Atasin 10 Tablet

Indications

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 hypertriglyceridaemia patients with increased blood triglyceride levels (Fredrickson Type IV).
• For the treatment of dysbetalipoproteinemia patients (Fredrickson Type III).
• Reduce myocardial ischemic episodes in people with asymptomatic or mild to moderate symptomatic coronary artery disease and high LDL cholesterol.
• Patients with hypercholesterolemia linked with or aggravated by diabetes mellitus or renal transplantation should have their total and LDL cholesterol levels reduced.

Pharmacology

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 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 the response.

Interaction

Concurrent use of cyclosporin, fibric acid derivatives, erythromycin, azole antifungals, and niacin increases the risk of myopathy while taking Atorvastatin. When Atorvastatin was used with antihypertensives or hypoglycemic medications, no clinically meaningful interactions were seen. If Atorvastatin is used with digoxin, erythromycin, oral contraceptives, colestipol, antacid, or warfarin, patients should be continuously watched.

Contraindications

Atasin 10 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.

Pregnancy & Lactation

Pregnancy: Atasin 10 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 atorvastatin 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. Atorvastatin is contraindicated during breastfeeding.

Precautions & Warnings

Effects on the liver: Liver function tests should be done before starting treatment and then on a regular basis after that. In patients who drink a lot of alcohol or have a history of liver illness, atorvastatin should be administered with caution. If severely raised CPK levels or myopathy is diagnosed or suspected, atorvastatin medication should be stopped.

Side Effects

Overdosing on atorvastatin does not have a specific treatment. Symptomatically, the patient should be treated, and supporting measures should be implemented as needed. Serum CK levels should be monitored and liver function tests should be conducted. Hemodialysis is unlikely to considerably improve atorvastatin clearance due to strong Atasin 10 binding to plasma proteins.

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

ACI Limited

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