Salofalk

Mesalazine.

Pharmacology: The mechanism of the anti-inflammatory action is unknown. The results of in vitro studies indicate that inhibition of lipoxygenase may play a role.
Effects on prostaglandin concentrations in the intestinal mucosa have also been demonstrated. Mesalazine (5 aminosalicylic acid / 5-ASA) may also function as a radical scavenger of reactive oxygen compounds.
Pharmacokinetics: Mesalazine and its metabolite N-Ac-5-ASA are eliminated via the faeces (major part), renally (varies between 20 and 50 %, depending on the kind of application, pharmaceutical preparation and route of mesalazine release, respectively), and biliary (minor part). Renal excretion predominantly occurs as N-Ac-5-ASA. About 1 % of the total orally administered mesalazine dose is excreted into the breast milk mainly as N-Ac-5-ASA.

For the treatment of acute episodes and the maintenance of remission of ulcerative colitis.

Tablet: Adults: Acute Treatment: Ulcerative Colitis: 150-300 mg in divided dose 3 times a day. Crohn's Disease: 150-450 mg in divided dose 3 times a day. Maintenance Treatment: 500 mg tab 3 times a day. Use only in patients with normal kidney functions. Salofalk should be taken 1 hr before meals with plenty of fluid.
Granules: Adults and the elderly: For the treatment of acute episodes of ulcerative colitis: Once daily, 1-2 sachets of Salofalk 1.5 g granules, (equivalent to 1.5-3.0 g mesalazine daily) preferably to be taken in the morning according to the individual clinical requirement.
For the maintenance of remission of ulcerative colitis: The standard treatment is 0.5 g mesalazine three times daily (in the morning, at midday and in the evening) corresponding to a total dose of 1.5 g mesalazine per day.
For patients known to be at increased risk for relapse for medical reasons or due to difficulties to adhere to application of three daily doses, the dosing schedule can be adapted to 3.0 g mesalazine given as a single daily dose, preferably in the morning.
Suppository: one or two suppositories two to three times daily.
Enema: Unless otherwise prescribed by your doctor, the recommended dose for the treatment of acute episodes of ulcerative colitis is one enema a day to be used at bedtime.

Patients with Hypersensitivity to the active substance, to salicylates or to any of the excipients.
Severe impairment of hepatic or renal function.
Use in children: Children 6 years of age and older: Active disease: To be determined individually, starting with 30-50mg/kg/day once daily preferably in the morning or in divided doses. Maximum dose: 75mg/kg/day. The total dose should not exceed the maximum adult dose.
Maintenance treatment: To be determined individually, starting with 15-30 mg/kg/day in divided doses. The total dose should not exceed the recommended adult dose.
It is generally recommended that half the adult dose may be given to children up to a body weight of 40kg and the normal adult dose to those above 40kg.

It is recommended that in patients with renal impairment, mesalazine should be used with caution and only after a careful evaluation of the potential benefit against risk of treatment.
Use in pregnancy & lactation: Animal studies on oral mesalazine do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Salofalk should only be used during pregnancy if the potential benefit outweighs the possible risk.
Use in Elderly: Salofalk should be used with caution in elderly patients.

Animal studies on oral mesalazine do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Salofalk should only be used during pregnancy if the potential benefit outweighs the possible risk.

Hypersensitivity eg, allergic exanthema (skin rash), drug fever, bronchospasm and lupus erythematosus (LE)-like syndrome cannot be excluded. Elevated methemoglobin levels may occur.

Specific interaction studies have not been performed. Lactulose or similar preparations which lower stool pH: possible reduction of mesalazine release from granules due to decreased pH caused by bacterial metabolism of lactulose. In patients who are concomitantly treated with azathioprine, 6-mercaptopurine or thioguanine, a possible increase in the myelosuppressive effects of azathioprine, 6-mercaptopurine or thioguanine should be taken into account. There is weak evidence that mesalazine might decrease the anticoagulant effect of warfarin.

Keep in a cool, dry place.

GIT Regulators, Antiflatulents & Anti-Inflammatories

A07EC02 - mesalazine ; Belongs to the class of aminosalicylic acid and similar antiinflammatory. Used in the treatment of intestinal inflammation.

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