Tablet Presentation

Each Film Coated Tablet Contains:
Rosuvastatin Calcium IP
Eq. to Rosuvastatin 10 mg
Fenofibrate IP 160 mg

Rosuvastatin falls under the category of statin. It lowers the increased lipid level and reduce the risk of cardiovascular diseases.

Fenofibrate belongs to the class of fibrates and is used with low fat food or other drugs to reduce the fatty substances such as cholesterol and circulating triglycerides in the blood or to increase the level of HDL (good fat)

Indications

• Dyslipidemia
• Reduces the risk of cardiovascular events
• Primary hypercholesterolemia
• severe hypertriglyceridemia

Mechanism of action

Rosuvastatin inhibits the enzyme hydroxymethylglutaryl coenzyme A Reductase which catalyzses the conversion of HMG-COA to mevalonic acid which involves in the synthesis of cholesterol so, rosuvastatin inhibits that enzyme.
Fenofibrate activates the PPAR-alpha receptors that further activates the gene transcription and gene translation to produce peroxisomes contains Hydroxyl Radicals , hydrogen peroxide, oxygen reactive species to promote lipolysis.

Pharmacokinetics

Absorption: Both the drugs are absorbed by oral route of administration
Protein binding: Rosuvastatin is about 88% bound to plasma protein, mainly to serum albumin.
Fenofibrate is mainly bound to albumin and it is about 99.9% bound to serum proteins
Metabolism: Rosuvastatin is metabolized to N-desmethylrosuvastatin
It undergoes hydroxylation and glucuronidation
Excretion: rosuvastatin is excreted via urine and feces
fenofibrate is excreted via urine

Side Effects

• Headache
• Muscle pain
• Weakness
• Nausea
• Dizziness
• Hypersensitivity reactions
• Stomach ache
• Vomiting
• Dark urine
• Yellowing of the eyes

Contraindication

• Contraindicated in patients with known hypersensitivity
• Contraindicated in patients with liver disease
• Contraindicated in pregnant women
• Contraindicated in the patients with renal impairment

Storage

Store it at room temperature.