IMODIUM
Active material: Loperamide
When ATH: A07DA03
CCF: Symptomatic antidiarrheal drug
ICD-10 codes (testimony): K52, K59.1, K91.4
When CSF: 11.07.03.02
Manufacturer: JOHNSON & JOHNSON LTD (Russia)
Pharmaceutical form, composition and packaging
◊ Lozenges white or nearly white, round, Lyophilized.
| 1 tab. | |
| loperamide hydrochloride | 2 mg |
Excipients: gelatin, mannitol, Aspartame, mint flavor, natriya carbonate.
6 PC. – blisters (1) – packs cardboard.
10 PC. – blisters (1) – packs cardboard.
Pharmacological action
Antidiarrheal medication. Loperamide, binding to opioid receptors in the gut wall, inhibits release of acetylcholine and prostaglandins, thereby reducing peristalsis and increasing the time of the contents of the intestines. Increases tone of the anal sphincter, reducing stool incontinence and urge to defecate.
Pharmacokinetics
Absorption
After oral administration absorption of loperamide 40%.
Distribution
Plasma protein binding – about 95%, mostly to albumin.
Metabolism
Subjected to intensive metabolism in the process of oxidative N-demethylation at “first pass” through the liver.
Deduction
T1/2 averages 10.8 no (from 9 to 14 no). It writes mainly in the faeces. A small part is excreted in urine as conjugated metabolites.
Testimony
- Acute and chronic diarrhea;
- For the purpose of regulation of the chair in patients with iliostoma.
Dosage regimen
The drug is prescribed inside.
At acute diarrhea adults and elderly patients administered in an initial dose of 4 mg, further – by 2 mg after each act of defecation in the case of loose stool. Children over 6 years administered in an initial dose of 2 mg, further – by 2 mg after each act of defecation in the case of loose stool.
At chronic diarrhea adults and elderly patients administered in an initial dose of 4 mg / day. Further, the dose is adjusted so, to stool frequency was 1-2 times / day, which is usually achieved with a maintenance dose of 2-12 mg / day. Children over 6 years administered in an initial dose of 2 mg / day. Further, the dose is adjusted so, to stool frequency was 1-2 times / day, which is usually achieved with a maintenance dose of 2-12 mg / day.
The maximum daily dose acute and chronic diarrhea in Adult – 16 mg; in children – 6 mg 20 kg body weight – to 16 mg.
When a normal chair or no chair more 12 h drug overturned.
Lozenge should be placed on the tongue. Within seconds, it is dissolved at the tongue and can be swallowed with saliva, not drinking water.
Side effect
From the digestive system: constipation and / or bloating, kišečnaâ how, pain or discomfort in the abdomen, nausea, vomiting, dry mouth; rarely – ileus.
From the central and peripheral nervous system: fatiguability, drowsiness, dizziness.
Allergic reactions: skin rash.
Other: perhaps a burning sensation or tingling tongue, occurs immediately after administration of the drug in the form of lozenges; rarely – urinary retention.
Contraindications
- Acute dysentery and other gastrointestinal infections (caused, incl. Salmonella spp., Shigella spp., Campylobacter spp.);
- Bowel obstruction (incl. if necessary, to avoid suppression of peristalsis);
- Diverticulosis;
- Severe ulcerative colitis;
- Pseudomembranous enterocolitis (diarrhea, caused by taking antibiotics);
- I trimester of pregnancy;
- Lactation (breast-feeding);
- Children up to age 6 years;
- Hypersensitivity to loperamide and / or other components of the drug.
FROM caution should be prescribed the drug for liver failure.
Pregnancy and lactation
Imodium® contraindicated in the I trimester of pregnancy.
Although there is no indication of teratogenic or fetotoxic effects, in the second and third trimesters of pregnancy Imodium® It can be administered only in cases, when the anticipated benefits of therapy to the mother outweighs the potential risk to the fetus.
Loperamide in small amounts excreted in breast milk, therefore, if necessary, use during lactation should stop breastfeeding.
Cautions
The drug must be stopped immediately, if developing constipation or bloating.
Since the diarrhea treatment Imodium® It is only symptomatic, along with this necessary, possibly, apply etiotropic funds.
When diarrhea, especially in children, hypovolemia may occur and the reduction of electrolytes. In such cases, the most important is the replacement therapy to replenish fluids and electrolytes.
In acute diarrhea, if during 48 h not observed clinical improvement, Imodium reception® should stop and eliminate the diarrhea of infectious origin.
Do not use with diarrhea mixed with blood in the stool and high fever.
AIDS patients should immediately discontinue treatment at the first signs of bloating. In some cases, patients with AIDS virus like infectious colitis, and in the treatment of bacterial Imodium® may develop toxic colon expansion.
Patients with impaired liver function should be closely monitored for timely detection of signs of CNS toxicity.
In the period of treatment to diet and fluid replacement.
It will be appreciated, that lozenges rather fragile, Therefore, to avoid damage to them can not push through the foil. For, to get the pill from the blister foil is necessary to take the edge, completely remove it from the hole, which is a tablet, and gently push the bottom, remove from the package the tablet.
Effects on ability to drive vehicles and management mechanisms
In the period of treatment should refrain from driving and transport activities potentially hazardous activities, require high concentration and speed of psychomotor reactions.
Overdose
Symptoms: CNS depression – stupor, incoordination, drowsiness, mioz, increased muscle tone, respiratory depression, ileus. Children are more sensitive to the effects on the central nervous system.
Treatment: gastric lavage, appointment of activated carbon (no later than 3 h after administration of Imodium®), IVL, symptomatic therapy. Antidote – Naloxone. Unnecessarily. the duration of Imodium® better, than naloxone (1-3 no), It may require the reappointment of the last. To detect possible CNS depression the patient should be monitored carefully, at least, during 48 no.
Drug Interactions
Drug drug interactions Imodium® not observed.
Conditions of supply of pharmacies
The drug is resolved to application as an agent Valium holidays.
Conditions and terms
The drug should be stored out of reach of children at temperature from 15 ° to 30 ° C. Shelf life – 5 years.
