in most cases terminated, allowing you to extend the normal period of pregnancy to birth.

Due to its beta₂-selectivity the drug had little effect on cardiac activity and blood flow of the pregnant woman and the fetus.

Pharmacokinetics

Absorption

Hexoprenaline well absorbed after oral administration.

Metabolism

The drug consists of two kateholaminovyh groups, who undergo methylation by the COMT. Hexoprenaline becomes biologically inactive only if methylation of both groups catecholamine. This property, as well as the ability of the drug to the adhesion to the surface considered reasons for its prolonged action.

Deduction

Write mainly with urine in an unmodified form and in the form of metabolites. For the first 4 hours after treatment 80% of the administered dose excreted in urine as free and hexoprenaline monometilmetabolita. Then increases excretion dimetilmetabolita and related compounds (gljukoronida and sulfate). A small portion is excreted in the bile in the form of complex metabolites.

Testimony

For solution

Acute tocolysis

— braking generic contractions during labor when severe intrauterine asphyxia, When the immobilization of the uterus before the caesarean section, before the turn of the lateral position of the fetus, prolapse of the umbilical cord, in complicated labor;

-emergency measure when premature birth pregnant before delivery in hospital.

Massive tocolysis

-inhibition of preterm contractions in the presence of ancestral smoothed the cervix and/or disclosure of the uterine OS.

Long-term tocolysis

-Prevention of preterm labour with enhanced or frequent bouts of without smoothing cervical or uterine OS disclosure;

-immobilization of the uterus before the, during and after cervical cerclage.

Pill

is the threat of premature birth (primarily as a continuation of the infusion therapy).

Dosage regimen

For solution

The contents of the ampoules should drive in/in slowly over 5-10 min. dosing automatically through infusion or by conventional infusion systems – After breeding izotoniceski solution of sodium chloride up to 10 ml. The dose should be selected individually.

At acute tokolize the drug is prescribed in a dose 10 g (1 amp. by 2 ml). Further, if necessary, treatment can be continued using infusions.

At massive tokolize the introduction of the drug start with 10 g (1 amp. by 2 ml) with the subsequent infusion of Giniprala with speed 0.3 mcg / min. As an alternative treatment is possible to use only drug infusions with speed 0.3 mcg/min without prior bolusni drug.

At long tokolize the drug is prescribed in form of a long drip infusion speed 0.075 mcg / min.

If during the 48 h does not occur the resumption of battles, should continue treatment pills Giniprala 500 g.

Pill

The tablets should be taken with a little water.

At the threat of premature birth the drug is prescribed in a dose 500 g (1 tab.) for 1-2 hours before the end of the infusion Giniprala.

The drug should be taken first by 1 tab. every 3 no, and then every 4-6 no. The daily dose is 2-4 mg (4-8 tab.).

Side effect

From the central and peripheral nervous system: headache, dizziness, anxiety, light tremor of the fingers.

Cardio-vascular system: maternal tachycardia (Fetal HEART RATE in most cases remains unchanged), hypotension (preferentially diastolic); rarely – arrhythmias (ventricular premature beats), kardialgii (rapidly disappearing after preparation).

From the digestive system: rarely – nausea, vomiting, inhibition of bowel motility, ileus (It is recommended to check the regularity of the Chair), temporary increase in transaminases.

Allergic reactions: difficulty breathing, bronchospasm, impairment of consciousness up to coma, anaphylactic shock (in patients with bronchial asthma or patients with hypersensitivity to sul'fitam).

From the laboratory parameters: kaliopenia, at the beginning of therapy hypocalcemia, raising the level of glucose in the blood plasma.

Other: increased perspiration, oligurija, swelling (especially in patients with renal diseases).

Side effects in infants: gipoglikemiâ, Acidosis.

Contraindications

- Thyrotoxicosis;

- Taxiaritmii;

- Miokardit;

— defect in the mitral valve and aortic stenosis;

- CHD;

- Arterial hypertension;

-severe liver disease and kidney failure;

- Zakrыtougolynaya glaucoma;

- Uterine bleeding, premature detachment of the placenta;

-intrauterine infection;

- I trimester of pregnancy;

- Lactation (breast-feeding);

- Hypersensitivity to the drug (especially in patients with bronchial asthma and hypersensitivity to sul'fitam in history).

