CEMICRESTO 20mg ® Tablets

Each Tablet contain :

• Rosuvastatin calcium 20 mg 

Cemicresto (rosuvastatin calcium)

Is indicated in adults as an adjunct to diet, at least equivalent to the Adult Treatment Panel III (ATP III TLC diet), for the reduction of elevated total cholesterol (Total-C), LDL-C, ApoB, the Total-C/HDL-C ratio and triglycerides (TG) and for increasing HDLC; in hyperlipidemic and dyslipidemic conditions, when response to diet and exercise alone has been inadequate including:

1- Primary hypercholesterolemia (Type IIa including heterozygous familial hypercholesterolemia and severe non-familial hypercholesterolemia)

2- Combined (mixed) dyslipidemia (Type Iib

3- Homozygous familial hypercholesterolemia where Cemicresto is used either alone or as an adjunct to diet and other lipid lowering treatments such as apheresis.

In adult patients without documented history of cardiovascular or cerebrovascular events, but with at least two conventional risk factors for cardiovascular disease, Cemicresto  is indicated to:

Reduce the risk of nonfatal myocardial infarction

Reduce the risk of nonfatal stroke

Reduce the risk of coronary artery revascularization

Dosage for a genetic condition characterized by increased levels of low-density lipoprotein cholesterol (Homozygous Familial Hypercholesterolemia)

Adult

• Recommended: 5-40 mg once a day
• Initial: 20 mg once a day
• Maximum: 40 mg

Children (7 to 17 years)

• Recommended: 20 mg once a day
• Initial: 5 to 10 mg once daily depending upon the patient’s weight, age, and previous statin therapy
• Maximum: 20 mg once daily

Dosage for a genetic disorder that causes extremely high levels of cholesterol, which can further result in heart diseases, heart attack, or damage to the brain (heterozygous familial hypercholesterolemia)

Children (8 to less than 10 years)

• Recommended: 5 to 10 mg once a day
• Initial: 5 mg/day
• Maximum: 10 mg

Children (10 to 17 years)

• Recommended: 5 to 20 mg once a day
• Maximum: 20 mg

Minimum Age

6 years

Maximum Age

75 years and above

• Cemicresto (rosuvastatin calcium) is contraindicated in:
• patients who are hypersensitive to any component of this medication (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING).
• patients with active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal (see 7 WARNINGS AND PRECAUTIONS).
• pregnant and breast-feeding women.
• patients using concomitant cyclosporine (see 9 DRUG INTERACTIONS).
• patients using concomitant sofosbuvir/velpatasvir/voxilaprevir (see 9 DRUG INTERACTIONS).
• Cemicrsto 40 mg is contraindicated in:
• Asian patients
• Patients with pre-disposing factors for myopathy/rhabdomyolysis (see 7 WARNINGS AND PRECAUTIONS, Musculoskeletal).

A jar containing 30 film coated tablets.

• Epidemiologic, clinical and experimental studies have established that high LDL-C, low HDL-C and high plasma triglyceride (TG) promote human atherosclerosis and are risk factors for developing cardiovascular disease. Some studies have also shown that the total cholesterol (total-C)/HDL-C ratio is the best predictor of coronary artery disease. In contrast, increased levels of HDL-C are associated with decreased cardiovascular risk. Drug therapies that reduce levels of LDL-C or decrease TG while simultaneously increasing HDL-C have demonstrated reductions in rates of cardiovascular mortality and morbidity.