Ganaton tabs 50mg #70

Instruction for Ganaton

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Ganaton is a stimulator of the release of acetylcholine, a drug that improves motility and tone of the gastrointestinal tract (GIT).

Release form and composition

The dosage form of Ganaton is coated tablets: white, round, on one side is engraved with "HC 803", on the other is a dividing risk (7, 10 or 14 pieces in a blister, in a cardboard bundle 1, 2, 3 4 or 5 blisters).
1 tablet contains:
    active substance: itoprida hydrochloride - 50 mg;
    auxiliary components: hypromellose, corn starch, carmellose, lactose, titanium dioxide, anhydrous silicic acid, macrogol 6000, magnesium stearate, carnauba wax.

Pharmacodynamics

The active substance of Ganaton is itoprid hydrochloride, which enhances the motility of the gastrointestinal tract due to the inhibition of acetylcholinesterase and the antagonism of D2-dopamine receptors. It activates the release of acetylcholine and leads to its destruction.
The substance also has an antiemetic effect (due to interaction with D2 receptors located in the trigger zone), activates propulsive motility of the stomach, and causes dose-dependent suppression of vomiting caused by apomorphine.
Due to the specific effect on the upper gastrointestinal tract, transit through the stomach is accelerated and its emptying improves.
Itoprid hydrochloride does not affect serum gastrin levels.

Pharmacokinetics

The substance is absorbed in the gastrointestinal tract quickly and almost in full. Its relative bioavailability is 60%. This is mainly due to metabolism during the first passage through the liver. Food does not affect the bioavailability indicator.
Cmax (maximum plasma concentration) after taking 50 mg of itoprid hydrochloride is achieved in 0.5-0.75 hours and is 0.28 μg / ml.
After repeated administration of itopride hydrochloride orally at a dose of 50-200 mg 3 times a day for 7 days, the pharmacokinetic parameters of the substance and its metabolites were linear, and the cumulation was minimal.
Binding to plasma proteins - 96% (mainly with albumin), binding to α1-acid glycoprotein - less than 15% of total binding.
After oral administration of itopride, an active distribution occurs in the tissues. Vd (distribution volume) is 6.1 l / kg. High concentrations of the substance are found in the liver, kidneys, small intestine, stomach and adrenal glands. Itopride penetrates into breast milk, enters the brain and spinal cord in a minimal amount.
Active biotransformation of itopride occurs in the liver. 3 metabolites have been identified, one of them exhibits insignificant activity, which does not have pharmacological significance (about 2-3% of that of itoprid). The primary metabolite is the N-oxide resulting from the oxidation of the quaternary amino-N-dimethyl group.
Metabolism occurs under the influence of flavin-dependent monooxygenase (FMO3). Depending on the genetic polymorphism, the effectiveness and number of FMO isoenzymes may vary. In rare cases, the development of an autosomal recessive condition, which is known as trimethylaminuria (fish odor syndrome), is noted. The half-elimination period of itopride in patients with trimethylaminuria is increasing.
Itopride does not have an inhibitory or inducing effect on CYP2C19 and CYP2E1. Therapy with itopride does not affect the activity of uridine diphosphate glucurononyl transferase or CYP.
Excretion of itoprid hydrochloride and its metabolites occurs mainly with urine. After a single dose of Ganaton in therapeutic doses, the renal excretion of itopride and its N-oxide in healthy people is 3.7 and 75.4%, respectively. The terminal half-elimination period of itopride hydrochloride is approximately 6 hours.

Indications for use

According to the instructions, Ganaton is indicated for the treatment of gastrointestinal symptoms caused by slow gastric motility and chronic gastritis (functional non-ulcer dyspepsia): rapid satiety, nausea and vomiting, feeling full in the stomach after eating, bloating, discomfort or pain in the epigastric region, heartburn , anorexia.

Contraindications

    gastrointestinal bleeding;
    perforation or mechanical obstruction of the gastrointestinal tract;
    age up to 16 years;
    period of pregnancy and breastfeeding;
    individual intolerance to the components of the drug.
With caution, Ganaton should be prescribed with concomitant therapy with other drugs, elderly patients, patients in whom the appearance of cholinergic adverse reactions can adversely affect the course of the underlying disease.

Instructions for use Ganaton: method and dosage

Ganaton tablets are taken orally before meals.
The dose of the drug is prescribed taking into account the clinical indications and the age of the patient.
Recommended dosage: 1 pc. 3 times a day. The duration of treatment is no more than 2 months.
The daily dose of Ganaton should not exceed 150 mg (3 tablets).

Side effects

    from the digestive system: abdominal pain, nausea, diarrhea, constipation, increased salivation, jaundice;
    on the part of the blood and lymphatic system: thrombocytopenia, leukopenia;
    endocrine disorders: gynecomastia, increased prolactin content;
    from the nervous system: headache, dizziness, tremor;
    allergic reactions: skin itch, rash, flushing of the skin, anaphylaxis;
    laboratory indicators: an increase in the concentration of bilirubin, the activity of gamma-glutamyltranspeptidase, aspartate aminotransferase (ACT), alanine aminotransferase (ALT), alkaline phosphatase.

Overdose

There is no evidence of an overdose.
In case of an overdose, gastric lavage is indicated, symptomatic treatment is performed.

Special instructions

In elderly patients, the use of the drug may cause a decrease in liver and / or kidney function.
Against the background of the use of Ganaton, acetylcholine enhances its effect, increasing the risk of developing cholinergic adverse reactions.
Since the effect of the drug may cause dizziness, caution should be exercised when driving vehicles and mechanisms.

Pregnancy and lactation

Ganaton during pregnancy / lactation is not prescribed.

Use in childhood

Ganaton therapy is contraindicated in patients under 16 years of age.

Use in old age

Ganaton therapy is prescribed to elderly patients with caution.

Drug interaction

Itoprid metabolism occurs under the influence of flavin monooxygenase.
With the simultaneous use of Ganaton:
    warfarin, diazepam, diclofenac sodium, ticlopidine hydrochloride, nifedipine, nicardipine hydrochloride do not cause changes in protein binding;
    oral drugs with a low therapeutic index, or enteric coating, or delayed release of the active substance may interfere with their absorption;
    ranitidine, cimetidine, teprenone, cetraxate (anti-ulcer drugs) do not affect the effect of the drug;
    anticholinergics can reduce the therapeutic effect of itopride.

Terms and conditions of storage

Keep out of the reach of children.
Store at temperatures up to 25 ° C in a place protected from moisture and light.
Shelf life is 5 years.

Reviews about Ganaton

According to reviews, Ganaton is rated as an effective drug. Helps with heartburn and gastritis pain, nausea, vomiting, bloating. It has good tolerance. The tablets are small in size, so they are easy to swallow. Of the shortcomings indicate a high cost.

Terms of sell

You don't need a prescription from a doctor to buy Ganaton.