Salofalk

Salofalk

mesalazine

Manufacturer:

Dr Falk

Distributor:

DCH Auriga
Concise Prescribing Info
Contents
Mesalazine
Indications/Uses
Gastro-resistant tab: Acute exacerbations of ulcerative colitis & Crohn's disease; relapse prophylaxis of ulcerative colitis. Supp: Acute episodes & maintenance of remission of ulcerative colitis that is limited to the rectum. Gastro-resistant PR granules: Acute episodes & maintenance of ulcerative colitis remission. Enema: Acute attacks of ulcerative colitis.
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. Relapse prophylaxis/long-term therapy: 1.5 g daily. Supp Adult & elderly Ulcerative colitis Acute episode: One 500-mg supp inserted into the rectum tds. Enema Adult & elderly Symptoms of acute inflammation 2 enema bottles once daily at bedtime. Gastro-resistant PR granules Adult & elderly Ulcerative colitis Acute episode: 1.5-3 g once daily, preferably taken in the morning. Maintenance of remission: 0.5 g tds. Total dose: 1.5 g/day. Childn ≥6 yr Active disease 30-50 mg/kg/day once daily preferably in the morning or in divided doses. Max: 75 mg/kg/day. Total dose should not exceed the max adult dose. Maintenance: 15-30 mg/kg/day in divided doses. Total dose should not exceed the recommended adult dose. >40 kg Normal adult dose; ≤40 kg ½ the adult dose.
Administration
Should be taken on an empty stomach: Take 1 hr before meals. Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity to salicylates or any of the excipients. Severe hepatic or renal impairment. Should not be used in childn w/ <40 kg body wt.
Special Precautions
Obtain blood tests (differential blood count & liver function parameters) & urinary status prior to & during treatment. Patients w/ pulmonary disease particularly asthma, history of adverse drug reactions to prep containing sulphasalazine. Discontinue if acute intolerance reactions occur. Patients w/ hepatic dysfunction/impairment. Should not be used in patients w/ renal impairment. Pregnancy & lactation. Gastro-resistant tab: Patients on a low Na/salt diet. Should not be used in childn <6 yr. Supp: May cause local skin irritation due to cetyl alcohol content. Enema: Can provoke allergic reactions w/ anaphylactic symptoms & bronchospasm in sensitive patients (particularly those w/ asthma or history of allergies) due to K metabisulphite content. Contains Na benzoate which may provoke hypersensitivity reactions. Gastro-resistant PR granules: Patients w/ phenylketonuria due to aspartame content.
Adverse Reactions
Rarely, headache, dizziness; myocarditis, pericarditis; abdominal pain, diarrhoea, flatulence, nausea, vomiting. Gastro-resistant PR granules: Rarely, photosensitivity.
Drug Interactions
Possible increase in the myelosuppressive effects of azathioprine or 6-mercaptopurine, or thioguanine. Gastro-resistant PR granules: Lactulose or similar prep lowering stool pH (possible reduction of release from granules due to decreased pH caused by bacterial metabolism of lactulose).
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 gastro-resistant PR granules 3 g
Packing/Price
20 × 1's
Form
Salofalk supp 500 mg
Packing/Price
30's
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 gastro-resistant PR granules 1.5 g
Packing/Price
35 × 1's
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