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Sodium Picosulfate

(British Approved Name, rINN)

Drug Nomenclature

International Nonproprietary Names (INNs) in main languages (French, Latin, Russian, and Spanish):

Synonyms: DA-1773; LA-391; Nátrium-pikoszulfát; Natrii Picosulfas; Natrii Picosulfas Monohydricus; Natrio pikosulfatas; Natriumpikosulfaatti; Natriumpikosulfat; Picosulfato de sodio; Picosulphol; Pikosíran sodný monohydrát; Sodium Picosulphate
BAN: Sodium Picosulfate
INN: Sodium Picosulfate [rINN (en)]
INN: Picosulfato de sodio [rINN (es)]
INN: Picosulfate de Sodium [rINN (fr)]
INN: Natrii Picosulfas [rINN (la)]
INN: Натрия Пикосульфат [rINN (ru)]
Chemical name: Disodium 4,4´-(2-pyridylmethylene)di(phenyl sulphate)
Molecular formula: C18H13NNa2O8S2,H2O =499.4
CAS: 10040-45-6
ATC code: A06AB08
Read code: y01Ru; y07d4

Pharmacopoeias. In Europe and Japan.

 

European Pharmacopoeia, 6th ed. (Sodium Picosulfate). A white or almost white, crystalline powder. Freely soluble in water slightly soluble in alcohol.

Adverse Effects and Precautions

As for Bisacodyl.

Bowel evacuation. Sodium picosulfate with magnesium citrate was considered a safe and effective bowel cleansing agent in adults and children with inflammatory bowel disease. They tolerated the preparation as well as patients with other colonic disorders with no adverse effect on their disease symptoms. Patients should be kept well hydrated (it may be appropriate to carry out bowel preparation in hospital in frail or elderly patients to avoid the risks of over- or underhydration), and this procedure should not be used in suspected toxic dilatation of the colon.

In Australia, the Adverse Drug Reactions Advisory Committee has warned that low volume sodium picosulfate solutions may cause marked dehydration, hyponatraemia, other electrolyte abnormalities, and associated complications. Patients at particular risk include infants, the elderly, the frail, and those with congestive heart failure or with renal impairment.

A grand mal seizure in a 64-year-old female given sodium picosulfate with magnesium citrate was assumed to have been caused by hyponatraemia the patient had normal electrolyte concentrations in the period before taking the bowel preparation. Care is needed when sodium picosulfate solutions are used in those with a low seizure threshold or potential sodium depletion.

Sodium Picosulfate

Pharmacokinetics

Like bisacodyl, sodium picosulfate is metabolised by colonic bacteria to the active compound bis(p-hydroxyphenyl)pyridyl-2-methane. Only a small amount of sodium picosulfate is absorbed after an oral dose this is subsequently excreted in the urine.

Uses and Administration

Sodium picosulfate is a stimulant laxative related to bisacodyl used for the treatment of constipation and for evacuation of the colon before investigational procedures or surgery. When taken orally it is metabolised by colonic bacteria to an active form that stimulates bowel movements. It is usually effective within 6 to 12 hours although when used with magnesium citrate for bowel evacuation an effect may be seen within 3 hours.

For constipation it is given as a single oral dose of 5 to 10 mg, usually at bedtime. (For doses in children see below.)

For bowel evacuation, a dose of sodium picosulfate 10 mg with magnesium citrate is given in the morning and again in the afternoon of the day before examination.

Administration in children. In the UK, the following oral doses of sodium picosulfate have been recommended for children in the treatment of constipation the dose is usually given at night:

• 1 month to 4 years: 250 micrograms/kg (maximum 5 mg)

• 4 to lOyears: 2.5 to 5 mg

• over 10 years: 5 to 10 mg

Most UK licensed product information gives similar doses to those above for bowel cleansing. Alternatively, some recommend that children may be given the following doses of a sachet containing sodium picosulfate 10 mg (with magnesium citrate):

• 1 to 2 years: / sachet in the morning and / sachet in the afternoon

• 2 to 4 years: / sachet in the morning and / sachet in the afternoon

• 4 to 9 years: 1 sachet in the morning and / sachet in the afternoon

• over 9 years: 1 sachet in the morning and 1 sachet in the afternoon
Sodium Picosulfate

Preparations

British Pharmacopoeia 2008: Compound Sodium Picosulfate Powder for Oral Solution; Sodium Picosulfate Oral Solution.

Proprietary Preparations

Argentina: Agarol Cirulaxia Dagol Dulcolax Factor Laxante Feen-A-Mint Gotalax Granulax † Kritel Laxamin Modaton Modernel † Opalino Rapilax Rogelina † Trali Verilax Yodolin

Australia: Durolax SP

Austria: Agaffin Agiopic Guttalax Laxasan

Belgium: Dulcolax Picosulphate Fructines Guttalax † Laxoberon Picolaxine

Brazil: Cronoplex Diltin Guttalax Picolax † Rapilax

Czech Republic: Agiolax Pico Darmol † Guttalax Laxygal Progut Regulax Pikosulfat

Denmark: Actilax Laxoberal Picolon

Finland: Laxoberon

France: Fructines

Germany: Agiolax Pico Darmol Pico Darmol † Dulcolax NP Laxans-ratiopharm Pico Laxoberal Liquidepurmit Natriumpicosulfat Midro Picof Regulax Picosulfat

Greece: Guttaiax Laxatol

Hong Kong: Sur-Lax

Hungary: Darmol Guttalax Laxygal

India: Cremalax

Indonesia: Laxoberon

Ireland: Dulcolax Perles Laxoberal

Italy: Euchessina CM Falquigut Gocce Lassative Aicardi Guttalax

Japan: Laxoberon

Mexico: Anara Laxoberon

The Netherlands: Dulcodruppels Dulcopearls

Norway: Laxoberal

Philippines: Laxoberal

Portugal: Fructines Guttalax Laxodal Picolax

Russia: Guttalax Laxygal

Spain: Contumax Evacuol Ezor Gutalax Lubrilax Skilax

Sweden: Cilaxoral Laxoberal

Switzerland: Fructines Laxoberon

UK: Dulcolax Laxoberal

Venezuela: Lasoberon

 

Multi-ingredient

Argentina: Agarol Cascara Sagrada Oligoplex

Australia: Colonprep † Picolax † Picoprep Prep Kit-C

Belgium: Pilules de Vichy

Brazil: Agarol Forlax

Canada: Pico-Salax

Ireland: Picolax

Malaysia: Picoprep

New Zealand: Picoprep

Spain: Emuliquen Laxante

Switzerland: Laxasan

UK: CitraFleet Picolax

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