COMPOSITION:

Each film coated tablet contains:

• For Borgastatin 10 mg Tablets:

Atorvastatin calcium ……… (Equivalent to Atorvastatin 10 mg)

• For Borgastatin 20 mg Tablets:

Atorvastatin calcium ……… (Equivalent to Atorvastatin 20 mg)

• For Borgastatin 40 mg Tablets:

Atorvastatin calcium ……… (Equivalent to Atorvastatin 40 mg)

PHARMACOLOGICAL ACTION:

Borgastatin (atorvastatin calcium) is a synthetic lipid-lowering agent. It is a selective, competitive inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol.

INDICATIONS AND CLINICAL USE:

Borgastatin is indicated as an adjunct to lifestyle changes, including diet, for the reduction of elevated total cholesterol (total-C), LDL-C, triglycerides (TG), the Total-C/HDL-C ratio and for increasing HDL-C in hyperlipidemic and dyslipidemic conditions, including:
• Primary hypercholesterolemia (Type IIa).
• Mixed hyperlipidemia (Type IIb), including familial combined hyperlipidemia,
• Dysbetalipoproteinemia (Type III).
• Hypertriglyceridemia (Type IV).

DOSAGE & ADMINISTRATION:

Hyperlipidemia and Mixed Dyslipidemia

The recommended starting dose of Borgastatin is 10 or 20 mg once daily. Patients who require a large reduction in LDL-C (more than 45%) may be started at 40 mg once daily. The dosage range of Atorvastatin is 10 to 80 mg once daily. Borgastatin can be administered as a single dose at any time of the day, with or without food. The starting dose and maintenance doses of Borgastatin should be individualized according to patient characteristics such as goal of therapy and response. After initiation and/or upon titration of Borgastatin, lipid levels should be analyzed within 2 to 4weeks and dosage adjusted accordingly.

Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10 Years to 17 Years of Age)

The recommended starting dose of Borgastatin is 10 mg/day; the usual dose range is 10 to 20 mg orally once daily. Doses should be individualized according to the recommended goal of therapy. Adjustments should be made at intervals of 4 weeks or more Homozygous Familial Hypercholesterolemia

The dosage of Borgastatin in patients with HoFH is 10 to 80 mg daily. Borgastatin should be used as an adjunct to other lipid- lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.

SIDE EFFECTS:

Borgastatin is generally well tolerated, the most frequent adverse events which may occure:

Constipation, Flatulence, dyspepsia, abdominal pain, arthritis, insomnia, dizziness.

CONTRA-INDICATIONS:

Borgastatin Tablets is contraindicated:

– In patients with hypersensitivity to rosuvastatin.
– In patients with active liver disease including unexplained, persistent elevations of serum transaminases and any serum transaminase elevation exceeding 3 x the upper limit of normal (ULN).
– During pregnancy and lactation and in women of childbearing potential not using appropriate contraceptive measures.

PRECAUTIONS & WARNINGS:

Hepatic Effects
Borgastatin is contraindicated in patients with active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal.
Borgastatin should be discontinued or the dose reduced if the level of transaminases is greater than 3 times the upper limit of normal.
Muscle Effects
Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with rosuvastatin and with other HMG-CoA reductase inhibitors.

PACKAGE & STORAGE:

Borgastatin 10 mg Tablets:

Carton box containing (transparent PVC/Alu) blister of 10 tablets

Borgastatin 20 mg Tablets:

Carton box containing (Alu/Alu) strip of 10 film coated tablets with insert leaflet

Borgastatin 40 mg Tablets:

Carton box containing (transparent PVC/Alu) blister of 10 tablets.
– Store at a temperature not exceeding 30 °C, in a dry place.
– Not to be used except under doctor supervision.

RELATED PRODUCTS: (Cardiovascular Products)

Borgavix 75
Betaxolol 10-20
Rosuvastatin 10

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