RiteMed Rosuvastatin

Prescription (RX) Medicine
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RiteMed Rosuvastatin

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QUANTITY:

Key Benefits:

  • Adult patients with primary hyperlipidemia including heterozygous familial hypercholesterolemia (Type IIa) or mixed dyslipidemia (Type IIb) as an adjunct to diet to reduce elevated total-C (cholesterol), LDL-C (low-density lipoprotein cholesterol), ApoB
  • Homozygous familial hypercholesterolemia.
  • Reducing the risk of atherosclerosis by lowering total cholesterol levels and LDL (low-density lipoprotein) cholesterol levels.
  • Heterozygous familial hypercholesterolemia.
  • Primary dysbetalipoproteinemia (type III).
  • Reducing the risk of cardiovascular diseases.
FDA Approved

FDA

Approved

Pharmacist Reviewed

Pharmacist

Reviewed

  • Adult patients with primary hyperlipidemia including heterozygous familial hypercholesterolemia (Type IIa) or mixed dyslipidemia (Type IIb) as an adjunct to diet to reduce elevated total-C (cholesterol), LDL-C (low-density lipoprotein cholesterol), ApoB
  • Homozygous familial hypercholesterolemia.
  • Reducing the risk of atherosclerosis by lowering total cholesterol levels and LDL (low-density lipoprotein) cholesterol levels.
  • Heterozygous familial hypercholesterolemia.
  • Primary dysbetalipoproteinemia (type III).
  • Reducing the risk of cardiovascular diseases.

FORMULATION

Each film-coated tablet contains:

Rosuvastatin (as calcium) ......................................................... 10.4 mg (as Rosuvastatin 10 mg)

Rosuvastatin (as calcium) ......................................................... 20.8 mg (as Rosuvastatin 20 mg)

PRODUCT DESCRIPTION

A pink, round, film-coated tablet.

  • Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl-coenzyme A to mevalonate, a precursor of cholesterol.

    • Adult patients with primary hyperlipidemia including heterozygous familial hypercholesterolemia (Type IIa) or mixed dyslipidemia (Type IIb) as an adjunct to diet to reduce elevated total-C (cholesterol), LDL-C (low-density lipoprotein cholesterol), ApoB (Apolipoprotein B), non-HDLC (Non-high-density lipoprotein cholesterol) and TG (Triglycerides) levels and to increase to HDL-C (High- density lipoprotein cholesterol).
    • Homozygous familial hypercholesterolemia
    • Reducing the risk of atherosclerosis by lowering total cholesterol levels and LDL (low-density lipoprotein) cholesterol levels.
    • Heterozygous familial hypercholesterolemia
    • Primary dysbetalipoproteinemia (type III)
    • Reducing the risk of cardiovascular diseases

    Dosage and Administration
    Primary hyperlipidemia (including heterozygous familial hypercholesterolemia Type IIa), Mixed dyslipidemia (type IIb), Primary dysbetalipoproteinemia (Type III) and Homozygous familial hypercholesterolemia: Usual Starting Dose: 5 mg once daily
    Recommended Maintenance Dose: 20 mg once daily
    Maximum Dose: 40 mg once daily
    Heterozygous familial hypercholesterolemia (10-17 years): Usual Dose: 5 mg once daily
    Maximum Dose: 20 mg once daily
    Over 70 years old: 10 mg once daily
    Under 10 years old: Do not take Rosuvastatin 10 mg Film-Coated Tablet (It is not established the safety and effectiveness of use for children yet.)

    Patient who have renal failure:

    A mild and moderate renal failure: 10 mg - 20 mg once daily
    Severe renal failure: Do not take Rosuvastatin 10 mg Film-Coated Tablet
    Patient who have liver failure: Do not take Rosuvastatin 10 mg Film-Coated Tablet
    Asian: Recommended Starting Dose: 5 mg once daily
    Patient who have myopathy: Recommended Starting Dose: 5 mg once daily
    Do not take 40 mg of Rosuvastatin daily

    Administration: Swallow each tablet whole with a drink of water at any time of the day and regardless of food intake.
    Missed Dose: Do not take a double dose to make up for the missed dose instead, take the next scheduled dose at the correct time