Stator 10mg tablets

Dexa Medica

Ingredients in every tablet

Atorvastatin 10 mg

Each package contains

3 blisters of 10 tablets

Other details

Dosage form:Tablet; coated
Flavour: None

W.H.O. classification

ATC Level 1: C - Cardiovascular system
ATC Level 2: C10 - Lipid Modifying Agents
ATC Level 3: C10A - Lipid Modifying Agents; Plain

Warnings

Pregnancy

NOT SAFEThis item is not safe for use during pregnancy.

Lactation

NOT SAFEThis item is not safe for use during lactation.

Alcohol

CAUTIONThis item may not be safe for use with alcohol. Use with caution.

Machinery

CONSULT YOUR DOCTORSafety of this item for use while operating heavy machinery has not been established. Please consult your doctor.

Available in

Indonesia

Dosage information

18 YEARS OLD AND ABOVE
Before instituting therapy with atorvastatin, an attempt should be made to control hypercholesterolemia with appropriate diet, exercise and weight reduction in obese patients, and to treat underlying medical problems. The patient should continue on a standard cholesterol-lowering diet during treatment with atorvastatin.

The usual starting dose is 10 mg once a day. The dosage range is 10 to 80 mg once daily. Doses may be given any time of the day, with or without food. Starting and maintenance dosage should be individualized according to baseline LDL-C levels, the goal of therapy, and patient response. After initiation and/or upon titration of atorvastatin, lipid levels should be analyzed within 2 to 4 weeks, and dosage adjusted accordingly.

Primary hypercholesterolemia and combined (mixed) hyperlipidemia:
The majority of patients are controlled with 10 mg atorvastatin once a day. A therapeutic response is evident within two weeks, and the maximum response is usually achieved within four weeks. The response is maintained during chronic therapy.

Homozygous familial hypercholesterolemia:
In a compassionate-use study of patients with homozygous familial hypercholesterolemia, most patients responded to 80 mg of atorvastatin.

Doses should be individualized according to the recommended goal of therapy. Adjustments should be made at intervals of 4 weeks or more.

0 TO 18 YEARS OLD
Treatment experience in a pediatric population is limited to doses of atorvastatin up to 80 mg/day for one year in 8 patients with homozygous FH. No clinical or biochemical abnormalities were reported in these patients.

Heterozygous familial hypercholesterolemia in pediatric patients (10-17 years of age)
The recommended starting dose of atorvastatin is 10 mg/day; the maximum recommended dose is 20 mg/day (doses greater than 20 mg have not been studied in this patient population).

Doses should be individualized according to the recommended goal of therapy. Adjustments should be made at intervals of 4 weeks or more.

65 YEARS OLD AND ABOVE
No differences in safety, efficacy or lipid treatment goal attainment were observed between elderly patients and the overall population

Doses should be individualized according to the recommended goal of therapy. Adjustments should be made at intervals of 4 weeks or more.

PATIENTS WITH HEPATIC INSUFFICIENCY
Atorvastatin should be used with caution in patients with hepatic impairment. Atorvastatin is contraindicated in patients with active liver disease.

PATIENTS WITH RENAL INSUFFICIENCY
Renal disease has no influence on the plasma concentrations or on the LDL-C reduction of atorvastatin. Thus, no adjustment of the dose is required.

COMBINATION WITH OTHER MEDICINAL COMPOUNDS
In cases where coadministration of atorvastatin with cyclosporine is necessary, the dose of atorvastatin should not exceed 10 mg (See section Warnings and precautions-skeletal muscle effects; and Drug interactions-transporter inhibitors).

Indication

Atorvastatin is indicated as an adjunct to diet for the reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B, and triglycerides in patients with primary hypercholesterolemia, combined (mixed) hyperlipidemia, and heterozygous and homozygous familial hypercholesterolemia when response to diet and other non pharmacological measure are inadequate.

Prevention of cardiovascular complications
In hypertensive patient (40 years or older) and dyslipidemia with at least 3 risk factors for future cardiovascular events such as LVH, ECG abnormalities NIDDM, peripheral vascular disease, post history of cerebrovascular events including TlA ≥3 months previously, microalbuminuria/proteinuria, smoking (regular smoker within the last year of 20 cigarettes or cigars/week), TC/HDL-C ratio ≥6, and history of coronary artery disease event in a first degree relative before age 55 (men) or 60 (women), atorvastatin is indicated to:
– Reduce the risk of fatal coronary heart disease and nonfatal myocardial infarction
– Reduce the risk of stroke.
– Reduce the risk of revascularization procedures and angina pectoris

Pediatric patients (10-17 years of age)
Atorvastatin is indicated 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 heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present:

a. LDL-C remains ≥190 mg/dl or
b. 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

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