Product Dossier
BISALAX
Product Dossier for BISALAX (bisacodyl, Orion Pharma (AUS)). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Orion Pharma (AUS)
- Active ingredient: bisacodyl
- Therapeutic area: Gastroenterology
- Related brand: GO-KIT
- Related brand: GLYCOPREP-O
- Same area: SALOFALK
- Same area: COLOFAC
What it is
GO-KIT is a medicine kit containing three yellow bisacodyl 5 mg tablets and one magnesium citrate 21.5 g sachet . Each bisacodyl tablet contains bisacodyl 5 mg as the active ingredient . Each sachet contains magnesium carbonate hydrate 7.2 g and citric acid 14.3 g as the active ingredients . The bisacodyl component is an enteric-coated tablet , whilst the magnesium citrate component is a powder for solution .
Approved indications
— Bowel emptying and cleansing in conjunction with barium meal, barium enema x-ray examination, air contrast examination, and prior to intravenous pyelograms .
Dosing overview
The first dose comprises three bisacodyl tablets taken with one full glass (approximately 250 mL) of water . The second dose comprises the magnesium citrate sachet ingested slowly but completely, followed by drinking adequate glasses of water or recommended clear fluids, at least one glass every hour after that . The sachet contents are dissolved by slowly adding the powder in approximately 250 mL of warm water using a suitable food grade container, and gently stirred until the effervescence ceases . The dosing regimen may be adjusted by a healthcare professional as required .
Key safety warnings
GO-KIT is likely to cause transient hypovolaemia, hence adequate fluid intake or replacement should be ensured . Use with caution in patients with inflammatory bowel disease, marked bloody diarrhoea, pre-existing electrolyte disturbances, congestive heart failure, diabetes and those with a stoma . GO-KIT should be administered with caution to patients using calcium channel blockers, diuretics or other medications that may affect electrolyte serum levels and exacerbate volume depletion, and these patients should be monitored . Caution should be exercised in the elderly as dehydration and electrolyte depletion may occur, and elderly patients must receive adequate fluids during administration . Nausea, vomiting and anal irritation are the most common reactions and are usually transient and subside rapidly . GO-KIT may cause bloating, distension or abdominal pain . Hypersensitivity reactions including angioedema and anaphylactoid reactions have been reported rarely .
Contraindications
GO-KIT should not be used by patients with acute abdominal conditions such as appendicitis, gastrointestinal obstruction, gastric retention, bowel perforation (frank or suspected), toxic megacolon, toxic colitis, ileus, body weight less than 20 kg, severe dehydration, or hypersensitivity to any of the ingredients .
Regulatory history
GO-KIT (formerly known by its component formulation) was first approved on 27 August 2012 . BISALAX bisacodyl 5 mg enteric-coated tablet was first listed on the ARTG on 3 December 2014 .