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Logo ASACOL tablets

Mesalazine

                                       
Aventis

SCHEDULING STATUS
S3

PROPRIETARY NAME
(and dosage form)

ASACOL tablets

COMPOSITION
Per tablet:
Mesalazine (5-aminosalicylic acid) 400 mg.

PHARMACOLOGICAL CLASSIFICATION:
A 11.10 Medicines acting on gastrointestinal tract, other

PHARMACOLOGICAL ACTION:
The acrylic-based resin coating, which is pH-dependent (pH = 7) delays the release of MESALAZINE (5-aminosalicylic acid) until the tablet reaches the distal ileum and colon. There it acts locally, probably involving the inhibition of prostaglandin and leucotrine synthesis. MESALAZINE is mostly excreted in the faeces either as 5-aminosalicylic acid (5-ASA) or N-acetyl-5-ASA. About 20 percent 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 one of approximately one hour.

INDICATIONS:
ASACOL is used for the treatment and maintenance of remission in ulcerative colitis.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients.
Sensitivity to salicylates.
Severe renal impairment.
Safety in pregnancy and lactation has not been established.
Safety and efficacy have not been established in children.

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

DOSAGE AND DIRECTIONS FOR USE:
Adults: Three to six tablets daily, in divided doses, increasing to a maximum of 10 tablets in severe cases.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Allergic manifestations may occur. Hypersensitivity reactions may occur occasionally.
Gastrointestinal:
Abdominal pain may occasionally occur. Mild nausea, colic, fever, headache and diarrhoea may occur.
Asacol may be associated with the exacerbation of colitis symptoms in those patients who have previously had such problems with sulphasalazine.
Urogenital:
Caution should be exercised in patients who have renal damage with a raised blood urea or proteinuria.
Pulmonary:
Less frequent cases of allergic lung reactions, alveolitis and eosinophilic pneumonia have been reported.
Haematologic:
Aplastic anaemia, leucopenia, neutropenia and thrombocytopenia have been reported less frequently.
Hepatic:
There have been less frequent reports of hepatitis.
Renal:
Interstitial nephritis, nephrotic syndrome and renal failure have been reported less frequently. Mesalazine-induced nephrotoxicity should be suspected in patients developing renal failure during treatment.
Other:
Pancreatitis, pericarditis and myocarditis have been less frequently reported. Drug-induced lupus may be a rare complication of mesalazine therapy with pericarditis and pleuropericarditis prominent symptoms, and also rashes and arthralgia.
Drug Interactions:
Mesalazine (5-aminosalicylic acid) should not be given with preparations which lower stool pH e.g. lactulose thereby preventing release of the active ingredient.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms of overdosage include that of salicylism.
There is no specific treatment for overdosage of Asacol but early gastric lavage is recommended.
Treatment is symptomatic and supportive.

IDENTIFICATION:
Oblong, red-brown, enteric-coated tablet.

PRESENTATION:
Tablets: 90' in blister packs.

STORAGE INSTRUCTIONS:
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
S/11.10/171

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

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
7 June 1991

Under licence to Tillotts Pharma AG. Ziefen, Switzerland

Aventis Pharma (Pty) Ltd.
2 Bond Street
Midrand
1685        AS12-B0701
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Updated on this site: January 2003
Current: April 2005
Source: Hospital Pharmacy

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