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CO-DANTHRAMER 25MG/200MG PER 5ML ORAL SUSPENSION

Active substance(s): DANTRON / POLOXAMER 188

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1.

NAME OF THE MEDICINAL PRODUCT
Co-Danthramer 25mg/200mg per 5ml Oral Suspension

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of suspension contains: Dantron 25 mg
Poloxamer 188 200 mg
For excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Oral Suspension.
Peach flavoured, yellow suspension.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
A lubricant, faecal softener and laxative for the prophylaxis and treatment of
constipation in terminally ill patients of all ages.

4.2

Posology and method of administration
Adults: One to two 5 ml spoonfuls at bedtime.
Children: Should be avoided in children, but if recommended, a suitable dose is half
to one 5 ml spoonful at bedtime.

4.3

Contraindications
1.
2.
3.
4.

4.3

Co-Danthramer 25mg/200mg per 5ml Oral Suspension is
contraindicated in pregnant and nursing mothers.
Co-Danthramer 25mg/200mg per 5ml Oral Suspension should
not be used in intestinal obstruction.
It should not be used if signs of appendicitis or inflamed bowel
are apparent.
Hypersensitivity to dantron, poloxamer 188 and/or any of the
excipients.

Special Warnings and Precautions for Use

Urine may be coloured red; avoid prolonged contact with skin (as in
incontinent patients) since irritation and excoriation may occur.
The oral administration of Dantron has been reported to cause
intestinal tumours in rats and mice.
The substance is hepatocarcinogenic in both species.
No evidence exists for a ‘no-effect’ dose. As such there may be a risk
of such effects in humans. In the presence of renal failure/insufficiency
hypermagnesemia may occur.
Not to be used in patients who are incontinent or in children wearing
napkins as superficial sloughing of discoloured skin may occur, (see
Section 4.8, Undesirable effects).
Glycerol may cause headache, stomach upset and diarrhea.
This product contains 1.3 g of sorbitol per 5 ml. When taken according
to the dosage recommendations each dose supplies up to 2.6 g of
sorbitol. Patients with rare hereditary problems of fructose intolerance
should not take this medicine. Propylene glycol may cause alcohollike symptoms.
Ethlyhydroxybenzoate (E214), propylhydroxybenzoate (E216) and
methylpropylbenzoate (E218) may cause allergic reactions (possibly
delayed).
This medicinal product contains 3.71% v/v of ethanol. Each dose
contains up to 0.15 g of alcohol. Harmful for those suffering from
alcoholism. To be taken into account in pregnant or breast-feeding
women, children and high-risk groups such as patients with liver
disease, or epilepsy.

4.5

Interaction with other medicinal products and other forms of interaction
Concurrent use with a stool softener laxative may enhance the systemic absorption of
Dantron.

4.6

Pregnancy and Lactation
Co-danthramer 25mg/200mg per 5ml Oral Suspension is
contraindicated in pregnant and nursing mothers. Dantron is excreted
in breast milk. Some rodent studies suggest that Dantron may be
associated with a potential carcinogenic risk.

4.7

Effects on ability to drive and use machines
Co-Danthramer 25mg/200mg per 5ml Oral Suspension may cause
unusual tiredness or weakness, therefore, if affected, the patient should
not drive or operate machinery while taking this medicine.

4.4

Undesirable Effect

1.

As a stimulant laxative it increased motility and may cause
abdominal cramp.

2.

Dantron may colour the perianal skin pink or red as well as
colour the urine.

3.

Superficial sloughing of discoloured skin may occur in
incontinent patients or children wearing napkins; Dantron
should not be used with such patients.

4.

The mucosa of the large intestine may be discoloured with
prolonged use or high dosage.

5.

Unusual tiredness or weakness.

6.

Rash

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the
medicinal product is important. It allows continued monitoring of the
benefit/risk balance of the medicinal product. Healthcare professionals
are asked to report any suspected adverse reactions via the Yellow
Card Scheme at www.mhra.gov.uk/yellowcard.
4.9

Overdose
Laxatives can cause diarrhoea if taken in overdose and constipation if over used.
Chronic overuse of laxatives may lead to the development of a ‘cathartic colon’, with
accompanying metabolic disturbances such as hypokalaemia and metabolic acidosis.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Dantron is an anthraquinone stimulant laxative, which acts on nerve endings in the
colonic mucosa. Poloxamer 188 is a wetting agent, which acts as a stool softener.

5.2

Pharmacokinetic properties
Like other anthraquinone compounds, Dantron 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. Dantron begins to act between 6 and 12 hours after administration.
Poloxamer 188, a non-ionic surfactant is not absorbed and is fully recovered in the
faeces.

5.3

Preclinical safety data
The oral administration of Dantron has been reported to cause intestinal tumours in
rats and mice.
The substance is hepatocarcinogenic in both species.
No evidence exists for a ‘no-effect’ dose. As such there may be a risk of such effects
in humans.
In the presence of renal failure/insufficiency hypermagnesemia may occur.
Rodents treated for 16 months with doses approximately 300 times those used in
humans associate Dantron with the development of intestinal and liver tumours.
However, two major studies did not show any association between ingestion of
anthraquinones and cancer in humans. Because of the concern over rodent
carcinogenicity use of Dantron tends to be restricted to the elderly and terminally ill
patients.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Aluminium Magnesium Silicate
Xanthan Gum
Glycerol
Sorbitol 70%
Saccharin Sodium
Propylene Glycol
Ethanol 96%
Methylhydroxybenzoate (E218)
Ethylhydroxybenzoate (E214)
Propylhydroxybenzoate (E216)
Citric Acid Monohydrate
Sodium Citrate
Purified Water
Peach Flavour Liquid

6.2

Incompatibilities
None known

6.3

Shelf life
3 years

6.4

Special precautions for storage
Do not store above 25ºC. Store in the original container.

6.1

Nature and Contents of Container

Pharmaceutical Grade Type III amber glass bottles with pilfer proof
screw cap and high density polyethylene bottles with tamper evident
seal.
Pack sizes: 100 ml, 150 ml, 200 ml, 300 ml, 500 ml, and 1 litre

6.2

Special precautions for disposal and other handling
Shake the bottle before use. Avoid contact with the skin to avoid
staining.

7

MARKETING AUTHORISATION HOLDER
Pinewood Laboratories Limited
Ballymacarbry
Clonmel
Co. Tipperary
Ireland

8

MARKETING AUTHORISATION NUMBER(S)
PL 04917/0025

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
15/03/2007

10

DATE OF REVISION OF THE TEXT
17/05/2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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