1. Name Of The Medicinal Product
Co-danthramer capsules
Strong Co-danthramer capsules
2. Qualitative And Quantitative Composition
Co-danthramer capsules contain Dantron 25 mg and Poloxamer 188 200 mg.
Strong Co-danthramer capsules contain Dantron 37.5 mg and Poloxamer 188 500 mg.
For excipients, see section 6.1.
3. Pharmaceutical Form
Capsule, hard
Co-danthramer capsules have light brown bodies, opaque orange caps and are marked CX and Napp.
Strong Co-danthramer capsules have light brown bodies, opaque green caps and are marked CXF and Napp.
4. Clinical Particulars
4.1 Therapeutic Indications
Constipation in terminally ill patients
4.2 Posology And Method Of Administration
Adults
One or two capsules at bedtime.
Children under 12 years of age
Co-danthramer capsules: One capsule at bedtime or as recommended by the physician.
Strong Co-danthramer capsules: Not recommended.
Elderly
As recommended by the physician.
4.3 Contraindications
In common with other gastro-intestinal evacuants, Co-danthramer capsules should not be given when acute or painful conditions of the abdomen are present or when the cause of the constipation is thought to be an intestinal obstruction. Hypersensitivity to any of the constituents of the product. Peanut or soya allergies. Pregnancy and lactation.
4.4 Special Warnings And Precautions For Use
Oral administration of dantron has been reported to cause liver or intestinal tumours in rats and mice. There is no sound evidence to conclude a no effect dose and therefore there may be a risk of such effects in humans.
Co-danthramer use should therefore be restricted to the licensed indications.
In babies, children and patients wearing nappies there may be staining of the buttocks. This may lead to superficial sloughing of the skin. Therefore, Co-danthramer should not be given to infants in nappies and should be used with caution in all incontinent patients.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None stated.
4.6 Pregnancy And Lactation
Co-danthramer capsules are contraindicated in pregnant women and nursing mothers.
4.7 Effects On Ability To Drive And Use Machines
None stated.
4.8 Undesirable Effects
Dantron may cause temporary harmless pink or red colouring of the urine and peri-anal skin. With prolonged high dosage the mucosa of the large intestine may become coloured.
4.9 Overdose
In case of overdosage, patients should be given plenty of fluids. An anti-cholinergic preparation such as atropine sulphate may be given to offset the excessive intestinal motility.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmacotherapeutic group: Dantron combinations
ATC code: A06A B53
Co-danthramer owes its laxative action to the mild purgative dantron which is the subject of a monograph in the British Pharmacopeia. This is an anthraquinone derivative chemically related to emodin, the active principle of cascara and other naturally occurring products such as senna, aloes and rhubarb. It acts on the nerve endings of the myenteric plexus and stimulates the muscles of the large intestine.
Poloxamer 188 is a wetting agent which increases the penetration of water into faecal material. The surface activity of the poloxamer has a lubricant effect on the gut contents.
5.2 Pharmacokinetic Properties
Like other anthraquinone compounds, dantron is partially absorbed from the small intestine. Because it does not affect the small intestine, griping and cramping do not occur. Dantron begins to act between 6-12 hours after administration.
Poloxamer 188 is not absorbed and is fully recovered in the faeces.
5.3 Preclinical Safety Data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Butylhydroxytoluene (E321)
Capsule shell
Gelatin
Erythrosine (E127)
Iron oxide (E172)
Indigo carmine (E132)
Titanium dioxide (E171)
Sodium dodecylsulphate
Printing ink
Opacode S-1-7020 HV white 005
(containing shellac, soya, lecithin, 2-ethoxyethanol,
dimethicone, E171))
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
Three years
6.4 Special Precautions For Storage
Do not store above 30oC.
6.5 Nature And Contents Of Container
Clear or pale yellow blister packs (aluminium foil sealed to 250µm PVC with a PVdC coating of at least 40 gsm thickness), containing 60 capsules.
6.6 Special Precautions For Disposal And Other Handling
No special requirements.
7. Marketing Authorisation Holder
Napp Pharmaceuticals Ltd
Cambridge Science Park
Milton Road
Cambridge CB4 0GW
United Kingdom
8. Marketing Authorisation Number(S)
PL 16950/0017-0018
9. Date Of First Authorisation/Renewal Of The Authorisation
19 October 1994/9 December 2005
10. Date Of Revision Of The Text
25 February 2009
11. Legal category
POM
® The Napp device is a Registered Trade Mark
© Napp Pharmaceuticals Ltd 2009
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