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Bisacodyl (Tablets, Suppositories) 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

Drugs for the treatment of constipation; contact laxatives

Pharmacological Action

A laxative agent, a derivative of diphenylmethane.

It increases mucus secretion in the colon and accelerates and enhances its peristalsis.

The action is due to direct stimulation of the nerve endings in the mucous membrane of the colon.

Pharmacokinetics

Bisacodyl is not absorbed from the gastrointestinal tract.

It is a prodrug; hydrolysis occurs in an alkaline environment, forming a substance that has an irritating effect on the gastrointestinal mucosa.

Indications

Constipation caused by hypotension and sluggish peristalsis of the colon (particularly in elderly patients; constipation after surgery, childbirth).

Regulation of stool in hemorrhoids, proctitis, anal fissures.

Preparation for surgical operations, instrumental and radiological 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
O99.6 Diseases of the digestive system complicating pregnancy, childbirth and the puerperium
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
JB64.6 Diseases of the digestive system complicating pregnancy, childbirth, or the puerperium
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.

For oral administration using tablets, swallow the tablet whole. Do not chew or crush. Take with a full glass of water. Do not take within one hour of consuming milk, antacids, or alkaline mineral water, as this may cause premature tablet disintegration.

The adult oral dose is 5 mg to 15 mg, taken once daily. For pre-operative or pre-examination bowel cleansing, the typical adult dose is 10 mg to 15 mg.

The pediatric oral dose for children 8 to 14 years is 10 mg once daily. For children 2 to 7 years, the dose is 5 mg once daily. Do not administer to children under 2 years of age.

Administer the oral dose once either at bedtime to produce a bowel movement the following morning, or in the morning 30 minutes before breakfast.

For rectal administration using suppositories, insert the suppository high into the rectum. The adult rectal dose is 10 mg, which may be increased to 20 mg if necessary. Use once daily.

The pediatric rectal dose for children 8 to 14 years is 10 mg once daily. For children 2 to 7 years, the dose is 5 mg once daily.

The duration of use should be short-term. Do not use for more than 7 consecutive days without medical supervision. Prolonged use can lead to laxative dependence and electrolyte imbalance.

If severe cramping, abdominal pain, or diarrhea occurs, discontinue use immediately and consult a physician. The desired effect is typically produced within 6 to 12 hours after an oral dose and within 15 to 60 minutes after a rectal dose.

Adverse Reactions

From the digestive system cramp-like abdominal pain, diarrhea (may lead to excessive loss of fluid and electrolytes and, consequently, the development of muscle weakness, cramps, arterial hypotension) are possible.

Contraindications

Intestinal obstruction, strangulated hernia, acute inflammatory diseases of the abdominal organs, abdominal pain of unclear origin, peritonitis, gastrointestinal bleeding, uterine bleeding, cystitis, spastic constipation, acute proctitis, acute hemorrhoids.

Use in Pregnancy and Lactation

Bisacodyl should be used with caution during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

Use with caution in patients with liver diseases.

Use in Renal Impairment

Use with caution in patients with kidney diseases.

Pediatric Use

Use is possible from 2 years of age according to the dosing regimen.

Special Precautions

Use with caution in patients with liver and kidney diseases.

Do not use for a long time.

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

Drug Interactions

With simultaneous use, a decrease in the plasma concentration of digoxin is possible.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°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.

Medical Disclaimer

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

Marketing Authorization Holder

Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)

Dosage Form

Bottle OTC Icon Bisacodyl-Akri® Tablets, enteric-coated, 5 mg: 30 or 40 pcs.

Dosage Form, Packaging, and Composition

Tablets, enteric-coated yellow, round, biconvex; the tablet core is white or almost white on the break.

1 tab.
Bisacodyl 5 mg

Excipients : Ludipress LCE [lactose monohydrate – 94.7-98.3%, povidone – 3-4%] – 123.7 mg, colloidal silicon dioxide – 0.65 mg, calcium stearate – 0.65 mg.

Shell composition: ready mixture “Acryl-Ease” yellow color (methacrylic acid and ethyl acrylate copolymer (1:1) – 40%, titanium dioxide – 12%, talc – 37.25%, triethyl citrate – 4.8%, colloidal anhydrous silicon dioxide – 1.25%, sodium bicarbonate – 1.2%, sodium lauryl sulfate – 0.5%, quinoline yellow dye – 2.92%, sunset yellow FCF dye – 0.08%) – 14.3 mg.

10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.

Marketing Authorization Holder

Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)

Dosage Form

Bottle OTC Icon Bisacodyl-Akri® Tablets, enteric-coated, 5 mg: 10, 20, 30 or 40 pcs.

Dosage Form, Packaging, and Composition

Tablets, coated 1 tab.
Bisacodyl 5 mg

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

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Bottle OTC Icon Bisacodyl Renewal Enteric film-coated tablets, 5 mg: 20, 28, or 30 pcs.

Dosage Form, Packaging, and Composition

Enteric film-coated tablets white or almost white, round, biconvex; surface roughness is allowed; the core is white or almost white on the cross-section.

1 tab.
Bisacodyl 5 mg

Excipients : lactose monohydrate, microcrystalline cellulose (MCC-101), potato starch, povidone K30, talc, calcium stearate.

Shell composition talc, methacrylic acid and ethyl acrylate copolymer (1:1), triethyl citrate, polysorbate 80 (tween 80), sodium lauryl sulfate.

10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
14 pcs. – contour cell packs (2) – cardboard packs.
15 pcs. – contour cell packs (2) – cardboard packs.

Marketing Authorization Holder

Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)

Dosage Form

Bottle OTC Icon Bisacodyl-Akrikhin Tablets, enteric-coated, 5 mg: 30 or 40 pcs.

Dosage Form, Packaging, and Composition

Tablets, enteric-coated yellow, round, biconvex; the tablet core is white or almost white on the break.

1 tab.
Bisacodyl 5 mg

Excipients : Ludipress LCE [lactose monohydrate – 94.7-98.3%, povidone – 3-4%] – 123.7 mg, colloidal silicon dioxide – 0.65 mg, calcium stearate – 0.65 mg.

Shell composition: ready mixture “Acryl-Ease” yellow color (methacrylic acid and ethyl acrylate copolymer (1:1) – 40%, titanium dioxide – 12%, talc – 37.25%, triethyl citrate – 4.8%, colloidal anhydrous silicon dioxide – 1.25%, sodium bicarbonate – 1.2%, sodium lauryl sulfate – 0.5%, quinoline yellow dye – 2.92%, sunset yellow FCF dye – 0.08%) – 14.3 mg.

10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.

Marketing Authorization Holder

Altpharm LLC (Russia)

Dosage Form

Bottle OTC Icon Bisacodyl-Altfarm Rectal suppositories 10 mg: 10 pcs.

Dosage Form, Packaging, and Composition

Rectal suppositories from white to white with a yellowish tint, torpedo-shaped, without visible inclusions on the longitudinal section.

1 supp.
Bisacodyl 10 mg

Excipients : hard fat (witepsol H15, kernosol 35) – 1 g.

5 pcs. – contour cell packs (2) – cardboard packs.

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Dosage Form

Bottle OTC Icon Bisacodyl-Nizhpharm Rectal suppositories 10 mg: 10 pcs.

Dosage Form, Packaging, and Composition

Rectal suppositories from white to white with a slightly yellowish tint, torpedo-shaped; the appearance of plaque on the surface of the suppository and the presence of an air rod and a funnel-shaped depression on the section are allowed.

1 supp.
Bisacodyl 10 mg

Excipients : hard fat.

5 pcs. – contour cell packs (2) – cardboard packs.

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