Indications of Divastin 20

Divastin 20 is indicated as an adjunct to diet to reduce elevated total cholesterol, LDL cholesterol, apolipoprotein B (Apo-B), and triglycerides levels in following diseases when the response to diet and other non-pharmacological measures is inadequate.

• To reduce total cholesterol and LDL cholesterol in patients with heterozygous and homozygous familial hypercholesterolemia.
• To reduce elevated cholesterol and triglycerides inpatients with mixed dyslipidemia (Fredrickson Type Ia and Ib).
• For the treatment of patients with elevated serum triglyceride levels in hypertriglyceridemia (Fredrickson Type IV).
• For the treatment of patients with dysbetalipoproteinemia (Fredrickson Type III).
• To reduce cardiac ischaemic events in patients with asymptomatic or mild to moderate symptomatic coronary artery disease with elevated LDL-cholesterol levels.
• To reduce total and LDL-cholesterol concentrations in patients with hypercholesterolemia associated with or exacerbated by diabetes mellitus or renal transplantation.

Pharmacology of Divastin 20

Atorvastatin is a selective HMG-CoA reductase inhibitor. This enzyme is the limiting enzyme responsible for converting HMG-CoA to mevalonate, which is the precursor to sterols (including cholesterol). Atorvastatin reduces plasma levels of cholesterol and lipoproteins by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver and increases the number of hepatic LDL receptors on the cell surface to enhance absorption and catabolism of LDL.

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 Divastin 20

The risk of myopathy during Divastin 20 treatment increases with the simultaneous administration of cyclosporin, fibric acid derivatives, erythromycin, azole antifungals, and niacin. When atorvastatin was used in combination with antihypertensive drugs or hypoglycemic drugs, no clinically significant interactions were observed. The patient should be closely monitored if atorvastatin is added to digoxin, erythromycin, oral contraceptives, colestipol, antacids, and warfarin.

Contraindications

Divastin 20 should not be given to patients who are allergic to any component of this drug. Divastin 20 is contraindicated for active liver disease or unexplained elevated serum transaminases. It is also contraindicated for patients with a history of serious adverse reactions to previous use of HMG-CoA reductase inhibitors.

Side Effects of Divastin 20

Divastin 20 is generally well tolerated. The most common side effects of atorvastatin are constipation, flatulence, indigestion, and abdominal pain. Other side effects include infection, headache, back pain, skin rash, weakness, joint pain, and myalgia.

Pregnancy & Lactation

Pregnancy: Divastin 20 is contraindicated during pregnancy. The safety of pregnant women has not been determined. No controlled clinical trials of atorvastatin have been conducted in pregnant women. Rare reports of birth defects have been received after intrauterine exposure to HMG-CoA reductase inhibitors. Animal studies have shown that it is toxic to reproduction. Treatment of mothers with Divastin 20 may reduce the fetus’s mevalonate levels, which is a precursor of cholesterol biosynthesis. Atorvastatin should not be used in women who are pregnant, trying to become pregnant, or are suspected of becoming pregnant. Divastin 20 treatment should be stopped during pregnancy or before it is determined that the woman is not pregnant.

Lactation period: It is unknown whether Divastin 20 or its metabolites are excreted from human milk. In rats, the plasma concentrations of Divastin 20 and its active metabolite are similar to those in milk. Due to the possibility of serious adverse reactions, women taking atorvastatin should not breastfeed their babies. Divastin 20 is contraindicated during lactation.

Precautions & Warnings

Liver effects: Liver function tests should be performed before starting treatment and regularly after treatment. Patients who drink a lot of alcohol or have a history of liver disease should use atorvastatin with caution. If there is a significantly elevated CPK level or myopathy is diagnosed or suspected, atorvastatin treatment should be discontinued.

Therapeutic Class

Other Anti-anginal & Anti-ischaemic drugs, Statins

Storage Conditions

Keep in a dry place away from light and heat. Keep out of the reach of children.

Pharmaceutical Name of Divastin 20

Drug International Ltd

Generic of Divastin 20

Atorvastatin Calcium