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Itomed tablets ppo 50mg No. 40

Compound

Active substance: itopride hydrochloride - 50 mg. Excipients: lactose monohydrate, pregelatinized corn starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate.

Pharmacokinetics

Suction

Quickly and well absorbed into the gastrointestinal tract. The relative bioavailability of the drug is 60%. After taking a dose of 50 mg, Cmax in plasma is 0.28 mcg/ml. The time to reach Cmax in plasma is about 0.5-0.75 hours. With repeated administration of 50-200 mg 3 times a day for 7 days, the pharmacokinetics are linear, accumulation is minimal.

Distribution

Binds to plasma proteins (mainly albumin) by 96%, with alpha-1-acid glycoprotein by less than 15%. It is actively distributed in tissues and is found in high concentrations in the kidneys, small intestine, liver, adrenal glands, and stomach. Vd is 6.1 l/kg. In therapeutic doses, it slightly penetrates into the brain and spinal cord and into breast milk.

Metabolism and excretion

Metabolized in the liver. 3 metabolites have been identified, one of which exhibits insignificant activity: 2-3% of the activity of itopride. Metabolized by flavin monooxygenase (FMO3). According to in vivo pharmacokinetic studies, itopride does not have an inhibitory or inducing effect on CYP2C19 and CYP2E1. The use of itopride does not affect the activity of uridine diphosphate glucuronyl transferase.

Itopride and its metabolites are excreted in the urine. T1/2 is 6 hours. T1/2 in patients with trimethylaminuria may be increased.

Indications for use

Symptomatic treatment of functional non-ulcer dyspepsia (chronic gastritis): flatulence, gastralgia, discomfort in the epigastric region, anorexia, heartburn, nausea, vomiting.

Contraindications

gastrointestinal bleeding;
mechanical obstruction and perforation of the gastrointestinal tract;
lactase deficiency;
lactose intolerance;
glucose-galactose malabsorption;
children under 16 years of age;
pregnancy;
lactation period;
hypersensitivity to itopride or any auxiliary component of the drug.

Carefully

prescribed to patients for whom the development of cholinergic adverse reactions (associated with increased action of acetylcholine during drug therapy) may aggravate the course of the underlying disease; patients with impaired liver and kidney function; elderly patients.

Directions for use and doses

Orally, before meals, one tablet 3 times a day.
The recommended daily dose of the drug is 3 tablets (150 mg). The indicated dose may be reduced taking into account the age and clinical condition of the patient. In clinical studies, the duration of treatment with the drug 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 a missed dose.

Storage conditions

In a place protected from light, at a temperature not exceeding 25°C.

Keep out of the reach of children.

Best before date

4 years. Do not use after the expiration date.

special instructions

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

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

Description

A drug that increases the tone and motility of the gastrointestinal tract. Acetylcholine release stimulator.

Dosage form

Tablets, film-coated, white or almost white, round, biconvex, scored on one side; at the break - white or almost white.

Use in children

Use is contraindicated for people under 16 years of age.

Pharmacodynamics

Strengthens gastrointestinal motility due to antagonism with dopamine D2 receptors and inhibition of acetylcholinesterase.
Activates the release of acetylcholine and 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 propulsive gastric motility due to antagonism with D2 receptors and dose-dependent inhibition of acetylcholinesterase activity.

It has a specific effect on the upper gastrointestinal tract, accelerates gastric transit, and improves emptying. Has no effect on serum gastrin concentrations.

Side effects

The frequency of side effects is classified according to WHO recommendations: very often (from ≥1/10); often (≥1/100 to <1/10); uncommon (from ≥1/1000 to <1/100); rare (from ≥1/10000 to <1/1000); very rare (<1/10000), frequency unknown (cannot be estimated based on available data).

From the hematopoietic system: infrequently - leukopenia; frequency unknown - thrombocytopenia.

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

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

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

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

Use during pregnancy and breastfeeding

Itopride is contraindicated during pregnancy.

When taking the drug in therapeutic doses, itopride slightly passes into breast milk, so you should stop taking the drug during lactation.

Interaction

No interaction was found when itopride was taken concomitantly 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 increases gastric motility, which may affect the absorption of drugs when used together orally. Particular caution should be exercised when taking drugs with a narrow therapeutic index, drugs with prolonged release of the active substance or drugs with enteric coating.
Antiulcer drugs such as cimetidine, ranitidine, teprenone and cetraxate do not affect the prokinetic efficacy of itopride.
M-anticholinergic agents reduce the effectiveness of itopride.
The cholinergic effect of itopride may be enhanced by the simultaneous use of m-cholinomimetics, as well as cholinesterase inhibitors.

Overdose

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

Impact on the ability to drive vehicles and operate machinery

The action of Itopride does not lead to impairment of psychomotor reactions, however, due to possible side effects (dizziness, tremor), a decrease in concentration and an impact on the ability to drive vehicles and operate machinery cannot be ruled out.

Pharmacological properties of the drug

Pharmacodynamics

Improvement of gastrointestinal motility is based on inhibition of acetylcholinesterase contained in the stomach and suppression of the activity of D2-dopamine receptors. The drug improves the secretion of acetylcholine and prevents its destruction.

The antiemetic effect is achieved through the interaction of the active component with D2 receptors. Itopride suppresses gagging and makes propulsive intestinal motility more active.

Pharmacokinetics

The active substance Itomed is distributed in equal proportions throughout the tissues of organs such as the stomach, liver, kidneys, adrenal glands and intestines. It practically does not penetrate into the brain and spinal cord, and its concentration level is low in breast milk. Thanks to the combination of these factors, the drug has a beneficial effect on the gastrointestinal tract, eliminating the symptoms of many diseases.

Similar medicines

Itomed analogues are drugs with a similar spectrum of action. A change in medication should only be made with the approval of a doctor, who must evaluate the need to choose other tablets and the possible benefits of this decision. One of these drugs is Ganaton, the composition of which is very similar to Itomed. The active substance in both of them is itopride hydrochloride.

Ganaton can be taken for a long time without fear of side effects; it is easily accepted by the body of the vast majority of patients. Indications for its use are identical to those of Itomed.

Motilium can be considered another analogue. It may be more preferable for patients because it comes in various forms: lozenges, oral tablets, or suspension. An undeniable advantage is the fact that it can be prescribed to children and adolescents. The active substance in it is the substance domperidone.

Medicines called Itopra and Itopride have a similar, but less pronounced effect. Due to their poor effectiveness and poor compatibility with other drugs, they are rarely prescribed.

special instructions

The instructions for the drug Itomed contain special instructions that must be taken into account before using the drug. These include:

a decrease in the functional activity of the liver in the presence of cirrhosis, which completely stops with the abolition of the drug;
since the drug has a beneficial effect on peristalsis, it promotes accelerated absorption of other drugs when taken simultaneously;
manifestations of hyperprolactinemia and gynecomastia should be considered as grounds for immediate discontinuation of Itomed;
drugs from the group of M-anticholinergics significantly reduce the effectiveness of Itomed;
When taking the medicine, you should temporarily stop carrying out activities associated with increased concentration of attention and which require a high speed of psychomotor reactions.

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When driving a car or other activities that require increased attention, it is better to limit the use of the drug.

You can purchase Itomed in a pharmacy only with a doctor's prescription. It is not recommended to choose it on your own for treatment or relief from symptoms, since the risk of harming yourself is quite high. The article provides informational information; only a doctor can make a diagnosis and prescribe a course of treatment with Itomed.