Generic drug of the therapeutic class: Metabolism and nutrition
active ingredients: Bézafibrate
laboratory: Arrow Generic
Box of 84
Hypercholesterolemia (type IIa) and endogenous hypertriglyceridemia in adults, isolated (type IV) or associated (type IIb and III):
- when an adapted and diligent regime has proved insufficient,
- especially since the cholesterolemia after diet remains high and / or there are risk factors associated.
Continuation of the regime is still essential.
At present, there are no long-term controlled trials demonstrating the efficacy of bezafibrate in the primary or secondary prevention of atherosclerosis complications.
Dosage BEFIZAL 200 mg Film-coated tablet Box of 84
In combination with the diet, this medication is a long-term symptomatic treatment whose effectiveness should be monitored periodically.
The dosage is on average 3 tablets per day, preferably taken during meals.
In case of renal impairment (see pharmacokinetic properties), the dosage should be adjusted according to serum creatinine and creatinine clearance * according to the dosing regimen below:
- creatinine clearance> 60 ml / min / serum creatinine <135 μmol / L (15 mg / L): 3 cps at 200 mg / d.
- creatinine clearance 60 to 40 ml / min / serum creatinine 136 to 225 μmol / L (16 to 25 mg / L): 2 cps at 200 mg / d.
- creatinine clearance 40 to 15 ml / min / serum creatinine 226 at 530 μmol / L (25 to 60 mg / L): 1 cp at 200 mg / d or every other day.
- Creatinine clearance 530 μmol / L (60 mg / L): contraindicated.
* Actual or estimated by Cockroft's formula: adjusted age, weight and sex adjusted serum creatinine value: Clcr = [(140 - age) x weight] / [0.814 x creatinine level]
with age expressed in years,
the weight in kilos,
creatinine in micromol / L.
This formula is valid for older, male subjects, and must be corrected for women by multiplying the result by 0.85.
In dialysis patients, the dosage should be reduced to 200 mg every 3 days, as bezafibrate is not dialysable.
This medication should never be prescribed in the following situations:
- hypersensitivity to bezafibrate, one of its components or other fibrates,
- Hepatic insufficiency,
known photosensitivity reactions to fibrates,
- severe renal insufficiency with serum creatinine> 60 mg / L (> 530 μmol / L) and creatinine clearance <15 ml / min,
- in combination with other fibrates (see section interactions).
NOT RECOMMENDED :
- This drug is generally not recommended in combination with HMG-CoA reductase inhibitors (see section interactions) and during breastfeeding: there is no information on the passage of bezafibrate in breast milk. The prescription is therefore not recommended.
Pregnancy: The results of animal studies have not shown any teratogenic effect. Clinically, no malformative or foetotoxic effect has appeared to date. However, the monitoring of pregnancies exposed to bezafibrate is insufficient to exclude any risk. There is no indication for the prescription of fibrates during pregnancy, with the exception of major hypertriglyceridemia (> 10 g / L) insufficiently corrected by dietetics and which expose to the maternal risk of acute pancreatitis.
Adverse effects Befizal
Cases of muscle damage (diffuse myalgia, painful tenderness, weakness), as well as exceptional cases of rhabdomyolysis, sometimes severe, have been reported as with other fibrates. They are most often reversible when the treatment is stopped (see warnings and precautions for use).
Other undesirable and mild effects have also been reported:
- digestive, gastric or intestinal disorders such as dyspepsia;
- elevation of transaminases (see warnings and precautions for use) and more rarely cholestasis;
- moderate elevation of serum creatinine;
- immunoallergic reactions including immediate or delayed hypersensitivity reactions;
- dizzying sensation;
- cutaneous reactions: pruritus, urticaria, rash, exceptionally photosensitivity reactions (as with other fibrates), alopecia;
- incapacity ; - rare cases of renal failure;
- rare cases of haematological reactions such as anemia, leukopenia, thrombocytopenia and pancytopenia.
Isolated cases of cutaneous hypersensitivity reactions such as erythema multiforme, Stevens-Johnson syndrome and bullous erythroderma may occur. There are currently no controlled studies to assess long-term adverse effects in general and more particularly the risk of cholelithiasis. Nevertheless, isolated cases of cholelithiasis have been reported.