Catad_pgroup Antidiarrheals

Imodium lozenges - official instructions by application

Registration number

Trade name

Imodium ®

International nonproprietary name

loperamide

Chemical name– 4-N,N-dimethyl-2,2-diphenylbutanamide hydrochloride

Dosage form

lyophilized tablets

Composition (per tablet):

Active substance: loperamide hydrochloride 2 mg.
Excipients: gelatin 5.863 mg, mannitol 4.397 mg, aspartame 0.750 mg, mint flavor 0.300 mg, sodium bicarbonate 0.375 mg.

Description

White or off-white round lyophilized tablets.

Pharmacotherapeutic group

antidiarrheal agent

ATX code– A07DA03.

Pharmacological properties

Pharmacodynamics
Loperamide, by binding to opioid receptors in the intestinal wall, inhibits the release of acetylcholine and prostaglandins, thus slowing down peristalsis and increasing the transit time of contents through the intestines. Increases tone anal sphincter, thereby reducing fecal incontinence and the urge to defecate.
Pharmacokinetics
Most loperamide is absorbed in the intestine, but due to extensive first-pass metabolism, systemic bioavailability is approximately 0.3%.
Data up to clinical trials indicate that loperamide is a substrate of P-glycoprotein. The binding of loperamide to plasma proteins (mainly albumin) is 95%.
Loperamide is predominantly metabolized in the liver, conjugated and excreted in bile. Oxidative N-demethylation is the main route of metabolism of loperamide and is carried out primarily with the participation of an inhibitor of the CYP3A4 and CYP2C8 isoenzymes. Due to active first-pass metabolism, the concentration of unchanged loperamide in the blood plasma is negligible.
In humans, the half-life of loperamide averages 11 hours, ranging from 9 to 14 hours. Unchanged loperamide and its metabolites are excreted primarily in the feces.
Pharmacokinetic studies have not been conducted in children. The pharmacokinetics of loperamide and its interactions with other medicines will be similar to those in adults. Indications for use Symptomatic treatment acute and chronic diarrhea (origin: allergic, emotional, medicinal, radiation; with changes in diet and quality composition food, in case of metabolic and absorption disorders). As an adjuvant drug for diarrhea infectious origin. Regulation of bowel movements in patients with ileostomy.

Indications for use

Acute and chronic diarrhea
- regulation of stool in patients with ileostomy

Contraindications

Imodium ® lyophilized tablets should not be used in children under 6 years of age.
Imodium ® is contraindicated in patients with hypersensitivity to loperamide and/or any of the components of the drug, as well as in the first trimester of pregnancy.
Imodium ® is not recommended for use during breastfeeding.
Imodium ® lyophilized tablets are contraindicated in patients with phenylketonuria.
Imodium ® should not be used as primary therapy:
- in patients with acute dysentery, which is characterized by bloody stools and high temperature;
- in patients with ulcerative colitis in the acute stage;
- in patients with bacterial enterocolitis caused by pathogenic microorganisms, including Salmonella, Shigella and Campylobacter;
- in patients with pseudomembranous colitis associated with antibiotic therapy wide range actions.
Imodium ® should not be used in cases where slowing of peristalsis is undesirable due to possible risk development serious complications, including intestinal obstruction, megacolon and toxic megacolon. Imodium ® should be discontinued immediately if constipation, bloating or intestinal obstruction occurs.

With caution

Imodium ® should be used with caution in patients with impaired liver function due to slow first-pass metabolism.

Use during pregnancy and breastfeeding

Use during pregnancy
There is no evidence that loperamide has teratogenic or embryotoxic effects.
During the first trimester of pregnancy, taking Imodium ® is contraindicated.
During the II-III trimesters of pregnancy, the use of Imodium ® is possible only after consultation with your doctor. The drug can be used only if the expected benefit of therapy for the mother outweighs the potential risk to the fetus.
Use during breastfeeding
Small amounts of loperamide may penetrate into breast milk Therefore, Imodium ® is not recommended for use during breastfeeding.

