TCL-R 10

Generic

Atorvastatin Calcium

 

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 hypertriglyceridemia 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 and Administration

Adults with primary hypercholesterolemia and concomitant hyperlipidemia: Usually 10 mg once daily; if necessary, up to 80 mg once daily at intervals of at least 4 weeks.

Child (10-18 years): Start with 10 mg once daily, then gradually increase over 4 weeks to the typical maximum of 20 mg once daily.

Adults with familial hypercholesterolemia: Start with 10 mg daily and gradually increase to 40 mg once daily over at least 4 weeks; if necessary, add to 80 mg once daily (or 40 mg once daily combined with anion-exchange resin in heterozygous familial hypercholesterolemia).

Child (10-18 years): Start with 10 mg once a day, then gradually increase to 80 mg once daily at least every four weeks if necessary.

Adults: Start with 10 mg once daily and adjust as needed based on response.

 

Interaction

Concurrent use of cyclosporin, fabric 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

Patients who are hypersensitive to any component of TCL-R 10 should avoid taking it. Active liver disease or unexplained chronic transaminase increases are contraindicated with TCL-R 10. It's also not recommended for patients who have had a significant reaction to HMG-CoA reductase inhibitors in the past.

 

Side Effects

Patients who are hypersensitive to any component of TCL-R 10 should avoid taking it. Active liver disease or unexplained chronic transaminase increases are contraindicated with TCL-R 10. It's also not recommended for patients who have had a significant reaction to HMG-CoA reductase inhibitors in the past.

 

Pregnancy & Lactation

TCL-R 10 is not recommended for use during pregnancy. There is no evidence of safety in pregnant women. There have been no controlled clinical trials with atorvastatin in pregnant women. There have been a few cases of congenital abnormalities following intrauterine exposure to HMG-CoA reductase inhibitors. Reproduction toxicity has been demonstrated in animal studies. The use of atorvastatin by the mother may lower the amount of mevalonate in the fetus, which is a precursor to cholesterol manufacturing. Women who are pregnant, trying to become pregnant, or fear they are pregnant should avoid taking atorvastatin. Treatment with atorvastatin should be discontinued during pregnancy or until the woman is no longer pregnant.

Lactation: It is unknown if atorvastatin or its metabolites are excreted in human milk. The amounts of atorvastatin and its active metabolites in rats' plasma are similar to those found in milk. Breastfeeding is not recommended for women taking atorvastatin because of the risk of major side effects. Taking atorvastatin while nursing is not recommended.

 

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.

 

Therapeutic Class

Statins and other anti-anginal and anti-ischemic medications.

 

Storage Conditions

Keep away from light and heat in a dry location. Keep out of children's reach.

 

Pharmaceutical Name

Aristopharma Ltd

 

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