INFORMATION FOR HEALTH PROFESSIONALS
Home | Consumers | Health Professionals | Regulatory | Other | Hot Topics | Search
Home | Consumers | Health Professionals | Regulatory | Other | Hot Topics | Search
The sponsor (pharmaceutical company) of this product has
advised Medsafe that this product has either been discontinued or is no longer
marketed in New Zealand.
Therefore this Data Sheet may not be up to date.
Medsafe has elected to leave it on this web site because supplies of this
product may still be available, and health professionals should continue to
have access to this product information in the interim.
You may be able to find a more current Data Sheet containing the same medicine
by returning to the main Data Sheet page and searching by ingredient name.
CODALAX Suspension: A peach flavoured, viscous, orange coloured liquid. Each 5mL spoonful contains poloxamer 188 200mg and danthron BP 25mg.
CODALAX FORTE Suspension: A peach flavoured, viscous, orange coloured liquid. Each 5mL spoonful contains poloxamer 188 1000mg and danthron BP 75mg.
CODALAX and CODALAX FORTE are mild laxatives, their action being due to the purgative action of danthron and the surfactant action of poloxamer 188.
Danthron is partially absorbed from the small intestine, where it has no action, and is carried via the circulation to the large intestine where it acts on the nerve endings of the myenteric plexus to stimulate the muscles of the large intestine. Because it does not affect the small intestine, griping and cramping are unlikely to occur.
Poloxamer 188 is a non-ionic surfactant which increases the penetration of water into the faeces thus preventing it from drying and hardening excessively.
This makes life more comfortable for the patient and the increased bulk, provided by the retention of water, acts also as a stimulus to peristaltic activity. The surface activity also has a useful lubricant effect.
Danthron is absorbed from the small intestine to some extent. It is excreted in the faeces and the urine, and also in other secretions including milk. Danthron begins to act between 6 and 12 hours after administration.
As a lubricant, faecal softener and laxative to be administered orally.
The use of this product is strictly limited to prevention or treatment of constipation in the terminally ill.
CODALAX Suspension:
Opioid Induced Constipation
Adults: 10 to 20mL once or twice daily may be required.
Children: 2.5 to 5mL as required.
CODALAX FORTE Suspension:
Opioid Induced Constipation
Adults: 5 to 20mL once or twice daily may be required.
Not recommended for children under 12 years.
In common with other gastrointestinal evacuants, CODALAX and CODALAX FORTE suspensions should not be given when acute or painful conditions of the abdomen are present or when the cause of constipation is suspected to be intestinal obstruction.
CODALAX suspension may cause staining of the buttocks in incontinent patients and in babies or children wearing napkins. This may proceed to superficial sloughing of the skin. For this reason CODALAX suspension is not recommended for the treatment of infants and children in napkins, and should be used with caution in all incontinent patients.
A similar warning applies for CODALAX Forte in adults.
Oral administration of danthron has been reported to cause intestinal tumours in rats and mice. It has also been reported to be hepato-carcinogenic in rats as well as in mice. There is no sound evidence to conclude a no effect dose and, therefore, there may be a risk of such effects in humans.
Pregnancy: There is inadequate evidence of safety of the medicine in pregnancy but it has been in wide use for many years without apparent ill consequence, animal studies having shown no hazard. Nevertheless, like all medicines care should be exercised in administering CODALAX or CODALAX Forte suspension in the first trimester of pregnancy.
Breast Feeding: Danthron may be secreted in breast milk but will not usually be in sufficient amounts to affect the infant.
Codalax and Codalax Forte are presumed to be safe or unlikely to produce an effect on the ability to drive or use machinery.
Danthron may cause temporary harmless pink or red colouring of the urine and perianal skin. In prolonged high dosage, the mucosa of the large intestine may become coloured.
Long term use may result in electrolyte disturbances and in atony and dilation of the colon.
There is no evidence that danthron or poloxamer react with other medicaments or interfere with their action.
Emergency Procedures, Antidotes: Patients should be given plenty of fluids. An anti-cholinergic preparation such as atropine methonitrate would help to offset the excessive intestinal motility.
Store below 25°C. Shake the bottle before use. The shelf use of Codalax is 24 months in glass or plastic bottles. The shelf life of Codalax Forte is 36 months in glass bottles and 24 months in plastic bottles.
Prescription Medicine.
CODALAX suspension: 300mL.
CODALAX FORTE suspension: 300mL.
The active ingredient, danthron, is mainly 1,8-dihydroxyanthra-quinone. Its molecular formula and weight are C14H8O4 and 240.2 respectively.
The active ingredient, poloxamer 188, is nonionic polyoxyethylene-polyoxypropylene co-polymer. It's molecular formula is HO(C2H4O)a (C3H6O)b (C2H4O)a H, where a is about 75 and b is about 30. It has an average molecular weight of 8350.
Other ingredients are: sorbitol syrup 70%, ethanol 96%, propylene glycol, aluminium magnesium silicate, peach flavour, flavour 30/19/024, hydroxy ethyl cellulose, glyceryl mono/di oleate, sodium phosphate, nipaset sodium, citric acid monohydrate, potassium sorbate, saccharin sodium and water.
Tragacanth mucilage BP or syrup BP should be used if diluents are required. It is not possible to dilute CODALAX Forte to obtain CODALAX since the proportions of the two ingredients are different.
Douglas Pharmaceuticals Ltd
P O Box 45-027
AUCKLAND 8
Ph: (09) 835-0660
Fax: (09) 835-0665
5 May 2000