Ginipral, 5 pcs., 2 ml, 10 mcg/2 ml, solution for intravenous administration

Ginipral injection solution is used for the following indications:

  • short-term treatment of uncomplicated preterm labor: inhibition of uterine contractility in patients with a gestational age of 22 to 37 weeks in the absence of medical or gynecological contraindications to tocolytic therapy;
  • before turning the fetus from a transverse position;
  • as an emergency measure in case of premature birth before transporting the pregnant woman to the hospital.

Contraindications

  • hypersensitivity to hexaprenaline or to any component of the drug;
  • the presence of any disease before 22 weeks of pregnancy;
  • use of the drug as a tocolytic agent in patients with a history of coronary heart disease or in patients with significant risk factors for the development of coronary heart disease;
  • threat of miscarriage during the first and second trimesters of pregnancy;
  • any disease of the mother or fetus in which continuation of the pregnancy is dangerous, for example, severe toxemia, intrauterine infection, vaginal bleeding due to placenta previa, eclampsia or severe preeclampsia, placental abruption or umbilical cord compression;
  • intrauterine fetal death, history of lethal congenital anomalies, or lethal chromosomal abnormalities;
  • bronchial asthma with hypersensitivity to sulfates;
  • diseases of the cardiovascular system, in particular tachyarrhythmia, myocarditis, mitral valve disease;
  • hyperthyroidism;
  • severe liver and kidney diseases;
  • glaucoma;
  • the use of the drug "Ginipral" is contraindicated in patients with diseases against which the use of beta-agonists may have undesirable effects, for example, pulmonary hypertension, diseases of the cardiovascular system (hypertrophic obstructive cardiomyopathy or obstruction of blood flow from the left ventricle, for example, aortic stenosis) .

Indications for use of the drug Ginipral

Acute tocolysis: rapid suppression of labor contractions in cases of acute intrauterine asphyxia (fetal distress); before manual rotation of the fetus from a transverse position; with prolapse of the umbilical cord; complicated labor; relaxation of the uterus before caesarean section. Massive tocolysis: inhibition of premature contractions in the presence of a smoothed cervix and/or dilatation of the uterine pharynx. Long-term tocolysis: danger of premature birth (uterine contractions without shortening and dilation of the cervix); relaxation of the uterus before, during and after cerclage application. Bronchial asthma (treatment and prevention), broncho-obstructive syndrome, bronchospastic reactions of various origins.

Mode of application

For intravenous bolus or infusion.

The indicated dosage can be used only as a guide, since tocolysis requires an individual approach to the patient.

Initiation of therapy with Ginipral should only be carried out by obstetricians/doctors with experience in the use of tocolytic agents. Treatment is carried out only in properly equipped institutions to ensure constant monitoring of the health of the mother and fetus.

The drug "Ginipral" should be used as early as possible after diagnosing premature birth and excluding any contraindications to the use of hexoprenaline.

During drug therapy, it is necessary to properly assess the state of the cardiovascular system using continuous ECG monitoring.

Dosages

Before turning the fetus from a transverse position and when used as an emergency measure for premature birth before transporting the pregnant woman to the hospital. The recommended dose is 10 mcg (one ampoule of 2 ml) of the drug "Ginipral", diluted in 10 ml of 0.9% sodium chloride solution or 5% glucose solution, administered intravenously over 5-10 minutes. If necessary, continue treatment with Ginipral, concentrate for the preparation of a solution for infusion.

Short-term treatment of premature labor in the presence of shortening and/or dilatation of the cervix. At the beginning of treatment, they begin with a jet injection of a dose of 10 mcg (one ampoule of 2 ml), followed by an infusion of the drug "Ginipral" at a rate of 0.3 mcg/minute. As an alternative treatment, it is possible to use only infusions of the drug "Ginipral" at a rate of 0.3 mcg/minute without prior jet administration of the drug. Administer intravenously (when calculating the rate of administration using conventional infusion systems, take into account that 20 drops = 1 ml). Dissolve the required amount of concentrate ampoules for infusion in 500 ml of 0.9% sodium chloride solution or 5% glucose solution.

