Composition, form of production and packaging
? Capsules 1 caps.
loperamide hydrochloride 2 mg
10 pieces. - packings of cellular contour (1) - packs cardboard.
10 pieces. - packings cellular planimetric (2) - packs cardboard.
10 pieces. - packings cellular planimetric (3) - packs cardboard.
7 pcs. - packings of cellular contour (1) - packs cardboard.
7 pcs. - packings cellular planimetric (2) - packs cardboard.
7 pcs. - packings cellular planimetric (3) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2012.
PHARMACHOLOGIC EFFECT
Linking to the opioid receptors of the intestinal wall (stimulation of choline and adrenergic neurons through guanine nucleotides), reduces tone and motility of the smooth muscles of the intestine, slows the passage of the contents of the intestine, reduces the release of fluid and electrolytes with feces. Increases the tone of the anal sphincter, promotes retention of fecal masses and reduced urge to defecate. The action comes quickly and lasts 4-6 hours.
PHARMACOKINETICS
Absorption - 40%. The connection with plasma proteins (mainly with albumins) is 97%. The half-life is 9-14 hours. It penetrates badly through the blood-brain barrier.Almost completely metabolized in the liver by conjugation. It is excreted mainly by the intestine, a small part - by the kidneys (in the form of conjugated metabolites).
INDICATIONS
- symptomatic treatment of acute (allergic, emotional, drug, radiation) and chronic (with irritable bowel syndrome) diarrhea;
- regulation of stool in patients with ileostomy.
As an auxiliary drug:
Diarrhea of ​​infectious genesis.
DOSING MODE
Inside. Adults with acute and chronic diarrhea are orally prescribed 2 capsules (4 mg), then 1 capsule (2 mg) after each act of defecation in the case of a loose stool.In chronic diarrhea, the dose is then adjusted so that the stool frequency is 1-2 times / day, which is usually achieved with a maintenance dose of 2-4 capsules (4-8 mg / day.
The maximum daily dose is 8 capsules (16 mg). In the absence of effect after taking 16 mg / day for 10 days, continued admission is impractical.
Children older than 6 years are prescribed 1 capsule (2 mg) after each act of defecation in the case of a loose stool. The maximum daily dose is 3 capsules (6 mg).
After normalization of the stool or in the absence of stool for 12 hours, treatment with loperamide should be discontinued.
Patients with renal insufficiency , as well as elderly patients, do not need correction of the dosing regimen.
SIDE EFFECT
Allergic reactions: skin rash, itching, angioedema, in some cases - erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis.
On the part of the digestive system: dryness of the oral mucosa, pain or discomfort in the abdomen, nausea, vomiting, constipation, bloating, intestinal colic, in some cases - intestinal obstruction.
From the central nervous system and peripheral nervous system: fatigue, drowsiness, dizziness.
Other: retention of urine.
CONTRAINDICATIONS
- hypersensitivity to the drug;
- diverticulosis;
- intestinal obstruction;
- ulcerative colitis in the acute stage;
- diarrhea against a background of acute pseudomembranous enterocolitis;
- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
- Pregnancy (I trimester);
- lactation period;
- Loperamide in capsules is not prescribed for children under 6 years of age;
- in the form of monotherapy - dysentery and other infections of the gastrointestinal tract.
With caution: liver failure.
PREGNANCY AND LACTATION
Contraindicated in pregnancy (I trimester) and during lactation.
APPLICATION FOR FUNCTIONS OF THE LIVER
Patients with renal insufficiency correction of the dosing regimen is not required.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With caution: liver failure.
APPLICATION FOR CHILDREN
Loperamide in capsules is not prescribed for children under 6 years.
Children older than 6 years are prescribed 1 capsule (2 mg) after each act of defecation in the case of a loose stool. The maximum daily dose is 3 capsules (6 mg).
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APPLICATION IN ELDERLY PATIENTS
Elderly patients do not need to adjust the dosage regimen.
SPECIAL INSTRUCTIONS
If there is no effect after 2 days of using loperamide, you should consult a doctor. If the treatment develop constipation or bloating, loperamide should be discarded. In patients with impaired liver function, careful monitoring of signs of toxic lesion of the central nervous system (stupor, impaired coordination of movements, drowsiness, miosis, muscle hypertonia, respiratory depression, fatigue, drowsiness, dizziness) is necessary.
Treatment with loperamide does not replace the correction of the water-electrolyte balance, which develops with diarrhea. During the treatment of diarrhea (especially in children) it is necessary to replenish the loss of fluid and electrolytes. Dehydration may contribute to a change in the response to loperamide.
In some cases, in patients with AIDS with infectious colitis, both viral and bacterial in nature, with the treatment with loperamide, toxic expansion of the colon can develop.
Impact on the ability to drive vehicles and manage mechanisms
During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
OVERDOSE
Symptoms: depression of the central nervous system (stupor, impaired coordination, drowsiness, miosis, muscle hypertension, respiratory depression, intestinal obstruction.
Treatment: antidote - naloxone; Considering that the duration of action of loperamide is greater than that of naloxone, it is possible to re-introduce the latter.Symptomatic treatment: activated charcoal, gastric lavage, artificial ventilation. Medical observation is necessary for at least 48 hours.
DRUG INTERACTION
Simultaneous administration of loperamide (in a dose of 16 mg) with drugs inhibitors of P-glycoproteins (quinidine, ritonavir) leads to an increase in the concentration of loperamide in blood plasma by 2-3 times. Inhibitors of P-glycoprotein can enhance the action of loperamide on the CNS.
With simultaneous application of 16 mg of loperamide and 600 mg of saquinavir, loperamide reduces the clinical efficacy of saquinavir.
TERMS OF RELEASE FROM PHARMACY
Without recipe.
TERMS AND CONDITIONS OF STORAGE
Keep out of the reach of children, dry, protected from light, at a temperature of no higher than 25 В° C.
Shelf life - 3 years.
