Rosuvastatin Calcium

ROSUVASTATIN CALCIUM- rosuvastatin calcium tablet, film coated
Northwind Pharmaceuticals, LLC

1 INDICATIONS AND USAGE

Rosuvastatin tablets are 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 diet for the treatment of adults with:
  • Primary dysbetalipoproteinemia.
  • Hypertriglyceridemia.

Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

2 DOSAGE AND ADMINISTRATION

2.1 General Dosage and Administration Information

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

2.3 Recommended Dosage in Pediatric Patients

Dosage 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.

Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

2.4 Dosing in Asian Patients

Initiate rosuvastatin tablets at 5 mg once daily due to increased rosuvastatin plasma concentrations. Consider the risks and benefits of rosuvastatin 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 <30 mL/min/1.73 m 2) 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) and 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 Tablets Dosage Modifications Due to Drug Interactions

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

Table 1: Rosuvastatin Tablets Dosage Modifications Due to Drug Interactions

Concomitantly Used Drug

Rosuvastatin Tablets Dosage Modifications

Cyclosporine

Do not exceed 5 mg once daily.

Teriflunomide

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 10 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.

Rosuvastatin Tablets Administration Modifications Due to Drug Interactions

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

3 DOSAGE FORMS AND STRENGTHS

Rosuvastatin Tablets, USP:

  • 5 mg of rosuvastatin: Pink colored, film-coated, circular tablets debossed with “G” on one side and “C” on the other side.
  • 10 mg of rosuvastatin: Pink colored, film-coated, circular tablets debossed with “G” on one side and “D” on the other side.
  • 20 mg of rosuvastatin: Pink colored, film-coated, circular tablets debossed with “G” on one side and “O” on the other side.
  • 40 mg of rosuvastatin: Pink colored, film-coated, oval shaped tablets debossed with “G264” on one side and “40” on the other side.

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