Rosuvastatin Calcium

ROSUVASTATIN CALCIUM- rosuvastatin calcium tablet, film coated
Tris Pharma Inc

1 INDICATIONS AND USAGE

Rosuvastatin calcium tablets is indicated:

  • To reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures in adults without established coronary heart disease who are at increased risk of cardiovascular (CV) disease based on age, hsCRP ≥2 mg/L, and at least one additional CV risk factor.
  • As an adjunct to diet to:
  • Reduce LDL-C in adults with primary hyperlipidemia.
  • Reduce low-density lipoprotein cholesterol (LDL-C) and slow the progression of atherosclerosis in adults.
  • Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH).
  • As an adjunct to diet for the treatment of adults with:
  • Primary dysbetalipoproteinemia.
  • Hypertriglyceridemia.

2 DOSAGE AND ADMINISTRATION

2.1 General Dosage and Administration Information

  • Administer rosuvastatin calcium tablets orally as a single dose at any time of day, with or without food. The tablet should be swallowed whole.
  • Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating rosuvastatin calcium tablets, and adjust the dosage if necessary.
  • If a dose is missed, advise patients not take an extra dose. Resume treatment with the next dose.

2.2 Recommended Dosage in Adult Patients

  • The dosage range for rosuvastatin calcium tablets is 5 to 40 mg orally once daily.
  • The recommended dose of rosuvastatin calcium tablets depends on a patient’s indication for usage, LDL- C, and individual risk for cardiovascular events.

2.3 Recommended Dosage in Pediatric Patients

D osage in Pediatric Patients 8 Years of Age and Older with HeFH

The recommended dosage range is 5 mg to 10 mg orally once daily in patients aged 8 years to less than 10 years and 5 mg to 20 mg orally once daily in patients aged 10 years and older.

D osage in Pediatric Patients 7 Years of Age and Older with HoFH

The recommended dosage is 20 mg orally once daily.

2.4 Dosing in Asian Patients

Initiate rosuvastatin calcium tablets at 5 mg once daily due to increased rosuvastatin plasma concentrations. Consider the risks and benefits of rosuvastatin calcium tablets when treating Asian patients not adequately controlled at doses up to 20 mg once daily [see Warnings and Precautions (5.1), Use in Specific Populations (8.8), and Clinical Pharmacology(12.3)].

2.5 Recommended Dosage in Patients with Renal Impairment

In patients with severe renal impairment (CLcr less than 30 mL/min/1.73 m2) not on hemodialysis, the recommended starting dosage is 5 mg once daily and should not exceed 10 mg once daily [see Warnings and Precautions (5.1)a nd Use in Specific Populations (8.6)].

There are no dosage adjustment recommendations for patients with mild and moderate renal impairment.

2.6 Dosage and Administration Modifications Due to Drug Interactions

Rosuvastatin Calcium Tablets Dosage Modifications Due to Drug Interactions

Table 1 displays dosage modifications for rosuvastatin calcium tablets due to drug interactions [see Warnings and Precautions (5.1)and Drug Interactions (7.1)].

Table 1: Rosuvastatin Calcium Tablets D osage Modifications Due to Drug Interactions

C oncomitantly Used Drug

Rosuvastatin Calcium Tablets D osage Modifications

Cyclosporine

Do not exceed 5 mg once daily.

Teriflunomide

Do not exceed 10 mg once daily.

Enasidenib Do not exceed 10 mg once daily.

Capmatinib

Do not exceed 10 mg once daily.

Fostamatinib

Do not exceed 20 mg once daily.

Febuxostat

Do not exceed 20 mg once daily.

Gemfibrozil

Avoid concomitant use. If used concomitantly, initiate at 5 mg once daily and do not exceed 10 mg once daily.

Tafamidis

Avoid concomitant use. If used concomitantly, initiate at 5 mg once daily and do not exceed 20 mg once daily.

Antiviral Medications

  • Sofbuvir/velpatasvir/voxilaprevir
  • Ledipasvir/sofosbuvir

Concomitant use not recommended.

  • Simeprevir
  • Dasabuvir/ombitasvir/paritaprevir/ritonavir
  • Elbasvir/Grazoprevir
  • Sofosbuvir/Velpatasvir
  • Glecaprevir/Pibrentasvir
  • Atazanavir/Ritonavir
  • Lopinavir/Ritonavir

Initiate at 5 mg once daily. Do not exceed 10 mg once daily.

Darolutamide

Do not exceed 5 mg once daily.

Regorafenib

Do not exceed 10 mg once daily.

R osuvastatin Calcium Tablets A dministration Modifications Due to Drug Interactions

When taking rosuvastatin calcium tablets with an aluminum and magnesium hydroxide combination antacid, administer rosuvastatin calcium tablets at least 2 hours before the antacid [ see Drug Interactions (7.2)].

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