Salofalk

Salofalk

mesalazine

Manufacturer:

Falk

Distributor:

DCH Auriga
Concise Prescribing Info
Contents
Mesalazine
Indications/Uses
Gastro-resistant tab/PR granules: Acute episodes & maintenance of ulcerative colitis remission. Gastro-resistant tab: Acute episodes of Crohn's diseases. Supp: Ulcerative colitis, proctitis & anal canal inflammation. Enema: Mild & moderate attacks of ulcerative colitis limited to rectum & sigmoid colon.
Dosage/Direction for Use
Gastro-resistant tab Adult Crohn's disease Acute episode: 1.5-4.5 g daily. Ulcerative colitis Acute episode: 1.5-3 g daily. Prevention of recurrence/long-term treatment: 1.5 g daily. PR granules Adult & elderly Acute episodes of ulcerative colitis 1-2 sachets once daily in the morning. Maintenance of remission: 0.5 g tds or 3 g as single daily dose in the morning. Total dose: 1.5 g daily. Supp Acute signs of inflammation Insert one 500-mg supp into the rectum tds. Remission: Reduce to one 250-mg supp tds. Enema Adult & elderly Acute inflammation Instill 2 enema bottles once daily at bedtime. Childn ≥6 yr Active disease: Individualized dosage, initially 30-50 mg/kg daily in divided doses. Max: 75 mg/kg daily. Total dose: Not to exceed max adult dose. Maintenance: Individualized dosage, initially 15-30 mg/kg daily in divided doses. Total dose: Not to exceed max adult dose. Recommended dose: Childn up to 40 kg ½ adult dose, >40 kg Adult dose.
Administration
Should be taken on an empty stomach: Tab: Take 1 hr before meals. Swallow whole, do not chew/crush. PR granules: Place on the tongue w/o chewing. Swallow w/ plenty of liqd.
Contraindications
Hypersensitivity to mesalazine or salicylates. Severe hepatic or renal impairment. Supp: Gastric & duodenal ulcers; haemorrhagic diathesis (predisposition to bleeding).
Special Precautions
Discontinue use at 1st appearance of severe skin reactions eg, skin rash, mucosal lesions or any other sign of hypersensitivity; acute intolerance reactions eg, abdominal cramps, acute abdominal pain, fever, severe headache & rash occur. Patients w/ pulmonary disease eg, asthma; history of adverse drug reactions to sulphasalazine-containing prep. Determine blood tests (eg, differential blood count, liver function parameters & serum creatinine) & urinary status prior to & during treatment. Not to be used w/ renal impairment. Hepatic impairment. Pregnancy & lactation. Gastro-resistant tab/PR granules/enema: Preexisting skin conditions eg, atopic dermatitis & eczema. Gastro-resistant tab/enema: Ensure adequate fluid intake during treatment. Gastro-resistant tab: Patients on low Na salt diet. PR granules: Patients w/ phenylketonuria due to aspartame. Supp: Not to be used in small childn & infants. Enema: May cause severe hypersensitivity reactions & bronchospasm due to K metabisulphite & local irritation due to Na benzoate.
Adverse Reactions
Gastro-resistant tab: Headache. PR granules/supp/enema: Rarely, headache, dizziness; myocarditis, pericarditis; abdominal pain, diarrhoea, flatulence, nausea, vomiting. PR granules/enema: Rarely, photosensitivity. Supp: Rarely, hypersensitivity; myalgia, arthralgia. 
Drug Interactions
Increased myelosuppressive effects w/ azathioprine, 6-mercaptopurine or thioguanine. Decreased anticoagulant effects of warfarin. PR granules: Decreased pH caused by bacterial metabolism w/ lactose or similar prep lowering stool pH. Supp: Potentiated anticoagulative action w/ anticoagulants. Increased gastric side effects w/ glucocorticoids. Potentiated hypoglycaemic effect w/ sulphonylureas. Increased MTX toxicity. Reduced uricosuric effects w/ probenecid, sulphinpyrazone. Reduced diuretic effects w/ spironolactone, furosemide. Reduced tuberculostatic effects w/ rifampicin.
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 2 g/30 mL
Packing/Price
7 × 1's
Form
Salofalk gastro-resistant tab 500 mg
Packing/Price
100's
Form
Salofalk PR granules 1.5 g
Packing/Price
100 × 1's;35 × 1's
Form
Salofalk supp 500 mg
Packing/Price
30's
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