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ATORVAZAL 40 ®

atorvazal40_small

Composition:

- Each film coated tablet of Atorvazal® 40 contains:

Atorvastatin 40 mg (as Atorvastatin Calcium Trihydrate).

- Each film coated tablet of Atorvazal® 20 contains:

Atorvastatin 20 mg (as Atorvastatin Calcium Trihydrate).

Indications:

- Atorvazal® is indicated as an adjunct to diet for reduction of elevated cholesterol and triglyceride values, when response to diet and other non pharmacological measures (such as: - physical exercises, weight loss) are inadequate in patient with:-

- Elevated total-Cholesterol, LDL-C, apolipoprotein-B.

- Elevated triglycerides with primary hypercholesterolemia including familial hypercholesterolemia, or Mixed hyper lipidemia.

- Multiple risk factors (including diabetes mellitus) for primary and secondary prophylaxis of cardiovascular events.

Dosage and administration:

-The patient should be placed on standard cholesterol lowering diet before receiving Atorvazal® and should continue on this diet during treatment with Atorvazal®.

- Dosage should be individualized according to baseline LDL-C levels, the goal of therapy, and the patient response.

-Each dose of Atorvazal® is given once a day and may be given at any time of day with or without food .

- The usual initial dose is 10 to 20 mg of Atorvazal® once daily, an initial dose of 40 mg daily may be used in patients who require a large reduction in LDL cholesterol. Adjustment of dose should be made at intervals of 4 weeks up to a maximum of 80 mg daily.

-Pediatric use should only be carried out by Specialist; the recommended starting dose in this population is 10 mg of Atorvazal® /day. The dose may be increased to 80 mg / day according to the response and tolerability.

Contraindications:

- Atorvazal® is contraindicated in patients with:-

- Hypersensitivity to Atorvastatin.

- Liver disease or unexplained elevation of hepatic function test values (Serum transaminases).

- During pregnancy, breast- feeding, and in women of child – bearing potential not using appropriate contraceptive measures.

- Skeletal Muscle disease.

Side effects:

Atorvazal® is generally well tolerated; the adverse effects observed are usually mild and transient.

-The Most frequent adverse events were: Constipation, flatulence, dyspepsia, abdominal pain, headache, nausea, Muscle pain, feeling of weakness , diarrhea and insomnia.

-Less common side effects: anorexia, weight gain, malaise, hypoglycemia, hyperglycemia, tinnitus, rarely cholestatic jaundice.

-Very rarely side effects: taste disturbances, hearing loss, Stevens Johnson syndrome and toxic epidermal necrolysis.

Precautions:

- Liver effects:

- Liver function should be tested prior the initiation of therapy then at regular intervals, patients who develop increased transaminase levels should be monitored until the abnormalities resolve.

If the liver function values are increased to more than triple the normal level and persist over longer period, dose reduction or withdrawal of Atrovastatin is recommended.

- Skeletal muscle effects:

Atorvazal® may, in rare occasion, affect the skeletal muscle and cause myalgia, myositis and myopthy. The increase of muscle enzyme (CPK) in blood should be examined. If it remains clearly elevated over a longer period of time the dose should be reduced or withdrawn.

Drug Interactions:

-The risk of myopathy during treatment with HMG-CoA reductase inhibitors is increased with concurrent administration of cyclosporine, fibric acid derivatives, macrolide antibiotics including erythromycin, azole antifungals, niacin and, on rare occasions, has resulted in rhabdomyolysis with renal dysfunction Secondary to Myoglobinuria

- Concurrent use of Atorvastatin and digoxin may increase digoxin serum concentrations.

- Concurrent use of Atorvastatin and Colestipol decrease plasma   concentration of Atorvastatin.

- Co administration of Atorvastatin with oral Contraceptives produce increases in plasma concentrations of norethindrone and ethinyl oestradiol.

- Co administration of Atorvastatin with an oral antacid suspension containing magnesium and aluminum hydroxides decreased

Plasma concentrations of Atorvastatin.

- Concurrent use of Atorvastatin with grapefruit juice can increase plasma concentrations of Atorvastatin Since grapefruit juice contains one or more components that inhibit CYP3A4, concomitant intake of large quantities of grapefruit juice and Atorvastatin is therefore not recommended.

Pregnancy and lactation:

- Atorvazal® is contraindicated in pregnancy and while breast feeding.

- Atorvazal® should be avoided in pregnancy as the decrease of cholesterol biosynthesis possibly, affects fetal development.

- Women of childbearing potential should use appropriate contraceptive measures.

Properties:

- Atorvastatin is a selective competitive inhibitor of HMG- CoA reductase which is the rate - limiting enzyme responsible for conversion of (HMG- CoA) to Mevalonate, a precursor of sterols including cholesterol.

- Atorvastatin is rapidly absorbed after oral administration; plasma concentrations (Cmax) occur witin 1-2 hours.

- Atorvastatin is 98%bound to plasma proteins.

- It has low absolute bioavailability of about 12%due to presystemic clearance in the liver.

-Atorvastatin is eliminated primarily in bile following hepatic and / or extra hepatic metabolism, the mean plasma elimination half life of Atorvastatin is about 14 hours.

- The half life of inhibitory activity for HMG-CoA reductase is approximately 20-30 hours due to the contribution of active metabolites.

Packaging:

Blister of 10 tablets pack of 3 blisters.

Storage:

Store in a dry and cool place at a temperature below 30o C.