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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

Laxative

Pharmacological Action

A laxative agent, a derivative of diphenylmethane. It increases mucus secretion in the large intestine, accelerates and enhances its peristalsis.

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

Pharmacokinetics

Bisacodyl is not absorbed from the gastrointestinal tract.

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

Indications

Constipation caused by hypotension and sluggish peristalsis of the large intestine (in particular, in elderly patients; constipation after surgeries, 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.

Suppositories

Rectally, once a day. The suppositories are inserted deep into the rectum.

Adults and children over 14 years old – 10-20 mg (1-2 suppositories), children aged 8-14 years – 10 mg (1 suppository), children aged 2-7 years – 5 mg (1/2 suppository).

In the case of prescribing the drug for bowel cleansing in preparation for surgery or radiological examination of the abdominal organs, Bisacodyl is prescribed in the evening 10-20 mg (2-4 tablets) orally and in the morning 10 mg (1 suppository) rectally.

Tablets

Take orally in the evening before bedtime, starting with 1 tablet. If there is no effect, the single dose is increased to 2-3 tablets.

Children over 6 years old are prescribed 1 tablet in the evening.

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

Adverse Reactions

From the digestive system colicky 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 dosage 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

Magistra C&C (Romania)

Dosage Form

Bottle OTC Icon Bisacodyl Rectal suppositories 10 mg: 6 or 10 pcs.

Dosage Form, Packaging, and Composition

Rectal suppositories white or almost white with a grayish or yellowish tint, torpedo-shaped, with a smooth oily surface.

1 supp.
Bisacodyl 10 mg

Excipients : semi-synthetic glycerides.

3 pcs. – blisters (2) – cardboard packs.
5 pcs. – blisters (2) – cardboard packs.

Marketing Authorization Holder

Alvils, LLC (Russia)

Manufactured By

YUGPHARM, LLC (Russia)

Dosage Form

Bottle OTC Icon Bisacodyl Enteric-soluble, film-coated tablets, 5 mg: 10, 20, 30, 40, 50, or 60 pcs.

Dosage Form, Packaging, and Composition

Enteric-soluble, film-coated tablets white or almost white, round, biconvex; the cross-section is white or almost white.

1 tab.
Bisacodyl 5 mg

Excipients : lactose monohydrate – 60 mg, microcrystalline cellulose (MCC-101) – 15 mg, potato starch – 10 mg, povidone K-25 – 3.8 mg, calcium stearate – 0.6 mg, talc – 0.6 mg.

Shell composition: ready-made film coating Acryl-iz 93A white – 4.5 mg; including: methacrylic acid and ethyl acrylate copolymer (1:1) – 2.97 mg, talc – 0.742 mg, titanium dioxide – 0.675 mg, colloidal silicon dioxide – 0.045 mg, sodium bicarbonate – 0.045 mg, sodium lauryl sulfate – 0.023 mg, triethyl citrate – 0.5 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.
10 pcs. – contour cell packs (5) – cardboard packs.
30 pcs. – contour cell packs (1) – cardboard packs.
30 pcs. – contour cell packs (2) – cardboard packs.

Marketing Authorization Holder

Balkanpharma-Dupnitsa, AD (Bulgaria)

Dosage Form

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

Dosage Form, Packaging, and Composition

Tablets, enteric-coated 1 tab.
Bisacodyl 5 mg

Excipients : lactose monohydrate – 49 mg, wheat starch – 40 mg, colloidal silicon dioxide – 1 mg, talc – 3 mg, magnesium stearate – 1 mg, gelatin – 1 mg.

Shell composition methacrylic acid and ethyl acrylate copolymer (1:1) (eudragit L100-55) – 6.9957 mg, macrogol 6000 – 0.7 mg, dye quinoline yellow 70 E104 – 0.33 mg, talc – 1.57 mg, titanium dioxide – 0.4 mg.

30 pcs. – blisters (1) – cardboard packs.

Marketing Authorization Holder

Biocom, JSC (Russia)

Dosage Form

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

Dosage Form, Packaging, and Composition

Tablets, enteric-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.
10 pcs. – contour cell packs (5) – cardboard packs.

Marketing Authorization Holder

Ozon, LLC (Russia)

Dosage Form

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

Dosage Form, Packaging, and Composition

Tablets, enteric-coated 1 tab.
Bisacodyl 5 mg

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

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Bottle OTC Icon Bisacodyl Rectal suppositories 10 mg: from 1 to 49 pcs.

Dosage Form, Packaging, and Composition

Rectal suppositories from white to white with a slightly yellowish tint, torpedo-shaped.

1 supp.
Bisacodyl 10 mg

Excipients : hard fat (witepsol (grades H15, W35), suppocire (grades NA15, NAS50)) – to obtain a suppository weighing 1.25 g.

From 1 to 4 pcs. – contour cell packs (from 1 to 10 pcs.) – cardboard packs.
5 pcs. – contour cell packs (from 1 to 9 pcs.) – cardboard packs.
6 pcs. – contour cell packs (from 1 to 8 pcs.) – cardboard packs.
7 pcs. – contour cell packs (from 1 to 7 pcs.) – cardboard packs.
8 pcs. – contour cell packs (from 1 to 6 pcs.) – cardboard packs.
9 pcs. – contour cell packs (from 1 to 5 pcs.) – cardboard packs.
10 pcs. – contour cell packs (from 1 to 4 pcs.) – cardboard packs.

Marketing Authorization Holder

Pharmaprim, LLC (Republic of Moldova)

Dosage Form

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

Dosage Form, Packaging, and Composition

Rectal suppositories 1 supp.
Bisacodyl 10 mg

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

Marketing Authorization Holder

Formula-FR, LLC (Russia)

Manufactured By

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Bottle OTC Icon Bisacodyl Rectal suppositories 10 mg: 4, 5, 6, 8, 10 or 12 pcs.

Dosage Form, Packaging, and Composition

Rectal suppositories from white to white with a slightly yellowish tint, torpedo-shaped.

1 supp.
Bisacodyl 10 mg

Excipients : hard fat (Witepsol grade H 15, Suppocire grade NA 15) – 0.62 g.

4 pcs. – contour cell pack (1) – cardboard packs.
4 pcs. – contour cell pack (2) – cardboard packs.
5 pcs. – contour cell pack (1) – cardboard packs.
5 pcs. – contour cell pack (2) – cardboard packs.
6 pcs. – contour cell pack (1) – cardboard packs.
6 pcs. – contour cell pack (2) – cardboard packs.

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