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Motopride film-coated tablets 50 mg blister No. 20

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Motopride film-coated tablets 50 mg blister No. 20
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350.70 грн.
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Active ingredient:Itopride hydrochloride
Adults:Can
ATC code:A DRUGS AFFECTING THE DIGESTIVE SYSTEM AND METABOLISM; A03 DRUGS USED IN FUNCTIONAL GASTROINTESTINAL DISORDERS; A03F PERISTALTIC STIMULATORS (PROPULSANTS); A03F A Peristaltic stimulants; A03F A07 Itopride
Country of manufacture:Ukraine
Diabetics:Can
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Motopride film-coated tablets 50 mg blister No. 20
350.70 грн.
Description

Instructions Motoprid film-coated tablets 50 mg blister No. 20

Composition

active ingredient: itopride hydrochloride;

1 tablet contains 50 mg of itopride hydrochloride;

excipients: lactose monohydrate; corn starch; carmellose calcium (calcium carboxymethylcellulose); colloidal anhydrous silicon dioxide; magnesium stearate;

shell: Opadray II White film-coating mixture: lactose monohydrate; hypromellose (hydroxypropylmethylcellulose); polyethylene glycol; titanium dioxide (E 171); triacetin.

Dosage form

Film-coated tablets.

Main physicochemical properties: tablets, round in shape with a biconvex surface, coated with a white film coating.

Pharmacotherapeutic group

Peristaltic stimulants. ATX code A03F A07.

Pharmacological properties

Pharmacodynamics

Itopride hydrochloride activates propulsive motility of the gastrointestinal tract due to antagonism with dopamine D2 receptors and inhibitory activity of acetylcholinesterase. Itopride hydrochloride activates the release of acetylcholine and inhibits its breakdown. Itopride hydrochloride also has an antiemetic effect due to interaction with D2 receptors localized in the chemoreceptor trigger zone, which was demonstrated by dose-dependent inhibition of apomorphine-induced vomiting in animals. The action of Itopride hydrochloride is highly specific for the upper gastrointestinal tract.

Itopride hydrochloride does not affect serum gastrin levels.

Pharmacokinetics

Absorption. Itopride hydrochloride is rapidly and almost completely absorbed from the gastrointestinal tract. Its relative bioavailability is 60%, which is associated with the effect of "first pass" through the liver. Food does not affect bioavailability. After taking 50 mg of itopride hydrochloride, Cmax is reached after 0.5-0.75 hours and is 0.28 μg/ml. With further use of the drug in doses from 50 to 200 mg 3 times a day for 7 days, the pharmacokinetics of itopride hydrochloride and its metabolites were linear with minimal cumulation.

Distribution: Approximately 96% of itopride hydrochloride is bound to plasma proteins (mainly albumin). Binding to α1-acid glycoprotein is less than 15%.

Metabolism. Itopride hydrochloride is actively biotransformed in the liver. Three metabolites have been identified, only one of which exhibits insignificant activity, which is of no pharmacological significance (approximately 2-3% of itopride hydrochloride). The primary metabolite is the N-oxide, which is formed as a result of oxidation of the quaternary amino-N-dimethyl group.

Itopride hydrochloride is metabolized by flavin-dependent monooxygenase (FMO3). The number and efficiency of FMO isoenzymes in humans may vary depending on genetic polymorphisms, which sometimes lead to the development of an autosomal recessive condition known as trimethylaminuria (fish odor syndrome). In patients with trimethylaminuria, T1/2 is increased.

According to in vivo pharmacokinetic studies, itopride hydrochloride does not inhibit or induce CYP2C19 and CYP2E1. The use of itopride hydrochloride does not affect the content of CYP or the activity of uridine diphosphate glucuronidyl transferase.

Excretion. Itopride hydrochloride and its metabolites are excreted mainly in the urine. Renal excretion of itopride hydrochloride and its N-oxide was 3.7% and 75.4%, respectively, after a single oral administration of the drug to healthy volunteers at a therapeutic dose.

The terminal half-life (T1/2) of itopride hydrochloride was approximately 6 hours.

Indication

Relief of gastrointestinal symptoms of functional non-ulcer dyspepsia (chronic gastritis), namely:

bloating; feeling of rapid satiety; pain and discomfort in the upper abdomen; anorexia; heartburn; nausea; vomiting.

Contraindication

Hypersensitivity to itopride hydrochloride and other components of the drug.