Directions for use and doses

Inside. The tablet is placed on the tongue, it dissolves within a few seconds, after which it is swallowed with saliva, without washing down with water.
Adults and children over 6 years of age: Acute diarrhea: initial dose – 2 tablets (4 mg) for adults and 1 tablet (2 mg) for children, then 1 tablet (2 mg) after each act of defecation in case of loose stool.
Chronic diarrhea: initial dose – 2 tablets (4 mg) per day for adults and 1 tablet (2 mg) for children; then the initial dose should be adjusted so that the frequency normal stool was 1-2 times a day, which is usually achieved with a maintenance dose of 1 to 6 tablets (2-12 mg) per day.
Maximum daily dose should not exceed 6 tablets (12 mg); the maximum daily dose in children is calculated based on body weight (3 tablets per 20 kg of child’s body weight), but should not exceed 6 tablets (12 mg). When stool normalizes or if there is no stool for more than 12 hours, the drug is discontinued.
Use in children
Do not use Imodium ® in children under 6 years of age.
Use in elderly patients
When treating elderly patients, no dose adjustment is required.
Use in patients with impaired renal function
When treating patients with impaired renal function, no dose adjustment is required.
Use in patients with liver dysfunction
Although pharmacokinetic data in patients with liver failure are absent, in such patients Imodium ® should be used with caution due to slow first-pass metabolism (see section “Special Instructions”).

Directions for use

Since lyophilized tablets are quite fragile, they should not be pressed through the foil to avoid damage.
In order to remove a tablet from the blister, you must perform the following steps:
- take the foil by the edge and completely remove it from the cell in which the tablet is located;
- Gently press down from below and remove the tablet from the package.

Side effect

Adverse reactions- these are adverse events for which a causal relationship with the use of loperamide should be considered proven based on a comprehensive assessment of the available information about undesirable event. IN in some cases It is quite difficult to reliably establish a cause-and-effect relationship between taking loperamide and the occurrence of these symptoms. In addition, since clinical studies are conducted in different conditions, the incidence of adverse reactions in clinical trials of one drug cannot be directly compared with the incidence of adverse reactions in clinical trials of another drug and may not reflect the incidence of adverse reactions in clinical practice.
According to clinical studies
>1% of patients taking Imodium ® for acute diarrhea: headache, constipation, flatulence, nausea, vomiting.
Adverse reactions observed in<1 % пациентов, принимавших Имодиум ® при острой диарее: сонливость, головокружение, головная боль, сухость во рту, боль в животе, тошнота, рвота, запор, дискомфорт и вздутие живота, боль в верхних отделах живота, сыпь.
Adverse reactions observed in ≥1% of patients taking Imodium ® for chronic diarrhea: dizziness, flatulence, constipation, nausea.
Adverse reactions observed in<1 % пациентов, принимавших Имодиум ® при хронической диарее: головная боль, боль в животе, сухость во рту, дискомфорт в области живота, диспепсия.
Based on spontaneous reports of adverse reactions
The following adverse reactions were classified as follows: very often (≥10%), often(≥1%, but<10%), infrequently(≥0.1%, but<1%), rarely(≥0.01%, but<0,1%) и very rarely (<0,01%, включая единичные сообщения).
Immune system disorders. Very rare: hypersensitivity reactions, anaphylactic reactions, including anaphylactic shock, and amaphylactoid reactions.
Nervous system disorders. Very rare: loss of coordination, depression of consciousness, hypertonicity, loss of consciousness, drowsiness, stupor.
Violations of the organ of vision. Very rare: miosis.
Gastrointestinal disorders. Very rare: intestinal obstruction (including paralytic ileus), megacolon (including toxic megacolon), glossalgia.
Disorders of the skin and subcutaneous tissues. Very rare: angioedema, bullous rash, including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme, pruritus, urticaria.
Renal and urinary tract disorders. Very rare: urinary retention.
General disorders. Very rare: fatigue.

