Superilop (Capsules) Instructions for Use

Marketing Authorization Holder

Panacea Biotec, Ltd. (India)

ATC Code

A07DA03 (Loperamide)

Active Substance

Loperamide (Rec.INN registered by WHO)

Dosage Form

Superilop

Capsules 2 mg: 20 pcs.

Dosage Form, Packaging, and Composition

10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.

Clinical-Pharmacological Group

Symptomatic antidiarrheal drug

Pharmacotherapeutic Group

Antidiarrheal agent

Pharmacological Action

Antidiarrheal agent. Reduces the tone and motility of the intestinal smooth muscle, apparently by binding to opioid receptors in the intestinal wall. Inhibits the release of acetylcholine and prostaglandins, reducing peristalsis and increasing the transit time of contents through the intestine.

Increases the tone of the anal sphincter. The effect occurs quickly and lasts for 4-6 hours.

Pharmacokinetics

After oral administration, the absorption of loperamide is about 40%; it undergoes intensive metabolism during the “first pass” through the liver. A small amount of unchanged loperamide enters the systemic circulation. Does not cross the blood-brain barrier.

Metabolized in the liver.

T_1/2 is 9-14 hours. Excreted in the bile with feces in the form of conjugated metabolites; a small part is excreted in the urine.

Indications

Symptomatic treatment of acute and chronic diarrhea of various origins (including allergic, emotional, drug-induced, radiation-induced; with changes in diet and food quality, with impaired metabolism and absorption; as an adjuvant for diarrhea of infectious origin). Regulation of stool in patients with ileostomy.

ICD codes

Dosage Regimen

For adults with acute diarrhea, the initial dose is 4 mg, then – 2 mg after each bowel movement in case of loose stools. For chronic diarrhea, the initial dose is 2 mg, the maintenance dose is selected so that the frequency of stool is 1-2 times per day (2-12 mg/day).

The maximum daily dose for adults is 12 mg.

For children aged 4-8 years – 1 mg 3-4 times/day for 3 days; 9-12 years – 2 mg 4 times/day for 5 days.

Adverse Reactions

From the digestive system: abdominal pain, bloating, nausea, constipation, dry mouth.

From the CNS: increased fatigue, drowsiness, dizziness.

Allergic reactions: skin rash.

Contraindications

Intestinal obstruction; constipation, abdominal distension, subileus, acute dysentery (as monotherapy), acute ulcerative colitis, pseudomembranous colitis caused by the use of broad-spectrum antibiotics; children under 4 years of age, first trimester of pregnancy, hypersensitivity to loperamide.

Use in Pregnancy and Lactation

Contraindicated in the first trimester of pregnancy. In the second and third trimesters of pregnancy, Loperamide can be prescribed in cases where the expected benefit of therapy for the mother outweighs the potential risk to the fetus.

Since a small amount of loperamide is detected in breast milk, use during breastfeeding is not recommended.

Use in Hepatic Impairment

Use with caution in patients with impaired liver function, with hepatic insufficiency.

Pediatric Use

Contraindicated in children under 4 years of age.

Special Precautions

Use with caution in hepatic insufficiency.

Should not be used in clinical situations where inhibition of intestinal peristalsis is required.

If there is no effect after 2 days of using loperamide, it is necessary to clarify the diagnosis and exclude the infectious origin of diarrhea.

Use with caution in patients with impaired liver function.

In case of loperamide overdose, naloxone is used as an antidote.

Drug Interactions

It is believed that cholestyramine may reduce the effectiveness of loperamide when used concomitantly.

When used concomitantly with co-trimoxazole, ritonavir, the bioavailability of loperamide increases, which is due to inhibition of its metabolism during the “first pass” through the liver.

In case of loperamide overdose, naloxone is used as an antidote.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.