Conditions in which increased contractile activity of the gastrointestinal tract may be harmful, such as gastrointestinal bleeding, mechanical obstruction or perforation.

Interaction with other medicinal products and other types of interactions

Metabolic interactions are not expected since itopride hydrochloride is primarily metabolized by flavin monooxygenase and not by cytochrome P450 isoenzymes. No changes in protein binding were observed when it was co-administered with warfarin, diazepam, diclofenac sodium, ticlopidine hydrochloride, nifedipine and nicardipine hydrochloride. Since itopride hydrochloride has a gastrokinetic effect, it may affect the absorption of other drugs administered orally at the same time.

Medicines with a narrow therapeutic index, sustained release or enteric-coated should be used with extreme caution.

Antiulcer drugs such as cimetidine, ranitidine, teprenone and cetraxate do not affect the prokinetic effect of itopride hydrochloride.

Anticholinergic drugs may reduce the effect of itopride hydrochloride.

Application features

Itopride hydrochloride enhances the action of acetylcholine and may cause cholinergic side effects. There are no data on long-term use.

In general, itopride hydrochloride should be administered to elderly patients with appropriate caution and further observation, taking into account the increased frequency of impaired renal function, liver function, concomitant diseases or concomitant therapy with other drugs in such patients.

The medicine contains lactose, therefore patients with rare hereditary diseases such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Ability to influence reaction speed when driving vehicles or other mechanisms

There is no information on the possible effect on reaction speed, but when deciding whether to drive or operate other mechanisms, the possibility of dizziness should be taken into account.

Use during pregnancy or breastfeeding

Fertility: There are no data on the effect of itopride on human fertility; animal studies are known to have shown no harmful effects of itopride.

Pregnancy. There are no or limited amount of data from the use of itopride in pregnant women (less than 300 pregnancy outcomes). Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of itopride during pregnancy.

Breastfeeding. Itopride is excreted in breast milk in animals, but there are insufficient data on the excretion of itopride in human breast milk. A risk to the breastfed child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from itopride therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Method of administration and doses

For adults, the recommended dose is 150 mg per day (1 tablet (50 mg) 3 times a day before meals). This dose may be reduced based on the patient's age and symptoms (see section "Special instructions").

It is known that during clinical trials the duration of use of itopride hydrochloride was up to 8 weeks.

Children

The safety of itopride hydrochloride in children under 16 years of age has not been established.

Overdose

Treatment: In case of excessive overdose, the usual measures of gastric lavage and symptomatic treatment should be taken.

Adverse reactions

Immune system disorders: hypersensitivity, including anaphylactoid reaction;

from the endocrine system: increased prolactin levels in the blood;

from the blood and lymphatic system: leukopenia, thrombocytopenia;

Gastrointestinal: abdominal pain, diarrhea, constipation; increased salivation, nausea;

from the nervous system: dizziness, headache, tremor;

Skin and subcutaneous tissue disorders: rash, erythema and itching;

Liver and biliary tract: jaundice;

Reproductive system and breast disorders: gynecomastia.

Laboratory tests: increased levels of AST (aspartate aminotransferase), ALT (alanine aminotransferase), GGT (gamma-glutamyltransferase), alkaline phosphatase, bilirubin in the blood, increased aminotransferase levels, decreased white blood cell count.

Expiration date

2 years.

Storage conditions

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging

10 tablets in a blister; 2 blisters in a pack.

Vacation category

According to the recipe.

Producer

JSC "KYIV VITAMIN FACTORY".

Location of the manufacturer and its business address

04073, Ukraine, Kyiv, Kopylivska St., 38.

Specifications
Characteristics
Active ingredient
Itopride hydrochloride
Adults
Can
ATC code
A DRUGS AFFECTING THE DIGESTIVE SYSTEM AND METABOLISM; A03 DRUGS USED IN FUNCTIONAL GASTROINTESTINAL DISORDERS; A03F PERISTALTIC STIMULATORS (PROPULSANTS); A03F A Peristaltic stimulants; A03F A07 Itopride
Country of manufacture
Ukraine
Diabetics
Can
Dosage
50 мг
Drivers
With caution
For allergies
With caution
For children
From the age of 16
Form
Film-coated tablets
Method of application
Inside, solid
Nursing
It is impossible.
Pregnant
It is impossible.
Primary packaging
blister
Producer
Kyiv Vitamin Plant JSC
Quantity per package
20 pcs
Trade name
Moto Pride
Vacation conditions
By prescription
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