Overdose

Symptoms
In case of overdose (including relative overdose due to impaired liver function), urinary retention, paralytic intestinal obstruction, and signs of central nervous system (CNS) depression may occur: stupor, loss of coordination, drowsiness, miosis, muscle hypertonicity, respiratory depression. Children may be more sensitive to the CNS effects of loperamide than adults.
Therapy
If symptoms of overdose occur, naloxone can be used as an antidote. Because the duration of action of loperamide is longer than that of naloxone (1-3 hours), repeated administration of naloxone may be necessary. Therefore, it is necessary to carefully monitor the patient’s condition for at least 48 hours in order to timely detect signs of possible central nervous system depression.

Interaction with other drugs

According to preclinical studies, loperamide is a substrate of P-glycoprotein. With the simultaneous use of loperamide (single dose of 16 mg) and quinidine or ritonavir, which are P-glycoprotein inhibitors, the concentration of loperamide in the blood plasma increased by 2-3 times. The clinical significance of the described pharmacokinetic interaction with P-glycoprotein inhibitors when loperamide is used at recommended doses is unknown.
The simultaneous use of loperamide (single dose of 4 mg) and itraconazole, an inhibitor of the CYP3A4 isoenzyme and P-glycoprotein, led to an increase in the concentration of loperamide in the blood plasma by 3-4 times. In the same study, the use of the CYP2C8 isoenzyme inhibitor, gemfibrozil, led to an approximately 2-fold increase in plasma concentrations of loperamide. When using a combination of itraconazole and gemfibrozil, the peak plasma concentration of loperamide increased by 4 times and the total concentration by 13 times. This increase was not associated with CNS effects as assessed by psychomotor tests (i.e., subjective sleepiness rating and digit substitution test).
The simultaneous use of loperamide (single dose of 16 mg) and ketoconazole, an inhibitor of CYP3A4 and P-glycoprotein, led to a fivefold increase in the concentration of loperamide in the blood plasma. This increase was not associated with an increase in pharmacodynamic effect assessed by pupil size.
With simultaneous oral administration of desmopressin, the concentration of desmopressin in the blood plasma increased 3-fold, probably due to a slowdown in gastrointestinal motility.
It is expected that drugs with similar pharmacological properties may increase the effect of loperamide, and drugs that increase the rate of passage through the gastrointestinal tract may decrease the effect of loperamide.

Special instructions

Treatment of diarrhea with Imodium ® is symptomatic only. In cases where it is possible to establish the cause of diarrhea, appropriate therapy should be carried out.
In patients with diarrhea, especially children, loss of fluid and electrolytes may occur. In such cases, it is necessary to carry out appropriate replacement therapy (replenishment of fluid and electrolytes).
Imodium ® lyophilized tablets contain a source of phenylalanine. Use by patients with phenylketonuria is contraindicated.
If there is no effect after 2 days of treatment, it is necessary to stop taking the drug, clarify the diagnosis and exclude the infectious genesis of diarrhea. Patients with AIDS taking Imodium ® for the treatment of diarrhea should stop taking the drug at the first sign of bloating.
There have been isolated reports of constipation with an increased risk of developing toxic megacolon in patients with AIDS and infectious colitis of viral and bacterial etiology who were treated with loperamide.
Although there are no data on the pharmacokinetics of loperamide in patients with hepatic impairment, Imodium should be used with caution in such patients due to slow first-pass metabolism, as this can lead to relative overdose and toxic damage to the central nervous system.
If the medicine has become unusable or has expired, do not throw it into wastewater or onto the street! Place the medication in a bag and place it in the trash. These measures will help protect the environment!

Impact on the ability to drive vehicles and machinery

During treatment with Imodium ®, you should refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions, as the drug can cause dizziness and other side effects that may affect these abilities.

Release form

Primary packaging: 6 or 10 lozenges in an aluminum/aluminium blister. Secondary packaging: 1 blister (6 or 10 tablets each) or 2 blisters (10 tablets each) along with instructions for medical use in a cardboard box.

Best before date

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

Storage conditions

Store at temperatures from 15 to 30 °C.
Keep out of the reach of children.
Store in original packaging.

Vacation conditions

Over the counter.

