Tablet Manufacturer/Distributor: Eskayef Bangladesh Ltd. Generic Name: Atorvastatin 10 mg Tablet
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Indications
When diet and other non-pharmacological methods fail to lower high total cholesterol, LDL cholesterol, apolipoprotein B (Apo-B), and triglyceride levels in the following illnesses, atorvastatin is prescribed as an adjuvant to diet.
To lower total cholesterol and LDL cholesterol in individuals 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 high 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 worsened 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 production in the liver, as well as increasing the number of hepatic LDL receptors on the cell surface, resulting in improved LDL absorption 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 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
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 or erythromycin, patients should be continuously watched.
Contraindications
Patients who are hypersensitive to any component of atorvastatin should avoid taking it. Active liver disease or unexplained chronic transaminase increases are contraindicated with atorvastatin. It's also not recommended for patients who have had a severe reaction to HMG-CoA reductase inhibitors in the past.
Side Effect
Lipicon 10 is well tolerated by most people. Constipation, flatulence, dyspepsia, and stomach discomfort are the most common Lipicon 10 side effects. Infection, headache, back pain, rash, asthenia, arthralgia, and myalgia are some of the other adverse effects.
Pregnancy & Lactation
Lipicon 10 is not recommended for use during pregnancy. There is no evidence of safety in pregnant women. There have been no controlled clinical studies using atorvastatin in pregnant women. There have been a few instances 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 production. Women who are pregnant, attempting to get pregnant, or believe they are pregnant should avoid taking atorvastatin.
It is unknown if atorvastatin or its metabolites are excreted in human milk during lactation. The amounts of atorvastatin and its active metabolites in rats' plasma are similar to those seen in milk. Breastfeeding is not recommended for women taking atorvastatin because of the risk of significant side effects. Taking atorvastatin during nursing is not recommended.
Precautions & Warnings
Effects on the liver: Liver function tests should be done before starting therapy and then on a regular basis after that. In individuals who drink a lot of alcohol or have a history of liver illness, atorvastatin should be taken with care. If substantially increased CPK levels or myopathy is detected or suspected, atorvastatin treatment should be stopped.
Therapeutic Class
Other Anti-anginal & Anti-ischaemic drugs, Statins
Storage Conditions
Keep away from light and heat in a dry area. Keep out of children's reach.
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