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Crestor

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Side Effects & Adverse Reactions

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FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

1.1 Hyperlipidemia and Mixed Dyslipidemia

CRESTOR is indicated as adjunctive therapy to diet to reduce elevated total-C, LDL-C, ApoB, nonHDL-C, and triglycerides and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia. Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate.

1.2 Hypertriglyceridemia

CRESTOR is indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia.

1.3 Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia)

CRESTOR is indicated as an adjunct to diet for the treatment of patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia).

1.4 Homozygous Familial Hypercholesterolemia

CRESTOR is indicated as adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, Total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia.

1.5 Slowing of the Progression of Atherosclerosis

CRESTOR is indicated as adjunctive therapy to diet to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower Total-C and LDL-C to target levels.

1.6 Limitations of Use

The effect of CRESTOR on cardiovascular morbidity and mortality has not been determined.

CRESTOR has not been studied in Fredrickson Type I and V dyslipidemias.

History

There is currently no drug history available for this drug.

Other Information

CRESTOR (rosuvastatin calcium) is a synthetic lipid-lowering agent for oral administration.

The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula:

chemicalstructure

The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0.

Inactive Ingredients: Each tablet contains: microcrystalline cellulose NF, lactose monohydrate NF, tribasic calcium phosphate NF, crospovidone NF, magnesium stearate NF, hypromellose NF, triacetin NF, titanium dioxide USP, yellow ferric oxide, and red ferric oxide NF.

Crestor Manufacturers

  • Crestor | A-s Medication Solutions Llc
    No Recall

    Crestor | A-s Medication Solutions Llc

    Crestor | A-s Medication Solutions Llc
    2.1 General Dosing Information

    The dose range for CRESTOR is 5 to 40 mg orally once daily.

    CRESTOR can be administered as a single dose at any time of day, with or without food.

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

    The 40 mg dose of CRESTOR 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)].

    2.2 Hyperlipidemia, Mixed Dyslipidemia, Hypertriglyceridemia, Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia), and Slowing of the Progression of Atherosclerosis

    The recommended starting dose of CRESTOR is 10 mg once daily. For patients with marked hyperlipidemia (LDL-C > 190 mg/dL) and aggressive lipid targets, a 20 mg starting dose may be considered.

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

    2.3 Homozygous Familial Hypercholesterolemia

    The recommended starting dose of CRESTOR is 20 mg once daily. Response to therapy should be estimated from pre-apheresis LDL-C levels.

    2.4 Dosage in Asian Patients

    Initiation of CRESTOR therapy with 5 mg once daily should be considered for Asian patients. [see Use in Specific Populations (8.8) and Clinical Pharmacology (12.3)].

    2.5 Use with Cyclosporine, or Lopinavir/Ritonavir

    In patients taking cyclosporine, the dose of CRESTOR should be limited to 5 mg once daily [see Warnings and Precautions (5.1) and Drug Interactions (7.1)]. In patients taking a combination of lopinavir and ritonavir the dose of CRESTOR should be limited to 10 mg once daily [see Warnings and Precautions (5.1) and Drug Interactions (7.3)].

    2.6 Concomitant Lipid-Lowering Therapy

    The risk of skeletal muscle effects may be enhanced when CRESTOR is used in combination with niacin or fenofibrate; a reduction in CRESTOR dosage should be considered in this setting. [see Warnings and Precuations (5.1) and see Drug Interactions (7.5, 7.6)]

    Combination therapy with gemfibrozil should be avoided because of an increase in CRESTOR exposure with concomitant use; if CRESTOR is used in combination with gemfibrozil, the dose of CRESTOR should be limited to 10 mg once daily [see Warnings and Precautions (5.1) and Drug Interactions (7.2)].

    2.7 Dosage in Patients With Severe Renal Impairment

    For patients with severe renal impairment (CLcr <30 mL/min/1.73 m2) not on hemodialysis, dosing of CRESTOR 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)].

  • Bryant Ranch Prepack
    Crestor | Bryant Ranch Prepack
    No Recall

    Crestor | Bryant Ranch Prepack

    Crestor | Bryant Ranch Prepack
    2.1 General Dosing Information

    The dose range for CRESTOR is 5 to 40 mg orally once daily. The usual starting dose is 10-20 mg.

    CRESTOR can be administered as a single dose at any time of day, with or without food.