Short-term treatment of premature labor without shortening or dilation of the cervix. Recommended dose: continuous infusion of 0.075 mcg/minute. Administer intravenously (when calculating the rate of administration using conventional infusion systems, take into account that 20 drops = 1 ml). Dissolve the required amount of concentrate ampoules for infusion in 500 ml of 0.9% sodium chloride solution or 5% glucose solution.

Duration of treatment

The duration of tocolytic treatment depends on the existing degree of risk of miscarriage (a tendency towards a decrease in the interval between contractions, the condition of the cervix) and on the severity of side effects (for example, an increase in heart rate). Side effects should be minimized as much as possible.

The duration of treatment should not exceed 48 hours, since research suggests that tocolytic therapy can delay labor by up to 48 hours. In randomized controlled trials, no statistically significant effect of treatment with Ginipral on perinatal mortality or morbidity was observed. Delaying birth with Ginipral can be used to implement other measures that significantly improve perinatal health.

Pharmacological properties of the drug Ginipral

Selective beta2-adrenomimetic, reduces the tone and contractile activity of the myometrium. Reduces the frequency and intensity of uterine contractions, suppresses spontaneous and oxytocin-induced labor contractions. During childbirth, it normalizes excessively strong or irregular contractions. Under the influence of the drug, premature contractions stop in most cases, which makes it possible to prolong pregnancy until the normal term of birth. Due to its beta2 selectivity, the drug has a slight effect on the cardiac activity and blood flow of the pregnant woman and the fetus.

Side effects

The most common side effects of the drug "Ginipral" are associated with the pharmacological properties of beta-agonists. In order to eliminate or reduce the occurrence of undesirable effects, carefully monitor hemodynamic parameters such as blood pressure, heart rate and adjust the dose of the drug accordingly. These effects usually disappear after stopping the drug.

Metabolic disorders: often (≥ 1:100, < 1:10) - hypokalemia.

From the nervous system: very often (≥ 1:10) - tremor.

From the cardiovascular system: very often (≥ 1:10) - tachycardia; often (≥ 1:100, < 1:10) - palpitations, decreased diastolic pressure, arterial hypotension.

From the skin and subcutaneous tissue: often (≥ 1:100, < 1:10) - sweating.

Overdose of the drug Ginipral, symptoms and treatment

An overdose of GINIPRAL can be determined by a strong increase in the mother's heart rate, the occurrence of tremor, palpitations, headache, and sweating. These manifestations can usually be removed by reducing the dose of the drug. To eliminate severe manifestations of drug overdose, it is necessary to use GINIPRAL antagonists - non-selective beta-adrenolytic drugs that completely neutralize the effect of GINIPRAL.

List of pharmacies where you can buy Ginipral:

  • Moscow
  • Saint Petersburg

Storage conditions

Store in original packaging at a temperature not exceeding 25°C, out of the reach of children.

Shelf life: 3 years.

Reconstituted solution: The chemical and physical stability of the reconstituted solution after dilution (0.9% sodium chloride solution or 5% glucose solution) has been demonstrated for 24 hours at a temperature of 15-25°C. From a microbiological point of view, the drug should be used immediately. In case of non-use immediately, the terms and conditions of storage of the reconstituted solution for its use are the responsibility of the user.

Product description certified by the manufacturer Takeda

.
Verified
Sevryukov Alexander Viktorovich

Ginipral 0.5 mg tab No. 20

Dosage

0.5 mg

Active substance

Hexoprenaline

Manufacturer

Globopharm Pharmaceuticals Products und Handelsgesellschaft mbh (Austria)

Shelf life

5 years

Storage conditions

In a place protected from light, at a temperature not exceeding 25 °C

Registration certificate number

P N015664/01 dated 05/24/2010

Description of the dosage form

Pills:

white, round, biconvex.

Pharmacokinetics

When taken orally, it is well absorbed. It is excreted in the form of a dimethylated derivative in the urine and in the bile - in the form of complex metabolites.

Ginipral® consists of 2 catecholamine groups, which in the human body undergo methylation via catecholamine-O-methyltransferase. Hexoprenaline becomes biologically inactive only if both of its catecholamine groups are methylated. When administered intrabronchially, 3H-labeled hexoprenaline is excreted in the urine in the form of a biologically active substance for a relatively long time. Part of the injected substance remains active at the injection site for quite a long time.

