Loperamide
Producer: CJSC FP OBOLENSKOYE Russia
Code of automatic telephone exchange: A07DA03
Release form: Firm dosage forms. Capsules.
General characteristics. Structure:
Active ingredient: 2 mg of loperamide of a hydrochloride in 1 capsule.
Excipients: starch corn, cellulose microcrystallic, magnesium stearate.
Gelatinous solid capsules (titanium dioxide, ferrous oxide black, yellow quinolinic, patent blue, diamond black, yellow sunset, gelatin).
Pharmacological properties:
Pharmacodynamics. Reduces a tone and motility of smooth muscles of intestines, slows down an intestines contents passage, reduces release of liquid and electrolytes with excrements. Raises a tone of a proctal sphincter. Action comes quickly and 4-6 hours proceed.
Pharmacokinetics. Absorption – 40%. Communication with proteins of plasma – 97%. An elimination half-life – 9-14 h. Does not get through a blood-brain barrier. It is almost completely metabolized in a liver by conjugation. It is removed preferential with bile and kidneys.
Indications to use:
Symptomatic treatment of acute and chronic diarrhea of various genesis (allergic, emotional, medicinal, beam; at change of a diet and qualitative structure of food, at disturbance of metabolism and absorption; as supportive application at diarrhea of infectious genesis).
Regulation of a chair at patients from ileostomy.
Route of administration and doses:
Inside. Adult at acute and chronic diarrhea originally appoint 2 capsules (4 mg), then on 1 capsule (2 mg) after each act of defecation in case of a liquid chair. The maximum daily dose – 8 capsules (16 mg).
To children 6 years are more senior appoint on 1 capsule (2 mg) after each act of defecation in case of a liquid chair. The maximum daily dose – 3 capsules (6 mg).
After normalization of a chair or in the absence of a chair more than 12 hours treatment by Loperamide should be stopped.
Features of use:
In the absence of effect after 2 days of use of Loperamide it is necessary to specify the diagnosis and to exclude infectious genesis of diarrhea.
Side effects:
Headache; a gastralgia, dryness in a mouth, allergic reactions (skin rash), drowsiness or sleeplessness, dizziness, intestinal colic, nausea, vomiting, a lock. Extremely seldom – intestinal impassability.
Contraindications:
Hypersensitivity to drug, a divertuculosis, intestinal impassability, ulcer colitis in an aggravation stage, diarrhea against the background of an acute pseudomembranous coloenteritis, in the form of monotherapy - dysentery and other infections of digestive tract; pregnancy (the I trimester), the lactation period, loperamide in capsules are not appointed to children up to 6 years.
With care – a liver failure.
Overdose:
Symptoms: oppression of the central nervous system (stupor, lack of coordination, drowsiness, miosis, muscular hypertension, respiratory depression), intestinal impassability.
Treatment: an antidote – Naloxonum; considering that duration of effect of loperamide is more, than at Naloxonum, perhaps repeated introduction of the last. Symptomatic treatment: absorbent carbon, gastric lavage, artificial ventilation of the lungs.
Medical observation, at least, within 48 hours is necessary.
Storage conditions:
In the dry, protected from light place, at a temperature not over 25 ºС. To store in the place, unavailable to children. A period of validity - 3 years. Not to apply after the expiry date specified on packaging.
Issue conditions:
Without recipe
Packaging:
Capsules of 2 mg. On 10 or 20 capsules in a blister strip packaging from a film of the polyvinyl chloride and printing aluminum foil varnished. On 1, 2 or 3 blister strip packagings together with the application instruction place in a pack from a cardboard.