Niaspam (Niaspam)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceMebeverinMebeverin
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    • Dosage form: & nbspTOapsules of prolonged action.
    Composition:

    One capsule of prolonged action contains:

    active substance: mebeverine hydrochloride 200 mg;

    Excipients: microcrystalline cellulose 65.60 mg, vegetable hydrogenated oil, type I 85.00 mg, talc purified 5.50 mg, magnesium stearate 3.00 mg, silicon dioxide colloid 0.90 mg;

    capsular shell: gelatin 64.28 mg, purified water 9.00 mg, methylparahyroxybenzoate 0.52 mg, propyl parahydroxybenzoate 0.13 mg, brilliant blue dye 0.03 mg, titanium dioxide 1.04 mg.

    Description:

    Hard gelatin capsules № 1, the case is transparent, the lid is blue. The contents of capsules - powder from white to almost white, it is allowed to compact and compact the powder into a column.

    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, does not affect normal intestinal peristalsis. Does not possess anticholinergic action.

    Pharmacokinetics:

    Suction

    Mebeverin is quickly and completely absorbed after ingestion. The modified release dosage form allows to use the dosing regimen 2 times a day.

    Distribution

    When taking repeated doses of the drug, significant accumulation does not occur.

    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. When taking repeated doses (200 mg twice a day), the maximum concentration of demethylated carboxylic acid in the blood plasma (Cmax) is 804 ng / ml, the time to reach the maximum concentration of demethylated carboxylic acid in the blood (TmOh) - about 3 hours.

    The average value of the relative bioavailability of the drug in the modified release capsule is about 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 (due to insufficient data), the period of breastfeeding.

    Pregnancy and lactation:

    Pregnancy

    There are only very limited data on the use of mebeverin by pregnant women. The drug is not recommended for use during pregnancy.

    Breastfeeding period

    Information on the excretion of mebeverin or its metabolites in breast milk is not enough. Do not take the drug during breastfeeding.

    Fertility

    Clinical data on the effect of the drug on fertility in men or women are not available, however, studies in animals have not demonstrated adverse effects of the drug.

    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, as their shell provides a sustained release of the drug.

    Take one capsule 2 times a day for 20 minutes before meals, one capsule in the morning and one capsule in the evening.

    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.

    Use in special patient groups

    Elderly patients, patients with hepatic and / or renal insufficiency, dose adjustment is not required.

    Side effects:

    The reports of the side effects listed below were spontaneous and it is not enough to accurately estimate the frequency of the available data.

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

    From the skin and subcutaneous tissues: urticaria, angioedema, including face, exanthema.

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

    Overdose:

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

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

    Interaction:

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

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

    Studies of the effect of the drug 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:

    10 capsules per strip of aluminum foil.

    By 3 strips in a cardboard pack together with instructions for use.

    Storage conditions:

    Keep in dry the dark place 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 expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-000027
    Date of registration:09.11.2010 / 10.11.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:San Pharmaceutical Industries Co., Ltd.San Pharmaceutical Industries Co., Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspSAN PHARMACEUTICAL INDUSTRIES LTD. SAN PHARMACEUTICAL INDUSTRIES LTD. India
    Information update date: & nbsp20.08.2016
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