Indications |
Oral Ulcerative colitis Adult: Dose is dependant on preparation and brand used. Pentasa® tablets: Acute attack: Initially, up to 4 g daily in 2-3 divided doses; maintenance of remission: Initially, 1.5 g daily in 2-3 divided doses, adjust subsequently based on response. Pentasa® granules: Acute attack: Initially, up to 4 g daily in 2-4 doses; maintenance of remission: 2 g daily in 2 divided doses. Asacol® tablets: Acute attack: Initially, 2.4 g daily in divided doses; maintenance of remission: 1.2-2.4 g daily in divided doses. Salofalk® tablets: Acute attack: Initially, 1.5 g daily in 3 divided doses; maintenance of remission: 0.75-1.5 g daily in divided doses. Salofalk® granules: Acute attack: Initially, 1.5-3 g daily in 1-3 divided doses; maintenance of remission: 1.5 g daily in 3 divided doses. Child: Dose is dependant on preparation and brand used. Pentasa® tablets: 5-15 yr: Acute attack: 15-20 mg/kg (max: 1 g) tid; maintenance of remission: 10 mg/kg (max: 500 mg) 2-3 times daily. Pentasa® granules: 5-12 yr: Acute attack: 15-20 mg/kg (max: 1 g) tid; maintenance of remission: 10 mg/kg (max: 500 mg) 2-3 times daily. Asacol® tablets: 12-18 yr: Acute attack: Initially, 2.4 g daily in divided doses; maintenance of remission: 1.2-2.4 g daily in divided doses. Salofalk® tablets: 12-18 yr: Acute attack: Initially, 1.5 g daily in 3 divided doses; maintenance of remission: 250-500 mg 2-3 times daily. Salofalk® granules: 6-12 yr: Acute attack: 10-15 mg/kg (max: 1 g) tid; maintenance of remission: 7.5-15 mg/kg (max: 500 mg) bid or 250 mg tid for patients weighing <40 kg.
Rectal Ulcerative proctitis Adult: Pentasa® suppository or suspension enema: 1 g daily. Asacol® suppository: 0.75-1.5 g daily in divided doses; Asacol ® foam enema: 1 g daily if disease affects the rectosigmoid regions or 2 g daily if disease affects the descending colon. Salofalk® suppository: 0.5-1 g bid-tid; Salofalk® foam or suspension enema: 2 g daily. Child: As suppository: Pentasa®: 12-18 yr: 1 g daily for 2-4 wk. Salofalk®: 12-18 yr: 0.5-1 g bid-tid according to response.
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Contraindications |
Hypersensitivity to mesalazine, salicylates and sulfasalazine. Severe impaired renal (CrCl < 20 ml/min) or hepatic function. Children <2 yr. | ||||||||
Warnings / Precautions |
Mild to moderate impaired renal or hepatic function (test serum creatinine before treatment, every 3 mth for 1st yr, every 6 mth for next 4 yr, then annually). Elderly; active peptic ulcer; pregnancy, lactation; patients predisposed to pericarditis or myocariditis. Counsel patients to report any unexplained bleeding, bruising, purpura, sore throat, fever or malaise during treatment; perform blood count and stop treatment if blood dyscrasias suspected. Counsel patients taking delayed release tablets to report repeatedly unbroken or partially broken tablets in their faeces. Pyloric stenosis may delay release into colon. | ||||||||
Adverse Reactions |
Abdominal pain (if new abdominal pain - consider pancreatitis); headache, nausea; flu; fatigue; fever, rash; sore throat; diarrhoea; joint pain; dizziness; bloating; back pain; haemorrhoids; itching; rectal pain, constipation; hair loss; intolerance syndrome; peripheral oedema; UTI; myocarditis, pre-existing pericarditis; pancreatitis; nephritis; hepatitis; lupus-like syndrome; alopecia; myalgia, arthralgia; increased liver enzyme values. Potentially Fatal: Blood dyscrasias, aplastic anaemia, agranulocytosis; renal toxicity. |
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Drug Interactions |
Do not give with lactulose or other drugs which lower pH for they prevent release of mesalazine. May decrease digoxin absorption. See Below for More mesalazine Drug Interactions |
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Lab Interactions |
Interferes with tests for glucosuria using copper reagents and for urobilinogen using Erhlick's reagent. | ||||||||
Mechanism of Actions |
Mesalazine is considered to be the active moiety of sulfasalazine. The mechanism of action is uncertain, but may be due to its ability to inhibit local chemical mediators of the inflammatory response especially leukotriene synthesis in the GI mucosa. Action may be topical in terminal ileum and colon rather than systemic. Absorption: Absorption variable, depending on formulation and route of admin. Distribution: Enters breast milk and crosses placenta (small amounts) after oral dosing; protein-binding: 40-80%. Distribution into other tissues: variable depending on route of admin. Metabolism: Exact metabolism pathways not established. Main site of metabolism is probably liver with some N-acetylation occurring in the intestinal wall and/or lumen (where intestinal flora are involved in the acetylation). Excretion: Dependant upon route of admin. Eliminated via urine <8% as unchanged metabolites) and faeces (<2%). |
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Storage Conditions |
Oral: Tablets: store at below 25°C. Capsule: protect from light and store at 15-30°C. Rectal: Store <25°C; may be refrigerated; do not freeze. Protect from direct heat, light and humidity. | ||||||||
ATC Classification |
A07EC02 - mesalazine ; Belongs to the class of aminosalicylic acid and similar antiinflammatory. Used in the treatment of intestinal inflammation. | ||||||||
Storage |
Oral: Tablets: store at below 25°C. Capsule: protect from light and store at 15-30°C. Rectal: Store <25°C; may be refrigerated; do not freeze. Protect from direct heat, light and humidity. | ||||||||
Available As |
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Mesalazine (Mesalamine)
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Mesalazine (Mesalamine) Containing Brands
Mesalazine (Mesalamine) is used in following diseases
Drug - Drug Interactions of Mesalazine (Mesalamine)
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