Loading…
ASACOL is a brand name for Mesalamine (also known as Mesalazine). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Ulcerative colitis: For the treatment of mild to moderate acute exacerbations. For the maintenance of remission. Crohn’s ileo-colitis: For the maintenance of remission.
Verbatim from this product's MHRA label. Tap a section to expand.
Swallow whole with water. Do not break, crush or chew the tablets before swallowing. 4g) a day in divided doses. 8g) a day in divided doses. 4g) a day once daily or in divided doses. 4g) a day in divided doses. 4).
CHILDREN:
Not recommended.
8g/day, there was no difference in the adverse event profiles between doses. 8 g/day treatment group Adverse events seen with oral mesalazine products are predominantly gastrointestinal, including nausea, vomiting, diarrhoea, and abdominal pain.
Headache and arthralgia/myalgia have also been reported. Undesirable effects reported from clinical studies and post marketing surveillance are listed below. Common, (≥1/100 to <1/10), uncommon (≥ 1/1,000 to <1/100), rare (≥ 1/10,000 to <1/1,000), very rare (< 1/10,000), frequency not known (cannot be estimated from the available data).
System organ class Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Frequency not known Blood and lymphatic system disorders leucopenia, neutropenia, agranulocytosis, aplastic anaemia and thrombocytopenia * Immune system disorders hypersensitiv ity reactions* Nervous system disorders headache peripheral neuropathy, vertigo Idiopathic intracranial hypertension * Cardiac disorders myocarditis, pericarditis* Respiratory thoracic and mediastinal disorders bronchospasm, eosinophilic pneumonia interstitial pneumoniti s Pleurisy, allergic and fibrotic lung reactions Gastrointestin al disorders nausea, vomiting, diarrhoea, abdominal pain pancreatitis exacerbatio n of the symptoms of colitis Constipatio n Hepato-biliary disorders abnormalities of hepatic function (including hepatic failure) / abnormal liver function test, hepatitis Skin and subcutaneous tissue disorders alopecia, lupus erythematosus- like reactions, rash (including urticaria), bullous skin reactions erythema multiforme Drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens- Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)* Musculoskelet al connective tissue and bone disorders arthralgia/ myalgia Renal and urinary disorders interstitial nephritis and nephrotic syndrome.
4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard
1 3 PHARMACEUTICAL FORM Modified ReleaseTablets Red-brown, oblong tablets marked ‘WC 800’. 1 Therapeutic indications Ulcerative colitis: For the treatment of mild to moderate acute exacerbations. For the maintenance of remission.
Crohn’s ileo-colitis:
For the maintenance of remission. 2 Posology and method of administration Swallow whole with water. Do not break, crush or chew the tablets before swallowing. 4g) a day in divided doses. 8g) a day in divided doses. 4g) a day once daily or in divided doses.
4g) a day in divided doses. 4).
CHILDREN:
Not recommended. 3 Contraindications A history of sensitivity to salicylates or any of the ingredients; renal sensitivity to sulfasalazine. Confirmed severe renal impairment (GFR less than 20 ml/min). Severe hepatic impairment. Gastric or duodenal ulcer, haemorrhagic tendency.
4 Special warnings and precautions for use Geriatric Use Use in the elderly should be cautious and subject to patients having normal renal function. Intolerance Mesalazine inhibits the thiopurine methyl-transferase (TPMT) activity in vitro and may therefore impair the metabolism of azathioprine, thioguanine and 6-mercaptopurine.
Standard haematological indices (including the white cell count) should be monitored repeatedly in patients taking azathioprine, especially at the beginning of such combination therapy, whether or not mesalazine is prescribed. Mesalazine has been implicated in the production of an acute intolerance syndrome characterized by cramping, acute abdominal pain and bloody diarrhoea, sometimes fever, headache and a rash; in such cases prompt withdrawal is required.
The patient’s history of sulfasalazine intolerance, if any, should be re-evaluated. If a rechallenge is performed later in order to validate the hypersensitivity, it should be carried out under close supervision and only if clearly needed, giving consideration to reduced dosage.
A history of sensitivity to salicylates or any of the ingredients; renal sensitivity to sulfasalazine. Confirmed severe renal impairment (GFR less than 20 ml/min). Severe hepatic impairment. Gastric or duodenal ulcer, haemorrhagic tendency.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Mesalamine in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
The possibility of increased absorption of mesalazine and concomitant renal tubular damage as noted in the preclinical studies must be kept in mind. Patients on mesalazine 1000 mg, especially those on concurrent oral products which contain or release mesalazine and those with pre-existing renal disease, should be carefully monitored with urinalysis, BUN and creatinine testing.
, in toilets cleaned with sodium hypochlorite contained in certain bleaches). Mesalazine is excreted rapidly by the kidney, mainly as its metabolite, N- acetyl-5-aminosalicylic acid. In rats, large doses of mesalazine injected intravenously produce tubular and glomerular toxicity.
3). Patients on mesalazine should have renal function monitored, (with serum creatinine levels measured) prior to treatment start. Renal function should then be monitored periodically during treatment, for example every 3 months for the first year, then every 6 months for the next 4 years and annually thereafter, based on individual patient history.
Physicians should take into account risk factors such as prior and concomitant medications, duration and severity of disease and concurrent illnesses. Mesalazine-induced nephrotoxicity should be suspected in patients developing renal dysfunction during treatment.
Treatment with mesalazine should be discontinued if renal function deteriorates. If dehydration develops, normal electrolyte and fluid balance should be restored as soon as possible. Nephrolithiasis Cases of nephrolithiasis have been reported with the use of mesalazine, including stones of 100% mesalazine content.
It is recommended to ensure adequate fluid intake during treatment. Hepatic Failure There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered mesalazine. Evaluate the risk and benefits of using mesalazine in patients with known liver impairment.
Blood Dyscrasias Serious blood dyscrasias (some with fatal outcome) have been reported very rarely with mesalazine. Haematological investigations including a complete blood count may be performed prior to initiation and whilst on therapy according to the physician’s judgement.
Such tests should be done immediately if the patient develops unexplained bleeding, bruising, purpura, anaemia, fever or sore throat. Treatment should be stopped if there is suspicion or evidence of blood dyscrasia. Severe cutaneous adverse reactions Severe cutaneous adverse reactions (SCARs), including Drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in association with mesalazine treatment.
Mesalazine should be discontinued, at the first appearance of signs and symptoms of severe skin reactions, such as skin rash, mucosal lesions, or any other sign of hypersensitivity. Sensitivity/Hypersensitivity Caution should be exercised when mesalazine (5-ASA) is initially used in patients known to be allergic to sulfasalazine.
These patients should be instructed to discontinue therapy if signs of rash or fever become apparent. In case of an allergic reaction, appropriate measures (standard of care) should be taken. Cardiac hypersensitivity reactions Mesalazine-induced cardiac hypersensitivity reactions (myo- and pericarditis) have rarely been reported with mesalazine containing products.
In case of previous […]