    When initiating CRESTOR therapy or switching from another HMG-CoA reductase inhibitor therapy, the appropriate CRESTOR 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 CRESTOR, lipid levels should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly.

    The 40 mg dose of CRESTOR 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)].

    2.2 Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10 to 17 years of age)

    The usual dose range of CRESTOR is 5-20 mg/day; the maximum recommended dose is 20 mg/day (doses greater than 20 mg have not been studied in this patient population). Doses should be individualized according to the recommended goal of therapy [see Clinical Pharmacology (12) and Indications and Usage (1.2)]. Adjustments should be made at intervals of 4 weeks or more.

    2.3 Homozygous Familial Hypercholesterolemia

    The recommended starting dose of CRESTOR is 20 mg once daily. Response to therapy should be estimated from preapheresis LDL-C levels.

    2.4 Dosage in Asian Patients

    Initiation of CRESTOR therapy with 5 mg once daily should be considered for Asian patients [see Use in Specific Populations (8.8) and Clinical Pharmacology (12.3)].

    2.5 Use with Cyclosporine, Lopinavir/Ritonavir or Atazanavir/Ritonavir

    In patients taking cyclosporine, the dose of CRESTOR should be limited to 5 mg once daily [see Warnings and Precautions (5.1) and Drug Interactions (7.1)]. In patients taking a combination of lopinavir and ritonavir or atazanavir and ritonavir, the dose of CRESTOR should be limited to 10 mg once daily [see Warnings and Precautions (5.1) and Drug Interactions (7.3)].

    2.6 Concomitant Lipid-Lowering Therapy

    The risk of skeletal muscle effects may be enhanced when CRESTOR is used in combination with niacin or fenofibrate; a reduction in CRESTOR dosage should be considered in this setting [see Warnings and Precautions (5.1) and Drug Interactions (7.5, 7.6)].

    Combination therapy with gemfibrozil should be avoided because of an increase in CRESTOR exposure with concomitant use; if CRESTOR is used in combination with gemfibrozil, the dose of CRESTOR should be limited to 10 mg once daily [see Warnings and Precautions (5.1) and Drug Interactions (7.2)].

    2.7 Dosage in Patients With Severe Renal Impairment

    For patients with severe renal impairment (CLcr <30 mL/min/1.73 m2) not on hemodialysis, dosing of CRESTOR 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)].

  • Crestor | Rebel Distributors Corp
    No Recall

    Crestor | Rebel Distributors Corp

    Crestor | Rebel Distributors Corp

    2.1 General Dosing Information

    The dose range for CRESTOR is 5 to 40 mg orally once daily.

    CRESTOR can be administered as a single dose at any time of day, with or without food.

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

    The 40 mg dose of CRESTOR 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)].

    2.2 Hyperlipidemia, Mixed Dyslipidemia, Hypertriglyceridemia, Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia), and Slowing of the Progression of Atherosclerosis

    The recommended starting dose of CRESTOR is 10 mg once daily. For patients with marked hyperlipidemia (LDL-C greater than 190 mg/dL) and aggressive lipid targets, a 20 mg starting dose may be considered.

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

    2.3 Homozygous Familial Hypercholesterolemia

    The recommended starting dose of CRESTOR is 20 mg once daily. Response to therapy should be estimated from pre-apheresis LDL-C levels.

    2.4 Dosage in Asian Patients

    Initiation of CRESTOR therapy with 5 mg once daily should be considered for Asian patients. [see Use in Specific Populations (8.8) and Clinical Pharmacology (12.3)].

    2.5 Use with Cyclosporine, or Lopinavir/Ritonavir

    In patients taking cyclosporine, the dose of CRESTOR should be limited to 5 mg once daily [see Warnings and Precautions (5.1) and Drug Interactions (7.1)]. In patients taking a combination of lopinavir and ritonavir the dose of CRESTOR should be limited to 10 mg once daily [see Warnings and Precautions (5.1) and Drug Interactions (7.3)].

    2.6 Concomitant Lipid-Lowering Therapy

    The risk of skeletal muscle effects may be enhanced when CRESTOR is used in combination with niacin or fenofibrate; a reduction in CRESTOR dosage should be considered in this setting. [see Warnings and Precuations (5.1) and see Drug Interactions (7.5, 7.6)]

    Combination therapy with gemfibrozil should be avoided because of an increase in CRESTOR exposure with concomitant use; if CRESTOR is used in combination with gemfibrozil, the dose of CRESTOR should be limited to 10 mg once daily [see Warnings and Precautions (5.1) and Drug Interactions (7.2)].

