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Bisacodyl

Drug Approvals

(British Approved Name, rINN)

International Nonproprietary Names (INNs) in main languages (French, Latin, and Spanish): Bisacodilo; Bisacodylum; Bisakodil; Bisakodilis; Bisakodyl; Bisakodyyli; Biszakodil.

BAN: Bisacodyl
INN: Bisacodyl [rINN (en)]
INN: Bisacodilo [rINN (es)]
INN: Bisacodyl [rINN (fr)]
INN: Bisacodylum [rINN (la)]
INN: Бисакодил [rINN (ru)]
Chemical name: 4,4´-(2-Pyridylmethylene)di(phenyl acetate)
Molecular formula: C22H19NO4 =361.4
CAS: 603-50-9 (bisacodyl); 1336-29-4 (bisacodyl tannex)
ATC code: A06AB02; A06AG02
Read code: y01RZ

Pharmacopoeias. In China, Europe, Japan, and US.

 

European Pharmacopoeia, 6th ed. (Bisacodyl). A white or almost white crystalline powder. Practically insoluble in water sparingly soluble in alcohol soluble in acetone. It dissolves in dilute mineral acids. Protect from light.

The United States Pharmacopeia 31, 2008(Bisacodyl). A white to off-white crystalline powder. Practically insoluble in water soluble in benzene soluble 1 in 210 of alcohol, 1 in 2.5 of chloroform, and 1 in 275 of ether sparingly soluble in methyl alcohol.

Bisacodyl Tannex

Drug Approvals

(BANM, US Adopted Name, rINNM)

Adverse Effects

Bisacodyl and other stimulant laxatives may cause abdominal discomfort such as colic or cramps. Prolonged use or overdosage can result in diarrhoea with excessive loss of water and electrolytes, particularly potassium there is also the possibility of developing an atonic non-functioning colon. Hypersensitivity reactions, including angioedema and anaphylactoid reactions, have been reported rarely. When given rectally, bisacodyl sometimes causes irritation and may cause proctitis or sloughing of the epithelium. To avoid gastric irritation bisacodyl tablets are enteric-coated.

Bisacodyl_10mg

Precautions

As with other laxatives, prolonged use should be avoided. Bisacodyl should not be given to patients with intestinal obstruction or acute abdominal conditions such as appendicitis care should also be taken in patients with inflammatory bowel disease. It should not be used in patients with severe dehydration. The suppositories should preferably be avoided in patients with anal fissures, proctitis, or ulcerated haemorrhoids.

Handling. Inhalation of bisacodyl powder and contact with eyes, skin, and mucous membranes should be avoided.

Pharmacokinetics

On oral or rectal use bisacodyl is converted to the active desacetyl metabolite bis(p-hydroxyphenyl)-pyridyl-2-methane by intestinal and bacterial enzymes. Absorption from the gastrointestinal tract is minimal with enteric-coated tablets or suppositories the small amount absorbed is excreted in the urine as the glu-curonide. Bisacodyl is mainly excreted in the faeces.

Uses and Administration

Bisacodyl is a diphenylmethane stimulant laxative used for the treatment of constipation and for bowel evacuation before investiga-tional procedures or surgery. Its action is mainly in the large intestine and it is usually effective within 6 to 12 hours after oral doses, within 15 to 60 minutes after rectal use by suppository, and within 5 to 20 minutes when given as an enema. Bisacodyl tablets should be swallowed whole and should not be taken within 1 hour of milk or antacids.

For constipation, bisacodyl is given in usual doses of 5 to 10 mg daily as enteric-coated tablets given at night or 10 mg as a suppository or enema given in the morning. Oral doses of 10 to 20 mg are given for complete bowel evacuation, followed by 10 mg as a suppository the next morning. For doses in children, see below. A complex of bisacodyl with tannic acid (bisacodyl tannex) has been given with a barium sulfate enema before radiographic examination of the colon.

Administration in children. For constipation, the following oral doses of bisacodyl are recommended for children, to be taken at night:

• 4 to 10 years: 5 mg

• over 10 years: 5 to 10 mg

Alternatively, the following rectal doses are recommended, to be inserted in the morning:

• under 10 years: 5 mg

• over 10 years: 10 mg

The BNFC gives similar doses, but limits the use of suppositories in children to those aged over 2 years.

For bowel clearance before surgery or radiological investigation, the following doses are recommended:

• 4 to 10 years: 5 mg orally the night before, followed by 5 mg as a suppository the next morning

• over 10 years: 10 to 20 mg orally the night before, followed by 10 mg as a suppository the next morning

The BNFC gives similar doses but allows for the use of oral doses for 2 nights before the procedure, followed, if necessary, by the rectal dose 1 hour before the procedure.

