Three months: instructions for using the medicine, structure, Contraindications

Active material: Trimebutin
When ATH: A03AA05
CCF: Preparation, regulating motor function of the gastrointestinal tract
ICD-10 codes (testimony): K21, K30, K58, K91.3, R10.1, R10.4, R11, R14, Z51.4
When CSF: 11.07.03.02
Manufacturer: OAO Valenta PHARMACEUTICS (Russia)

Three months: dosage form, composition and packaging

◊ Pills white, Valium, with an embossed symbol on one side in the form of letters “TM”, the top and bottom of which are arranged in a line along the three triangles; on the other side – two intersecting risks.

Excipients: lactose, colloidal silicon dioxide, talc, corn starch, magnesium stearate.

10 PC. – packings Valium planimetric (3) – packs cardboard.

◊ Pills white, round, lenticular, with an embossed symbol on one side in the form of two elements and droplet line on the other side.

Excipients: lactose, colloidal silicon dioxide, talc, corn starch, magnesium stearate.

10 PC. – packings Valium planimetric (3) – packs cardboard.

Three months: pharmachologic effect

GI motility regulator. Trimebutin, Acting enkephalinergic intestinal system, it is a regulator of motility. With affinity receptor stimulation and suppression, has a stimulating effect when hypokinetic conditions of smooth muscles of the intestine and skin – when hyperkinetic.

The drug acts throughout the gastrointestinal tract, reduces the pressure of the sphincter of the esophagus, promotes gastric emptying and increase intestinal motility, and also contributes to the response of smooth muscles of the colon to food stimuli.

Trimebutin restores the normal physiological activity of the muscles of the intestine in various diseases of the digestive tract, associated with impaired motor skills.

Three months: pharmacokinetics

Absorption

Once inside trimebutin rapidly absorbed from the gastrointestinal tract. C_max plasma levels achieved after 1-2 no. Bioavailability is 4-6%.

Distribution

The degree of binding to plasma proteins is low – about 5%. V_d – 88 l. Trimebutin slightly crosses the placental barrier.

Metabolism

Trimebutin biotransformed in the liver.

Deduction

Trimebutine excreted in the urine primarily as metabolites (about 70% during the first 24 no.). T_1/2 – about 12 no.

Three months: testimony

Gastrointestinal dysmotility in the following functional diseases and conditions:

• gastroesophageal reflux disease;
• dyspeptic disorders in gastroduodenal diseases (stomach ache, indigestion, nausea, vomiting);
• Irritable Bowel Syndrome, manifested by pain, abdominal colic, enterospasm, meteorizmom, diarrhea and / or constipation;
• postoperative paralytic ileus;
• preparation for x-ray / endoscopic examination of the gastrointestinal tract;
• dyspeptic disorders in children, related gastrointestinal dysmotility.

Three months: dosing regimen

Adults and older children 12 years drug appointed interior 100-200 mg 3 times / day, for children 5-12 years – by 50 mg 3 times / day, for children 3-5 years – by 25 mg 3 times / day.

Three months: side effects

Rarely: skin reactions.

Three months: Contraindications

• Children up to age 3 years;
• hypersensitivity to the drug.

Three months: Pregnancy and lactation

It is not recommended to use the drug Trimedat^® I trimester of pregnancy.

It is not recommended to use the drug Trimedat^® lactation (breast-feeding) due to the lack of reliable clinical data, confirming the safety of the drug.

IN experimental studies did not reveal data on drug teratogenicity and embryotoxicity.

Three months: Special instructions

The data is not provided.

Three months: overdose

So far, cases of drug overdose Trimedat^® not reported.

Three months: drug interaction

Data on drug interactions drug Trimedat^® not disclosed.

Three months: terms of dispensing from pharmacies

The drug is resolved to application as an agent Valium holidays.

Three months: terms and conditions of storage

The drug should be stored out of reach of children at or above 25 ° C. Shelf life – 3 year.