Salofalk Granules / Prolonged Release

Mesalazine
500mg
DR. FALK PHARMA GMBH
Pack size 50 Sachets
Dispensing mode POM
Source GERMANY
AgentPHARMALINK
Retail Price 85.00 AED

Indications

Salofalk Granules / Prolonged Release is used for: Ulcerative colitis, Hairy cell leukaemia

Adult Dose

Oral Ulcerative colitis Adult: Dose is dependant on preparation and brand used. Acute attack: Initially, up to 4 g daily in 2-4 doses; Maintenance of remission: 2 g daily in 2 divided doses.

Child Dose

Oral Ulcerative colitis 5-12 yr: Acute attack: 15-20 mg/kg (max: 1 g) tid; Maintenance of remission: 10 mg/kg (max: 500 mg) 2-3 times daily.

Renal Dose

Renal impairment: CrCl (ml/min) Dosage Recommendation <20 Avoid.

Administration

Contra Indications

Hypersensitivity to mesalazine, salicylates and sulfasalazine. Severe impaired renal (CrCl < 20 ml/min) or hepatic function. Children <2 yr.

Precautions

Mild to moderate impaired renal or hepatic function (test serum creatinine before treatment, every 3 mth for 1st yr, every 6 mth for next 4 yr, then annually). Elderly; active peptic ulcer; pregnancy, lactation; patients predisposed to pericarditis or myocariditis. Counsel patients to report any unexplained bleeding, bruising, purpura, sore throat, fever or malaise during treatment; perform blood count and stop treatment if blood dyscrasias suspected. Counsel patients taking delayed release tablets to report repeatedly unbroken or partially broken tablets in their faeces. Pyloric stenosis may delay release into colon.

Pregnancy-Lactation

Interactions

Do not give with lactulose or other drugs which lower pH for they prevent release of mesalazine. May decrease digoxin absorption.

Adverse Effects

Side effects of Mesalazine : Abdominal pain (if new abdominal pain - consider pancreatitis); headache, nausea; flu; fatigue; fever, rash; sore throat; diarrhoea; joint pain; dizziness; bloating; back pain; haemorrhoids; itching; rectal pain, constipation; hair loss; intolerance syndrome; peripheral oedema; UTI; myocarditis, pre-existing pericarditis; pancreatitis; nephritis; hepatitis; lupus-like syndrome; alopecia; myalgia, arthralgia; increased liver enzyme values. Potentially Fatal: Blood dyscrasias, aplastic anaemia, agranulocytosis; renal toxicity.

Mechanism of Action

Mesalazine is considered to be the active moiety of sulfasalazine. The mechanism of action is uncertain, but may be due to its ability to inhibit local chemical mediators of the inflammatory response especially leukotriene synthesis in the GI mucosa. Action may be topical in terminal ileum and colon rather than systemic.

Note

Salofalk 500mg Granules / Prolonged Release manufactured by DR. FALK PHARMA GMBH. Its generic name is Mesalazine. Salofalk is availble in United Arab Emirates. Farmaco UAE drug index information on Salofalk Granules / Prolonged Release is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.

Some other brands of Mesalazine :