    2.7 Dosage in Patients With Severe Renal Impairment

    For patients with severe renal impairment (CLcr less than 30 mL/min/1.73 m2) not on hemodialysis, dosing of CRESTOR 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)].

  • Crestor | H.j. Harkins Company, Inc.
    No Recall

    Crestor | H.j. Harkins Company, Inc.

    Crestor | H.j. Harkins Company, Inc.
    2.1 General Dosing Information

    The dose range for CRESTOR is 5 to 40 mg orally once daily. The usual starting dose is 10-20 mg.

    CRESTOR can be administered as a single dose at any time of day, with or without food.

    When initiating CRESTOR therapy or switching from another HMG-CoA reductase inhibitor therapy, the appropriate CRESTOR 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 CRESTOR, lipid levels should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly.

    The 40 mg dose of CRESTOR 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)].

    2.2 Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10 to 17 years of age)

    The usual dose range of CRESTOR is 5-20 mg/day; the maximum recommended dose is 20 mg/day (doses greater than 20 mg have not been studied in this patient population). Doses should be individualized according to the recommended goal of therapy [see Clinical Pharmacology (12) and Indications and Usage (1.2)]. Adjustments should be made at intervals of 4 weeks or more.

    2.3 Homozygous Familial Hypercholesterolemia

    The recommended starting dose of CRESTOR is 20 mg once daily. Response to therapy should be estimated from preapheresis LDL-C levels.

    2.4 Dosage in Asian Patients

    Initiation of CRESTOR therapy with 5 mg once daily should be considered for Asian patients [see Use in Specific Populations (8.8) and Clinical Pharmacology (12.3)].

    2.5 Use with Cyclosporine, Lopinavir/Ritonavir or Atazanavir/Ritonavir

    In patients taking cyclosporine, the dose of CRESTOR should be limited to 5 mg once daily [see Warnings and Precautions (5.1) and Drug Interactions (7.1)]. In patients taking a combination of lopinavir and ritonavir or atazanavir and ritonavir, the dose of CRESTOR should be limited to 10 mg once daily [see Warnings and Precautions (5.1) and Drug Interactions (7.3)].

    2.6 Concomitant Lipid-Lowering Therapy

    The risk of skeletal muscle effects may be enhanced when CRESTOR is used in combination with niacin or fenofibrate; a reduction in CRESTOR dosage should be considered in this setting [see Warnings and Precautions (5.1) and Drug Interactions (7.5, 7.6)].

    Combination therapy with gemfibrozil should be avoided because of an increase in CRESTOR exposure with concomitant use; if CRESTOR is used in combination with gemfibrozil, the dose of CRESTOR should be limited to 10 mg once daily [see Warnings and Precautions (5.1) and Drug Interactions (7.2)].

    2.7 Dosage in Patients With Severe Renal Impairment

    For patients with severe renal impairment (CLcr <30 mL/min/1.73 m2) not on hemodialysis, dosing of CRESTOR 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)].

  • Physicians Total Care, Inc.
    Crestor | Physicians Total Care, Inc.
    No Recall

    Crestor | Physicians Total Care, Inc.

    Crestor | Physicians Total Care, Inc.
    2.1 General Dosing Information

    The dose range for CRESTOR is 5 to 40 mg orally once daily. The usual starting dose is 10-20 mg.

    CRESTOR can be administered as a single dose at any time of day, with or without food.

    When initiating CRESTOR therapy or switching from another HMG-CoA reductase inhibitor therapy, the appropriate CRESTOR 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 CRESTOR, lipid levels should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly.

    The 40 mg dose of CRESTOR 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)].

    2.2 Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10 to 17 years of age)

    The usual dose range of CRESTOR is 5-20 mg/day; the maximum recommended dose is 20 mg/day (doses greater than 20 mg have not been studied in this patient population). Doses should be individualized according to the recommended goal of therapy [see Clinical Pharmacology (12) and Indications and Usage (1.2)]. Adjustments should be made at intervals of 4 weeks or more.

