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

Excipients: lactose (milk sugar) - 95.90 mg, microcrystalline cellulose - 40.00 mg, silicon dioxide colloid (aerosil) - 0.70 mg, magnesium stearate -1.40 mg;

shell capsules: housing: titanium dioxide - 2.1%, gelatin - up to 100%, cap: blue diamond dye -0,12%, dye azorubin (dye Karmazin) 0.004%, dye floxin B 0.01%, titanium dioxide 1.27%, gelatin up to 100%

Description:

Hard gelatin capsules No. 3: white body with a blue lid. The contents of capsules are white or white powder with a yellowish tinge.

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 transit time of intestinal contents. Increases the tone of the anal sphincter, promotes retention of fecal masses and reduced urge to defecate.Action develops 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 (I trimester), lactation period, loperamide capsules are not prescribed for children under 6 years.

Carefully:

With caution - liver failure; II - III trimester of pregnancy with a risk / benefit ratio.

Dosing and Administration:

Inside.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 Loperamide should be discontinued.

Side effects:

Headache, gastralgia, dry mouth, allergic reactions (skin rash), snotty or insomnia, dizziness, intestinal colic, pain or discomfort in the abdomen, nausea, vomiting, constipation, flatulence. Rarely, urine retention. Very rarely - 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.

Special instructions:

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.

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, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:

Capsules 2 mg.

Packaging:

10 capsules in a planar cell package.

For 20 capsules in cans of light-protective glass or cans of polymer or polymer bottles.

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

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 stated on the package.

Terms of leave from pharmacies:Without recipe

Registration number:P N002454 / 01

Date of registration:14.01.2009

Expiration Date:Unlimited

The owner of the registration certificate:NORTH STAR, CJSC NORTH STAR, CJSC Russia

Manufacturer: & nbsp

NORTH STAR, CJSC Russia

Information update date: & nbsp02.04.2018

Illustrated instructions

Instructions

Loperamide (Loperamide)