Manufacturer

Manufacturer of the finished dosage form:
Catalent UK Swindon Zydis Limited, UK / Catalent UK Swindon Zydis Ltd, United Kingdom
Legal address:
Frankland Road, Blagrove, Swindon, Wiltshire, SN58RU, United Kingdom/Frankland Road, Blagrove, Swindon, Wiltshire, SN58RU, United Kingdom

Packaging and releasing quality control:
Janssen-Cilag S.p.A., Italy/ Janssen-Cilag S.p.A., Italy
Legal address:
Cologno Monzese (MI) – Via Michelangelo Buonarroti, 23, Italy/Cologno Monzese (province of Milan), st. Michelangelo Buonarroti, 23, Italy

Organization receiving complaints:
Johnson & Johnson LLC, Russia
121614, Moscow, st. Krylatskaya, 17, building 2

The drug Imodium's indications for use are laconic: caused by intestinal motility disorders and external irritants of a non-bacterial nature. But despite the apparent ease of use, this medicine cannot be used thoughtlessly.

What do Imodium tablets actually help with?

Stomach upset and diarrhea can occur for a variety of reasons. Imodium will effectively cope with diarrhea of ​​any origin, but this will not always benefit the patient. Let's find out why.

The main active ingredient in this drug is loperamide. It selectively acts on receptors of the intestinal mucosa, blocking some of them. As a result, motor functions weaken, the sphincter closes more tightly, the movement of feces slows down and mucus production stops. The effect has been achieved - the contents of the intestines no longer ask to be released. But diarrhea didn’t just start out of nowhere!

If the body is in a hurry to empty itself, it means it needs to get rid of some substances. The use of Imodium is justified in cases where diarrhea does not stop for a long time and the body continues to spew out water and waste products. In this case, diarrhea must be stopped urgently to avoid dehydration and other dangerous phenomena. Imodium will cope with this task better than any other product. If the situation is not so critical, it is better to choose an antidiarrheal drug from a number of enterosorbents or microbiotic drugs.

Imodium has the following indications for use:

• allergic diarrhea;
• diarrhea of ​​a neuro-emotional nature;
• diarrhea caused by certain medications and radiation therapy;
• upset stomach due to changes in climate, diet, water;
• ileostomy causing fecal incontinence.

How to use Imodium

For adults, the drug is indicated for use 2-3 times a day, 2 mg, that is, one capsule at a time. The maximum daily dose is 16 mg. In emergency cases, the first dose may include 4 mg of Imodium. Children are recommended to take 1-2 capsules per day, the maximum possible amount of the drug is 8 mg per day. Children under 6 years of age should only use Imodium under medical supervision. The dose should be selected strictly individually.

The drug begins to act within an hour after administration, the maximum effect is achieved after 2-3 hours. After 4 hours, Imodium is inhibited by the liver and kidneys and leaves the body in the urine. If you have used other antidiarrheals, the effect of the medicine may be completely unpredictable - prolonged or short-term. It is advisable to avoid such cases.

Contraindications to the use of Imodium

This medicine has quite a lot of contraindications. First of all, these include the following factors:

Also, the drug is not used in the treatment of children under 5 years of age and in the first trimester of pregnancy. Imodium can be used only by doctor's prescription for people with impaired kidney and liver function.

The drug Imodium-plus has no different indications for use and contraindications; the drug contains a component that reduces flatulence and relieves cramps. The only difference between Imodium and Imodium-plus is that the latter is somewhat easier to tolerate and eliminates the symptoms associated with diarrhea.

The composition of the drug includes as an active substance - . Additional capsule components: lactose, talc, corn starch, magnesium stearate. The capsule shell contains yellow iron oxide, titanium dioxide, erythrosine, black iron oxide, indigo carmine, gelatin.

Release form

The medicine is available in capsules and lozenges.

Pharmacological action

Pharmacodynamics and pharmacokinetics

The medicine works like antidiarrheal means. Its active substance is a synthetic selective inhibitor opioid receptors . It affects the cells of the intestinal walls. Release acetylcholine and in the gastrointestinal tract is blocked by affecting the functions cholinergic And adrenergic neurons.

After taking Imodium, an increase in the tone of the anal sphincter and rectum is observed. Feces are better retained, and the urge to defecate becomes less frequent. Intestinal motility decreases. The contents travel through the gastrointestinal tract longer.