    2.3 Homozygous Familial Hypercholesterolemia

    The recommended starting dose of CRESTOR is 20 mg once daily. Response to therapy should be estimated from preapheresis LDL-C levels.

    2.4 Dosage in Asian Patients

    Initiation of CRESTOR therapy with 5 mg once daily should be considered for Asian patients [see Use in Specific Populations (8.8) and Clinical Pharmacology (12.3)].

    2.5 Use with Cyclosporine, Lopinavir/Ritonavir or Atazanavir/Ritonavir

    In patients taking cyclosporine, the dose of CRESTOR should be limited to 5 mg once daily [see Warnings and Precautions (5.1) and Drug Interactions (7.1)]. In patients taking a combination of lopinavir and ritonavir or atazanavir and ritonavir, the dose of CRESTOR should be limited to 10 mg once daily [see Warnings and Precautions (5.1) and Drug Interactions (7.3)].

    2.6 Concomitant Lipid-Lowering Therapy

    The risk of skeletal muscle effects may be enhanced when CRESTOR is used in combination with niacin or fenofibrate; a reduction in CRESTOR dosage should be considered in this setting [see Warnings and Precautions (5.1) and Drug Interactions (7.5, 7.6)].

    Combination therapy with gemfibrozil should be avoided because of an increase in CRESTOR exposure with concomitant use; if CRESTOR is used in combination with gemfibrozil, the dose of CRESTOR should be limited to 10 mg once daily [see Warnings and Precautions (5.1) and Drug Interactions (7.2)].

    2.7 Dosage in Patients With Severe Renal Impairment

    For patients with severe renal impairment (CLcr <30 mL/min/1.73 m2) not on hemodialysis, dosing of CRESTOR 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)].

  • Lake Erie Medical & Surgucal Supply Dba Quality Care Products Llc
    Crestor | Lake Erie Medical & Surgucal Supply Dba Quality Care Products Llc
    No Recall

    Crestor | Lake Erie Medical & Surgucal Supply Dba Quality Care Products Llc

    Crestor | Lake Erie Medical & Surgucal Supply Dba Quality Care Products Llc
    2.1 General Dosing Information

    The dose range for CRESTOR is 5 to 40 mg orally once daily. The usual starting dose is 10-20 mg.

    CRESTOR can be administered as a single dose at any time of day, with or without food.

    When initiating CRESTOR therapy or switching from another HMG-CoA reductase inhibitor therapy, the appropriate CRESTOR 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 CRESTOR, lipid levels should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly.

    The 40 mg dose of CRESTOR 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)].

    2.2 Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10 to 17 years of age)

    The usual dose range of CRESTOR is 5-20 mg/day; the maximum recommended dose is 20 mg/day (doses greater than 20 mg have not been studied in this patient population). Doses should be individualized according to the recommended goal of therapy [see Clinical Pharmacology (12) and Indications and Usage (1.2)]. Adjustments should be made at intervals of 4 weeks or more.

    2.3 Homozygous Familial Hypercholesterolemia

    The recommended starting dose of CRESTOR is 20 mg once daily. Response to therapy should be estimated from preapheresis LDL-C levels.

    2.4 Dosage in Asian Patients

    Initiation of CRESTOR therapy with 5 mg once daily should be considered for Asian patients [see Use in Specific Populations (8.8) and Clinical Pharmacology (12.3)].

    2.5 Use with Cyclosporine, Lopinavir/Ritonavir or Atazanavir/Ritonavir

    In patients taking cyclosporine, the dose of CRESTOR should be limited to 5 mg once daily [see Warnings and Precautions (5.1) and Drug Interactions (7.1)]. In patients taking a combination of lopinavir and ritonavir or atazanavir and ritonavir, the dose of CRESTOR should be limited to 10 mg once daily [see Warnings and Precautions (5.1) and Drug Interactions (7.3)].

    2.6 Concomitant Lipid-Lowering Therapy

    The risk of skeletal muscle effects may be enhanced when CRESTOR is used in combination with niacin or fenofibrate; a reduction in CRESTOR dosage should be considered in this setting [see Warnings and Precautions (5.1) and Drug Interactions (7.5, 7.6)].

    Combination therapy with gemfibrozil should be avoided because of an increase in CRESTOR exposure with concomitant use; if CRESTOR is used in combination with gemfibrozil, the dose of CRESTOR should be limited to 10 mg once daily [see Warnings and Precautions (5.1) and Drug Interactions (7.2)].