Preparations

British Pharmacopoeia 2008: Bisacodyl Suppositories; Gastro-resistant Bisacodyl Tablets;

The United States Pharmacopeia 31, 2008: Bisacodyl Delayed-release Tablets; Bisacodyl Rectal Suspension; Bisacodyl Suppositories.

Proprietary Preparations

Argentina: Dulcolax; Laxamin; Modaton; Tractoduo; Australia: Bisalax; Dulcolax; Austria: Dulcolax; Laxbene; Belgium: Carters; Dulcolax; Henafurine; Mucinum; Nosik-Lax; Purgo-Pil; Brazil: Bisalax; Cronoplex; Dislax; Dulcolax; Fideine; Isilax; Plesonax; Canada: Alophen; Bisacolax; Carters Little Pills; Correctol; Dulcolax; Feen-A-Mint †; Gentlax; Laxcodyl †; Soflax EX; Chile: Alsylax; Czech Republic: Fenolax; Pyrilax †; Stadalax; Denmark: Dulcolax; Perilax; Toilax; Finland: Metalax; Toilax; France: Contalax; Dulcolax; Germany: Agaroletten; Bekunis; Bisacodyl; Bisco-Zitron; Drix Bisacodyl; Dulcolax; Florisan N; Laxagetten; Laxanin N †; Laxans-ratiopharm; Laxbene †; Laxoberal Bisa; Laxysat Burger Marienbader Pillen N; Mediolax; Pyrilax; Stadalax †; Tempolax; Tirgon; Vinco-Abfuhr-Perlen †; Greece: Dulcolax; Florisan N; Hong Kong: Dulcolax; Marcholax; Hungary: Dulcolax; Stadalax; India: Bo-Lax; Dulcolax; JuLax; JuLax-M †; Indonesia: Bicolax; Dulcolax; Laxacod; Laxamex; Stolax; Ireland: Dulcolax; Toilax; Israel: Atzirut X; Contalax; Laxadin; Italy: Alaxa; Confetto CM; Dulcolax; Normalene; Stixenil; Verecolene CM; Malaysia: Beacolux † ;Dulcolax; Mexico: Dulcolan; The Netherlands: Bekunis Bisacodyl; Dulcolax; Kruidvat Laxeertabletten ;Nourilax; Toilax; Trekpleister Laxeerdragees †; Norway: Dulcolax; Toilax; New Zealand: Dulcolax; Fleet Laxative; Philippines: Dulcolax; Vesilac; Portugal: Dulcolax; Moderlax; Russia: Dulcolax; South Africa: Dulcolax; Megalax †; Perilax; Singapore: Dulcolax; Spain: Dulco Laxo; Sweden: Dulcolax; Toilax; Switzerland: Bekunis Dragees; Demolaxin; Dulcolax; Muxol; Prontolax; Tavolax nouvelle formule; Thailand: Conlax; Dulcolax; Emulax; Gencolax; Kadolax; Laxcodyl; Laxitab; Vacolax; Turkey: Bisakol; Sekolaks; United Arab Emirates: Laxocodyl; UK: Biolax; Dulcolax; Entrolax; USA: Alophen; Bisa-Lax; Correctol; Doxidan; Dulcolax; Evac-Q-Tabs; Ex-Lax Ultra; Feen-A-Mint; Fleet Bisacodyl; Fleet Laxative; Gentlax; Modane; Venezuela: Dulcolan.

Multi-ingredient Argentina: En-Ga-Lax; Laxicona; Nigalax; Australia: Coloxyl Durolax X-Pack †; Go Kit; Go Kit Plus †; Austria: Laxbene; Prepacol; Purgazen; Purigoa † ;Belgium: Prepacol; Softene; Canada: Bicholate; Extra Strong Formula 12 †; Fruitatives †; Gentlax S; Royvac Kit; Chile: Laxogeno; Czech Republic: Prepacol; France: Prepacol; Germany: Potsilo N; Prepacol; Greece: Florisan; Hungary: Laxbene; New Zealand: Coloxyl; Portugal: Bekunis; Spain: Bekunis Complex; Boldolaxin Thailand: Bisolax; Turkey: Bekunis; USA: Dulcolax Bowel Prep Kit; Fleet Prep Kit No. 1; Fleet Prep Kit No. 2; Fleet Prep Kit No. 3; HalfLytely; X-Prep Bowel Evacuant Kit-1.

The symbol † denotes a preparation no longer actively marketed.

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