The drug normalizes the amount of mucus in the intestinal lumen by reducing its secretion. It also improves the absorption of fluids and electrolytes from the gastrointestinal tract, reduces the likelihood of dehydration and problems with electrolyte balance, which often appear with diarrhea . The active substance reduces pain that can be caused by spasm of the smooth muscles of the intestinal wall.

The medicine is easily absorbed from the gastrointestinal tract. It works quickly. It is broken down in the liver and excreted mainly with bile and feces. Half-life is 9-14 hours. The systemic impact is negligible.

Indications for use of Imodium

Indications for the use of Imodium: the need for symptomatic therapy acute And chronic diarrhea . Recommended for use when traveler's diarrhea . In this case, the drug is used for two days. But whatever the indications for the use of Imodium, the use of this drug should be discontinued if bloody discharge appears in the stool until the cause is determined.

Contraindications

This medicine should not be used if hypersensitivity to its components. In addition, the following contraindications are known:

• acute (especially with blood in the stool and fever);
• pseudomembranous , caused by ;
• paralytic ileus and other diseases that are accompanied by impaired intestinal motility;
• lactose intolerance;
• acute ulcerative colitis ;
• bacterial enterocolitis ;

Prescribe with caution for liver dysfunction. Before using the drug, contraindications must be excluded.

Side effects

Adverse reactions may depend on the nature of the disease:

• Acute diarrhea: constipation , dry mouth, cramps and colic in the abdominal area,.
• Chronic diarrhea: constipation , nausea, pain in the stomach, colic and abdominal cramps, vomiting, bloating .

In addition, the following side effects are known:

• skin: skin rash;
• Gastrointestinal tract: megacolon , ;
• nervous system:, loss of consciousness, depression of consciousness;
• general disorders: severe hypersensitivity reactions, including anaphylactoid reactions ;
• urinary system: urinary retention.

In rare cases, it has been reported bullous rashes.

Interaction

Combination with blockers P-glycoproteins may lead to an increase in content loperamide at least 2-3 times. Loperamide ;

Loperamide Grindeks ;

Loperamide Hydrochloride ;

Stoperan ;

Imodium Lingual ;

Loperamide-Health .

All medications have their own application characteristics. Imodium analogues are not recommended for use without consulting a doctor. If the drug turns out to be ineffective, you need to contact a specialist before purchasing another replacement product.

The price of analogues, as a rule, is noticeably lower than the cost of Imodium.

Imodium for children

Only a specialist knows what the tablets will help with in each specific case and how to take them for children under 6 years of age, so they should be given under strict medical supervision.

Imodium for children over 6 years of age should be given in lower dosages than for adults. They are determined by a specialist individually.

It is not advisable to give Imodium to children under 6 years of age in capsule form.

Imodium during pregnancy and lactation

Imodium is prescribed with caution when. He doesn't provide teratogenic , embryotoxic And mutagenic influence on the fetus. During pregnancy, it may be prescribed if the expected benefit to the mother outweighs the possible risk to the child.

Cannot be used when If admission is necessary, discontinuation of breastfeeding should be considered.

In the life of each of us there is such an unpleasant and annoying, and in some cases very dangerous, condition as diarrhea. The modern human body is weakened by stress, poor environment, unhealthy diet, and uncontrolled use of medications. So the gastrointestinal tract reacts to these irritants accordingly - with nausea, vomiting, diarrhea.

To be able to quickly stop such undesirable conditions, it is important to have effective antidiarrheals in your home and car medicine cabinets.

The drug Imodium, the generic version of which is the domestic Loperamide, is very popular among the population of our country due to its affordable cost, high efficiency, availability in pharmacies and convenient release form. But before taking medicine for diarrhea, it is important to read the detailed instructions.

Instructions for use of the drug Imodium from the manufacturer contain detailed information on pharmacodynamics and pharmacokinetics. The drug, the key component of which is loperamide hydrochloride, has a powerful antidiarrheal effect. The active substance is a synthetic selective inhibitor that acts on opioid receptors, suppressing the release of acetylcholine and prostaglandin. At the same time, the physiological intestinal microflora remains unchanged. The following is observed quickly after taking the medicine:

• Decreased mucus secretion;
• increased tone of the walls of the rectum and sphincter;
• decreased peristalsis;
• reduction in the urge to defecate.

