Salofalk

Salofalk

mesalazine

Manufacturer:

Dr Falk

Distributor:

Zuellig
/
Agencia Lei Va Hong

Marketer:

A. Menarini
Concise Prescribing Info
Contents
Mesalazine
Indications/Uses
Gastro-resistant tab/PR granules/supp Treatment of acute episodes & prevention of further episodes of ulcerative colitis. Gastro-resistant tab Treatment of acute episodes of Crohn's disease. Enema Treatment of acute episodes of ulcerative colitis.
Dosage/Direction for Use
Gastro-resistant tab Adult & elderly Acute episodes of ulcerative colitis 250-mg tab 2-4 tab tds. 500-mg tab 1-2 tab tds. Prevention of recurrence/long-term treatment of ulcerative colitis 250-mg tab 2 tab tds. 500-mg tab 1 tab tds. Acute episode of Crohn's disease 250-mg tab 2-6 tab tds. 500-mg tab 1-3 tab tds. Childn ≥6 yr Acute episodes 30-50 mg/kg/day in divided doses. Max: 75 mg/kg/day. Total dose should not exceed the max adult dose. Prevention of relapse of ulcerative colitis 15-30 mg/kg/day in divided doses. Total dose should not exceed the recommended adult dose. Gastro-resistant PR granules 1,000 mg Adult, the elderly & childn >40 kg Treatment of acute episodes 3 sachets PO once daily (3 g/day) preferably in the morning, or 1 sachet PO tds. Prevention of further episodes for patients at increased risk for recurrence 3 sachets PO once daily (3 g/day) preferably in the morning. Childn ≥6 yr Treatment of acute episodes Initially 30-50 mg/kg/day once daily or in divided doses. Max: 75 mg/kg/day. Prevention of further episodes Initially 15-30 mg/kg/day in divided doses. Gastro-resistant PR granules 3 g Adult & the elderly Treatment of acute episodes 1 sachet PO once daily preferably in the morning. Prevention of further episodes Patient at increased risk for recurrence: 1 sachet PO once daily preferably in the morning. Childn ≥6 yr, weighing >40 kg Normal adult dose, ≤40 kg ½ of adult dose. Supp Adult & elderly Treatment of acute episodes Insert two 250-mg OR one 500-mg supp into the rectum tds (equivalent to 1,500 mg daily). Long-term prevention of recurrences One 250-mg supp into the rectum tds. Enema Adult & elderly 1 enema once daily.
Administration
Should be taken on an empty stomach: Take 1 hr before meals. Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity to mesalazine, salicylic acid, salicylates or any of the excipients. Serious liver or kidney disease.
Special Precautions
History of lung problems, particularly bronchial asthma. History of allergy to sulphasalazine. Renal & hepatic impairment. Pregnancy & lactation. Childn. Gastro-resistant tab/PR granules/supp Perform regular blood & urine tests during treatment. Gastro-resistant tab Patients on a controlled Na diet. Gastro-resistant PR granules Contains aspartame & sucrose. Enema Contains K metabisulphite & Na benzoate.
Adverse Reactions
Allergic skin rash, breathing difficulties, fever, sore throat & mouth. Gastro-resistant tab/supp Rarely, abdominal pain, diarrhoea, flatulence, nausea & vomiting; headache, dizziness; chest pain, breathlessness or swollen limbs; photosensitivity.
Drug Interactions
Possible interactions w/ azathioprine, 6-mercaptopurine or thioguanine; blood clotting inhibitors eg, warfarin. Gastro-resistant PR granules Possible interaction w/ lactulose or other prep that can alter acidity of stools.
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
Salofalk enema 4 g/60 mL
Packing/Price
60 mL x 7 × 1's
Form
Salofalk gastro-resistant tab 250 mg
Packing/Price
100's
Form
Salofalk gastro-resistant tab 500 mg
Packing/Price
100's
Form
Salofalk gastro-resistant PR granules 1,000 mg
Packing/Price
50 × 1's
Form
Salofalk gastro-resistant PR Granules 3 g
Packing/Price
30 × 1's
Form
Salofalk supp 250 mg
Packing/Price
30's
Form
Salofalk supp 500 mg
Packing/Price
30's
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