Universal reference book for medicines
Name of the preparation: IMODIUM ® (IMODIUM ® )

Active substance: loperamide

Type: An antidiarrhoeal symptomatic drug

Manufacturer: JOHNSON & JOHNSON (Russia) manufactured by CATALENT UK SWINDON ZYDIS (UK) issuing quality control and serial production of JANSSEN-CILAG (Italy)
? Tablets are lyophilized white or almost white in color, round.
1 tab.

loperamide hydrochloride 2 mg

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

6 pcs.
- blisters (1) - packs of cardboard.
10 pieces.
- blisters (1) - packs of cardboard.
10 pieces.
- blisters (2) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2014.

PHARMACHOLOGIC EFFECT

Antidiarrhoeal drug.
Loperamide, by binding to opioid receptors in the intestinal wall, inhibits the release of acetylcholine and prostaglandins, thereby reducing peristalsis and increasing the transit time of the contents through the intestine. Increases the tone of the anal sphincter, thereby reducing the incontinence of stool and the urge to defecate.
PHARMACOKINETICS

Suction

After taking the drug, the absorption of loperamide is 40%.

Distribution

Binding to plasma proteins is about 95%, mainly with albumins.

Metabolism

It is subjected to intensive metabolism in the process of oxidative N-demethylation at the "first passage" through the liver.

Excretion

T 1/2 is an average of 10.8 hours (9 to 14 hours).
It is excreted mainly with feces. A small part is excreted in the urine in the form of conjugated metabolites.
INDICATIONS

acute and chronic diarrhea;

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

DOSING MODE

The drug is used inside.

In acute diarrhea, adults and elderly patients: the initial dose is 4 mg, then - 2 mg after each act of defecation in the case of a loose stool.
Children older than 6 years: the initial dose of 2 mg, then - 2 mg after each act of defecation in the case of a loose stool.
In chronic diarrhea, adults and elderly patients are prescribed an initial dose of 4 mg / day.
Then the dose is adjusted so that the stool frequency is 1-2 times / day, which is usually achieved with a maintenance dose of 2-12 mg / day. Children older than 6 years are prescribed in an initial dose of 2 mg / day. Then the dose is adjusted so that the stool frequency is 1-2 times / day, which is usually achieved with a maintenance dose of 2-12 mg / day.
The maximum daily dose for acute and chronic diarrhea in adults is 16 mg;
in children - 6 mg per 20 kg body weight - up to 16 mg.
When a normal chair appears or if there is no stool for more than 12 hours, the drug is canceled.

The tablet for resorption should be put on the tongue.
Within a few seconds, it dissolves on the surface of the tongue and it can be swallowed with saliva without water.
SIDE EFFECT

From the digestive system: constipation and / or bloating, intestinal colic, pain or discomfort in the abdomen, nausea, vomiting, dry mouth;
very rarely - intestinal obstruction.
From the central nervous system and peripheral nervous system: fatigue, drowsiness, dizziness.

Allergic reactions: skin rash.

Other: there may be a burning sensation or tingling of the tongue, which occurs immediately after taking the drug in the form of tablets for resorption;
rarely - urine retention.
CONTRAINDICATIONS

- Acute dysentery and other infections of the gastrointestinal tract (caused, including Salmonella spp., Shigella spp., Campylobacter spp.);

- intestinal obstruction (including if necessary to avoid suppression of peristalsis);

- diverticulosis;

acute ulcerative colitis;

- pseudomembranous enterocolitis (diarrhea caused by taking antibiotics);

- I trimester of pregnancy;

- lactation period (breastfeeding);

- children's age till 6 years;

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

With caution should prescribe the drug for liver failure.

PREGNANCY AND LACTATION

Imodium ® is contraindicated in the first trimester of pregnancy.

Although there is no indication of a teratogenic or embryotoxic effect, Imodium ® can be given in the II and III trimesters of pregnancy only in cases where the intended benefit of therapy for the mother exceeds the potential risk to the fetus.

Because small amounts of the drug can penetrate into breast milk, taking resorption tablets is contraindicated during breastfeeding.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution should prescribe the drug for liver failure.
Patients with a dysfunction of the liver should be carefully monitored for the timely detection of signs of toxic CNS damage.
APPLICATION FOR CHILDREN

Contraindicated in children under 6 years.

APPLICATION IN ELDERLY PATIENTS

The application is possible according to the dosing regimen.

SPECIAL INSTRUCTIONS

The drug should be stopped immediately if constipation or bloating develops.

Since the treatment of diarrhea by Imodium is only symptomatic, along with this it is necessary, if possible, to use etiotropic drugs.

In diarrhea, especially in children, hypovolemia and a decrease in the electrolyte content may occur.
In such cases, the most important is replacement therapy to replenish fluid and electrolytes.
In acute diarrhea, if there is no clinical improvement within 48 hours, Imodium intake should be discontinued and the infectious genesis of diarrhea should be excluded.

Do not use for diarrhea with an admixture of blood in the stool and high fever.

Patients with AIDS should immediately stop treatment at the first sign of bloating.
In some cases, in patients with AIDS with infectious colitis, both viral and bacterial in the treatment with Imodium, toxic expansion of the large intestine may develop.
Patients with a dysfunction of the liver should be carefully monitored in order to identify signs of toxic damage in a timely manner.

During the treatment period, it is recommended that the diet be followed and the fluid replenished.

It should be borne in mind that the tablets for resorption are quite fragile, so to avoid damage they can not be pushed through the foil.
In order to get a tablet from the blister, it is necessary to take the foil by the edge, completely remove it from the hole in which the tablet is placed, and gently pushing from below, take the tablet out of the package.
Impact on the ability to drive vehicles and manage mechanisms

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

OVERDOSE

Symptoms: CNS depression - stupor, coordination disorders, drowsiness, miosis, increased muscle tone, respiratory depression, intestinal obstruction.
Children are more sensitive to the effects on the central nervous system.
Treatment: gastric lavage, the appointment of activated charcoal (no later than 3 hours after taking Imodium), IVL.
The antidote is naloxone. Because the duration of Imodium's action is greater than that of naloxone (1-3 hours), it may be necessary to re-designate the latter. To identify possible oppression of the central nervous system, the patient should be under close supervision, at least for 48 hours.
DRUG INTERACTION

The drug interaction of Imodium ® was not noted.

TERMS OF RELEASE FROM PHARMACY

The drug is approved for use as a means of OTC.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of the reach of children at a temperature of 15 ° to 30 ° C.
Shelf life - 5 years.
The information is provided for your information, do not self-medicate, it is dangerous for your health.

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