Itomed tablets p / o 50mg, No. 100

Symptomatic treatment of functional non-ulcer dyspepsia (chronic gastritis):

• flatulence

• gastralgia

• feeling of discomfort in the epigastric region

• anorexia

• heartburn

• nausea

• vomiting.

Inside before meals, one tablet 3 times a day.

The recommended daily dose of the drug is 3 tablets (150 mg).

The indicated dose can be reduced taking into account the age and clinical condition of the patient.

In clinical studies, the duration of drug treatment was up to 8 weeks.

If the drug was not taken on time, then in the future it should be taken at regular intervals.

It is not recommended to take a double dose to compensate for the missed

For 1 tablet:

Active ingredient: itopride hydrochloride - 50.00 mg.

Excipients:

core: lactose monohydrate, pregelatinized corn starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate;

sheath: opadry 85F18422 white (polyvinyl alcohol, partially hydrolyzed, titanium dioxide, macrogol 4000, talc).

• Hypersensitivity to itopride or any auxiliary component of the drug

• gastrointestinal bleeding

• mechanical obstruction and perforation of the gastrointestinal tract

• lactase deficiency

• lactose intolerance

• glucose-galactose malabsorption

• children's age (up to 16 years old)

• pregnancy

• lactation period

It is prescribed with caution to patients for whom the development of cholinergic side reactions (associated with an increase in the action of acetylcholine during drug therapy) can aggravate the course of the underlying disease; patients with impaired liver and kidney function; elderly patients.

Trade name of the drug

ItomedЃ

International non-proprietary name

Itoprid

Dosage form

film-coated tablets

Composition

For 1 tablet:

Active ingredient: itopride hydrochloride - 50.00 mg.

Excipients:

core: lactose monohydrate, pregelatinized corn starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate;

sheath: opadry 85F18422 white (polyvinyl alcohol, partially hydrolyzed, titanium dioxide, macrogol 4000, talc).

Description

Round, biconvex film-coated tablets, white or almost white, with a notch on one side. At the break - white or almost white.

Pharmacotherapeutic group

Prokinetic

ATX code

A03FA07

Pharmacodynamics:

Enhances gastrointestinal motility due to antagonism with D2-dopamine receptors and inhibition of acetyl choline esterase. Activates the release of acetylcholine and inhibits its destruction.

It has an antiemetic effect due to interaction with D2 receptors located in the trigger zone. Causes dose-dependent suppression of apomorphine-induced vomiting.

Activates propulsive gastric motility due to antagonism with D2 receptors and dose-dependent inhibition of acetylcholinesterase activity.

Has a specific effect on the smooth muscles of the gastrointestinal tract, accelerates transit through the stomach and improves its emptying. Has no effect on serum gastrin concentrations.

Pharmacokinetics:

It is quickly and well absorbed in the digestive tract. The relative bioavailability of the drug is 60%. The maximum plasma concentration (Cmax) is 028 ?g / ml. after taking 50 mg of the drug, the time to reach the maximum plasma concentration (TCmax) is about 05-075 hours.

With repeated administration of 50-200 mg 3 times a day for 7 days, the pharmacokinetics has a linear character, the cumulation is minimal.

Binds to plasma proteins (mainly albumin) by 96%; with? 1-acid glycoprotein - less than 15%. It is actively distributed in tissues and is found in high concentrations in the kidneys of the small intestine of the liver, adrenal glands, stomach. The volume of distribution is 61 l / kg. In therapeutic doses, it slightly penetrates into the brain and spinal cord into breast milk.

It is metabolized in the liver. Three metabolites have been identified, one of which exhibits insignificant activity: 2-3% of the activity of itopride. Metabolized by flavin monooxygenase (FMO3). The amount and effectiveness of human isozymes may be related to genetic polymorphism, which in rare cases leads to the development of an autosomal recessive condition known as trimethylaminuria (fishy odor syndrome). The half-life of the drug in patients with trimethylaminuria may be increased.

According to in vivo pharmacokinetic studies, itopride has no inhibitory or inducing effect on CYP2C19 and CYP2E1. The use of itopride does not affect the activity of uridine diphosphate glucoronyl transferase.

Itopride and its metabolites are excreted by the kidneys. The half-life of the drug (T1 / 2) is 6 hours.

Indications:

Symptomatic treatment of functional non-ulcer dyspepsia (chronic gastritis):

• flatulence

• gastralgia

• feeling of discomfort in the epigastric region

• anorexia

• heartburn

• nausea

• vomiting.

