Imodium plus - instructions for use, dose, side effects, contraindications

Active substanceLoperamide + SimethiconeLoperamide + Simethicone

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pills inwards

Dosage form: & nbspchewing tablets

Composition:

Active substance (per 1 tablet): loperamide hydrochloride 2 mg, simethicone (in an amount equivalent to polydimethylsiloxane) 125 mg.

Excipients (per 1 tablet): sucrose 52.2 mg, microcrystalline cellulose 5.8 mg, polymethacrylate 4.57 mg, cellulose acetate (acetyl content 40%) 6.86 mg, sorbitol 300 mg, dehydrated hydrated 641.7 mg, naturally -Synthetic flavor "Vanilla-mint" 17 mg, sodium saccharinate 0.4 mg, stearic acid 3 mg, calcium phosphate 130 mg.

Description:

White steep flat tablets with engraving "IMO "on the one hand, with the smell of vanilla and mint.

Pharmacotherapeutic group:Antidiarrhoeic remedy

ATX: & nbsp

A.07.D.A.53 Loperamide in combination with other drugs

A.07.D.A Drugs that reduce the peristalsis of the digestive tract

Pharmacodynamics:

Loperamide binds to opioid receptors in the intestinal wall, which leads to inhibition of propulsive peristalsis, increased intestinal transit time and increased resorption of water and electrolytes. Loperamide does not change the physiological microflora of the intestine and increases the tone of the anal sphincter. Imodium® Plus does not have a central effect. Simethicone It is not absorbed in the intestines, but loperamide, absorbed, is subjected to intensive metabolism in the liver after the first passage. As a result, a very small amount of loperamide enters the systemic bloodstream.

Simethicone is an inert surface-active compound with defoaming properties, and therefore facilitates the symptoms associated with diarrhea, in particular flatulence, abdominal discomfort and spasmodic pain.

Pharmacokinetics:

In humans, the half-life of loperamide is an average of 10.8 hours, varying from 9 to 14 hours. Loperamide is well absorbed from the intestine, but almost completely metabolized in the liver and then excreted with bile in the form of conjugated metabolites. Due to the intensive metabolism of the first passage in the plasma, very low concentrations of unaltered loperamide are present. Metabolites loperamida excreted mainly with feces. Simethicone generally not absorbed from the gastrointestinal tract.

Indications:Imodium® Plus is indicated for diarrhea of any etiology and associated symptoms. The latter are often caused by the removal of intestinal gases and include abdominal discomfort, spastic pain and flatulence.

Contraindications:

Imodium Plus can not be administered to children under 12 years of age and to patients with hypersensitivity (allergy) to any of the components of this drug.

Imodium® Plus can not be used as the main therapy for acute dysentery, which is characterized by a stool with an admixture of blood and high fever.

Imodium Plus should not be given to patients with acute ulcerative colitis or pseudomembranous colitis associated with broad-spectrum antibiotic treatment.

Imodium Plus can not be administered to patients with bacterial enterocolitis caused by microorganisms of the genus Salmonella, Shigella and Campylobacter.

Imodium® Plus does not follow apply in cases where slowing of peristalsis is undesirable because of the possible risk of serious complications, such as intestinal obstruction, megacolon or toxic megacolon.

Imodium Plus should be immediately discontinued if there is constipation, bloating, or intestinal obstruction.

Carefully:

Imodium® Plus should be used with caution in patients with severe impairment of liver function, because they have a slowed metabolism of the first pass.

Pregnancy and lactation:

Application during pregnancy

Currently, there is no evidence that loperamide or simethicone have teratogenic or embryotoxic effects. Imodium Plus, like other drugs, should not be taken during pregnancy, especially in the first trimester, without the presence of strong clinical indications.

Application, during lactation

A small amount of loperamide can penetrate into breast milk women, and therefore Imodium® Plus is not recommended during breastfeeding.

Dosing and Administration:

Adults and children over 12 years of age:

First 2 tablets, then 1 tablet after each liquid stool. A day can use no more than 4 tablets, the duration of taking tablets should not exceed 2 days.

Use in Pediatrics:

Imodium® Plus is not recommended for children under 12 years of age.

Use in elderly patients

In the treatment of elderly patients, dose adjustment is not required.

Use in patients with impaired renal function:

In the treatment of patients with impaired renal function, there is no need to reduce the dose of Imodium Plus.

Side effects:

According to clinical research

Hnegative reactions, observed in ≥1% of patients taking Imodium® Plus: nausea, a taste disorder.

Undesirable reactions, observed in <1% of patients taking Imodium® Plus: constipation, dry mouth, abdominal pain, flatulence, vomiting, rash, asthenia.

Undesirable reactions, observed in patients with loperamide monotherapy: headache, dizziness, discomfort and bloating, pain in the upper abdomen.

According to spontaneous reports of undesirable phenomena

The following are undesirable effects classified in the following way: highly frequent (≥ 10%), frequent (≥ 1%, but <10%), not frequent (≥ 0.1% but <1%), rare (≥ 0.01%, but <0.1%) and very rare (<0.01%), including individual cases.

Impaired immune system. Very rarely: reactions increased sensitivity, anaphylactic reactions, including anaphylactic shock and anaphylactoid reactions.

Violations from the nervous system. Rarely: dizziness. Very rare for loperamide: violation coordination, depression, hypertonus, loss of consciousness, drowsiness, stupor.

