Loperamide STADA - instructions for use, doses, side effects, contraindications

ExcipientsLactose (milk sugar) - 72.0 mg potato starch - 25.0 mg Calcium stearate - 1.0 mg; hard gelatin capsules (gelatin, silica, titanium quinoline yellow dye, colorant azorubin, patent blue dye, the dye Brilliant Black, methyl parahydroxybenzoate, propyl parahydroxybenzoate).

Description:Capsules of green color № 3. Contents of capsules - a powder of white or white with a yellowish shade of color.

Pharmacotherapeutic group:Antidiarrhoeic remedy

ATX: & nbsp

A.07.D.A Drugs that reduce the peristalsis of the digestive tract

A.07.D.A.03 Loperamide

Pharmacodynamics:

By binding to opioid receptors of the intestinal wall (stimulation of cholinergic and adrenergic neurons via guanine nucleotides) and reduces the tonus of the smooth muscle of the intestine motility, slow passage of the intestinal contents and reduces fluid and electrolyte excretion in faeces. 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 %. Connection with plasma proteins (mainly with albumins) - 97 %. The half-life is 9-14 hours. It penetrates badly through the blood-brain barrier. It is 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. As an adjuvant - with diarrhea of infectious genesis. Regulation of stool in patients with ileostomy.

Contraindications:

Hypersensitivity to the drug, diverticulosis, intestinal obstruction, ulcerative colitis in the acute stage, diarrhea on the background of acute pseudomembranous enterocolitis, in the form of monotherapy - dysentery and other infections of the gastrointestinal tract; deficiency of lactase, lactose intolerance, glucose-galactose malabsorption; pregnancy (I trimester), lactation period, loperamide capsules are not prescribed for children under 6 years.

Carefully:Liver failure.

Dosing and Administration:

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 per day, which is usually achieved with a maintenance dose of 2-4 capsules (4-8 mg) per day.

The maximum daily dose is 8 capsules (16 mg). In the absence of effect after taking 16 mg per day for 10 days continued reception 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 effects:

Allergic reactions: skin rash, itching, angioedema, in some cases - erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis.

Co the sides of the digestive system: dryness of the oral mucosa, pain or discomfort in the abdomen, nausea, vomiting, constipation, abdominal distention, intestinal colic, in some cases - intestinal obstruction.

From the side of the central nervous system and the peripheral nervous system: fatigue, drowsiness, dizziness.

Other: retention of urine.

Overdose:

Symptoms: oppression 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 carbon, gastric lavage, artificial ventilation. Medical observation is necessary for at least 48 hours.

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 central nervous system.

With the simultaneous use of 16 mg loperamide and 600 mg saquinavir loperamide reduces the clinical efficacy of saquinavir.

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 canceled.

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 can contribute to changing the response to loperamide.

In some cases, in patients with AIDS with infectious colitis, both viral and bacterial in the treatment with loperamide, toxic expansion of the colon can develop.

Effect on the ability to drive transp. cf. and fur:During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Capsules 2 mg.

Packaging:

10 capsules in a planar cell packaging made of polyvinylchloride film and aluminum foil.

1, 2 or 3 contour mesh packages together with instructions for use in a pack of cardboard.

Storage conditions:

In a dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:P N002271 / 01

Date of registration:21.04.2008 / 24.09.2014

Expiration Date:Unlimited

The owner of the registration certificate:NIZHFARM, JSC NIZHFARM, JSC Russia

Manufacturer: & nbsp

HEMOFARM, LLC Russia

SKOPINSKY FARM ZAVOD, ZAO Russia

Representation: & nbspNizhpharm, JSCNizhpharm, JSCRussia

Information update date: & nbsp02.04.2018

Illustrated instructions

Instructions

Loperamide STADA (Loperamide STADA)