HIGHLIGHT
Salofalk

Salofalk

mesalazine

Manufacturer:

Falk

Distributor:

DCH Auriga
Concise Prescribing Info
Contents
Mesalazine
Indications/Uses
Treatment & prevention of recurrences of ulcerative colitis & Crohn's disease.
Dosage/Direction for Use
Tab Crohn's disease (acute attack) 1.5-4.5 g daily. Ulcerative colitis Acute attack: 1.5-3 g daily. Remission: 1.5 g daily. Supp Ulcerative colitis Acute attack: 1.5 g daily. Remission: 0.75 g daily. Enema Administer 60 mL in the evening. Granules Ulcerative colitis Adult Acute attack: 1-2 sachets once daily in the morning. Remission: 0.5 g tds or 3 g as single daily dose in the morning. Childn Active disease: Individualized dosage, initially 30-50 mg/kg daily in the morning or in divided doses. Max dose: 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. Active peptic ulcer; blood clotting abnormalities. Severe hepatic & renal impairment. Babies & infants.
Special Precautions
Discontinue use if acute intolerability reactions eg, abdominal cramps, acute abdominal pain, fever, severe headache & rash occur. Pulmonary disease eg, asthma. Photosensitivity in patients w/ pre-existing skin conditions eg, atopic dermatitis & eczema. Determine blood tests eg, differential blood count; liver function tests eg, ALT or AST; serum creatinine & dip stick urinalysis prior to & during treatment. Not recommended in renal impairment. Hepatic impairment. Pregnancy & lactation. Elderly. Granules: Unsuitable for phenylketonurics.
Adverse Reactions
Allergic exanthema, drug fever; bronchospasm; lupus erythematosus-like syndrome.
Drug Interactions
Enhanced hypoglycemic effects of sulfonylureas. Coumarins, methotrexate, probenecid, sulfinpyrazone, furosemide, rifampicin. Granules: Possible reduction of release due to decreased pH caused by bacterial metabolism w/ lactulose or similar prep lowering stool pH. Possible increased myelosuppressive effects of azathioprine, 6-mercaptopurine or thioguanine. Decreased anticoagulant effect of warfarin.
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 PR granules 1.5 g
Packing/Price
100 × 1's;35 × 1's
Form
Salofalk supp 500 mg
Packing/Price
30's
Form
Salofalk supp 250 mg
Packing/Price
30's
Form
Salofalk tab 250 mg
Packing/Price
100's
Form
Salofalk enema 2 g/30 mL
Packing/Price
7 × 1's
Form
Salofalk tab 500 mg
Packing/Price
100's
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