Biocon Pharma Inc

Biocon Pharma Inc Drugs

• Rosuvastatin Calcium
  

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  Rosuvastatin Calcium

  

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  2.1 General Dosing Information

  The dose range for rosuvastatin calcium tablets in adults is 5 to 40 mg orally once daily. The usual starting dose is 10 to 20 mg once daily. The usual starting dose in adult patients with homozygous familial hypercholesterolemia is 20 mg once daily.

  The maximum rosuvastatin dose of 40 mg should be used only for those patients who have not achieved their LDL-C goal utilizing the 20 mg dose [see Warnings and Precautions (5.1)].

  Rosuvastatin calcium tablets can be administered as a single dose at any time of day, with or without food.The tablet should be swallowed whole.

  When initiating rosuvastatin calcium tablets therapy or switching from another HMG-CoA reductase inhibitor therapy, the appropriate rosuvastatin calcium tablets starting dose should first be utilized, and only then titrated according to the patient’s response and individualized goal of therapy.

  After initiation or upon titration of rosuvastatin calcium tablets, lipid levels should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly.

  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.

  2.3 Dosing in Asian Patients

  In Asian patients, consider initiation of rosuvastatin calcium tablets therapy with 5 mg once daily due to increased rosuvastatin plasma concentrations. The increased systemic exposure should be taken into consideration when treating Asian patients not adequately controlled at doses up to 20 mg/day. [see Use in Specific Populations (8.8) and Clinical Pharmacology (12.3)].

  2.4 Use with Concomitant Therapy

  Patients taking cyclosporine

  The dose of rosuvastatin calcium tablets should not exceed 5 mg once daily [see Warnings and Precautions (5.1) , Drug Interactions (7.1), and Clinical Pharmacology (12.3)]

  Patients taking gemfibrozil

  Avoid concomitant use of rosuvastatin calcium tablets with gemfibrozil. If concomitant use cannot be avoided initiate rosuvastatin calcium tablets at 5 mg once daily. The dose of rosuvastatin calcium tablets should not exceed 10 mg once daily [see Warnings and Precautions (5.1) , Drug Interactions (7.2), and Clinical Pharmacology (12.3)].

  Patients taking atazanavir and ritonavir, lopinavir and ritonavir, or simeprevir

  Initiate rosuvastatin calcium tablets therapy with 5 mg once daily. The dose of rosuvastatin calcium tablets should not exceed 10 mg once daily [see Warnings and Precautions (5.1) , Drug Interactions (7.3), and Clinical Pharmacology (12.3)].

  2.5 Dosing in Patients with Severe Renal Impairment

  For patients with severe renal impairment (CLcr <30 mL/min/1.73 m2) not on hemodialysis, dosing of rosuvastatin calcium tablets should be started at 5 mg once daily and not exceed 10 mg once daily [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

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