Pentasa

Pentasa

mesalazine

Manufacturer:

Ferring

Distributor:

Metro Drug
Concise Prescribing Info
Contents
Mesalazine
Indications/Uses
PR tab/PR granules: Mild to moderate ulcerative colitis & Crohn's disease. Supp: Acute mild to moderate ulcerative colitis that is limited to rectum (ulcerative proctitis). Enema: Ulcerative proctosigmoiditis.
Dosage/Direction for Use
PR tab Ulcerative colitis Adult Active disease: Up to 4 g daily in divided doses. Maintenance: 2 g once daily or in divided doses. Childn ≥6 yr Active disease: Initially 30-50 mg/kg/day in divided doses. Max: 75 mg/kg/day in divided doses. Do not exceed 4 g/day total dose. Maintenance: Initially 15-30 mg/kg/day in divided doses. Do not exceed 2 g/day total dose. Crohn's disease Adult Active disease: Up to 4 g daily in divided doses. Childn ≥6 yr Active disease: Initially 30-50 mg/kg/day in divided doses. Max: 75 mg/kg/day in divided doses. Do not exceed 4 g/day total dose. Maintenance: Initially 15-30 mg/kg/day in divided doses. Do not exceed 4 g/day total dose. PR granules Ulcerative colitis Adult Active disease: Up to 4 g once daily or divided into 2-4 doses. Maintenance: 2 g once daily. Childn ≥6 yr Active disease: Initially 30-50 mg/kg/day in divided doses. Max: 75 mg/kg/day in divided doses. Do not exceed 4 g/day total dose. Maintenance: Initially 15-30 mg/kg/day in divided doses. Do not exceed 2 g/day total dose. Childn >40 kg Normal adult dose, up to 40 kg ½ of adult dose. Crohn's disease Childn ≥6 yr Active disease: Initially 30-50 mg/kg/day in divided doses. Max: 75 mg/kg/day in divided doses. Maintenance: Initially 15-30 mg/kg/day in divided doses. Do not exceed 4 g/day total dose. Childn >40 kg Normal adult dose, up to 40 kg ½ of adult dose. Supp Ulcerative proctitis 1 supp once daily to bid. Enema Adult 1 rectal susp at bedtime.
Administration
May be taken with or without food: PR tab: Swallow whole, do not chew. May be dispersed in 50 mL cold water to facilitate swallowing the tab. Stir & drink immediately. PR granules: Contents of sachet should be emptied onto the tongue & wash down w/ water/orange juice. Alternatively, can be taken w/ yogurt & consume immediately. Do not chew.
Contraindications
Hypersensitivity to mesalazine or salicylates. Severe liver &/or renal impairment.
Special Precautions
Discontinue immediately in case of acute intolerance reactions, 1st appearance of signs & symptoms of severe skin reactions, or any other signs of hypersensitivity. Discontinue treatment on suspicion or evidence of blood dyscrasia. Assess liver function parameters (eg, ALT or AST) prior to & during treatment. Regularly monitor renal function (eg, serum creatinine) especially during initial phase of treatment. Increase monitoring frequency of renal function in concurrent use of other known nephrotoxic agents. Perform blood test for differential blood count prior to & during treatment. Reports of nephrolithiasis; ensure adequate fluid intake during treatment. Patients allergic to sulphasalazine. Patients w/ impaired liver function. Not recommended in patients w/ renal impairment. Pregnancy & lactation. Discontinue breastfeeding if infants develop diarrhea. PR granules: Monitor patients w/ pulmonary disease, in particular asthma, during course of treatment. Determine urinary status (dip sticks) prior to & during treatment. Perform follow-up tests 14 days after commencement of treatment, then further 2-3 tests at 4-wk interval; every 3 mth if findings are normal. Perform follow-up tests immediately if additional symptoms occur. 1 g PR tab/PR granules/supp: May produce red-brown urine discoloration after contact w/ Na hypochlorite bleach (eg, in toilets cleaned w/ Na hypochlorite contained in certain bleaches).
Adverse Reactions
Headache; diarrhoea, abdominal pain, nausea, vomiting, flatulence; rash (including urticaria, erythematous rash). Supp/enema: Anal discomfort & irritation at application site, pruritus (anal), rectal tenesmus.
Drug Interactions
Higher frequency of myelosuppressive effects w/ azathioprine, 6-mercaptopurine, or thioguanine.
MIMS Class
GIT Regulators, Antiflatulents & Anti-Inflammatories
ATC Classification
A07EC02 - mesalazine ; Belongs to the class of aminosalicylic acid and similar antiinflammatory. Used in the treatment of intestinal inflammation.
Presentation/Packing
Form
Pentasa enema 1 g/100 mL
Packing/Price
7 × 1's
Form
Pentasa PR granules 2 g
Packing/Price
60 × 1's
Form
Pentasa PR tab 1 g
Packing/Price
60's
Form
Pentasa PR tab 500 mg
Packing/Price
100's
Form
Pentasa supp 1 g
Packing/Price
28's