Borgastatin 10- 40 mg

COMPOSITION:
Each film coated tablet contains:
• For Borgastatin 10 mg Tablets:

Atorvastatin calcium ……… (Equivalent to Atorvastatin 10 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:

Patients should be placed on a standard cholesterol-lowering diet before receiving
Borgastatin, and should continue on this diet during treatment with Borgastatin.
The recommended starting dose of Borgastatin is 10 once daily.
Patients who require a large reduction in LDL-C may be require increasing the dose at intervals of four weeks with maximum dose of 80 mg once daily.
The dosage of Borgastatin should be individualized according the baseline LDL-C, total-C/HDL-C ratio and/or TG levels to achieve the recommended desired lipid values at the lowest dose needed to achieve LDL-C desired level.

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 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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