Itopra tabs 50mg #40

Itopra instruction for use

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Form of release, composition and packaging

The tablets covered with a film membrane of white or almost white color, round, biconcave; on one side of the tablet the method of stamping is marked with "ID 50"; the core is white or almost white in cross section.
1 tab.
Itopride hydrochloride 50 mg
Excipients: lactose monohydrate - 40 mg, corn starch - 10 mg, giprolose - 4 mg, carmellose sodium - 15 mg, magnesium stearate - 3 mg.

pharmachologic effect

Itopra that stimulates the motility of the gastrointestinal tract. Itopride enhances GI motility by antagonizing dopamine D2 receptors and inhibiting acetylcholinesterase. Itopride activates the release of acetylcholine and suppresses its destruction. Itopride has antiemetic effect due to interaction with D2-receptors located in the trigger zone. Causes a dose-dependent suppression of emesis caused by apomorphine.
Itopride activates propulsive motility of the stomach due to antagonism with D2 receptors and a dose-dependent inhibition of acetylcholinesterase activity.
Itopride has a specific effect on the upper gastrointestinal tract, accelerates transit through the stomach, improves its emptying.
Has no effect on serum concentrations of gastrin.

Pharmacokinetics

Suction

Ittopride hydrochloride is rapidly and well absorbed in the gastrointestinal tract.
Relative bioavailability of 60%. Maximum concentration in blood plasma (Stach) - 0.28 μ / ml. The period of reaching the maximum concentration in the blood plasma (TCata) - 0.5-0.75 hours after taking 50 mg of the drug. At repeated reception on 50-200 mg 3 times a day for 7 days pharmacokinetics is linear, cumulation of Itopra is minimal.
The connection with proteins is 96% (mainly with albumin); with alpha1-sour glycoprotein - less than 15%.

Distribution

Ittopride hydrochloride is distributed in the kidneys, small intestine, liver, adrenal gland, stomach. The volume of distribution (Vd) is 6.1 l / kg.
In the therapeutic doses of tenthpride hydrochloride slightly penetrates the head and spinal cord, as well as in breast milk.

Metabolism and excretion

The drug me! aboliziruetsya in the liver under the influence of flavin-zaviiimoy monooxygenase.
Three metabolites have been identified, only one of them exhibits an insignificant activity (2 - 3% of the activity of tautoprid hydrochloride), which does not have pharmacological value.
Itopride hydrochloride and its metabolites are excreted mainly by the kidneys. Period half-life (T1 / 2) - is 6 hours, in patients with trimethylaminuria T1 / 2 increases.

Indications for Itopra

Symptomatic treatment of functional non-ulcer dyspepsia (chronic gastritis) including:
- bloating (flatulence);
- pain or discomfort in the epigastric region (gastralgia);
Anorexia;
- Heartburn;
- nausea, vomiting;
- a feeling of rapid saturation.

Contraindications

- hypersensitivity to taepride or any auxiliary substance of Itopra;
- gastrointestinal bleeding;
- mechanical obstruction and perforation of the digestive tract;
- Children's age till 16 years;
- Pregnancy;

Lactation period (breastfeeding).

With caution: due to the presence of lactose in the formulation, ittopride is used with caution in congenital lactase deficiency, lactose intolerance, glucose-galactose malabsorption and in geriatrics in elderly patients with impaired hepatic and renal function.

Dosage

Inside, before meals, 50 mg 3 times / day.
The recommended daily dose is 150 mg.
The specified dose can be reduced taking into account the age of the patient.

Side effects of Itopra

On the part of the hematopoiesis system: leukopenia, thrombocytopenia.
Allergic reactions: skin hyperemia, skin itching, rash, anaphylactic shock.
On the part of the endocrine system: gynecomastia, increased prolactin levels.
On the part of the digestive system: increased salivation, nausea, diarrhea, constipation, abdominal pain, jaundice.
From the nervous system: headache, dizziness, tremor.
Laboratory indicators: increased activity of ACT, ALT, GGT, alkaline phosphatase, bilirubin level.

Overdose

Cases of overdose in humans are not described.
Treatment: a possible overdose shows gastric lavage and symptomatic therapy.

Drug Interactions

Metabolic interaction is unlikely, because Teopride hydrochloride is metabolized by flavin monooxygenase, not CYP450.
With the simultaneous use of warfarin, diazepam, diclofenac sodium, ticlopidine hydrochloride, nifedipine and nicardipine hydrochloride, no binding changes were observed with the proteins.
Itopride hydrochloride enhances gastric motility, so the drug can affect the absorption of other drugs that are prescribed internally. Particular care should be taken when using drugs with a low therapeutic index, as well as forms with delayed release of the active substance or preparations with an enteric coating.
The prokinetic effect of tiotyprid hydrochloride does not change under the influence of antiulcer drugs (cimetidine, ranitidine, tehrrenone, cetraxate).
Anticholinergic drugs weaken the action of Itopra.

special instructions for Itopra

Caution should be used in the preparation of Itopra in patients for whom the appearance of cholinergic adverse reactions (associated with increased action of acetylcholine under the influence of the drug) may aggravate the course of the underlying disease.
With the withdrawal of the drug Itopra, the symptoms of the withdrawal syndrome are not described.
Special precautions for the destruction of unused medicinal product is not required.

Impact on the ability to drive vehicles and manage mechanisms

The action of the components of the drug does not lead to a disturbance of psychomotor reactions. However, in connection with possible side effects (dizziness, tremor), it is impossible to exclude a decrease in the concentration of attention and influence on the ability to drive vehicles and control mechanisms.

Pregnancy and lactemia

The drug Itopra is contraindicated in pregnancy and lactation (breastfeeding).

Conditions of leave from pharmacies

You can buy Itopra without a prescription.

Terms and conditions of storage

The drug should be stored out of reach of children, dry, protected from light at a temperature of no higher than 25 ° C. Shelf life - 3 years.