Active substanceHexoprenalineHexoprenaline
Similar drugsTo uncover
  • Ginipral®
    pills inwards 
    BIOTEK MFPDK, CJSC     Russia
  • Ginipral®
    solution in / in 
    Nycomed Austria GmbH     Austria
  • Dosage form: & nbsppills
    Composition:
    1 tablet contains:
    Active substance: hexoprenaline sulfate 0.5 mg;
    Excipients: corn starch, pregelatinized starch, lactose monohydrate, copovidone, disodium edetate dihydrate, talc, magnesium stearate, glyceryl palmitostearate.
    Description:White round biconvex tablets.
    Pharmacotherapeutic group:Tocolytic agent - beta2-adrenomimetic selective
    ATX: & nbsp

    R.03.C.C.05   Hexoprenaline

    Pharmacodynamics:

    Selectively stimulates beta2-adrenergic receptors, activates adenylate cyclase, followed by an increase in the formation of cyclic adenosine monophosphate (cAMP), which stimulates the work of a calcium pump that redistributes calcium ions (Ca2+) in myocytes, resulting in a decrease in the concentration of the latter in myofibrils.

    Expands bronchi, blood vessels, reduces contractile activity and tone of myometrium, thereby contributing to the improvement of uteroplacental blood flow. Stimulates glycogenolysis. Because of its beta2-selectivity Ginipral® has a negligible effect on cardiac activity and the blood flow of the pregnant and fetus. Under the influence of Ginipral®, the uterine tone decreases, the frequency and intensity of uterine contractions decreases,up to their complete cessation, which allows prolonging the pregnancy, incl. before the onset of timely delivery.

    Pharmacokinetics:

    Suction

    After ingestion, 5-11% of hexoprenaline is absorbed from the gastrointestinal tract. Maximum concentration (FROMmax) is achieved after 2 hours

    Distribution

    There is no data on the distribution of hexoprenaline in the human body. In studies on animals with intravenous administration, a significant concentration of hexoprenaline was observed in the liver, kidneys and skeletal muscles, to a lesser extent in the brain and myocardium.

    Metabolism

    Hexoprenaline is metabolized by catechol-O-methyl transferase to mono-3-O-methyl-hexoprenaline and di-3-O-methyl-hexoprenaline.

    Excretion

    When administered orally, the half-life (T1/2) - about 50 minutes. It is excreted through the intestine to 90%, is excreted by the kidneys to 5% in the form of glucuronides - derivatives of di-3-O-methylated metabolite.