    2.7 Dosage in Patients With Severe Renal Impairment

    For patients with severe renal impairment (CLcr <30 mL/min/1.73 m2) not on hemodialysis, dosing of CRESTOR 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)].

  • Pd-rx Pharmaceuticals, Inc.
    Crestor | Pd-rx Pharmaceuticals, Inc.
    No Recall

    Crestor | Pd-rx Pharmaceuticals, Inc.

    Crestor | Pd-rx Pharmaceuticals, Inc.
    2.1 General Dosing Information

    The dose range for CRESTOR is 5 to 40 mg orally once daily. The usual starting dose is 10-20 mg.

    CRESTOR can be administered as a single dose at any time of day, with or without food.

    When initiating CRESTOR therapy or switching from another HMG-CoA reductase inhibitor therapy, the appropriate CRESTOR 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 CRESTOR, lipid levels should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly.

    The 40 mg dose of CRESTOR 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)].

    2.2 Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10 to 17 years of age)

    The usual dose range of CRESTOR is 5-20 mg/day; the maximum recommended dose is 20 mg/day (doses greater than 20 mg have not been studied in this patient population). Doses should be individualized according to the recommended goal of therapy [see Clinical Pharmacology (12) and Indications and Usage (1.2)]. Adjustments should be made at intervals of 4 weeks or more.

    2.3 Homozygous Familial Hypercholesterolemia

    The recommended starting dose of CRESTOR is 20 mg once daily. Response to therapy should be estimated from preapheresis LDL-C levels.

    2.4 Dosage in Asian Patients

    Initiation of CRESTOR therapy with 5 mg once daily should be considered for Asian patients [see Use in Specific Populations (8.8) and Clinical Pharmacology (12.3)].

    2.5 Use with Cyclosporine, Lopinavir/Ritonavir or Atazanavir/Ritonavir

    In patients taking cyclosporine, the dose of CRESTOR should be limited to 5 mg once daily [see Warnings and Precautions (5.1) and Drug Interactions (7.1)]. In patients taking a combination of lopinavir and ritonavir or atazanavir and ritonavir, the dose of CRESTOR should be limited to 10 mg once daily [see Warnings and Precautions (5.1) and Drug Interactions (7.3)].

    2.6 Dosage in Patients With Severe Renal Impairment

    For patients with severe renal impairment (CLcr <30 mL/min/1.73 m2) not on hemodialysis, dosing of CRESTOR 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)].

  • Pd-rx Pharmaceuticals, Inc.
    Crestor | Pd-rx Pharmaceuticals, Inc.
    No Recall

    Crestor | Pd-rx Pharmaceuticals, Inc.

    Crestor | Pd-rx Pharmaceuticals, Inc.
    2.1 General Dosing Information

    The dose range for CRESTOR is 5 to 40 mg orally once daily. The usual starting dose is 10-20 mg.

    CRESTOR can be administered as a single dose at any time of day, with or without food.

    When initiating CRESTOR therapy or switching from another HMG-CoA reductase inhibitor therapy, the appropriate CRESTOR 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 CRESTOR, lipid levels should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly.

    The 40 mg dose of CRESTOR 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)].

    2.2 Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10 to 17 years of age)

    The usual dose range of CRESTOR is 5-20 mg/day; the maximum recommended dose is 20 mg/day (doses greater than 20 mg have not been studied in this patient population). Doses should be individualized according to the recommended goal of therapy [see Clinical Pharmacology (12) and Indications and Usage (1.2)]. Adjustments should be made at intervals of 4 weeks or more.

    2.3 Homozygous Familial Hypercholesterolemia

    The recommended starting dose of CRESTOR is 20 mg once daily. Response to therapy should be estimated from preapheresis LDL-C levels.

    2.4 Dosage in Asian Patients

    Initiation of CRESTOR therapy with 5 mg once daily should be considered for Asian patients [see Use in Specific Populations (8.8) and Clinical Pharmacology (12.3)].

    2.5 Use with Cyclosporine, Lopinavir/Ritonavir or Atazanavir/Ritonavir

    In patients taking cyclosporine, the dose of CRESTOR should be limited to 5 mg once daily [see Warnings and Precautions (5.1) and Drug Interactions (7.1)]. In patients taking a combination of lopinavir and ritonavir or atazanavir and ritonavir, the dose of CRESTOR should be limited to 10 mg once daily [see Warnings and Precautions (5.1) and Drug Interactions (7.3)].