Contraindications:

• Hypersensitivity to itopride or any auxiliary component of the drug

• gastrointestinal bleeding

• mechanical obstruction and perforation of the gastrointestinal tract

• lactase deficiency

• lactose intolerance

• glucose-galactose malabsorption

• children's age (up to 16 years old)

• pregnancy

• lactation period

It is prescribed with caution to patients for whom the development of cholinergic side reactions (associated with an increase in the action of acetylcholine during drug therapy) can aggravate the course of the underlying disease; patients with impaired liver and kidney function; elderly patients.

Pregnancy and lactation:

Itoprid is contraindicated in pregnancy.

When taking the drug in therapeutic doses, itoprid slightly penetrates into breast milk; therefore, you should stop taking the drug during breastfeeding (see section 'Contraindications').

Method of administration and dosage:

Inside before meals, one tablet 3 times a day.

The recommended daily dose of the drug is 3 tablets (150 mg).

The indicated dose can be reduced taking into account the age and clinical condition of the patient.

In clinical studies, the duration of drug treatment was up to 8 weeks.

If the drug was not taken on time, then in the future it should be taken at regular intervals.

It is not recommended to take a double dose to compensate for the missed

Side effects:

The frequency of side effects is classified according to the recommendations of the World Health Organization: very often (? 1/10); often (? 1/100 to <1/10); infrequently (? 1/1000 to <1/100); rarely (? 1/10000 to <1/1000); very rare (<1/10 000) frequency unknown (cannot be estimated from available data).

From the side of hematopoietic organs : infrequently - leukopenia; frequency unknown - thrombocytopenia.

From the endocrine system: infrequently - hyperprolactinemia; frequency unknown - gynecomastia.

From the digestive system: infrequently - diarrhea, constipation; pain in the epigastric region; increased salivation; frequency unknown - nausea jaundice.

From the nervous system: infrequently - headache; sleep disturbance. dizziness irritability; frequency unknown - tremor.

Allergic reactions: rarely - skin rash, redness, itching; frequency unknown - anaphylactoid reactions.

From the urinary system: infrequently - an increase in the level of creatinine and urea nitrogen in the blood (BUN).

From the musculoskeletal system: infrequently - pain in the chest or in the back.

Laboratory indicators: frequency unknown - increased activity of asparaginine aminotransferase (ACT) alanine aminotransferase (ALT) gamma-glutamine transferase (GGT) alkaline phosphatase (NDF) hyperbilirubinemia. Others : infrequently - fatigue.

Overdose:

In case of an overdose, gastric lavage and symptomatic therapy are performed.

Interaction:

No interaction was found while taking itopride with warfarin, diazepam, diclofenac, ticlopidine, nifedipine and nicardipine.

Metabolic interaction at the level of isoenzymes of the CYP450 system is not expected since the metabolism of itopride occurs mainly through flavin monooxygenase. Itopride enhances gastric motility, which can affect the absorption of drugs when taken orally.

Particular care should be taken when taking drugs with a narrow therapeutic index of drugs with prolonged release of the active substance or drugs with an enteric coating.

Antiulcer drugs such as cimetidine ranitidine teprenone and cetraxate do not interfere with the prokinetic efficacy of itopride.

M-anticholinergics reduce the effectiveness of itopride.

The cholinergic effect of itopride can increase with the simultaneous use of M-cholinomimetics and cholinesterase inhibitors.

Special instructions:

Patients with impaired liver or kidney function should be closely monitored by a physician; if necessary, the dose of the drug should be reduced or discontinued with the drug.

If symptoms of galactorrhea and gynecomastia appear, treatment should be interrupted or completely stopped.

Impact on the ability to drive vehicles. Wed and fur .:

The action of Itoprid does not lead to a violation of psychomotor reactions, however, due to possible side effects (dizziness, tremor), a decrease in concentration and the effect on the ability to drive vehicles and control mechanisms cannot be ruled out.

Release form / dosage:

Film-coated tablets 50 mg.

Packaging:

20 tablets in a blister made of IVCh / PVDC / aluminum foil.

2 or 5 blisters with instructions for medical use in a cardboard box

Storage conditions:

In a dark place at a temperature not exceeding 25 ? C.

Keep out of the reach of children.

Shelf life:

4 years.

Do not use after the expiration date.

Vacation conditions

On prescription