PHARMACOLOGICAL CLASSIFICATION A 11.10 Medicines acting on gastro-intestinal tract, special combinations
PHARMACOLOGICAL ACTION ASACOL (Mesalazine) enema acts locally, probably involving the inhibition of prostaglandin and leukotriene synthesis.
ASACOL (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 approximately one hour.
INDICATIONS ASACOL (Mesalazine) is used for the treatment and maintenance of remission in ulcerative colitis.
CONTRA-INDICATIONS Allergy to salicylates
WARNING Safety and efficacy have not been established in children.
DOSAGE AND DIRECTIONS FOR USE Adult dose: Two gram administered at night per rectum
SIDE-EFFECTS AND SPECIAL PRECAUTIONS Mild nausea, colic, headache, diarrhoea and anal irritation may occur.
Caution should be exercised in patients who have renal damage with a raised blood urea or proteinuria. Mesalazine (5-Aminosalicylic acid) should not be given with preparations which lower stool pH, e.g. lactulose, and thereby prevent 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 A pale brown-pink, slightly aerated suspension with a slightly acrid odour
PRESENTATION 50 mL single enema
STORAGE INSTRUCTIONS Store below 25°C and protect from light.
KEEP OUT OF REACH OF CHILDREN
REGISTRATION NUMBER Z/11.10/205
NAME AND BUSINESS ADDRESS OF THE APPLICANT NORISTAN LIMITED
326 MARKS STREET, WALTLOO, PRETORIA
DATE OF PUBLICATION OF THIS PACKAGE INSERT 27 June 1996
ETHIMED Division of
NORISTAN LIMITED, WALTLOO, PRETORIA
Under licence to Tillots Pharma AG, Ziefen, Switzerland
ASACOL enema