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

Excipients: lactose monohydrate -135.4 mg, potato starch - 15.8 mg, silicon dioxide colloid (aerosil) -3.2 mg, calcium stearate -1.6 mg; gelatin capsule composition: body: gelatin-17.311 mg, titanium dioxide E171- 0.353 mg; lid: gelatin - 29,422 mg, titanium dioxide E 171 - 0,303 mg, iron dye oxide yellow E 172 - 0.520 mg, indigocarmine E 132 - 0.091 mg.

Description:

Hard gelatin capsules No. 3, white body, lid green. The contents of the capsules are white or white powder with a yellow tint of color.

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 cholinergic and adrenergic neurons through guanine nucleotides), reduces tone and motility of the smooth muscles of the intestine, slows the passage of the contents of the intestine, reduces the secretion of fluid and electrolytes with feces. 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%.The connection with plasma proteins is 97%. The half-life is 9-14 hours. Does not penetrate the blood-brain barrier. Once in the systemic circulation, it is almost completely metabolized in the liver by conjugation. It is excreted mainly with bile, an insignificant part of the kidneys (in the form of conjugated metabolites).

Indications:

Symptomatic treatment of acute and chronic diarrhea (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, lactose intolerance, lactase deficiency or glucose-galactose malabsorption, 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, loperamide capsules are not prescribed for children under 6 years.

Carefully:Liver failure.

Pregnancy and lactation:

In the II and III trimesters of pregnancy loperamide can be prescribed in cases where the expected benefit of therapy for the mother exceeds the potential risk to the fetus.

Dosing and Administration:

Inside: not liquid, squeezed water. 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 with acute diarrhea appoint 1 capsule (2 mg) after each act defecation in case of a loose stool. The maximum daily dose is 3 capsules (6 mg). Duration of treatment is 7-20 days. After normalization of the stool or in the absence of stool for more than 12 hours, treatment with loperamide should be discontinued.

Side effects:

Discomfort in the abdomen, flatulence, gastralgia, dry mouth, allergic reactions (skin rash), intestinal colic, nausea, vomiting, constipation, headache, drowsiness or insomnia, dizziness, urinary retention, intestinal obstruction.

Overdose:

Symptoms: oppression of the central nervous system (stupor, impaired coordination, 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. Medical surveillance is necessary for at least 48 hours.

Interaction:

The simultaneous use of loperamide with opioid analgesics or colestyramine may increase the risk of severe constipation.

When used simultaneously with co-trimoxazole, ritonavir, the bioavailability of loperamide is increased, which is due to the inhibition of its metabolism in the "first passage "through the liver.

Special instructions:

Loperamide should be used with extreme caution in patients with liver dysfunction. it is metabolized in the liver. Patients with liver dysfunction need careful monitoring of signs of toxic CNS damage under the influence of the drug. Such antidiarrhoeic agents as Loperamide, can cause an intestinal obstruction and a toxic megacolon. Treatment should be immediately interrupted if there is bloating or other indirect symptoms.If there is no effect after 2 days of Loperamide use, it is necessary to clarify the diagnosis and exclude the infectious genesis of diarrhea. Children under 6 years of age should not be prescribed Loperamide in capsules or tablets.

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

During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

Form release / dosage:

Capsules of 2 mg.

Packaging:

10 capsules per contour cell package.

For 1 or 2 contour packs with instructions for use in a pack of cardboard.

Storage conditions:

In a dry, the dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LS-001166

Date of registration:09.02.2012

Expiration Date:Unlimited

The owner of the registration certificate:BIOKOM, CJSC BIOKOM, CJSC Russia

Manufacturer: & nbsp

BIOKOM, CJSC Russia

Information update date: & nbsp02.04.2018

Illustrated instructions

Instructions

Loperamide (Loperamide)