Generic Name: Atorvastatin 10mg
Manufacturer/Distributor: Drug International Limited
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Indications of Divastin 10
Atorvastatin 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 hypercholesterolaemia.
To reduce elevated cholesterol and triglycerides inpatient with mixed dyslipidemia (Fredrickson Type Ia and Ib).
For the treatment of patients with elevated serum triglyceride levels in hypertriglyceridaemia (Fredrickson Type IV).
For the treatment of patients with dysbetalipoproteinaemia (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
Atorvastatin is a selective HMGCoA reductase inhibitor. This enzyme is the limiting enzyme responsible for converting HMGCoA to mevalonate, which is the precursor to sterols (including cholesterol). Atorvastatin reduces plasma levels of cholesterol and lipoproteins by inhibiting HMGCoA 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 of Divastin 10
Primary hypercholesterolaemia and combined hyperlipidaemia-
Adults: Usually 10 mg once daily; if necessary, may be increased at intervals of at least 4 weeks to 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 usual max. 20 mg once daily.
Familial hypercholesterolaemia-
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 hypercholesterolaemia).
Child (10-18 years): Initially 10 mg once daily, increased if necessary at intervals of at least 4 weeks to usual max. 80 mg once daily.
Prevention of cardiovascular events-
Adults: Initially 10 mg once daily adjusted according to response.
Interaction of Divastin 10
The risk of myopathy during Divastin 10 treatment increases with the simultaneous administration of cyclosporin, fibric acid derivatives, erythromycin, azole antifungals, and niacin. When Divastin 10 was used in combination with antihypertensive drugs or hypoglycemic drugs, no clinically significant interactions were observed. If atorvastatin is added to digoxin, erythromycin, oral contraceptives, colestipol, antacids, and warfarin, the patient should be closely monitored.
Contraindications
Divastin 10 should not be given to patients who are allergic to any component of this drug. Atorvastatin 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 HMGCoA reductase inhibitors.
Side Effects of Divastin 10
Divastin 10 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 10 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 HMGCoA reductase inhibitors. Animal studies have shown that it is toxic to reproduction. Treatment of mothers with atorvastatin 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. Atorvastatin treatment should be stopped during pregnancy or before it is determined that the woman is not pregnant.
Lactation period: It is unknown whether Divastin 10 or its metabolites are excreted from human milk. In rats, the plasma concentrations of atorvastatin 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. Atorvastatin 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, Divastin 10 treatment should be discontinued.
Storage Conditions
Keep in a dry place away from light and heat. Keep out of the reach of children.
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