Pregnancy and lactation

The drug is contraindicated for use in the I trimester of pregnancy and lactation (breast-feeding). In II and III trimestrah pregnancy drug is used according to the.

Cautions

During the period of Giniprala^® It is recommended that you conduct a thorough monitoring of the cardiovascular system (Heart Rate, FROM) mother and fetus. We recommend that you record the ECG before and during treatment.

In patients with hypersensitivity to simpatomimetikam should appoint Ginipral^® in small doses, Customised, under the constant supervision of a doctor.

With a significant increase in heart rate in the mother (more 130 u. / min) or/and expressed declining AD should reduce the dose of the drug.

When you see the wheezing, pain in the heart, signs of heart failure use Giniprala^® should cease immediately.

Use Giniprala^® can cause increased plasma glucose (especially in the initial period of treatment), Therefore, you should monitor the carbohydrate metabolism in mothers with diabetes. If deliveries are performed directly after treatment Ginipralom^®, It is necessary to take into account the possibility of the newborn gipoglikemii and azidoza because transplacentarnogo infiltration of mammary and ketone acids.

When applying Giniprala^® reduces diurez, Therefore, you should carefully monitor symptoms, associated with water retention in the body.

In some cases, the simultaneous use of CORTICOSTEROIDS during infusions Giniprala^® may cause pulmonary edema. Therefore, infusion therapy must be continued careful clinical monitoring of patients. This is especially important in the combined treatment of CORTICOSTEROIDS in patients with renal diseases. Strict restriction of excess fluid intake. The risk of a possible pulmonary edema development requires the limitation of infusions as possible, as well as the use of solutions for breeding, not containing electrolytes. You should limit your intake of salt in food.

It is recommended that you monitor the regularity of intestinal activity during the period of application.

Tocolytic therapy before you must take drugs potassium, tk. if hypokalemia sympathomimetic effect on the myocardium intensifies.

The simultaneous use of funds for general anesthesia (halothane) and sympathomimetics may lead to violations of heart rhythm. Welcome Giniprala^® must stop before using galotana.

When prolonged tocolytic therapy, it was necessary to monitor the State of fetoplacental complex, make sure there are no detachment of the placenta. Clinical symptoms of premature detachment of the placenta can be smoothed out against the backdrop of tocolytic therapy. When rupture of membranes and cervical dilatation of more than 2-3 see the effectiveness of tocolytic therapy is low.

During the tocolytic therapy using beta-adrainomimetikov could increase symptoms accompanying distroficheskoj miotonii. In such cases it is recommended to use drugs difenilgidantoina (phenytoin).

In applying the drug in pill form with tea or coffee may increase side effects Giniprala^®.

Overdose

Symptoms: maternal tachycardia expressed, arrhythmia, tremor fingers, headache, increased perspiration, anxiety, kardialgii, decrease in blood pressure, breathlessness.

Treatment: use of antagonists Giniprala^® – nonselective beta-adrenoblokatorov, that completely neutralize the drug.

Drug Interactions

When coupled with the use of beta-adrenoblokatorami weakened or neutralized the effect Giniprala^®.

When coupled with the use with methylxanthines (incl. theophylline) amplifies the effectiveness of Giniprala^®.

When Giniprala^® with SCS reduced the intensity of the accumulation of glycogen in the liver.

When Ginipral^® ters effect gipoglikemicakih oral drugs.

When Giniprala^® with other drugs with sympathomimetic activity (cardiovascular and bronholiticheskie drugs) may increase the actions of drugs on cardiovascular system and the emergence of symptoms of overdose.

When coupled with the use of ftorotanom and beta-adrainostimulatorami amplified side effects Giniprala^® from the circulatory system.

Ginipral^® incompatible with LPV alkaloids, MAO inhibitors, tricyclic antidepressants, as well as drugs, containing calcium and vitamin D, digidrotahisterolom and mineralokortikoidami.

Is sulfite component should be disposed, Therefore, you should refrain from mixing Giniprala^® with other solutions, except izotoniceski solution of sodium chloride and 5% dextrose (Glucose).

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

List B. The drug should be stored in the dark, out of reach of children at a temperature of 18° c to 25° c. Shelf life solution for the on/in the introduction – 3 year. Shelf life Tablets – 5 years.