Stoperan (loperamide) hard capsules 2 mg. №8

Description

Stoperan (loperamide) hard capsules 2 mg. №8

Composition

active substance: loperamide;

1 capsule contains loperamide hydrochloride 2 mg;

Excipients: lactose monohydrate, corn starch, talc, magnesium stearate; capsule: gelatin, quinoline yellow (E 104), erythrosine (E 127), patented blue V (E 131), titanium dioxide (E 171).

Dosage form

Hard capsules.

Main physical and chemical properties: hard gelatin capsules with a gray body and a blue cap.

Pharmacotherapeutic group

Antidiarrheal drugs; drugs used to treat infectious and inflammatory bowel diseases. Means that suppress peristalsis. Loperamide.
ATX code A07D A03.

Pharmacological properties

Loperamide hydrochloride binds to opiate intestinal wall receptors. As a result, the release of acetylcholine and prostaglandins is reduced, which reduces propulsive peristalsis and increases the time of passage of the contents through the digestive tract, as well as the ability of the intestinal wall to absorb fluid. Loperamide hydrochloride increases the tone of the anal sphincter, thereby reducing fecal incontinence and the urge to defecate.

Indication

Symptomatic treatment of acute diarrhea in adults and children over 12 years of age.

Symptomatic treatment of acute episodes of diarrhea due to irritable bowel syndrome (IBS) in adult patients after initial diagnosis by a physician.

Contraindication

Hypersensitivity to loperamide hydrochloride or to any of the components of the drug is known.
Children under 12 years.
Acute dysentery, characterized by the presence of blood in the stool and fever.
Acute ulcerative colitis or pseudomembranous colitis associated with the use of broad-spectrum antibiotics.
Bacterial enterocolitis caused by microorganisms of the families Salmonella, Shigella, Campylobacter.
Stoperan should not be used if peristalsis suppression is to be avoided due to the potential risk of significant complications, including intestinal obstruction, megacolon and toxic megacolon.

It is necessary to stop taking the drug immediately if you develop constipation, bloating or intestinal obstruction.

Do not use in patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency.

Use during pregnancy or breastfeeding

Pregnancy
The safety of the drug in human pregnancy has not been established, although animal studies do not indicate that loperamide hydrochloride has any teratogenic or embryotoxic properties.

As with all medicines, Stoperan is not recommended during pregnancy, especially during the first trimester of pregnancy.

Breastfeeding period
Because small amounts of loperamide may be excreted in human milk, the drug is not recommended during breast-feeding.

Therefore, pregnant and breastfeeding women should be advised to consult their physician for appropriate treatment.

Method of application and dosage

Stoperan is not intended for the initial treatment of severe diarrhea accompanied by decreased fluid and electrolyte levels. In particular, in children, it is desirable to compensate for this loss by prescribing replacement therapy parenterally or orally.

Capsules should be taken with liquid.

Symptomatic treatment of acute diarrhea in adults and children over 12 years of age

The initial dose is 2 capsules (4 mg), then 1 capsule (2 mg) is used after each subsequent liquid stool. The usual dose is 3-4 capsules (6-8 mg) per day. The maximum daily dose for acute diarrhea should not exceed 6 capsules (12 mg).

Symptomatic treatment of acute attacks of diarrhea caused by IBS in adults over 18 years of age after primary diagnosis by a physician

The initial dose is 2 capsules (4 mg), then take 1 capsule (2 mg) after each case of loose stools or according to previous doctor’s recommendations. The maximum daily dose should not exceed 6 capsules (12 mg).

In acute diarrhea, if no clinical improvement is observed within 48 hours, Stoperan should be discontinued.

Children

The drug should be used in children over 12 years of age for the symptomatic treatment of acute diarrhea.

Overdose

In case of overdose (including relative overdose due to liver dysfunction), CNS depression (stupor, incoordination, drowsiness, miosis, muscle tension, respiratory depression), constipation, urinary retention, and a complex of symptoms similar to intestinal obstruction may occur. Children and adult patients with hepatic impairment are more sensitive to the CNS due to the fact that their blood-brain barrier is not yet fully functional.

Side effects:

• From the nervous system: headache;
• From the digestive tract: constipation, bloating, nausea.