INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo DIPENTUM® 250 Capsules
SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

DIPENTUM® 250 Capsules

COMPOSITION:
Each capsule contains 250 mg olsalazine sodium

PHARMACOLOGICAL CLASSIFICATION:
A 11.9.2 Medicines acting on the gastro-intestinal tract - Other

PHARMACOLOGICAL ACTION:
Olsalazine consists of two molecules of 5-amino-salicylic acid (5-ASA) joined through an azo bond. Olsalazine is activated in the colon where it is converted into 5-ASA, the active moiety.
The systemic absorption of olsalazine is minimal and the action is neither pH nor timed-release dependent. Thus there is no absorption of 5-ASA from the small bowel, and more than 98% of an oral dose will reach the colon. The concentration of 5-ASA in the colon approaches 1000 times that found in serum. Further, the mode of action remains unknown.

INDICATIONS:
Long-term maintenance of patients with ulcerative colitis in remission.
Treatment of acute ulcerative colitis of mild to moderate severity, with or without the concomitant use of steroids.

CONTRA-INDICATIONS:
Allergy to salicylates.
Safety during pregnancy and lactation has not been established.

DOSAGE AND DIRECTIONS FOR USE:
DIPENTUM should be taken at regular intervals during the day, immediately after meals.
Active disease
Adults, including the elderly:
To ensure maximum tolerability commence treatment with 0,5 g the first day (2 capsules) and increase the dose each day by 0,5 g (2 capsules) to 8 capsules (2 g) daily in divided doses.
If no response is achieved with 2 g and the drug is well tolerated the total dose may be increased to 3 g daily. A single dose should not exceed 1 g.
Remission
Adults, including the elderly:
2 Capsules (0,5 g) twice daily, taken immediately after meals.
Concomitant oral or rectal steroids may be used.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The most commonly reported adverse effects have been gastro-intestinal: diarrhoea, nausea, abdominal pain and upset stomach. Rash, headache, and joint pain have also been reported.
Caution is advised in patients suffering from severe allergy or asthma. Trials so far have excluded patients with renal, hepatic and cardio-pulmonary impairment and caution should be exercised in these patients.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
There is no specific antidote to DIPENTUM. Treatment of overdose should be symptomatic and supportive.

IDENTIFICATION:
Opaque, beige-coloured capsules radially printed with the words "DIPENTUM 250 mg".

PRESENTATION:
Bottles containing 100 capsules.

STORAGE INSTRUCTIONS:
Store in a dry place in a well-closed container at room temperature (15°C to 30°C).
Keep out of reach of children.

REGISTRATION NUMBER:
V/11.9.2/301

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Pharmacia South Africa (Pty) Ltd
Alphen West G
George Street
Midrand
1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
30 January 1991

New addition to this site: January 2005
Source: Pharmaceutical Industry

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