Itomed, pills 50mg, 100pcs

Composition

Active ingredient:  

Itopridee hydrochloride 50 mg;

Auxiliary substances:

lactose monohydrate-74.68 mg;

pregelatinized corn starch-5 mg;

croscarmellose sodium-1.8 mg;

colloidal silicon dioxide-1 mg;

magnesium stearate-2.52 mg;

Film shell:

Opadry 85F18422 white-3 mg (partially hydrolyzed polyvinyl alcohol-1.2 mg, titanium dioxide-0.75 mg, macrogol 4000-0.606 mg, talc-0.444 mg)

Pharmacological action

Itomed-stimulating the tone and motility of the gastrointestinal tract, antiemetic.

Pharmacodynamics

Increases gastrointestinal motility by antagonizing_D2-dopamine receptors and inhibiting acetylcholinesterase. Activates the release of acetylcholine, suppresses 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 the propulsive motility of the stomach due to antagonism with_D2-receptors and dose-dependent inhibition of acetylcholinesterase activity.

It has a specific effect on the upper gastrointestinal tract, accelerates Tranzit through the stomach, improves its emptying. It has no effect on serum gastrin concentrations.

Pharmacokinetics

It is quickly and well absorbed in the gastrointestinal tract. The relative bioavailability of the drug is 60%. _cmax — 0.28 mcg / ml, after taking 50 mg of the drug, Tmax in plasma is about 0.5-0.75 hours. With repeated use of 50-200 mg 3 times a day for 7 days, the pharmacokinetics are linear, the accumulation is minimal.

It binds to plasma proteins (mainly albumin) by 96%, with_α1-acid glycoprotein by less than 15%. It is actively distributed in tissues (vd-6.1 l / kg) and is found in high concentrations in the kidneys, small intestine, liver, adrenal glands, stomach. In therapeutic doses, it slightly penetrates the brain and spinal cord, breast milk.

It is metabolized in the liver by flavin-dependent monooxygenase. 3 metabolites were identified, one of which shows insignificant activity: 2-3% of the activity of Itopridee.

It is excreted by the kidneys. T_1/2 is 6 hours, and T_{1/2 increases in patients with trimethylaminuria}.

Indications

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

• flatulence;
• gastralgia;
• epigastric discomfort;
• anorexia;
• heartburn;
• nausea;
• vomiting.

Use during pregnancy and lactation

Itopridee is contraindicated during pregnancy.

When taking the drug in therapeutic doses, Itopridee slightly penetrates into breast milk, so you should stop taking the drug during breastfeeding (see “Contraindications”).

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;
• pregnancy;
• lactation;
• children (up to 16 years);

With caution:  patients taking cholinesterase inhibitors and m-cholinomimetics, as well as elderly patients with reduced liver and kidney function.

Side effects

From the side of hematopoietic organs:  leukopenia, thrombocytopenia.

From the endocrine system:  gynecomastia, hyperprolactinemia.

From the digestive system:  increased salivation, nausea, diarrhea, constipation, jaundice, epigastric pain.

Nervous system disorders:  headache, sleep disturbance, irritability, dizziness, tremor.

Allergic reactions:  urticaria, anaphylactic shock.

Laboratory parameters:  increased activity of AST, ALT, GGT, ALP, hyperbilirubinemia.

Interaction

Accelerates the absorption of other drugs.

The prokinetic effect of the drug does not change under the influence of agents that reduce the acidity of gastric juice (cimetidine, ranitidine, teprenone, cetraxate).

M-holinoblockers reduce the effectiveness of Itopridee.

The cholinergic effect of Itopridee may increase with simultaneous use of m-cholinomimetics, as well as cholinesterase inhibitors.

How to take, course of use and dosage

Inside, before meals,1 tablet 3 times a day.

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

In elderly patients, the dose is reduced.

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 one.

Overdose

Treatment:  gastric lavage and symptomatic therapy.

Special instructions

If symptoms of galactorrhea and gynecomastia occur, treatment should be interrupted or completely discontinued.

In the treatment of primary biliary cirrhosis, temporary decompensation of liver cirrhosis may occur, which disappears after discontinuation of the drug.

Influence on the ability to drive vehicles or perform work that requires increased speed of physical and mental reactions. During the treatment period, it is necessary to refrain from driving vehicles and engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Tablet Form of production

Storage conditions

Store in a dry place, protected from light, at a temperature of 15-25 °C.

Shelf life

3 years

Active ingredient

Itopride

Conditions of release from pharmacies

By prescription

Dosage form

Tablets