Imodium Express Lyophilized tablets, 2 mg, No. 10

Release form, composition and packaging

Lyophilized tablets, white or almost white, round.

1 tab.

loperamide hydrochloride 2 mg

gelatin - 5.863 mg, mannitol - 4.397 mg, aspartame - 0.75 mg, mint flavor - 0.3 mg, sodium bicarbonate - 0.375 mg.

6 pcs.

- blisters (1) - cardboard packs.

10 pieces.

- blisters (1) - cardboard packs.

10 pieces.

- blisters (2) - cardboard packs.

pharmachologic effect

Loperamide, by binding to opioid receptors in the intestinal wall, inhibits the release of acetylcholine and prostaglandins, thereby slowing down peristalsis and increasing the transit time of the contents through the intestine.

Increases the tone of the anal sphincter, thereby reducing fecal incontinence and the urge to defecate.

Pharmacokinetics

Suction

Most of loperamide is absorbed in the intestine, but due to active first-pass metabolism, the systemic bioavailability is approximately 0.3%.

Distribution

Plasma protein binding is 95%, mainly with albumin.

Metabolism

Loperamide is predominantly metabolized in the liver, conjugated and excreted in the bile.

Oxidative N-demethylation is the main pathway of loperamide metabolism and is carried out mainly with the participation of an inhibitor of the isoenzymes CYP3A4 and CYP2C8.

Due to active presystemic metabolism, the concentration of unchanged loperamide in the blood plasma is negligible.

Preclinical data indicate that loperamide is a substrate for P-glycoprotein.

Withdrawal

In humans, T1 / 2 of loperamide averages 11 hours, varying from 9 to 14 hours. Unchanged loperamide and its metabolites are excreted mainly in the feces.

Pharmacokinetics in special patient groups

Pharmacokinetic studies in children have not been conducted.

The pharmacokinetics of loperamide and its interactions with other drugs are expected to be similar to those in adults.

Indications for use

- symptomatic treatment of acute and chronic diarrhea (allergic, emotional, drug, radiation genesis, with a change in diet and quality composition of food, with metabolic and absorption disorders)

- as an adjunct drug for infectious diarrhea

- for the purpose of stool regulation in patients with ileostomy.

Contraindications for use

- children under 6 years old

- Acute dysentery, which is characterized by bloody stools and high fever

- ulcerative colitis in the acute phase

- bacterial enterocolitis caused by pathogenic microorganisms, incl.

Salmonella spp., Shigella spp.

and Campylobacter spp.)

- pseudomembranous colitis associated with taking broad-spectrum antibiotics

- in cases where slowing down of peristalsis is undesirable due to the possible risk of developing serious complications, incl.

intestinal obstruction, megacolon and toxic megacolon

- phenylketonuria

- I trimester of pregnancy

- lactation period (breastfeeding)

- hypersensitivity to loperamide and / or other components of the drug.

With caution, the drug should be prescribed to patients with impaired liver function due to slowed presystemic metabolism.

Dosage regimen

The drug is administered orally.

The tablet is put on the tongue, it dissolves within a few seconds, after which it is swallowed with saliva, without drinking water.

Adults and children over 6 years old

For acute diarrhea, the initial dose is 2 tab.

(4 mg) for adults and 1 tab.

(2 mg) for children, then 1 tab.

(With 2 mg) after each bowel movement in case of loose stools.

For chronic diarrhea, the initial dose is 2 tab.

(4 mg) / day for adults and 1 tab.

(With 2 mg) for children

further, the initial dose should be adjusted so that the frequency of normal stool is 1�2 times / day, which is usually achieved with a maintenance dose of 1 to 6

Name ENG

IMODIUM EXPRESS

Clinical and pharmacological group

Antidiarrheal drug

ATX code

Loperamide

Dosage

2mg

Structure

Loperamide hydrochloride 2 mg.

Excipients: gelatin - 5.863 mg, mannitol - 4.397 mg, aspartame - 0.75 mg, mint flavor - 0.3 mg, sodium bicarbonate - 0.375 mg

Indications

symptomatic treatment of acute and chronic diarrhea (allergic, emotional, medicinal, radiation genesis, with a change in diet and the qualitative composition of food, with metabolic and absorption disorders)

as an adjunct drug for infectious diarrhea

for the regulation of stool in patients with ileostomy.

Contraindications

children under 6 years old

acute dysentery, which is characterized by bloody stools and high fever

ulcerative colitis in the acute phase

bacterial enterocolitis caused by pathogenic microorganisms, incl.

Salmonella spp., Shigella spp.

and Campylobacter spp.)

pseudomembranous colitis associated with taking broad-spectrum antibiotics

in cases where slowing down of peristalsis is undesirable due to the possible risk of serious complications, incl.

intestinal obstruction, megacolon and toxic megacolon

phenylketonuria

I trimester of pregnancy

lactation period (breastfeeding)

hypersensitivity to loperamide and / or other components of the drug.

With caution, the drug should be prescribed to patients with impaired liver function due to slowed presystemic metabolism.

INN / Active ingredient

loperamide

Storage conditions and periods

At a temperature of 15-30 degrees.

Expiration date: 5 years

Specifications

Category

Preparations for the gastrointestinal tract

,

Diarrhea

Scope of the medicinal product

Gastrointestinal tract

Release form

Tablet

Manufacturer country

Great Britain

Package quantity, pcs

ten

Scope of application

Gastroenterology

Minimum age from

6 years

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Brand name

Imodium

The amount of the dosage form in the primary package

10 pieces.

Primary packaging type

Blister

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Antidiarrheal agent

Anatomical and therapeutic characteristics

A07DA03 Loperamide

Dosage form

Lyophilisate tablets

The target audience

Children

Expiration date in days

1825

Dosage (volume) of the substance in the preparation

2 mg

Package weight, g

ten

Mode of application

:

Inside. The tablet is put on the tongue, within a few seconds it dissolves, after which it is swallowed with saliva without drinking water. < br> < br> Adults, including the elderly, and children over 6 years old: < br> < br> Acute diarrhea (diarrhea): initial dose - 2 tablets (4 mg) for adults and 1 tablet (2 mg) for children, then take 1 tablet (2 mg) after each act of defecation in case of loose stools. < br> < br> Chronic diarrhea (diarrhea): initial dose - 2 tablets (4 mg) per day for adults and 1 tablet (2 mg) for children this dose is then usually individually adjusted so that the stool frequency is 1-2 times a day, which is usually achieved with a maintenance dose of 1 to 6 tablets per day. < br> < br> Maximum daily dose.For acute and chronic diarrhea (diarrhea) in adults - 8 tablets (16 mg) in children, the maximum daily dose is calculated based on body weight (3 tablets per 20 kg of the child's body weight - up to 8 tablets (16 mg)). < br> < br> When normal stool appears or in the absence of stool for more than 12 hours, the drug is canceled.

Information on technical characteristics, delivery set, country of manufacture