Active substanceLoperamideLoperamide
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  • Dosage form: & nbspcapsules
    Composition:

    1 capsule contains:

    Loperamide hydrochloride 2 mg.

    Excipients:

    Lactose, corn starch, microcrystalline cellulose, sodium carboxymethyl starch, magnesium stearate, talc; the composition of the capsule shell - purified water, gelatin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium lauryl sulfate, povidone, titanium dioxide, brilliant blue dye.

    Description:Hard gelatin capsules number 2, the body is white with a lid of blue color, the contents of the capsules - white or almost white powder.

    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, binding to opioid receptors of the intestinal wall (stimulation of choline and adrenergic neurons through guanine nucleotides), reduces tone and motility of smooth intestinal muscles (by inhibiting the release of acetylcholine and prostaglandins). Slows down the peristalsis and increases the time of passage of intestinal contents of the intestine, reduces the secretion of fluid and electrolytes with feces. Increases the tone of the anal sphincter. The action comes quickly and lasts 4-6 hours.

    Pharmacokinetics:

    Absorption - 40%. The connection with plasma proteins is 97%.The half-life is 9-14 hours. It does not penetrate the blood-brain barrier. It is almost completely metabolized in the liver by conjugation. It is excreted mainly with bile and kidneys.

    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 (1 trimester), lactation period, loperamide capsules are not prescribed for children under 6 years.

    Carefully:

    With caution - liver failure.

    Dosing and Administration:

    Adults with acute and chronic diarrhea initially assigned 2 capsules (4 mg), then 1 capsule (2 mg) after each act of defecation in the case of a loose stool.The maximum daily dose is 8 capsules (16 mg).

    Children older than 6 years are prescribed 1 capsule (2 mg) after each act of defecation in the case of a loose stool. The maximum daily dose is 3 capsules (6 mg).

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

    Side effects:

    It is observed, as a rule, only with prolonged intake of the drug. Possible headache, pain and discomfort in the epigastrium, dry mouth, hypovolemia, electrolyte disorders, flatulence, urinary retention. Rarely - drowsiness or sleep disturbance, dizziness, intestinal spasms, nausea, vomiting, constipation. Very rarely - intestinal obstruction.

    Allergic reactions (skin rash).

    Overdose:

    Symptoms: signs of oppression of the central nervous system (stupor, impaired coordination, drowsiness, narrowing of the pupils, increased tone of skeletal muscles, respiratory depression), intestinal obstruction.

    Treatment: gastric lavage, reception of activated charcoal (in the first 3 hours after taking the drug). As a specific antagonist, naloxone.

    In case of symptoms of an overdose, seek medical attention immediately.Medical surveillance is necessary for at least 48 hours.

    Interaction:

    Loperamide is a substrate of P-glycoprotein. The combined use of loperamide (16 mg single dose) together with a single dose (600 mg) of quinidine, or ritonavir, each of which is an inhibitor of P-glycoprotein, leads to a two-three-fold increase in plasma concentrations of loperamide. Caution should be exercised when using loperamide with quinidine, rinavir and P-glycoprotein inhibitors at recommended doses (2 mg to 16 mg maximum daily dose) because of the possibility of increasing the main effects.

    When a single dose of 16 mg of loperamide is taken in conjunction with 600 mg of a single dose of saquinavir, loperamide reduces the action of saquinavir 54%, which can be of clinical importance, as the therapeutic effect of saquinavir is reduced. The action of saquinavir on loperamide has no clinical significance. That's why when loperamide is used in conjunction with saquinavir, the therapeutic effect of saquinavir should be controlled.

    Special instructions:

    If there is no effect after 2 days of Superpyrea, it is necessary to clarify the diagnosis and exclude the infectious genesis of diarrhea. Use with caution in patients with impaired hepatic function.

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


    Form release / dosage:Capsules 2 mg.
    Packaging:

    Primary packaging:

    10 capsules in blisters made of polyvinylchloride and aluminum foil.

    Secondary packaging:

    2 blisters per cardboard pack with instructions for medical use.
    Storage conditions:

    In a dry, protected from light place, at a temperature of no higher than 30 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years. Do not use the product after the expiry date printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N012900 / 01
    Date of registration:21.07.2008
    The owner of the registration certificate:Panacea Biotech Co., Ltd.Panacea Biotech Co., Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspPANACEA BIOTEC Co., Ltd. PANACEA BIOTEC Co., Ltd. India
    Information update date: & nbsp22.10.2015
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