Active substanceLoperamideLoperamide
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  • Dosage form: & nbsppills
    Composition:

    Each tablet contains:

    Active substance:

    Loperamide hydrochloride 0.002 g.

    Excipients:

    Milk sugar (lactose) 0.07591 g,

    Potato starch 0.04879 g,

    Polyvinylpyrrolidone (povidone) 0.00630 g

    Aerosil (silicon dioxide colloidal) 0.002798 g

    Talc 0.00280 grams

    Magnesium stearate 0.00140 g

    Description:Tablets are white or white with a yellowish tint of color, flat-cylindrical shape.
    Pharmacotherapeutic group:Antidiarrhoeic remedy
    ATX: & nbsp

    A.07.D.A   Drugs that reduce the peristalsis of the digestive tract

    A.07.D.A.03   Loperamide

    Pharmacodynamics:

    Loperamide, by binding to the opioid receptors of the intestinal wall (modulation of choline and adrenergic neurons through guanine nucleotides), reduces the tone and motility of smooth intestinal muscles (by inhibiting the release of acetylcholine and Pg). Slows down the peristalsis and increases the transit time of intestinal contents. Increases the tone of the anal sphincter, promotes retention of fecal masses and reduced urge to defecate.

    The action comes quickly and lasts 4-6 hours.

    Pharmacokinetics:

    Absorption - 40%. Tcm(the maximum concentration in blood plasma) is 2.5 hours. The connection with plasma proteins is 97%. Does not penetrate the blood-brain barrier (BBB).

    It is almost completely metabolized by the liver by conjugation.T1 / 2 (half-life) is 9-14 hours. It is excreted mainly with bile and kidneys (in the form of conjugated metabolites).

    Indications:

    Symptomatic treatment of acute and chronic diarrhea of ​​various genesis (allergic, emotional, drug, radiation, with a change in diet and quality of food, in violation of metabolism and absorption, as an auxiliary for diarrhea of ​​infectious genesis).

    Regulation of stool in patients with ileostomy.

    Contraindications:

    Hypersensitivity to the drug, diverticulosis, intestinal obstruction, ulcerative colitis in the acute stage, diarrhea on the background of acute pseudomembranous enterocolitis, in the form of monotherapy - dysentery and other infections of the gastrointestinal tract; pregnancy (I trimester), lactation period, children's age (up to 5 years).

    Carefully:

    Carefully: apply loperamide with hepatic insufficiency.

    Dosing and Administration:

    Inside. Adults with acute and chronic diarrhea appointed in an initial dose of 2 tablets (4 mg); then - 1 tablet (2 mg) after each act of defecation (in the case of a loose stool); the maximum daily dose is 8 tablets (16 mg).

    In acute diarrhea, children older than 5 years are prescribed in an initial dose of 2 mg, then 2 mg after each act of defecation; the maximum daily dose of 3 tablets (6 mg).

    With normalization of the stool or in the absence of stool for more than 12 hours, treatment with Loperamide should be discontinued.

    Side effects:

    Gastralgia, dry mouth, allergic reactions (skin rash), drowsiness, dizziness, intestinal colic, nausea, vomiting, constipation. Very rarely - intestinal obstruction.

    Overdose:

    Symptoms: depression of the central nervous system (CNS) (stupor, impaired coordination of movements, drowsiness, miosis, muscle hypertension, respiratory depression), intestinal obstruction.

    Treatment: antidote - naloxone; Considering that the duration of action of loperamide is greater than that of naloxone, it is possible to re-introduce the latter. Symptomatic treatment: Activated carbon, gastric lavage, artificial ventilation (IVL). Medical surveillance is necessary for at least 48 hours.

    Special instructions:

    In the absence of effect after two days of treatment, it is necessary to clarify the diagnosis and exclude the infectious genesis of diarrhea.

    If the treatment develop constipation or bloating, loperamide should be canceled.

    In patients with impaired liver function, careful monitoring of signs of toxic CNS damage is necessary.

    During the treatment of diarrhea, it is necessary to replenish the loss of fluid and electrolytes.
    Effect on the ability to drive transp. cf. and fur:

    During the treatment period, it is necessary to refrain from engaging in potentially dangerous activities that require a high concentration of attention and speed of psychomotor reactions.

    Form release / dosage:

    Tablets of 2 mg.

    Packaging:

    10 tablets per contour cell pack. For 10 or 20 tablets in a can of lightproof glass.

    Each jar or 1, 2 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

    Storage conditions:

    In dry, protected from light, out of reach of children at a temperature of no higher than 25 ° C.

    Shelf life:

    3 years. Do not use the drug with expired shelf life.

    Terms of leave from pharmacies:Without recipe
    Registration number:P N000336 / 01
    Date of registration:20.12.2011 / 17.09.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:VEROPHARM SA VEROPHARM SA Russia
    Manufacturer: & nbsp
    Information update date: & nbsp01.02.2017
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