    2.6 Dosage in Patients With Severe Renal Impairment

    For patients with severe renal impairment (CLcr <30 mL/min/1.73 m2) not on hemodialysis, dosing of CRESTOR 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)].

  • Bryant Ranch Prepack
    Crestor | Bryant Ranch Prepack
    No Recall

    Crestor | Bryant Ranch Prepack

    Crestor | Bryant Ranch Prepack
    2.1 General Dosing Information

    The dose range for CRESTOR is 5 to 40 mg orally once daily. The usual starting dose is 10-20 mg.

    CRESTOR can be administered as a single dose at any time of day, with or without food.

    When initiating CRESTOR therapy or switching from another HMG-CoA reductase inhibitor therapy, the appropriate CRESTOR 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 CRESTOR, lipid levels should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly.

    The 40 mg dose of CRESTOR 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)].

    2.2 Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10 to 17 years of age)

    The usual dose range of CRESTOR is 5-20 mg/day; the maximum recommended dose is 20 mg/day (doses greater than 20 mg have not been studied in this patient population). Doses should be individualized according to the recommended goal of therapy [see Clinical Pharmacology (12) and Indications and Usage (1.2)]. Adjustments should be made at intervals of 4 weeks or more.

    2.3 Homozygous Familial Hypercholesterolemia

    The recommended starting dose of CRESTOR is 20 mg once daily. Response to therapy should be estimated from preapheresis LDL-C levels.

    2.4 Dosage in Asian Patients

    Initiation of CRESTOR therapy with 5 mg once daily should be considered for Asian patients [see Use in Specific Populations (8.8) and Clinical Pharmacology (12.3)].

    2.5 Use with Cyclosporine, Lopinavir/Ritonavir or Atazanavir/Ritonavir

    In patients taking cyclosporine, the dose of CRESTOR should be limited to 5 mg once daily [see Warnings and Precautions (5.1) and Drug Interactions (7.1)]. In patients taking a combination of lopinavir and ritonavir or atazanavir and ritonavir, the dose of CRESTOR should be limited to 10 mg once daily [see Warnings and Precautions (5.1) and Drug Interactions (7.3)].

    2.6 Concomitant Lipid-Lowering Therapy

    The risk of skeletal muscle effects may be enhanced when CRESTOR is used in combination with niacin or fenofibrate; a reduction in CRESTOR dosage should be considered in this setting [see Warnings and Precautions (5.1) and Drug Interactions (7.5, 7.6)].

    Combination therapy with gemfibrozil should be avoided because of an increase in CRESTOR exposure with concomitant use; if CRESTOR is used in combination with gemfibrozil, the dose of CRESTOR should be limited to 10 mg once daily [see Warnings and Precautions (5.1) and Drug Interactions (7.2)].

    2.7 Dosage in Patients With Severe Renal Impairment

    For patients with severe renal impairment (CLcr <30 mL/min/1.73 m2) not on hemodialysis, dosing of CRESTOR 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)].

  • Lake Erie Medical Dba Quality Care Products Llc
    Crestor | Lake Erie Medical Dba Quality Care Products Llc
    No Recall

    Crestor | Lake Erie Medical Dba Quality Care Products Llc

    Crestor | Lake Erie Medical Dba Quality Care Products Llc

    Enter section text here

  • Remedyrepack Inc.
    Crestor | Remedyrepack Inc.
    No Recall

    Crestor | Remedyrepack Inc.

    Crestor | Remedyrepack Inc.

    The dose range for CRESTOR is 5 to 40 mg orally once daily. The usual starting dose is 10-20 mg.

    CRESTOR can be administered as a single dose at any time of day, with or without food.

    When initiating CRESTOR therapy or switching from another HMG-CoA reductase inhibitor therapy, the appropriate CRESTOR 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 CRESTOR, lipid levels should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly.

    The 40 mg dose of CRESTOR 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)].

     

    The usual dose range of CRESTOR is 5-20 mg/day; the maximum recommended dose is 20 mg/day (doses greater than 20 mg have not been studied in this patient population). Doses should be individualized according to the recommended goal of therapy [see Clinical Pharmacology (12) and Indications and Usage (1.2)]. Adjustments should be made at intervals of 4 weeks or more.

