Composition, form of production and packaging
? Capsules hard gelatinous, with the case of gray color and a dark green lid; the contents of the capsules are a homogeneous white powder.
1 caps.
loperamide hydrochloride 2 mg
Excipients: lactose monohydrate - 127 mg, corn starch - 40 mg, talc - 9 mg, magnesium stearate - 2 mg.
The composition of the hard gelatin capsule body: gelatin - 28.33 mg, iron (III) oxide black (E172) - 0.12 mg, titanium dioxide - 0.35 mg.
The composition of the lid of a hard gelatin capsule: gelatin - 18.68 mg, iron (III) oxide yellow (E131) - 0.23 mg, dye blue (E131) - 0.03 mg, iron (III) oxide black (E172) - 0.068 mg, titanium dioxide (E171 ) - 0.192 mg.
10 pieces. - blisters (1) - cardboard boxes.
10 pieces. - blisters (2) - cardboard boxes.
10 pieces. - blisters (3) - cardboard boxes.
10 pieces. - blisters (5) - cardboard boxes.
? Tablets are white or almost white, round, convex on the one hand, with a risk on the other hand, the surface of the tablet is chamfered to the risk.
1 tab.
loperamide hydrochloride 2 mg
Excipients: lactose monohydrate - 88.15 mg, calcium hydrophosphate dihydrate - 46 mg, corn starch - 8 mg, sodium starch glycolate - 3.5 mg, silicon dioxide colloid - 0.6 mg, magnesium stearate - 1.75 mg.
10 pieces. - blisters (1) - cardboard boxes.
10 pieces. - blisters (2) - cardboard boxes.
10 pieces. - blisters (3) - cardboard boxes.
10 pieces. - blisters (5) - cardboard boxes.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2013.
PHARMACHOLOGIC EFFECT
Antidiarrheal symptomatic drug.
Linking to the opioid receptors of the intestinal wall, loperamide reduces the tone and motility of the smooth muscles of the intestine. Slows down the peristalsis and increases the transit time of intestinal contents. Increases the tone of the anal sphincter. Promotes retention of fecal masses and reduced urge to defecate.
The action comes quickly and lasts for 4-6 hours.
PHARMACOKINETICS
Suction
Absorption of loperamide - 40%. The time to reach C max is 2.5 h.
Distribution
Binding to plasma proteins - 97%. Does not penetrate the BBB.
Metabolism
Almost completely metabolized in the liver by conjugation.
Excretion
It is excreted mainly with bile and urine. T 1/2 is 9-14 hours.
INDICATIONS
- symptomatic treatment of acute and chronic diarrhea of ​​allergic, emotional, medicinal and radiation genesis;
- diarrhea with a change in diet, quality of food, impaired absorption and metabolism;
- as an aid for diarrhea of ​​infectious genesis;
- regulation of stool in patients with ileostomy.
DOSING MODE
The drug should be taken orally, tablets and capsules swallowed, without chewing, squeezed 100 ml of water.
Adults with acute and chronic diarrhea are prescribed initially 4 mg, then 2 mg after each act of defecation in the case of a loose stool. The maximum daily dose is 16 mg.
Children over 6 years of age are prescribed 2 mg after each act of defecation in the case of a loose stool. The maximum daily dose is 6 mg.
After normalization of the stool or in the absence of stool for more than 12 hours, treatment should be discontinued.
SIDE EFFECT
On the part of the digestive system: gastralgia, dry mouth, nausea, vomiting, intestinal colic, constipation; very rarely - intestinal obstruction.
From the side of the central nervous system: drowsiness or insomnia, dizziness, headache.
Allergic reactions: skin rash.
CONTRAINDICATIONS
- diverticulosis;
- intestinal obstruction;
- ulcerative colitis in the acute stage;
- diarrhea against a background of acute pseudomembranous enterocolitis;
- in the form of monotherapy in dysentery and other gastrointestinal infections;
- I trimester of pregnancy;
- lactation period;
- children's age till 6 years;
- Hypersensitivity to the components of the drug.
Caution should be used in patients with liver failure.
PREGNANCY AND LACTATION
The drug is contraindicated in the first trimester of pregnancy and lactation.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Caution should be used in patients with liver failure. In patients with impaired liver function, careful monitoring of signs of toxic CNS damage is necessary.
APPLICATION FOR CHILDREN
Contraindicated in children under 6 years. Children over 6 years of age are prescribed 2 mg after each act of defecation in the case of a loose stool. The maximum daily dose is 6 mg.
SPECIAL INSTRUCTIONS
If there is no effect after 2 days of Lopedium В®, it is necessary to clarify the diagnosis and exclude the infectious genesis of diarrhea.
If the treatment develops constipation or bloating, the drug should be discarded.
In patients with impaired liver function, careful monitoring of signs of toxic CNS damage is necessary.
During the treatment period it is necessary to replenish the loss of fluid and electrolytes.
Each tablet or capsule of the drug Lediumum В® corresponds to 0.01 XE.
Impact on the ability to drive vehicles and manage mechanisms
In case of drowsiness or dizziness, you should refrain from driving and handling machinery.
OVERDOSE
Symptoms: CNS depression (stupor, coordination disorder, drowsiness, miosis, muscle hypertonia, respiratory depression), intestinal obstruction.
Treatment: antidote - naloxone. Since loperamide has a longer duration of action than naloxone, it is possible to re-administer the latter. Conduct symptomatic therapy (activated charcoal, gastric lavage, ventilation). It is necessary to observe the patient for at least 48 hours.
DRUG INTERACTION
Clinically significant interaction of loperamide with other drugs has not been established.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of no higher than 25 В° C. Shelf life - 5 years.
