Atorvastatin & Fenofibrat Tablets - Manufacturers & Suppliers - Third Party Contract Manufacturing - PCD Pharma Franchise
CORAVAS FB includes Atorvastatin 10mg and Fenofibrate 160 mg.
Atorvastatin belongs to ‘statin’ class of drugs. These drugs are used in maintaining the lipid profile and prevents the events associated with cardiovascular diseases.
Fenofibric acid is a lipid-lowering agent that is used in severe hyper triglyceridemia, primary hyperlipidemia, and mixed dyslipidemia. It works to decrease elevated low-density lipoprotein cholesterol, total cholesterol, triglycerides, apo lipoprotein B, while increasing high-density lipoprotein cholesterol.
Indications
Raise the levels of good cholesterol (HDL)
Mechanism of action
Atorvastatin produces its action by acting as HMG Co A enzyme inhibition which converts 3-hydroxy-3-methylglutaryl-coenzyme A to mevalonate, which is a precursor of cholesterol and sterols.
Fenofibrate activates peroxisome proliferator activated receptor alpha (PPARα), increasing lipolysis, activating lipoprotein lipase, and reducing apoprotein C-III.8,11,12 PPARα is a nuclear receptor and its activation alters lipid, glucose, and amino acid homeostasis.
Dosage
As prescribed by the physician.
Pharmacology
Absorption
Atorvastatin attains its peak plasma concentration attains in 1-2 hrs after oral administration. The bioavailability of the drug is approximately 14%. The presence of food affects the drug availability.
A single 300mg oral dose of fenofibrate reaches a Cmax of 6-9.5mg/L with a Tmax of 4-6h in healthy, fasting volunteers
Distribution
Atorvastatin’s nearly about 98% of the drug is bound to plasma protein. The drugs produce its action by forming its metabolites.
The volume of distribution of fenofibrate is 0.89L/kg,4 and can be as high as 60L.
Excretion
After pharmacological action atorvastatin is excreted through bile. The elimination half life is 14 hrs.
5-25% of a dose of fenofibrate is eliminated in the feces, while 60-88% is eliminated in the urine.
Precautions
• Patients with hepatic dysfunction
• Increase in fasting glucose level
• In pregnant and lactating mothers
• Contraindications
• Hypersensitivity to any of the ingredient
• In lactating and pregnant mothers
Contraindications
Hypersensitivity to the active substance or to any of the excipients