Dutan - instructions for use, dose, side effects, contraindications

Excipients: cellulose microcrystalline 7.436 mg, mannitol 18.876 mg, sucrose (sugar) 34.32 mg, sodium lauryl sulfate 1.716 mg, povidone K-30 (polyvinylpyrrolidone) 5.72 mg;

excipients for the shell: ethyl cellulose 8.58 mg, hypromellose 8.58 mg, cetyl alcohol 0.572 mg;

hard gelatine capsules: body and cap capsule - read 1.25% or 2% dioxide, gelatin to 100%.

Description:

Hard gelatin capsules №0 with a body and a lid of white color.The contents of capsules are spherical white or almost white.

Pharmacotherapeutic group:antispasmodic

ATX: & nbsp

A.03.A.A.04 Mebeverin

A.03.A.A Synthetic holinoblokatory - ethers with tertiary amino group

Pharmacodynamics:

Spazmolitik myotropic action, has a direct effect on the smooth muscles of the gastrointestinal tract. Eliminates spasm without affecting normal intestinal motility. Systemic side effects, including anticholinergic, are absent. Numerous mechanisms, such as reduced permeability of ion channels, blockade of norepinephrine reuptake, local anesthetic effect, and changes in water absorption may cause local action of mebeverine on the gastrointestinal tract. Through these mechanisms mebeverin has an antispasmodic effect, normalizing peristalsis of the intestine and not causing a constant relaxation of the smooth muscle tissue of the gastrointestinal tract.

Pharmacokinetics:

Suction:

Mebeverin is quickly and completely absorbed after ingestion. The drug form of prolonged action allows using the dosing regimen 2 times a day.

Distribution:

When taking repeated doses of mebeverine, no significant accumulation occurs.

Metabolism:

Mebeverina hydrochloride is mainly metabolized by esterases, which in the first stage split the ether into veratric acid and mebeverine alcohol. The main metabolite circulating in the blood plasma is demethylated carboxylic acid. The half-life in the equilibrium state of the demethylated carboxylic acid is approximately 5.77 hours. With repeated doses (200 mg twice daily), the maximum concentration of demethylated carboxylic acid in the blood plasma (C_mOh) is 804 ng / ml, the time to reach the maximum concentration of demethylated carboxylic acid in blood plasma (T_mOh) - about 3 hours.

The average value of the relative bioavailability of the drug in the sustained-release capsule is 97%.

Excretion:

Mebeverin as such is not excreted from the body, but is completely metabolized; its metabolites are almost completely eliminated from the body. Veratric acid is excreted by the kidneys. Mebeverine alcohol is also excreted by the kidneys, partly in the form of a carboxylic acid and partly as a demethylated carboxylic acid.

Indications:

Symptomatic treatment of pain, spasms, dysfunction and discomfort in the intestinal tract associated with irritable bowel syndrome.

Symptomatic treatment of spasms of the gastrointestinal tract (including those caused by organic diseases).

Contraindications:

Hypersensitivity to any component of the drug.

Age under 18 years (due to insufficient data on efficiency and safety).

Pregnancy and the period of breastfeeding (due to insufficient data).

Pregnancy and lactation:

Pregnancy:

Data on the use of mebeverin in pregnant women is not enough. It is not recommended to use Dutan® during pregnancy.

Breastfeeding period:

Information on the excretion of mebeverin or its metabolites with breast milk is not enough. Do not take Dutan ® during breastfeeding.

Fertility:

Clinical data on the effects of mebeverin on fertility in men or women are not available, however, animal studies have not demonstrated adverse effects of mebeverine.

Dosing and Administration:

For oral administration.

Capsules must be swallowed by washing with a sufficient amount of water (at least 100 ml). Capsules should not be chewed.

One capsule 2 times at day, one - in the morning and one - in the evening, 20 minutes before meals. Duration of the drug is not limited.

If the patient forgot to take one or more doses, take the drug with the next dose. Do not take one or more missed doses in addition to the usual dose.

Dosage regimen studies in elderly patients, patients with renal and / or hepatic insufficiency not conducted. Available data on post-marketing use of the drug did not reveal specific risk factors for its use in elderly patients and patients with renal and / or liver failure. Changes in the dosing regimen in these patients are not required.

Side effects:

Reports of the following adverse events were received during the post-marketing period and were of a spontaneous nature, in order to accurately assess the incidence of the available data, it is not enough.

Allergic reactions were observed mainly from the skin,but there were also other manifestations of allergy.

From the skin: urticaria, angioedema, including face, exanthema.

From the immune system: hypersensitivity reactions (anaphylactic reactions).

Overdose:

Symptoms: Theoretically, in case of an overdose, it is possible to increase the excitability of the central nervous system. In cases of an overdose of mebeverine, the symptoms either were absent, or were insignificant and, as a rule, quickly reversible. The symptoms of overdose were neurological and cardiovascular.

Treatment: The specific antidote is unknown. Symptomatic treatment is recommended. Gastric lavage is necessary only if intoxication is detected within about one hour after taking several doses of the drug. Measures to reduce absorption are not required.

Interaction:

Only studies on the interaction of mebeverine with alcohol were carried out. Studies in animals demonstrated the absence of any interaction between mebeverin and ethyl alcohol.

Effect on the ability to drive transp. cf. and fur:

Studies of the influence of mebeverin on the ability to drive and other mechanisms have not been carried out. The pharmacological properties of the preparation, as well as the experience of its use, do not indicate any adverse effect of mebeverin on the ability to drive and other mechanisms.

Form release / dosage:

Capsules of prolonged action, 200 mg.

Packaging:

For 10, 15 capsules in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

For 1, 2, 3, 4, 5, 6 contour squares, together with the instruction, they are placed in a pack of cardboard.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-003300

Date of registration:10.11.2015

Expiration Date:10.11.2020

The owner of the registration certificate:OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia

Manufacturer: & nbsp

OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia

Representation: & nbspOBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSCOBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSCRussia

Information update date: & nbsp20.08.2016

Illustrated instructions

Instructions

Dutane® (Djutan®)