Lopedium
Producer: Hexal AG (Geksal AG) Germany
Code of automatic telephone exchange: A07DA03
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active agent: loperamide a hydrochloride – 2 mg.
Excipients:
Tablets: lactoses monohydrate, hydrophosphate calcium a dihydrate, starch corn, sodium of starch glikolit, silicon dioxide colloid, magnesium stearate.
Capsules: lactoses monohydrate, starch corn, talc, magnesium stearate.
Pharmacological properties:
Contacting opioid receptors of an intestinal wall, reduces a tone and motility of smooth muscles of intestines. Slows down a peristaltics and increases time of passing of intestinal contents. Raises a tone of a proctal sphincter. Promotes deduction of fecal masses and an urezheniye of desires to defecation. Action comes quickly and 4-6 hours proceed.
Pharmacokinetics. Absorption – 40%. Time of achievement of the maximum concentration 2,5 hours. 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, tablets and capsules to swallow without chewing, washing down 100 ml of water. The adult at acute and chronic diarrhea originally appoint 4 mg, then on 2 mg after each act of defecation in case of a liquid chair. The maximum daily dose – 16 mg.
To children 6 years are more senior appoint 2 mg after each act of defecation in case of a liquid chair. The maximum daily dose – 6 mg.
After normalization of a chair or in the absence of a chair more than 12 hours treatment should be stopped.
Features of use:
In the absence of effect after 2 days of use of Lopedium it is necessary to specify the diagnosis and to exclude infectious genesis of diarrhea.
If at treatment the lock or abdominal distention develops, drug should be cancelled.
At patients with an abnormal liver function careful control of signs of toxic damage of the central nervous system is necessary.
During treatment it is necessary to make up for loss of liquid and electrolytes.
In case of drowsiness or dizziness it is necessary to refrain from control of vehicles and work with mechanisms.
Each tablet or the capsule corresponds 0,01 bread. piece.
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.
Interaction with other medicines:
It is not established clinically significant interactions of loperamide with other medicines.
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 (I trimester), lactation period. Loperamide in capsules and tablets is 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, muscle hyper tone, 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:
At a temperature not above 25 °C, in the place, unavailable to children.
Issue conditions:
Without recipe
Packaging:
On 10 tablets or capsules in blisters (PVC/aluminium or software/aluminium).
On 1, 2, 3 or 5 blisters together with the application instruction in a cardboard pack.