Posology : מינונים

4.2     Posology and method of administration

Posology (oral and rectal)
During the acute inflammatory stage and in long-term maintenance therapy, Rafassal must be taken reliably and consistently by the patient. This is essential in order to attain the desired therapeutic success.

Rafassal Caplets

For acute inflammatory symptoms:
Individual dosage up to 4 gram/day, divided into 2 or 3 doses.
Rafassal Caplets should be taken with an ample amount of fluid 1 hour before meals.
As soon as remission occurs, the dose should be reduced (to 2 g divided into 2 or 3 doses, to avoid recurrence.


Children
There is only limited documentation for an effect in children (age 6-18 years).
Children 6 years of age and older
Active disease: To be determined individually, starting with 30-50 mg/kg/day in divided doses. Maximum dose: 75 mg/kg/day. The total dose should not exceed the maximum adult dose (4 grams).
Maintenance treatment (ulcerative colitis): To be determined individually, starting with 15-30 mg/kg/day in divided doses. The total dose should not exceed the recommended adult dose (2 grams).

It is generally recommended that half the adult dose may be given to children up to a body weight of 40 kg; and the normal adult dose to those above 40 kg.

Rafassal Suppositories

For acute inflammatory symptoms: 1 suppository of 500 mg 3 times daily. The suppositories should be inserted deeply.
As soon as remission occurs, the dose should be reduced.


Rafassal Enemas
Dosage should be adjusted to the individual response to each patient.

Higher daily doses are recommended for acute disease episodes, with dose strength tapering as disease remits.
Rectal suspensions of 5-aminosalicylic acid are best retained if administered at bedtime. Optimal results are expected for those individuals retaining the medication during the entire rest period.
Initiate therapy with bedtime administration of a 4 gram enema.

Response to therapy and adjustment of dosage should be determined by periodic examination, including endoscopy and assessment of symptomatology, i.e. frequency of bowel movements and rectal bleeding.
The daily dosage should be tapered when a significant response (improvement) or remission is attained.
Abrupt withdrawal of therapy without tapering to lower daily doses is not recommended.

Maintenance therapy is indicated to assure continued remission. The dosing schedule may be every other day, every third day, or as required. The optimum maintenance dose should be determined for each patient.
If symptoms recur, dosage should be increased to the previously effective level.

The 1 gram enema provides flexibility in dosing.