Ganaton: instructions for using the medicine, structure, Contraindications
Active material: Itoprid
When ATH: A03FA
CCF: Preparation, increases tone and motoriku stomach. Stimulant release acetylcholine
ICD-10 codes (testimony): K29, K30, R10.1, R11, R12, R14, R 63.0
When CSF: 11.07.02.01
Manufacturer: ABBOTT GmbH & Co. KG (Germany)
Ganaton: dosage form, composition and packaging
Pills, coated white, round, with Valium on one party and chasing “HC 803” on the other side.
| 1 tab. | |
| itoprida hydrochloride | 50 mg |
Excipients: lactose, corn starch, karmelloza, silicic acid, anhydrous, magnesium stearate, gipromelloza, macrogol 6000, Titanium dioxide, carnauba wax.
7 PC. – blisters (1) – packs cardboard.
7 PC. – blisters (2) – packs cardboard.
7 PC. – blisters (3) – packs cardboard.
7 PC. – blisters (4) – packs cardboard.
7 PC. – blisters (5) – packs cardboard.
10 PC. – blisters (1) – packs cardboard.
10 PC. – blisters (2) – packs cardboard.
10 PC. – blisters (3) – packs cardboard.
10 PC. – blisters (4) – packs cardboard.
10 PC. – blisters (5) – packs cardboard.
14 PC. – blisters (1) – packs cardboard.
14 PC. – blisters (2) – packs cardboard.
14 PC. – blisters (3) – packs cardboard.
14 PC. – blisters (4) – packs cardboard.
14 PC. – blisters (5) – packs cardboard.
Ganaton: pharmachologic effect
The drug stimulates the blood motoriku. Itoprida hydrochloride propul′sivnuû strengthens motoriku stomach due to antagonism with dopaminovymi (D)2-receptors and inhibition of acetylcholinesterase activity dose-depending. Itoprid activates the release of acetylcholine and suppresses its destruction.
Itoprida hydrochloride has a specific effect on the upper section of the GASTROINTESTINAL TRACT, speeds up transit through the stomach and improves its emptying.
The drug also has anti-Emetic effect through the interaction with D2-receptors, located in the trigger zone. Itoprid caused a dose-dependent inhibition of vomiting, caused by apomorfinom.
Ganaton: pharmacokinetics
Absorption
Itoprida hydrochloride quickly and almost completely absorbed from the digestive tract. Relative bioavailability is 60%, that due to the effect “first pass” through the liver. Food does not affect the bioavailability.
Upon receiving 50 mg itoprida hydrochloride inside Cmax achieved through 0.5-0.75 h at 0.28 µg/ml. The readmission of the drug in a dose 50-200 mg 3 times / day for 7 days of pharmacokinetics of the drug and its metabolites was linear, While cumulation proved to be minimal.
Distribution
Plasma protein binding (mostly to albumin) is 96%. Linking α1-acid glikoproteinom is less than 15% of the total binding.
Actively distributed in the tissues (Vd 6.1 l / kg) and is found in high concentrations in the kidneys, small intestine, liver, the adrenal glands and the stomach. GEB in minimum quantities. Provided with breast milk.
Metabolism
Itoprid undergoes active biotransformation in the liver. Identified 3 metabolite, only one of which shows a small activity, which has no pharmacological value (about 2-3% from itoprida). A primary metabolite is N-oxide, which is formed by the oxidation of Quaternary amino-N-dimetil′noj group.
Itoprid is metabolized under the influence of a Flavin-dependent monooksigenazy (FMO3). Number and effectiveness of isoenzymes FMO in humans can vary depending on genetic polymorphism, that in rare cases leads to the development of an autosomal recessive condition, known as trimetilaminurii (syndrome “the smell of fish”). In patients with trimetilaminuriej T1/2 itoprida increases.
According to pharmacokinetic studies in vivo itoprid has no inhibitory or inducing acts on CYP2C19 and Cyp2е1 Isoenzymes. Itopridom therapy does not affect CYP activity or uridindifosfatglûkuroniziltransferazy.
Deduction
Itoprida hydrochloride and its metabolites are excreted mainly with urine. Itoprida renal excretion and its N-oxide after receiving a drug inside therapeutic doses in healthy people was 3.7 and 75.4% respectively.
The final T1/2 itoprida hydrochloride is about 6 no.
Ganaton: testimony
Mild symptoms of functional non-ulcer dyspepsia (chronic gastritis), including:
- vzdutiya life;
- feelings of rapid satiety;
- pain or discomfort in the upper abdomen;
- anoreksii;
- Heartburn;
- nausea;
- vomiting.
Ganaton: dosing regimen
Adults appointed interior 50 mg (1 tab.) 3 times / day before meals. The recommended daily dose is 150 mg. The specified dose can be reduced, taking into account the age of the patient.
Ganaton: side effects
From the hematopoietic system: leukopenia, thrombocytopenia.
On the part of the endocrine system: elevated prolactin levels, gynecomastia.
CNS: dizziness, headache, tremor.
From the digestive system: diarrhea, constipation, abdominal pain, increased salivation, nausea, jaundice, increased activity of AST and ALT, GGT, ALP and bilirubin levels.
Allergic reactions: dermahemia, itching, rash, anaphylaxis.
Ganaton: Contraindications
- gastrointestinal bleeding, mechanical obstruction or perforation of DIGESTIVE TRACT;
- pregnancy;
- lactation (breast-feeding);
- Children up to age 16 years;
- hypersensitivity to itopride or any auxiliary component of the drug.
Ganaton: Pregnancy and lactation
Application of Ganatona in pregnancy and lactation is possible only in cases, When there is a safer alternative, and the expected benefit to the mother outweighs the potential risk to the fetus or child.
Ganaton: Special instructions
FROM caution the drug should be used in patients, for which the emergence of cholinergic side effects (actions relating to the increase in acetylcholine under the influence itoprida), can aggravate the course of the basic disease.
Ganaton: overdose
Cases of overdose have not been described in humans.
Treatment: overdose showing gastric lavage and symptomatic therapy.
Ganaton: drug interaction
Metabolic interaction is unlikely, tk. itoprid is metabolized under the influence of a Flavin-dependent monooksigenazy, rather than the cytochrome P450 system Isoenzymes.
If you are applying to Ganatona with warfarin, diazepamom, diclofenac sodium, tiklopidina hydrochloride, nifedipine and nikardipina hydrochloride itoprida binding protein changes were observed.
Itoprid strengthens motoriku stomach, Therefore, it can affect the absorption of both applied inside drugs. Special caution should be exercised when applying the preparations with a low therapeutic index, as well as the forms with a slow release of the active substance or drugs with enteric-soluble shell.
Peptic ulcer remedies, such as cimetidine, ranitidine, teprenon and cetraksat, do not affect prokinetičeskoe activity itoprida.
Antiholinergicakie funds could weaken the effect Ganatona.
Ganaton: terms of dispensing from pharmacies
The drug is released under the prescription.
Ganaton: terms and conditions of storage
List B. The drug should be stored in a dry place, protected from light, inaccessible to children at temperature not exceeding 25 ° C. Shelf life – 5 years.
