Drug Interaction:
Fenofibrate- Oral anticoagulants-
It increase clotting time and causes bleeding complications. Concomittant administration needs frequent prothrombin time determination
Resins- it impede the absorption the absorption of fenofibrate
Atorvastatin- The risk of myopasthy during treatment with other drugs of this class is increased with concurrent administration.of cyclosporine, fibric acid derivatives, niacin ( nicotinic acid ) eryrthromycin, azole antifungals
Antacids, colestitpol, when coadministred with atorvastatin decreases the plasma concentration of atorvastatin
Co-administration of atorvastain with digoxin, eryhrthromycin,
oral contraceptivs increases the plasma concentration of digoxin, eryhtromycin and oral contraceptives
Indication:
Mixed dyslipidermia
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
FDC of Atorvastatin Calcium 10mg+ 22-12-2004
Finofibrate 160mg Tablet
For Hyperlipdemia
Adverse Reaction:
Fenofibrate- Abnormal liver function tests ,abdominal pain, back pain, respiratory disorder, rhinitis, increase in SGOT, SGPT and creatinine phosphoinase
Atorvastatin- Constipation, flatulence, dyspepsia, abdominal pain, headache, nausea, myalgia, asthenia, diarrhoea, insomnia
Contra-Indications:
Fenofibrate-
Hypersentivity, hepatic and renal dysfunction,unexplained persistent liver function abnormality and primary billiary cirrhosis.
Patients with preexisting gall bladder disease and in lactating mothers.
Atorvastatin-
Active liver disease or unexplained persistent elevation of serum transaminases. Hypersensitivity to any component of this mnedication
Pregnancy and lactation Women of child bearing potential unless on an effective contraceptive and highly unlikely to conceive
Dosages/ Overdosage Etc:
Approved by (DCI) Drug Controller GENERAL - India For Marketing (Ref- IDMA Publication)
Name of Drug Indication Date of Approval
FDC of Atorvastatin Calcium 10mg+ 22-12-2004
Finofibrate 160mg Tablet
For Hyperlipdemia
Indication-
Mixed dyslipidermia
Dosage-
1 tab daily
Pharmacology/ Pharmacokinetics:
Pharmacology
Fenofibrate- reduces plasma total cholestrerol (TC) LDL- C , triglyceride TG ans very low density liopoprotein cholesterol (HDL-C), and apolipoprotein (Apo) AL and ApoAII levels in patients with dyslipedemia.
The lipid modifying effects of fenofubrate are mediated via the activation of the peroxisome proliferator- activated receptors ( PPARs )
Atorvastatin- inhibits hydroxymethylglutaryl coenzyme A HMG-CoA reductase in vivo and in vitro and impedes the formation of mevalonic acid which is the rate limiting step in the biosynthesis of cholesterol.
The reduction in intracellular cholesterol increases the number of LDL receptors, thus increasing the clearance of LDL-C from plasma.
Pharmacokinetics
The result of the study showed that atorvastatin fenofibrate combination reduced total cholesterol by 37%, LDL cholestrol by 46%.
The study concluded that atorvastain-fenofibrate combination has a highly beneficial efect on all lipid parameters and plasma fibronogen in patients with type 2 diabetes and combined hyperlipidermia
Pregnancy and lactation:
Use contraindicated observe caution