The rapid action of Imodium in capsules (many patients prefer to take lyophilized tablets) prevents such a dangerous condition as dehydration, which can quickly develop with frequent loose stools and vomiting. Patients who took Imodium for diarrhea also noted a decrease in pain caused by intestinal distress

The drug is actively absorbed by the intestinal walls. The breakdown of the active substance is carried out by the liver. Excretion of conjugated metabolites occurs in feces and urine.

Interaction

Imodium in capsules and lozenges should not be taken simultaneously with medications containing P-glycoprotein blockers or medications that have a depressant effect on the nervous system.

Attention! In order not to cause a serious blow to the liver and not to aggravate the condition of poisoning, it is strictly forbidden to combine Imodium and alcohol!

Composition and release form

The drug Imodium is available in capsules and lyophilized tablets with absolutely identical effects. Imodium lyophilized tablets and capsules contain: loperamide hydrochloride 2 mg, additional components (more details in the manufacturer's instructions)

The drug is supplied to the pharmacy chain in blisters packed in cardboard packs.

Indications

What can taking Imodium cure? We bring to your attention the basic list for using the medicine. Indications for use of Imodium are as follows:

• Diarrhea in acute and chronic form.
• Ileostomy.
• Traveler's diarrhea.

Important! If bloody inclusions are detected in the stool, the drug should be stopped!

Contraindications

The list of contraindications for taking the drug Imodium, indicated in the manufacturer's instructions, is quite extensive. First of all, it is important to immediately stop using the antidiarrheal medication if you are hypersensitive to any component of the composition. Among the contraindications, it is also worth noting the following pathological conditions:

• Acute dysentery.
• Acute ulcerative colitis.
• Intestinal obstruction.
• I trimester of pregnancy.
• Age up to 6 years.
• Constipation, etc.

Side effects

When taking Imodium anti-diarrhea tablets, patients may experience constipation, abdominal cramps, nausea, headache, drowsiness, flatulence, allergic reactions on the skin, etc. In rare cases, Quincke's edema and anaphylactic reactions develop.

Directions for use

The drug is available in pharmacies without a prescription, but before taking Imodium, it is advisable to consult a specialist and read reviews on thematic resources. At the beginning of the course of treatment, adults are prescribed 2 drops. (maximum - 8 per day), children and adolescents - 1 drop. (maximum – 3 per day per 20 kg of weight, no more than 8). Next, the dose is selected depending on the frequency of bowel movements. Taking the next dose of medication is indicated after each loose stool.

Imodium Plus instructions for use indicate that the tablet should be placed on the tongue, wait until the drug dissolves and swallow without drinking water.

The indication for completing the course of treatment for diarrhea using Imodium is the absence of loose stools for half a day.

What to do in case of overdose?

If the dosage of the drug Imodium is violated, patients may experience the following side effects:

• Pronounced symptoms of depression.
• Urinary retention.
• Signs of acute intestinal obstruction.
• Respiratory dysfunction.

Naloxone is often used as an antidote to loperamide hydrochloride (provided that no more than 3 hours have passed since taking Imodium). In case of mild overdose, symptomatic treatment at home is allowed. When identifying side effects of poisoning in children, it is important to immediately perform gastric lavage and force the child to take an effective enterosorbent.

If the dose is repeatedly exceeded and subsequent conditions occur, it is important to seek medical help as soon as possible. If breathing is impaired, artificial ventilation may be required. In a hospital setting, patients with an overdose of Imodium are observed for at least 2 days.

Special instructions for use

We have found out why and how to take Imodium; now we suggest that you familiarize yourself with the special instructions for using this antidiarrheal drug:

• The use of the drug in childhood should be done under the strict supervision of a physician. He also determines the correct dose of the medicine and gives recommendations for taking it.
• The use of Imodium in the treatment of diarrhea during lactation is unacceptable, since the active substance can pass into mother's milk and harm the baby.
• It is extremely important to stop taking the drug if bloating is detected in patients with AIDS.
• Lozenges are quite fragile; you should remove them from the blister as carefully as possible.
• During the treatment period, you should refrain from drinking alcohol and driving.

