ATOCOR TABLET 40MG

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

ATORVASTATIN CALCIUM

Available from:

THE ZYFAS MEDICAL CO.,

INN (International Name):

ATORVASTATIN CALCIUM

Units in package:

28'stablet Tablets; 30tablet Tablets

Manufactured by:

Dr. Reddy`s Laboratories Ltd.

Summary of Product characteristics

180 - 480 mm
PC - xxxx
Folding size : 180 x 40 mm
to <5 times ULN, treatment discontinuation should be considered.
v
If symptoms resolve and CK levels return to normal, then
re-introduction of atorvastatin or
introduction of an alternative statin may be considered at the lowest
dose and with close
monitoring.
v
Atorvastatin must be discontinued if clinically significant elevation
of CK levels (> 10 times
ULN) occur, or if rhabdomyolysis is diagnosed or suspected.
_Increased risk of rhabdomyolysis_
Risk of rhabdomyolysis is increased when atorvastatin is administered
concomitantly with certain
medications that may increase the plasma concentration of atorvastatin
such as potent inhibitors of
CYP3A4 or transport proteins (eg. ciclosporine, telithromycin,
clarithromycin, delavirdine, stiripentol,
ketoconazole, voriconazole, itraconazole, posaconazole , and
HIV-protease inhibitors including
ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc). The risk
of myopathy may also be increased
with the concomitant use of gemfibrozil and other fibric acid
derivates, erythromycin, niacin and
ezetimibe. If possible alternative (non-interacting) therapies should
be considered instead of these
medicinal products.
_Concomitant treatment with other medicinal products_
Co-administration
of
strong
CYP3A4
inhibitors
(e.g.
ciclosporin,
telithromycin,
clarithromycin,
delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole,
posaconazole and HIV protease
inhibitors including ritonavir, lopinavir, atazanavir, indinavir,
darunavir, etc.) should be avoided if
possible. In cases where co-administration of these medicinal products
with atorvastatin cannot be
avoided, lower starting and maximum doses of atorvastatin should be
considered and appropriate
clinical monitoring of the patient is recommended. In patients taking
telaprevir, concomitant use of
atorvastatin should be avoided. The dose of atorvastatin should not
exceed 40 mg daily when taking
with boceprevir and close clinical monitoring is recommended.
The concurrent u