Disorders from the side of the organ of sight. Very rarely for loperamide: miosis.

Disorders from the gastrointestinal tract. Very rarely: bloating, indigestion. Highly rarely for loperamide: intestinal obstruction, including paralytic intestinal obstruction, megacolon, toxic megacolon.

Disturbances from the skin and subcutaneous tissues. Very rarely for loperamide: angioedema, itching, urticaria, bullous rash, including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis.

Disorders from the kidneys and urinary tract. Very rarely for loperamide: retention of urine.

General disorders and disorders at the site of administration. Very rare for Loperamide: fatigue.

In some cases, it is rather difficult to establish a causal relationship between the administration of loperamide and the onset of these symptoms. And also the frequency of occurrence of undesirable reactions in clinical studies may not reflect the frequency of occurrence in clinical practice.

Overdose:

Symptoms: In the case of an overdose (including an overdose due to impaired liver function), central nervous system depression (stupor, movement coordination disorder, drowsiness,miosis, increased muscle tone, respiratory depression) and paralytic obstruction of the intestine. In children, CNS depression may occur more often than in adults.

Treatment: If symptoms of an overdose occur, the patient should be administered as an antidote naloxone. Because the loperamide lasts longer than naloxone (from 1 to 3 h), it may be necessary to re-introduce naloxone. To identify possible oppression of the central nervous system, the patient should be carefully monitored for at least 48 h.

Interaction:

By preclinical research loperamide is an substrate of P-glycoprotein. With simultaneous application loperamide (once in a dose of 16 mg) and quinidine or ritonavir, which are inhibitors of P-glycoprotein, concentration Loperamide in blood plasma increases 2-3 times. The clinical significance of the described pharmacokinetic interaction with P-glycoprotein inhibitors when using loperamide in the recommended doses is unknown.

Simultaneous application loperamide (once in a dose of 4 mg) and itraconazole, an inhibitor CYP3A4 and P-glycoprotein, leads to an increase in plasma the concentration of loperamide is 3-4 times.In the same study, the use of an inhibitor CYP2C8, gemfibrozil, led to an increase concentration of loperamide in blood plasma in 2 times. The combination of itraconazole and gemfibrozil 4 times increased the peak concentration of loperamide in plasma and 13 times increased the total exposure in blood plasma. This increase was not associated with an effect on the central nervous system (CNS), the function of which was assessed by psychomotor tests (i.e., subjective assessment of drowsiness and the replacement test of digital symbols). Simultaneous use of loperamide (once in a dose of 16 mg) and ketoconazole, an inhibitor CYP3A4 and P-glycoprotein, led to a fivefold increase in the concentration of loperamide in blood plasma. This increase was not associated with an increase in the pharmacodynamic effect, estimated by the size of the pupil.

With simultaneous use with desmopressin, the concentration of desmopressin in the blood plasma increased by 3 times, probably because of motor deceleration gastrointestinal tract.

It is expected that drugs with similar pharmacological properties can enhance effects loperamide, and drugs that increase the rate of passage through the gastrointestinal tract, can reduce the effects of loperamide.

Because the simethicone Not absorbed from the gastrointestinal tract, the interaction of simethicone with other drugs is not expected.

Special instructions:

Since the treatment of diarrhea with Imodium® Plus only it is also necessary to carry out, where possible, therapy aimed at eliminating the cause of diarrhea. In patients with severe diarrhea, fluid and electrolyte loss may occur. In such cases it is necessary to carry out appropriate replacement therapy (fluid and electrolyte intake).

In the absence of clinical improvement within 48 hours of admission Imodium® Plus is necessary to cease. Patients should consult a doctor.

Patients fromabout AIDS, taking Imodium Plus, should stop therapy at the first sign of bloating. Received an isolated reports of intestinal obstruction with an increased risk of toxic megacolon in patients with AIDS and infectious colitis of viral and bacterial etiology, which was treated with loperamide.Although pharmacokinetic data in patients with hepatic In such patients, Imodium® Plus should be used with caution because of reduced metabolism, when first passing through the liver. Patients with a dysfunction of the liver should be carefully monitored for the timely detection of signs of toxic CNS damage. Have Patients with severe impairment of liver function Imodium Plus should only be used under medical supervision.

If the medicine has become unusable or the expiration date has expired, do not throw it into the waste water and into the street! Place Drug the package and put it in the trash. These measures will help protect the environment!

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

In the treatment of diarrhea with Imodium® Plus, fatigue, dizziness, or drowsiness may occur. When these symptoms appear, patients should refrain from driving and working with machinery.

Form release / dosage:

Tablets chewing, 2 mg / 125 mg.

Packaging:

For 4 or 6 tablets in a blister pack Aclar® (trifluoroethylene) -PVC-aluminum foil.One blister for 4 tablets or two blisters for 6 tablets together with instructions for medical use in a pack of cardboard.

Storage conditions:

At a temperature of 15 to 30 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date stated on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N013430 / 01

Date of registration:06.05.2008 / 19.09.2016

Expiration Date:Unlimited

The owner of the registration certificate:Johnson & Johnson, LLC Johnson & Johnson, LLC Russia

Manufacturer: & nbsp

JANSSEN-CILAG, S.p.A. Italy

Information update date: & nbsp07.11.2017

Illustrated instructions

Instructions

Imodium Plus (Imodium® plus)