NORMALIP F

(Rosuvastatin 5, 10 mg + Fenofibrate 160mg Tablet)

Cardiology

NORMALIP F

(Rosuvastatin 5, 10 mg + Fenofibrate 160mg Tablet)

Cardiology

Indications

Hyperlipidaemias:
Elevated lipid (fat) levels in the blood. Hyperlipidemia can be inherited and increases the risk of disease of the blood vessels leading to stroke and heart disease.

Mixed Dyslipidemia:
Mixed dyslipidemia is defined as elevations in LDL cholesterol and triglyceride (TG) levels that are often accompanied by low levels of HDL cholesterol.

Monotherapy resistant Dyslipidemia.

Prophylaxis of cardiovascular events in high-risk patients

How it works

Rosuvastatin is a synthetic, enantiomerically pure antilipemic agent. It is used to lower total cholesterol, low density lipoprotein-cholesterol (LDL-C), apolipoprotein B (apoB), non-high density lipoprotein-cholesterol (non-HDL-C), and trigleride (TG) plasma concentrations while increasing HDL-C concentrations.
Fenofibrate is a lipid regulating agent indicated as adjunctive therapy to diet to reduce elevated LDL-C, Total-C,Triglycerides and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Fenofibrate is also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia)

Indications

Hyperlipidaemias:
Elevated lipid (fat) levels in the blood. Hyperlipidemia can be inherited and increases the risk of disease of the blood vessels leading to stroke and heart disease.

Mixed Dyslipidemia:
Mixed dyslipidemia is defined as elevations in LDL cholesterol and triglyceride (TG) levels that are often accompanied by low levels of HDL cholesterol.

Monotherapy resistant Dyslipidemia.

Prophylaxis of cardiovascular events in high-risk patients

Dosage

Once daily therapy

Rosuvastatin
Adult: Initially, 5 or 10 mg once daily, may increase dose at 4-weekly intervals to 20 mg daily if necessary. Max: 40 mg once daily.
Renal impairment:  <30 CrCl ml/dl – Contraindicated
Fenofibrate:
Adult: Formulation with improved bioavailability: 40-160 mg once daily may be used.
Hepatic impairment: Contraindicated.

Side Effects

Headache, dizziness, constipation, nausea, vomiting, abdominal pain, myalgia, chest pain, peripheral oedema, depression, insomnia, rash, paraesthesia, asthenia, abnormal LFT, elevated serum transaminase levels.
Potentially Fatal: Severe rhabdomyolysis w/ acute renal failure. Hepatitis, pancreatitis. Rare: Stevens-Johnson syndrome, anaphylaxis, toxic epidermal necrolysis.

Contraindication

Active liver disease or unexplained persistent elevated serum transaminases
Severe renal impairment
Concomitant use w/ ciclosporin and gemfibrozil
Pregnancy and lactation

Technical information

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Cardiology

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