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

Logo ASACOL® suppositories

SCHEDULING STATUS:
S3

PROPRIETARY NAME:
(and dosage form)

ASACOL® suppositories

COMPOSITION:
Per suppository:
Mesalazine (5-aminosalicylic acid)        500 mg

PHARMACOLOGICAL CLASSIFICATION:
A 11.10 Medicines acting on gastro-intestinal tract, special combinations

PHARMACOLOGICAL ACTION:
ASACOL suppositories act locally, probably involving the inhibition of prostaglandin and leukotriene synthesis.
ASACOL is mostly excreted in the faeces either as 5-aminosalicylic acid (5-ASA) or N-acetyl-5-ASA. About 20 per cent of the 5-ASA released in the colon, is absorbed and rapidly acetylated to N-acetyl-5-ASA, which is excreted in the urine.
The acetylated metabolite (active ingredient) has a half-life of approximately 10 hours and that of the parent compound approximately one hour.

INDICATIONS:
ASACOL is used for the treatment and maintenance of remission in ulcerative colitis. The suppositories are used for the treatment of mild to moderate proctitis and proctosigmoiditis.

CONTRA-INDICATIONS:
Hypersensitivity to any ingredients.
Allergy to salicylates.
Patients with impaired renal function.
Safety in pregnancy and lactation has not been established.
Safety and efficacy have not been established in children.

WARNINGS:
It is not recommended in patients with renal impairment and caution should be exercised in patients with a raised blood urea or proteinuria.
Mesalazine-induced nephrotoxicity should be suspected in patients developing renal failure during treatment.
Use with caution in the elderly and usage is subject to patients having a normal renal function.

DOSAGE AND DIRECTIONS FOR USE:
Adult dose: In proctitis and proctosigmoiditis one suppository to be inserted rectally up to three times daily, after defaecation. The dosage is dependent upon the severity of the disease and it may be possible to reduce the dosage as the condition improves.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects are predominantly gastrointestinal. Mild nausea, colic, headaches, diarrhoea, anal irritation, abdominal pain, fever and hypersensitivity reactions may occur.
Asacol may be associated with the exacerbation of colitis symptoms in those patients who have previously had such problems with sulphasalazine.
Pancreatitis, myocarditis, pericarditis, intestinal nephritis, nephrotic syndrome and renal failure have been reported with oral treatment, usually reversible on withdrawal.
There are some reports of nephrotoxicity and peripheral neuropathy.
Drug-induced lupus may be a less frequent complication of mesalazine therapy, with pericarditis and pleuropericarditis prominent symptoms, and also rashes and arthralgia.
There have been less frequent reports of allergic lung reactions, eosinophylic pneumonia, hepatitis and blood dyscrasias such as leucopenia, neutropenia, thrombocytopenia and aplastic anaemia.
Mesalazine (5-aminosalicylic acid) should not be given with preparations which lower stool pH e.g. lactulose thereby preventing release of the active ingredient. Allergic manifestations may occur.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
In case of accidental oral ingestion symptoms of overdosage include that of salicylism, e.g. dizziness, tinnitus, deafness, sweating, nausea and vomiting, headache, mental confusion, hyperventilation, fever, restlessness, ketosis, respiratory alkalosis and metabolic acidosis. Depression of the central nervous system may lead to coma; cardiovascular collapse and respiratory failure.
There is no specific treatment for overdosage of Asacol but early lavage is recommended, if accidentally taken by mouth.
Treatment is symptomatic and supportive.

IDENTIFICATION:
An opaque, pale beige, torpedo-shaped suppository with a faint fatty odour.

PRESENTATION:
Cartons of 20 suppositories in white opaque cavity-formed PVC strips, printed on one side.

STORAGE INSTRUCTIONS:
Store below 25°C in a cool place, protected from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
Z/11.10/206

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Aventis Pharma (Pty) Ltd.
2 Bond Street, Midrand, 1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
28 June 1996

Under licence to Tillotts Pharma AG, Ziefen, Switzerland       

Aventis Pharma (Pty) Ltd
2 Bond Street
Midrand
1685

        AS22-B0701

Updated on this site: July 2003
Source: Community Pharmacy

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2003