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CO-DANTHRAMER 25/200 ORAL SUSPENSION

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Co-Danthramer 25/200 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. Pinorax Co-Danthramer Suspension 25/200 Oral Suspension is contraindicated in
pregnant and nursing mothers.
2. Pinorax Co-Danthramer Suspension 25/200 Oral Suspension should not be used in
intestinal obstruction.
3. It should not be used if signs of appendicitis or inflamed bowel are apparent.
4. Hypersensitivity to dantron, poloxamer 188 and/or any of the excipients.

4.4

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).
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 alcohol-like 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
Pinorax 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
Pinorax Co-Danthramer 25mg/200mg Oral Suspension may cause unusual tiredness
or weakness, therefore, if affected, the patient should not drive or operate machinery
while taking this medicine.

4.8

Undesirable effects
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.

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.

6.5

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

6.6

Special precautions for disposal
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
15/03/2007

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