Imodium Plus
Active material: Loperamide, Simethicone
When ATH: A07DA53
CCF: Symptomatic antidiarrheal drug
ICD-10 codes (testimony): K52, K59.1
When CSF: 11.07.03.02
Manufacturer: JOHNSON & JOHNSON LTD (Russia)
Pharmaceutical form, composition and packaging
◊ Chewable Tablets white, round, flat, Engraved “IMO” on one side, vanilla and mint.
| 1 tab. | |
| loperamide hydrochloride | 2 mg |
| simethicone | 125 mg |
Excipients: sucrose, microcrystalline cellulose, polymethacrylate, cellulose acetate, sorbitol, dekstratы (hydrated), vanilla-mint flavor (natural and synthetic), sodium saccharin, stearic acid, calcium phosphate.
4 PC. – blisters (1) – packs cardboard.
6 PC. – blisters (2) – packs cardboard.
Pharmacological action
Antidiarrheal medication.
Loperamide binds to opioid receptors in the gut wall, which leads to inhibition of propulsive motility, enhance the resorption of water and electrolytes. Loperamide does not change the physiological intestinal microflora and increases the tone of the anal sphincter.
Simethicone is an inert surface-active compound. It has a defoaming action, and thus relieves the symptoms, associated diarrhea (flatulence, abdominal discomfort, cramping).
Imodium® Plus does not have a central action.
Pharmacokinetics
Absorption
Loperamide is well absorbed from the gut. Simethicone is not absorbed from the gastrointestinal tract.
Metabolism
Loperamide undergoes effect “first pass”, thus almost completely metabolized in the liver and excreted in the bile in the form of conjugated metabolites. Due to intensive metabolism in the blood plasma concentration of the unchanged loperamide very low.
Deduction
T1/2 loperamide averages 10.8 no (range from 9 to 14 no). The metabolites are excreted in the feces of loperamide.
Testimony
- Diarrhea of any etiology, and its accompanying symptoms (flatulence, abdominal discomfort, cramping).
Dosage regimen
The drug is prescribed adults and children over 12 years at an initial dose 2 tab., further – by 1 tab. after each loose stool. The maximum daily dose – 4 tab. The duration of the – no more 2 d.
In applying the drug in elderly patients dose adjustment is required.
In applying the drug in patients with impaired renal function a dose reduction is not required.
Side effect
Below listed side effects is classified as follows: Often (>10%), often (>1%, but <10%), infrequently (>0.1%, but <1%), rarely (>0.01%, but <0.1%), rarely (<0.01%), including isolated cases.
Allergic reactions: rarely – skin rash, hives, itch; in a few cases – angioedema, bullous rash (incl. Stevens-Johnson syndrome), erythema multiforme, toxic epidermal necrolysis, anaphylactic shock, anaphylactoid reactions.
From the digestive system: rarely – distortion of taste, abdominal pain, nausea, constipation, abdominal distention, vomiting, dispespiya, ileus, megacolon (including the option of toxic flow).
With the genitourinary system: in a few cases – urinary retention.
CNS: rarely – dizziness; in a few cases – drowsiness.
Reports of adverse reactions in clinical studies and post-marketing loperamide for diarrhea syndrome characterized (dry mouth, abdominal pain, abdominal discomfort, nausea, vomiting, constipation, abdominal distention, fatigue, drowsiness, dizziness). Therefore, to establish a reliable association between the drug and the above symptoms is quite difficult.
Contraindications
- Ostraya dysentery, which is characterized by bloody diarrhea, or fever (as monotherapy);
- Bacterial enterocolitis, вызванный Salmonella spp., Shigella spp., Campylobacter spp.;
- Severe ulcerative colitis;
- Psevdomembranoznыy colitis, due antibiotiokoterapiey;
- Children up to age 12 years;
- Hypersensitivity to the drug.
Pregnancy and lactation
The use Imodium® Plus during pregnancy (especially in the I trimester) possible if strict indications.
Small amounts of loperamide passes into breast milk. Therefore it is not recommended to apply the drug during breast-feeding.
There is currently no established teratogenic or fetotoxic effect of loperamide and simethicone.
Cautions
Precautions should be prescribed Imodium® Plus, patients with impaired liver function, tk. they slowed metabolism “first pass”. In these cases it is necessary to monitor changes in the health status of the patient.
Since treatment with Imodium® Plus symptomatic, should be carried out simultaneously etiotropic and rehydration therapy.
In the absence of clinical improvement during 48 h reception Imodium® Plus should be discontinued. The patient should be informed, that in this situation should consult a doctor.
Imodium® Plus is not recommended in cases, when to avoid the oppression of peristalsis.
If you have constipation and / or bloating in the treatment Imodium® Plus drug treatment should immediately stop.
Use in Pediatrics
The drug is not prescribed children under the age of 12 years.
Effects on ability to drive vehicles and management mechanisms
Imodium® Plus it does not affect the rate of mental and physical reactions. However, patients, who after taking the drug are marked drowsiness, fatigue or dizziness, We should refrain from driving and working with potentially dangerous machinery.
Overdose
It includes overdose, due to impaired liver function.
Symptoms: CNS depression (stupor, dystaxia, drowsiness, mioz, increase in muscle tone, respiratory depression) and paralytic ileus. Children CNS depression may occur more frequently, than in adults.
Treatment: Antidote – Naloxone. Since loperamide has a longer duration of action, Cem naloxone (1-3 no), may require additional naloxone. To detect possible CNS depression necessary to monitor the patient during 48 no.
Drug Interactions
Except for preparations, having similar pharmacological action, by reason of mutual reinforcement effects, interaction with other drugs is not established.
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 – 3 year.
