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Bisacodyl (Tablets) Instructions for Use

ATC Code

A06AB02 (Bisacodyl)

Active Substance

Bisacodyl (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Laxative drug that stimulates intestinal peristalsis

Pharmacotherapeutic Group

Laxative

Pharmacological Action

Laxative. It irritates the receptor apparatus of the intestine, has a direct effect on the intestinal mucosa, enhancing its peristalsis and increasing mucus secretion in the large intestine.

The effect occurs after 6 hours when taken orally, and after 8-12 hours when taken before bedtime.

Pharmacokinetics

It is not absorbed in the intestine. It is a prodrug; hydrolysis occurs in an alkaline environment with the formation of a metabolite that has an irritating effect on the gastrointestinal mucosa.

Indications

  • Hypotonic and atonic constipation (including constipation in the elderly; constipation after surgery and childbirth);
  • Regulation of bowel movements (hemorrhoids, proctitis, anal fissures);
  • Preparation for surgical operations, instrumental and X-ray examinations.

ICD codes

ICD-10 code Indication
K59.0 Constipation
K60 Fissure and fistula of anus and rectum
K62.8 Other specified diseases of anus and rectum (including proctitis)
K64 Hemorrhoids and perianal venous thrombosis
Z51.4 Preparatory procedures for subsequent treatment or examination, not elsewhere classified
ICD-11 code Indication
DB32.1 Slow-transit constipation
DB50.Z Fissure or fistula of anal region, unspecified
DB6Z Hemorrhoids or perianal venous diseases, unspecified
DB70.Z Infections of anal and rectal regions, unspecified
DB72.Z Some specified diseases of the anal canal, unspecified
DD91.1 Functional constipation
DE2Z Diseases of the digestive system, unspecified
EG61 Infections of the anus or perianal skin
QB9A Preparatory procedures for subsequent treatment

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Tablets

Tablets are taken orally once a day before bedtime or 30 minutes before breakfast.

For adults and children over 14 years old, the drug is prescribed 1-3 tablets (5-15 mg) per dose.

For children aged 8-14 years – 1-2 tablets (5-10 mg), for children aged 3 to 7 years – 1 tablet (5 mg).

For preparation for surgical operations, instrumental and X-ray examinations, 2 tablets are prescribed at night one day before the examination and 2 tablets at night on the eve of the operation or examination.

Tablets should be swallowed whole, without breaking, without chewing, with a small amount of water.

Adverse Reactions

Possible: intestinal colic, diarrhea (dehydration, water-electrolyte imbalance, muscle weakness, cramps, decreased blood pressure), abdominal pain, flatulence, allergic reactions.

Contraindications

  • Intestinal obstruction;
  • Incarcerated hernia;
  • Acute inflammatory diseases of the abdominal organs;
  • Abdominal pain of unclear origin;
  • Gastroenteritis;
  • Appendicitis;
  • Peritonitis;
  • Gastrointestinal bleeding;
  • Metrorrhagia;
  • Cystitis;
  • Spastic constipation;
  • Acute proctitis;
  • Acute hemorrhoids;
  • Children under 3 years of age.
  • Hypersensitivity.

With caution pregnancy, lactation period, hepatic and/or renal failure.

Use in Pregnancy and Lactation

With caution: pregnancy, lactation period.

Use in Hepatic Impairment

With caution hepatic failure.

Use in Renal Impairment

With caution renal failure.

Pediatric Use

For children aged 8-14 years – 1-2 tablets (5-10 mg), for children aged 3 to 7 years – 1 tablet (5 mg).

For children under 3 years old, the drug is contraindicated.

Special Precautions

Bisacodyl should not be prescribed for the treatment of chronic constipation for a long time (more than 10 days).

If rectal bleeding begins during the use of bisacodyl, the patient should be advised to stop taking the drug.

As a result of using the drug, purple discoloration of urine and feces is possible.

Overdose

Symptoms diarrhea, dehydration, water-electrolyte imbalance, hypokalemia, atony of the colon.

Treatment symptomatic.

Drug Interactions

Concomitant use with antacids may lead to premature dissolution of its coating and irritation of the stomach and duodenum.

It is not recommended to take simultaneously with milk and alkaline mineral water.

Storage Conditions

Store in a dry, light-protected place, at a temperature from 15°C (59°F) to 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Hemofarm, A.D. (Serbia)

Manufactured By

Hemofarm, A.D. (Serbia)

Or

Hemofarm, LLC (Bosnia and Herzegovina)

Packaging and Quality Control Release

HEMOFARM, A.D. (Serbia)

Dosage Form

Bottle OTC Icon Bisacodyl-Hemofarm Enteric-coated tablets, 5 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated tablets yellow, round, on the cross-section, a core of almost white color and a yellow coating are visible.

1 tab.
Bisacodyl 5 mg

Excipients : lactose monohydrate – 23.677 mg, corn starch, povidone K25, sodium carboxymethyl starch, colloidal silicon dioxide, magnesium stearate.

Composition of the enteric coating methacrylic acid and methyl methacrylate copolymer (1:2), macrogol 6000, talc.
Composition of the sugar coating sucrose – 22.36 mg, acacia gum, macrogol 6000, talc, quinoline yellow dye (E104), titanium dioxide (E171).

10 pcs. – blisters (3) – cardboard packs.

Marketing Authorization Holder

FP Obolenskoe, JSC (Russia)

Dosage Form

Bottle OTC Icon Bisacodyl-OBL Enteric film-coated tablets, 5 mg: 10, 20, 30, 40, 60, or 80 pcs.

Dosage Form, Packaging, and Composition

Enteric film-coated tablets yellow, round, biconvex; on the cross-section, two layers are visible: a core of white or almost white color and a yellow coating.

1 tab.
Bisacodyl 5 mg

Excipients : lactose monohydrate, potato starch, sucrose (sugar), pregelatinized starch, hypromellose (hydroxypropylcellulose), calcium stearate.

Coating composition methacrylic acid and ethyl acrylate copolymer (1:1) (Kollicoat MAE 100P), povidone K30, polysorbate 80 (Tween 80), simethicone, macrogol 6000 (polyethylene glycol 6000), yellow iron oxide dye, talc, titanium dioxide.

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
20 pcs. – contour cell packaging (1) – cardboard packs.
20 pcs. – contour cell packaging (2) – cardboard packs.
20 pcs. – contour cell packaging (3) – cardboard packs.
20 pcs. – contour cell packaging (4) – cardboard packs.

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