Terms of sale and storage

Imodium can be purchased at a pharmacy without a doctor's prescription, but to avoid negative consequences, you should consult with a specialist before starting to take capsules or tablets. In addition, only a doctor can recommend the most effective method of use.

It is recommended to store the medicine at room temperature, avoiding exposure of the packaging to direct sunlight, out of the reach of children. It is unacceptable to take Imodium after the expiration date (5 years from the date of manufacture)!

Latin name: Imodium
ATX code: A07D A03
Active ingredient: loperamide
Manufacturer: Janssen-Cilag
(Belgium, Italy, France)
Release from the pharmacy: Over the counter
Storage conditions: at t° 15-30°C
Best before date: 5 l.

Imodium is an antidiarrheal agent in capsules and sublingual tablets.

Directions for use

• Symptomatic treatment of acute or chronic diarrhea of ​​various origins
• Treatment of infectious diarrhea (as an additional drug)
• Regulation of bowel movements in patients with ileostomy.

Composition of the drug

Imodium capsules

• Active ingredient: 2 mg loperamide
• Additional ingredients: lactose monohydrate, corn starch, talc, E 171
• Capsule: gelatin, E 171, E 172 (black, red, yellow), E 132.

Medicines in the form of dense two-color capsules. The case is dark gray, with white JANSSEN markings. The cap is green or brown, with white markings in the form of the name of the drug Imodium. Filling: white powder mixture. The drug is packaged in blisters of 6 or 20 pieces. There is 1 plate in a cardboard pack along with an annotation.

Imodium is also available in the form of lozenges. Contains 2 mg loperamide.

Medicinal properties

The antidiarrheal effect of Imodium is achieved due to the presence of loperamide hydrochloride in its composition. The substance interacts with opioid nerve endings, suppressing the release of acetylcholine and prostaglandins. As a result, peristalsis is inhibited and the passage of intestinal contents through the digestive tract is prolonged.

Features of pharmacokinetics

A significant portion of loperamide is absorbed in the intestine, but then undergoes metabolism, resulting in its bioavailability becoming less than 1%.

Almost completely binds to plasma proteins.

It is biotransformed in the liver with the participation of isoenzymes of the P450 system and is excreted along with bile. The unchanged substance is excreted from the body along with feces.

The properties of loperamide on the children's body have not been studied. The mechanism of action is not expected to differ from adults.

Directions for use

How to take Imodium for diarrhea

Price of tablets: (6 pcs.) – 226 rubles, (10 pcs.) – 319 rubles, (20 pcs.) – 554 rubles. Price of capsules: (6 pcs.) – 226 rubles, (20 pcs.) – 432 rubles.

The drug should not be used for the initial treatment of severe diarrhea in which water and electrolyte levels are low. To eliminate the imbalance, replacement therapy using parenteral and oral medications is necessary.

Imodium should be taken in accordance with the dosage form of the drug: according to the instructions for use, capsules - whole, tablets - kept on the tongue until dissolved and then swallowed along with saliva.

Treatment regimen

If the disease manifests itself acutely, then at the beginning of treatment, adults need to take Imodium for diarrhea at a dosage of 4 mg, then take 2 mg for each episode of diarrhea. The daily maximum, which is not recommended to be exceeded, is 15 mg.

For chronic diarrhea, the daily dosage is 4 mg, if necessary, the maximum amount can be taken - 16 mg. The dosage must be titrated individually so as to achieve bowel movements 1-2 times a day.

Imodium for children

The drug in lyophilized tablets is recommended to be given to children 4-8 years old at a dosage of 1 mg, the frequency of administration is 3-4 times a day. The recommended course duration is 3 days. Children's Imodium for older patients (9-12 years) is given in the amount of 2 mg up to 4 times a day. Course – 5 days.

