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.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
Loperamide, binding to 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 intestinal contents, 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 time required to reach C max is 2.5 h. The connection with plasma proteins is 97%. T 1/2 - 9-14 hours. It does not penetrate the blood-brain barrier. Almost completely metabolized in the liver by conjugation. Excreted mainly by the intestine; a small part is excreted by the kidneys (in the form of conjugated metabolites).
INDICATIONS
Symptomatic treatment of acute and chronic diarrhea of ​​various genesis (allergic, emotional, drug, radiation: with a change in diet and quality of food, in violation of metabolism and absorption: as an auxiliary for diarrhea of ​​infectious genesis). Regulation of stool in patients with ileostomy.
DOSING MODE
Inside, not liquid, squeezed water.
Adults with acute and chronic diarrhea are initially assigned 2 capsules (0.004 g), then 1 capsule (0.002 g) after each act of defecation in the case of a loose stool. In acute diarrhea, children over 6 years of age are prescribed 1 capsule (0.002 g) after each act of defecation in the case of a loose stool.
The maximum daily dose. In acute and chronic diarrhea in adults - 8 capsules (0.016 g); in children - 3 capsules (0.006 g).
After normalization of the stool or in the absence of stool for more than 12 hours, treatment with Loperamide should be discontinued.
SIDE EFFECT
Allergic reactions (skin rash), drowsiness or insomnia, dizziness, hypovolemia, electrolyte disorders; dryness of the oral mucosa, intestinal colic, gastralgia, pain or discomfort in the abdomen, nausea, vomiting, flatulence.
Rarely - urinary retention, extremely rare - intestinal obstruction.
CONTRAINDICATIONS
Hypersensitivity to the drug, lactose intolerance, lactase deficiency or glucose-galactose malabsorption, diverticulosis, intestinal obstruction, ulcerative colitis in the acute stage, diarrhea on the background of acute pseudomembranous enterocolitis, as monotherapy - dysentery and other infections of the gastrointestinal tract;Pregnancy (I trimester), lactation period, loperamide in capsules is not prescribed for children under 6 years.
With caution . Liver failure.
PREGNANCY AND LACTATION
Contraindicated in the first trimester of pregnancy.
In the II and III trimesters of pregnancy Loperamide can be prescribed in cases where the expected benefit of therapy for the mother exceeds the potential risk to the fetus. Since a small amount of Loperamide is found in breast milk, taking it during breastfeeding is not recommended.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With caution: liver failure.
In patients with impaired liver function, careful monitoring of signs of toxic CNS damage is necessary.
APPLICATION FOR CHILDREN
Loperamide in capsules is not prescribed for children under 6 years.
SPECIAL INSTRUCTIONS
In the absence of effect after 2 days. Loperamide should be taken to 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 CNS damage is necessary.
During the treatment of diarrhea, it is necessary to replenish the loss of fluid and electrolytes.
During the treatment period, care must be taken when driving vehicles and engaging in other potentially dangerous activities that require an increased concentration of attention 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.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The preparation should be stored in a dry place, protected from light, out of reach of children, at a temperature not exceeding 25 В° РЎ.
Shelf life - 2 years. Do not use after the expiry date printed on the package.