Pharmacodynamics

Relaxes the muscles of the uterus, reduces the frequency and intensity of contractions, suppresses spontaneous and oxytocin-induced labor contractions. During childbirth, it normalizes the strength and regularity of contractions, suppresses (in most cases) premature contractions and helps prolong pregnancy until the normal due date. Has little effect on the cardiovascular system of the pregnant woman and fetus.

Contraindications

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

thyrotoxicosis;

cardiovascular diseases, especially cardiac arrhythmias occurring with tachycardia; myocarditis, mitral valve disease and aortic stenosis;

IHD;

arterial hypertension;

severe liver and kidney diseases;

angle-closure glaucoma;

premature placental abruption, uterine bleeding, intrauterine infections;

pregnancy (first trimester);

lactation period.

Use during pregnancy and breastfeeding

Contraindicated in the first trimester of pregnancy. Breastfeeding should be stopped during treatment.

Directions for use and doses

Inside

with a small amount of water.

In the absence of other recommendations, the indicated dosage should be strictly followed.

Threat of premature birth:

1–2 hours before the end of the Ginipral® infusion, start taking tablets at a dose of 0.5 mg (1 tablet) every 3 hours, then every 4–6 hours (4–8 tablets per day).

Side effects

Dizziness, anxiety, slight tremor of the fingers, increased sweating, tachycardia, headache, increased activity of liver enzymes.

A decrease in blood pressure, especially diastolic, is possible. In some cases, nausea and vomiting develop.

In rare cases - ventricular extrasystole, pain in the heart (cardialgia). These symptoms disappear quickly after stopping the drug.

Blood sugar levels increase due to the glycogenolytic effect of the drug (especially in diabetes).

Diuresis decreases at the beginning of treatment. In patients with a tendency to retain fluid in the tissues, this can lead to edema.

During treatment with Ginipral®, the intensity of intestinal motility may decrease (pay attention to the regularity of stool).

In newborns - hypoglycemia, acidosis, bronchospasm, anaphylactic shock.

Interaction

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

Methylxanthines (for example theophylline) enhance the effect of Ginipral®.

The effect of oral hypoglycemic agents during therapy with Ginipral® is weakened.

General anesthesia (halothane) and adrenergic stimulants (cardiovascular and anti-asthmatic drugs) increase side effects from the cardiovascular system.

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

Overdose

Symptoms:

anxiety, tremor, increased sweating, severe tachycardia, arrhythmia, headaches, cardialgia, decreased blood pressure, shortness of breath.

Treatment:

the use of Ginipral® antagonists - non-selective β-blockers that completely neutralize its effect.

special instructions

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

In patients with diabetes, blood sugar levels should be monitored.

Under the influence of Ginipral®, diuresis decreases, so you should carefully monitor symptoms reflecting fluid retention in the body (for example, swelling of the legs, difficulty breathing). This is especially important in the case of simultaneous use of corticosteroids or in cases of kidney disease.

Strict limitation of excess fluid intake is necessary.

You should limit your salt intake from food.

During tocolytic treatment, it is necessary to monitor bowel movements.

With prolonged tocolytic therapy, it is necessary to monitor the state of the fetoplacental complex. When the membranes rupture and when the cervix is ​​dilated by more than 2–3 cm, the effectiveness of tocolytic therapy is low.

If surgical intervention is necessary, the anesthesiologist should be informed about Ginipral® therapy.

It is necessary to take into account the use of any other drugs when prescribing therapy with Ginipral®.

Coffee and tea may increase the side effects of Ginipral®.

You should immediately inform your doctor about contraindications or the development of side effects.

Conditions for dispensing from pharmacies

On prescription.

Pharmgroups

Selective beta2-adrenergic agonist (Tocolytics)

Pharmaceutical actions

tocolytic

Note!

Description of the drug Ginipral solution d/in. 10mcg/2ml amp. 2ml No. 5 on this page is a simplified author’s version of the apteka911 website, created on the basis of the instructions for use.
Before purchasing or using the drug, you should consult your doctor and read the manufacturer's original instructions (attached to each package of the drug). Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.

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