Indications of Atova 40

When diet and other non-pharmacological approaches fail to lower increased total cholesterol, LDL cholesterol, apolipoprotein B (Apo-B), and triglyceride levels in the following conditions, atorvastatin is prescribed as an adjuvant to diet.

• To lower total cholesterol and LDL cholesterol in patients with familial hypercholesterolemia, both heterozygous and homozygous.
• To treat patients with combined dyslipidemia who have high cholesterol and triglycerides (Fredrickson Type Ia and Ib).
• For the treatment of hypertriglyceridemia patients with increased blood triglyceride levels (Fredrickson Type IV).
• For the treatment of dysbetalipoproteinemia patients (Fredrickson Type III).

Pharmacology of Atova 40

HMG-CoA reductase inhibitor atorvastatin is a selective inhibitor. The rate-limiting enzyme in the conversion of HMG-CoA to mevalonate, a precursor of sterols including cholesterol, is this enzyme. Atorvastatin reduces plasma cholesterol and lipoprotein levels via blocking HMG-CoA reductase and cholesterol synthesis in the liver, as well as increasing the number of hepatic LDL receptors on the cell surface, resulting in improved LDL uptake and catabolism.

Dosage & Administration

Primary hypercholesterolemia and combined hyperlipidemia-

• Adults: Usually 10 mg once daily; if necessary, may be increased at intervals of at least 4 weeks to the max. 80 mg once daily.
• Child (10-18 years): Initially 10 mg once daily, increased if necessary at intervals of at least 4 weeks to the usual max. 20 mg once daily.

Familial hypercholesterolemia-

• Adults: Initially 10 mg daily, increased at intervals of at least 4 weeks to 40 mg once daily; if necessary, further increased to max. 80 mg once daily (or 40 mg once daily combined with anion-exchange resin in heterozygous familial hypercholesterolemia).
• Child (10-18 years): Initially 10 mg once daily, increased if necessary at intervals of at least 4 weeks to the usual max. 80 mg once daily.

Prevention of cardiovascular events-

• Adults: Initially 10 mg once daily adjusted according to the response.

Interaction of Atova 40

The risk of myopathy during treatment with Atorvastatin is increased with concurrent administration of cyclosporin, fibric acid derivatives, erythromycin, azole antifungals, and niacin. No clinically significant interactions were seen when Atorvastatin was administered with antihypertensives or hypoglycemic agents. Patients should be closely monitored if Atorvastatin is added to digoxin, erythromycin, oral contraceptives, colestipol, antacid, and warfarin.

Contraindications

Atova 40 should not be used in patients with hypersensitivity to any component of this medication. Atorvastatin is contraindicated in active liver disease or unexplained persistent elevations of serum transaminases. It is also contraindicated in patients with a history of serious adverse reactions to prior administration of HMG-CoA reductase inhibitors.

Side Effects of Atova 40

Atova 40 is generally well-tolerated. The most frequent side effects related to Atorvastatin are constipation, flatulence, dyspepsia, abdominal pain. Other side effects include infection, headache, back pain, rash, asthenia, arthralgia, myalgia.

Pregnancy & Lactation

Pregnancy: Atova 40 is contraindicated during pregnancy. Safety in pregnant women has not been established. No controlled clinical trials with atorvastatin have been conducted in pregnant women. Rare reports of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors have been received. Animal studies have shown toxicity to reproduction. Maternal treatment with atorvastatin may reduce the fetal levels of mevalonate which is a precursor of cholesterol biosynthesis. Atorvastatin should not be used in women who are pregnant, trying to become pregnant or suspect they are pregnant. Treatment with atorvastatin should be suspended for the duration of pregnancy or until it has been determined that the woman is not pregnant

Lactation: It is not known whether Atova 40 or its metabolites are excreted in human milk. In rats, plasma concentrations of atorvastatin and its active metabolites are similar to those in milk. Because of the potential for serious adverse reactions, women taking atorvastatin should not breastfeed their infants. Atova 40 is contraindicated during breastfeeding.

Precautions & Warnings

Liver effects: Liver function tests should be performed before the initiation of treatment and periodically thereafter. Atova 40 should be used with caution in patients who consume substantial quantities of alcohol or have a history of liver disease. Atova 40 therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected.

Therapeutic Class

Other Anti-anginal & Anti-ischaemic drugs, Statins

Storage Conditions

Protect from light and moisture by storing in a cool, dry place below 30°C. Keep out of children’s reach.

Pharmaceutical Name of Atova 40

Beximco Pharmaceuticals Ltd

Generic of Atova 40

Atorvastatin Calcium