Source: Υπουργείο Υγείας (CY) Revision Year: 2011 Publisher: Medochemie Ltd, p.o box 51409, Limassol, Cyprus
Zafibral is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following:
Tablets should be swallowed whole with a little water following food.
Bezafibrate 600 mg daily, administered as three 200 mg doses, each dose administered following a meal.
No specific dosage reduction is required on the grounds of age alone.
There is inadequate clinical information regarding bezafibrate usage in children to recommend an appropriate dosage.
Bezafibrate is contraindicated in significant hepatic impairment (see “Contraindications”), and should be used with caution in cases of mild hepatic impairment. Bezafibrate is metabolised in the liver; the exact extent is unknown.
Dosage adjustment is mandated in cases of renal impairment, the extent is dependent upon creatinine clearance or serum creatinine levels, as indicated in the following table:
| Creatinine clearance [ml/minute] | Serum creatinine [μmol/L] | Dosage |
|---|---|---|
| >60 ml/minute | <135 μmol/L | 600 mg/day (3 tablets) |
| 60–40 ml/minute | 136–225 μmol/L | 400 mg/day (2 tablets) |
| 40–15 ml/minute | 226–530 μmol/L | 200 mg (1 tablet) every one or two days |
| <15 ml/minute | >530 μmol/L | Contraindicated – see 4.3 |
Further dosage reduction is required for dialysis patients. A 200 mg dose (one tablet) every third day is generally recommended to prevent overdose. Such patients should be closely monitored and supervised.
A rapid therapeutic response is generally obtained, although progressive improvement may become evident over several weeks. In the event there is no adequate clinical response following three to four months of therapy, bezafibrate should be withdrawn and alternative therapy substituted.
No specific affects of acute overdose are known. Rhabdomyolysis has occurred. In case of overdose the administration of the drug should be interrupted. Renal function should be monitored closely. Treatment is symptomatic and supportive. Elimination of the drug may be increased by forced diuresis. Haemodialysis does help in drug removal.
Sixty (60) months.
Store at a temperature not exceeding 25°C, in a dry place.
PVC-Al blisters.
Boxes of 50, 100, 200 and 1000 tablets.
None.
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