When bowel movements are normalized or there is no bowel movement for more than 12 hours, the drug should be discontinued.

If diarrhea continues during treatment with Imodium, you should consult a doctor to find out the reason why the drug does not help, and after clarifying the diagnosis, undergo appropriate therapy.

During pregnancy and breastfeeding

During pregnancy, you should not take medicine: in the first three months, the drug Imodium for diarrhea is strictly prohibited. In subsequent months, the drug may be prescribed, but only if the benefit to the mother clearly outweighs the risk of expected harm to the fetus.

Loperamide passes into human milk. For this reason, women who are breastfeeding should avoid taking Imodium.

Contraindications and precautions

Imodium should not be taken if:

• Hypersensitivity to constituent substances
• Intestinal obstruction, bloating
• Constipation
• Acute form of dysentery (as a monotherapy), accompanied by bloody stool and fever
• Acute form of ulcerative or pseudomembranous colitis due to antibiotics
• Bacterial enterocolitis caused by salmonella, shigella, campylobacter
• 1st trimester of pregnancy, lactation
• Congenital lactase deficiency, lactose intolerance, GG malabsorption
• Up to 4 years of age.

Imodium should be discontinued if it causes bloating, constipation or intestinal obstruction.

Caution during treatment with Imodium is required in patients with liver dysfunction.

Cross-drug interactions

There are reports that as a result of the interaction of loperamide with medications that have a similar depressant effect on the central nervous system, an increase in the suppressive effect occurs. For this reason, simultaneous use of such drugs should be avoided.

Preclinical studies of Imodium have shown that its active substance is a substrate of P-glycoprotein. If the drug is taken together with substance inhibitors, then the plasma concentration of loperamide increases.

It is assumed that if Imodium is combined with drugs of similar action, the effect of loperamide is enhanced, and when combined with medications that accelerate passage into the gastrointestinal tract, it is reduced.

Features of application

Imodium therapy is intended to relieve symptoms. It is necessary to diagnose the cause of diarrhea and prescribe appropriate treatment.

Children, elderly and weakened people may develop electrolyte imbalance. Drinking plenty of fluids and taking electrolytes will be required.

If the patient suffers from persistent diarrhea, the symptom may indicate serious illness, so the drug should not be used for a long time. It is necessary to establish the cause of the pathology and carry out appropriate therapy.

If there is no improvement in well-being for more than two days, then the drug should be discontinued and the patient should be further examined.

HIV patients taking Imodium should stop taking it immediately at the first sign of bloating to avoid toxic megacolon.

Patients with hepatic dysfunction should use drugs with caution so as not to provoke an overdose, which may result in toxic damage to the central nervous system.

Imodium should be used to neutralize attacks of acute diarrhea due to irritable bowel disease only if the diagnosis is confirmed by a doctor.

Side effects and overdose

After using Imodium, patients may develop undesirable reactions in the form of various disorders:

• NS: headaches, dizziness, coordination disorders, fainting, depression of consciousness, increased blood pressure, drowsiness
• Gastrointestinal tract: bloating, nausea, dry mouth, flatulence, pain/discomfort, vomiting, pain in the upper abdomen
• Dermis: skin rash, erythema malignant exudative, Lyell's syndrome
• Immune system: extremely rare - manifestations of sensitivity, anaphylaxis
• Vision: occasionally – miosis
• Kidneys: urinary retention
• Other: rapid fatigue.

Intoxication can develop both as a result of taking a large amount of the drug, and with liver dysfunction. An overdose is manifested by difficulty urinating, intestinal obstruction, and increased central nervous system disorders.

The consequences of intoxication must be eliminated with the help of an antidote - naloxone. The patient's condition should be monitored for at least 2 days, since the effect of loperamide is longer than that of naloxone, and an additional antidote may be required.

Analogues

"Obolenskoye" (RF)

Price:(10 capsules) – 29 rub., (12 tablets) – 103 rub.

Antidiarrheal drug containing loperamide. Used to eliminate diarrhea of ​​various origins. Recommended for the treatment of patients from 6 years of age.

Pros:

• Imodium analogue
• Cheap remedy.

Flaws:

• Side effects.