    Indications:The threat of spontaneous abortion or premature birth from the 20th week of pregnancy.
    Contraindications:
    - Hypersensitivity to the components of the drug;
    - Thyrotoxicosis;
    - Diseases of the heart;
    - Arterial hypertension;
    - Severe liver and kidney disease;
    - Closed-angle glaucoma;
    - Bleeding from the vagina of any etiology;
    - Intrauterine infections.
    Because of the lactose content, it is not recommended to use Ginipral® tablets in patients with hereditary diseases associated with lactose intolerance, lactase deficiency or glucose-galactose malabsorption.
    Carefully:Hypersensitivity to adrenomimetics, arterial hypotension, diabetes mellitus, dystrophic myotonia, intestinal atony, simultaneous treatment with glucocorticosteroids, concomitant diseases accompanied by edema.
    Pregnancy and lactation:
    The drug should not be used until the 20th week of pregnancy and during lactation (breastfeeding).
    From the 20th week of pregnancy the drug is used according to the indications.
    Dosing and Administration:
    Inside, not liquid, squeezed water.
    Treatment, as a rule, begins with intravenous infusion; with an adequate decrease in contractile activity, the myometrium is switched to oral administration - in this case, the first tablet of Ginipral® should be taken 1-2 hours before the end of the last intravenous injection.
    Doses are selected individually taking into account the effectiveness and tolerability. Initially, appoint 1 tablet of Ginipral ® every 3 hours, and then every 4-6 hours (from 4 to a maximum of 8 tablets per day).
    Side effects:
    Headache, anxiety, slight tremor of the fingers, increased sweating, dizziness, nausea, vomiting, temporary increase in the activity of "liver" transaminases, atony of the intestine, tachycardia (the fetal heart rate in most cases does not change or changes little), lowering of blood pressure a decrease in diastolic blood pressure); ventricular extrasystole, cardialgia; increase in the concentration of glucose (sugar level) in the blood (in patients with diabetes mellitus - hyperglycemia), decreased diuresis (especially in the initial phase of treatment); hypokalemia at the beginning of therapy (further the content of potassium is normalized).
    In newborns - hypoglycemia and acidosis, bronchospasm, anaphylactic shock.
    Overdose:
    Symptoms: tachycardia, tremor, anxiety, dizziness, increased sweating, arrhythmia, headaches, cardialgia, lowering of blood pressure (BP), dyspnea.
    Treatment: symptomatic therapy. As antidotes, non-selective beta-blockers are recommended, which completely neutralize the effect of Ginipral®, but it is necessary to consider the possibility of bronchospasm development in patients with bronchial asthma.
    Interaction:
    Non-selective beta-blockers weaken or neutralize the action of Ginipral®.
    Methylxanthines (for example, theophylline) enhance the action of Ginipral®.
    Ginipral® weakens the effect of oral hypoglycemic drugs. Some non-selective adrenomimetics (incl. epinephrine) and beta2-adrenomimetiki, halogen-containing drugs for general anesthesia (for example, halothane) increase the side effects of Ginipral® from the side of the cardiovascular system.
    Do not use ginipral® together with monoamine oxidase inhibitors, tricyclic antidepressants, with preparations containing calcium and vitamin D. Co-administration with dihydrotachysterol, as well as with ergot alkaloids or mineralocorticoids can increase the hemodynamic effect of hexoprenaline.
    Special instructions:
    Patients with hypersensitivity to adrenomimetics should use Ginipral® in small doses prescribed individually, under the constant supervision of a physician.
    Before starting treatment with Ginipral®, ECG monitoring should be performed.
    During the period of treatment with Ginipral®, periodic monitoring of the ECG, pulse and blood pressure in the mother, and the heart rate of the fetus are necessary. When the mother's heart rate rises (more than 130 beats / min) or with significant fluctuations in blood pressure, the dose of the drug should be reduced.
    When pain occurs in the heart (including compressive, angina), difficulty breathing and signs of heart failure, Ginipral® is immediately withdrawn and ECG monitoring is performed.
    Initial hypokalemia should be corrected before treatment drugs kyattiya If the birth took place immediately after Ginipralom® treatment, newborns need to conduct a survey to identify hypoglycemia and acidosis (blood pH).
    In patients with diabetes mellitus during the treatment with Ginipral®, regular monitoring of the glucose concentration in the blood plasma is necessary.
    Clinical signs of premature placental abruption against the background of tocolytic therapy with Ginipral® may be less pronounced.
    With prolonged tocolytic therapy, it is necessary to check the condition of the fetoplacental system using standard methods of investigation.
    If the integrity of the bladder is compromised and the cervix is ​​opened more than 2-3 cm, the effectiveness of tocolytic therapy is unlikely.
    During the period of treatment with Ginipral®, excessive fluid intake should be avoided, as diuresis decreases under the influence of the drug. It should be carefully monitored for symptoms that reflect fluid retention in the body (swelling of the legs, shortness of breath), especially with simultaneous treatment with glucocorticosteroids and with concomitant diseases that contribute to fluid retention (kidney disease, gestosis, proteinuria and hypertension). It is necessary to reduce salt intake. The daily intake of liquid should not exceed 2 liters. If there are signs of fluid retention and symptoms of pulmonary edema (cough, shortness of breath), the drug should be discarded.
    During tocolytic therapy with Ginipral®, regularity of the stool should be monitored, the drug suppresses the intestinal peristalsis.
    If halothane anesthesia is planned, therapy with Ginipral® should be discontinued. If an operative intervention is necessary, the anesthetist should be informed of the therapy with Ginipral®.
    Tokoliticheskaya therapy with beta-adrenomimetics can strengthen the symptoms of the present dystrophic myotonia. In such cases, the administration of phenytoin is recommended.
    It is necessary to take into account the intake of any other drugs in case of Ginipral® therapy.
    Caffeine-containing drinks (including coffee and tea) can enhance the side effects of Ginipral®.
    If there are side effects or conditions related to contraindications, it is necessary to inform the doctor.
    Effect on the ability to drive transp. cf. and fur:During the treatment period, care should be taken when driving vehicles and during classes with potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:Tablets of 0.5 mg.
    Packaging:
    For 10 tablets in a blister of PVC / PVDC film and aluminum lacquered foil.
    Two blisters with instructions for use are placed in a cardboard box.
    Storage conditions:
    List B.
    Store at a temperature of no higher than 25 ° C in a dark place.
    Keep out of the reach of children.
    Shelf life:5 years. Do not use after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:P N 015664/01
    Date of registration:25.03.2009 / 24.02.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:BIOTEK MFPDK, CJSC BIOTEK MFPDK, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp16.04.2017
    Illustrated instructions
      Instructions
      Up