Company: Ferring Ireland Ltd.
Legal category: Prescription. GMS. Sport permitted.
Active ingredient: Mesalazine 4g.
Description: White-grey to pale white-brown prolonged-release granules in sachet.
Presentation: 30, €90.28.
Indication: Mild to moderate ulcerative colitis.
Pharmacology: Mesalazine is the active component of sulfasalazine. It inhibits leukocyte chemotaxis, decrease cytokine and leukotriene production and scavenge for free radicals. The mechanism of action of mesalazine is, however, still not understood.
Dosage: Adult: Determine doses individually. Active: Up to 4g once daily or divided into 2-4 doses, placed on the tongue and washed down with water or orange juice (do not chew). Maintenance: 2g once daily. Elderly: As per adults. Children: Determine doses individually. 6-18 years, limited data. Active: Initially 30-50mg/kg/day in divided doses. Maximum 75mg/kg/day in divided doses; maximum total dose 4g/day. Maintenance: Initially, 15-30mg/kg/day in divided doses; maximum 2g/day. General recommendation: Up to 40kg body weight, half the adult dose; >40kg, as per adults. <6 years, safety and efficacy not established.
Contraindications: Hypersensitivity to the active ingredient or to any of the excipients. Severe liver/renal impairment.
Special precautions: Not recommended: Haemorrhagic diathesis, renal impairment. Caution: Active peptic ulcer, allergy to sulphasalazine, hepatic impairment. Acute intolerance symptoms (discontinue immediately). Regularly monitor serum creatinine (especially at start of treatment); determine urinary status prior to and during treatment; if renal dysfunction develops suspect nephrotoxicity. Pulmonary disease (especially asthma); carefully monitor. Prior to and during treatment, monitor hepatic/renal function, differential blood counts. Follow-up tests recommended, 14 days after initiation, 2-3 tests at 4 week intervals, every 3 months thereafter; additional symptoms (test immediately). Cardiac hypersensitivity reactions, blood dyscrasias, reported rarely/very rarely, respectively; discontinue. Lactation (diarrhoea, discontinue), pregnancy; only if benefit outweighs risk.
Drug interactions: Caution: Azathioprine, 6-mercaptopurine, thioguanine. Warfarin, other nephrotoxic agents (e.g. non-steroidal anti-inflammatory drugs).
Adverse drug reactions: Headache, gastrointestinal disorders, rash.
Full prescribing information and references available from Ferring Ireland Ltd. Telephone: (01) 4637355. Email: enquiries.ireland@ferring.com