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Atasin®
Atorvastatin
Description
Atasin® is a preparation of Atorvastatin which is a lipid-lowering agent. It’s a selective,
competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-
hydroxy-3-methylglutaryl-coenzyme A to Mevalonate, a precursor of sterols, including
cholesterol. Cholesterol and triglycerides circulate in the bloodstream as part of
lipoprotein complexes. Elevated plasma levels of total cholesterol (total-C), LDLcholesterol
(LDL-C), and apolipoprotein B (Apo B) promote human atherosclerosis and
are risk factors for developing cardiovascular disease, while increased levels of HDL-C
are associated with a decreased cardiovascular risk.
Indications
Therapy with lipid-altering agents should be only one component of multiple risk factor
intervention in individuals at significantly increased risk for atherosclerotic vascular
disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to
diet when the response to a diet restricted in saturated fat and cholesterol and other
nonpharmacologic measures alone has been inadequate. In patients with CHD or
multiple risk factors for CHD, Atasin® can be started simultaneously with diet.
(a) Prevention of cardiovascular disease
(a.1) In adult patients without clinically evident coronary heart disease, but with
multiple risk factors for coronary heart disease such as smoking, hypertension, age,
low HDL-C [Overweight (BMI: 25-29 kg/m2) or obesity (BMI: >30 kg/m2), high
carbohydrate intake (>60% of total energy intake), physical inactivity etc.], a family
history of early coronary heart disease. Atasin® is indicated to reduce the risk of :
Myocardial infarction
Stroke
Revascularization procedures and angina
(a.2) In patients with type 2 diabetes and without clinically evident coronary heart
disease, but with at least one additional risk factor for cardiovascular disease such as
retinopathy, albuminuria, smoking, hypertension, age, family history of early CHD etc.,
Atasin® is indicated to reduce the risk of :
Myocardial infarction
Stroke
(a. 3) In patients with clinically evident coronary heart disease, Atasin® is indicated to
reduce the risk of :
Myocardial infarction
Fatal and non-fatal stroke
Revascularization procedures
Hospitalization for CHF
Angina
(b) Hyperlipidemia
(b.1) As an adjunct to diet to reduce elevated total-C, LDL-C, Apo B, and TG levels
and to increase HDL-C patients with primary hypercholesterolemia and mixed
dyslipidemia.
(b.2) As an adjunct to diet to reduce total-C, LDL-C, and Apo B levels in boys and
postmenarchal girls, 10 to 17 years of age, with an adequate trial of diet therapy the
following findings are present :
i. LDL-C remains ≥190 mg/dL or
i i. LDL-C remains ≥160 mg/dL and :
There is a positive family history of premature cardiovascular disease or
Two or more other CVD risk factors are present in the pediatric patient
Dosage and administration
Atasin® can be administered as a single dose at any time of the day, with or without
food. The starting dose and maintenance doses of Atasin® should be individualized
according to patient characteristics such as goal of therapy and response.
The recommended starting dose of Atasin® is 10 or 20 mg once daily. Patients who
require a large reduction in LDL-C (more than 45%) may be started at 40 mg once
daily, The dosage range of Atasin® is 10 to 80 mg once daily.
After initiation and/or upon titration of Atasin®, lipid levels should be analyzed within 2
to 4 weeks and dosage adjusted accordingly.
Patients with renal impairment
Renal disease does not affect the plasma concentrations nor LDL-C reduction of
Atorvastatin; thus, Dosage adjustment in patients with renal Dysfunction is not
necessary.
Geriatric use: No overall differences in safety or effectiveness were observed between
elderly and younger subjects, and other reported clinical experience has not identified
differences in responses between the elderly and younger patients, but greater
sensitivity of some older adults cannot be ruled out. Since advanced age (>65years) is
a predisposing factor for myopathy, Atorvastatin should be prescribed with caution in
the elderly.
Children and adolescents: Safety and effectiveness in patients 10-17 years of age
with heterozygous familial hypercholesterolemia have been evaluated in a controlled
clinical trial of 6 months’ duration in adolescent boys and postmenarchal girls. Patients
treated with Atorvastatin had an adverse experience profile generally similar to that of
patients treated with placebo. Doses greater than 20 mg have not been studied in this
patient population.
Atorvastatin has not been studied in controlled clinical trials involving pre-pubertal
patients or patients younger than 10 years of age.
Use in pregnancy and lactation
Pregnancy category X. Atorvastatin is contraindicated in women who are or may
become pregnant. It is not known whether Atorvastatin is excreted in human milk, but
a small amount of another drug in this class does pass into breast milk. Statins have a
potential to cause serious adverse reactions in nursing infants, women requiring
Atorvastatin treatment should be advised not to nurse their infants.
Side-effects
The most commonly reported adverse reactions in patients treated with Atorvastatin in
placebo-controlled trials regardless of causality were: nasopharyngitis, arthralgia,
diarrhea, myalgia, pain in extremity, and urinary tract infection.
Contraindications
Atorvastatin is contraindicated in patients who are hypersensitive to any component of
this product or to any of its ingredients. It is also contraindicated in patients with
active liver disease, which may include unexplained persistent elevations in hepatic
transaminase levels.
Precautions
Atorvastatin should be used with caution in patients who consume substantial
quantities of alcohol and/ar have a history of liver disease. A history of renal
impairment may be a risk factor for the development of rhabdomyolysis. Atorvastatin,
like other Statins, occasionally causes myopathy, defined as muscle aches or muscle
weakness. The concomitant use of higher doses of Atorvastatin with certain drugs such
as cyclosporine and strong CYP3A4 inhibitors (e.g., ctarithromycin, itraconazole, and
HIV protease inhibitors increases the risk of myopathy / rhabdomyolysis
Drug Interactions
The risk of myopathy during treatment with Statins is increased with concurrent
administration of fibric acid derivatives, lipid-modifying doses of niacin, cyclosporine, or
strong CYP3A4 inhibitors (e.g., clarithromycin, rifarnpin, efavirenz, HIV protease
inhibitors, and itraconazole).
Overdosage
There is no specific treatment for Atorvastatin overdosage. In the event or an
overdose, the patient should be treated symptomatically, and supportive measures
instituted as required. Due to extensive clrug binding to plasma proteins, hemodialysis
is not expected to significantly enhance Atorvastatin clearance.
Pharmaceutical precautions
Store in a cool and dry place. Protect from light.
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