     

    The recommended starting dose of CRESTOR is 20 mg once daily. Response to therapy should be estimated from preapheresis LDL-C levels.

     

    In Asian patients, consider initiation of CRESTOR 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)].

     

    Patients taking cyclosporine

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

    Patients taking gemfibrozil

    Initiate CRESTOR therapy with 5 mg once daily. The dose of CRESTOR should not exceed 10 mg once daily [see Warnings and Precautions (5.1) and Drug Interactions (7.2), and Clinical Pharmacology (12.3)].

    Patients taking lopinavir and ritonavir or atazanavir and ritonavir

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

     

    For patients with severe renal impairment (CLcr <30 mL/min/1.73 m2) not on hemodialysis, dosing of CRESTOR 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)].

     

     

  • Crestor | Delaval
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    Crestor | Delaval

    Crestor | Delaval

    There is currently no dosage information available for this product. We apologize for any inconvenience.

  • Crestor | Cardinal Health
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    Crestor | Cardinal Health

    Crestor | Cardinal Health
    2.1 General Dosing Information

    The dose range for CRESTOR is 5 to 40 mg orally once daily. The usual starting dose is 10‑20 mg.

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

    When initiating CRESTOR therapy or switching from another HMG‑CoA reductase inhibitor therapy, the appropriate CRESTOR 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 CRESTOR, lipid levels should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly.

    The 40 mg dose of CRESTOR should be used only for those patients who have not achieved their LDL‑C goal utilizing the 20 mg dose [seeWarnings and Precautions (5.1)].

    2.2 Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10 to 17 years of age)

    The usual dose range of CRESTOR is 5‑20 mg/day; the maximum recommended dose is 20 mg/day (doses greater than 20 mg have not been studied in this patient population). Doses should be individualized according to the recommended goal of therapy [seeClinical Pharmacology (12) and Indications and Usage (1.2)]. Adjustments should be made at intervals of 4 weeks or more.

    2.3 Homozygous Familial Hypercholesterolemia

    The recommended starting dose of CRESTOR is 20 mg once daily. Response to therapy should be estimated from preapheresis LDL‑C levels.

    2.4 Dosing in Asian Patients

    In Asian patients, consider initiation of CRESTOR 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. [seeUse in Specific Populations (8.8) andClinical Pharmacology (12.3)].

    2.5 Use with Concomitant Therapy

    Patients taking cyclosporine

    The dose of CRESTOR 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

    Initiate CRESTOR therapy with 5 mg once daily. The dose of CRESTOR should not exceed 10 mg once daily [seeWarnings and Precautions (5.1) and Drug Interactions (7.2), and Clinical Pharmacology (12.3)].

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

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

    2.6 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 CRESTOR should be started at 5 mg once daily and not exceed 10 mg once daily [seeUse in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

  • Aphena Pharma Solutions – Tennessee, Llc
    Crestor | Aphena Pharma Solutions - Tennessee, Llc
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    Crestor | Aphena Pharma Solutions - Tennessee, Llc

    Crestor | Aphena Pharma Solutions - Tennessee, Llc
    2.1 General Dosing Information

    The dose range for CRESTOR is 5 to 40 mg orally once daily. The usual starting dose is 10‑20 mg.

    CRESTOR can be administered as a single dose at any time of day, with or without food.

    When initiating CRESTOR therapy or switching from another HMG‑CoA reductase inhibitor therapy, the appropriate CRESTOR 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 CRESTOR, lipid levels should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly.

    The 40 mg dose of CRESTOR 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)].

    2.2 Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10 to 17 years of age)

    The usual dose range of CRESTOR is 5‑20 mg/day; the maximum recommended dose is 20 mg/day (doses greater than 20 mg have not been studied in this patient population). Doses should be individualized according to the recommended goal of therapy [see Clinical Pharmacology (12) and Indications and Usage (1.2)]. Adjustments should be made at intervals of 4 weeks or more.

    2.3 Homozygous Familial Hypercholesterolemia

    The recommended starting dose of CRESTOR is 20 mg once daily. Response to therapy should be estimated from preapheresis LDL‑C levels.

    2.4 Dosing in Asian Patients

    In Asian patients, consider initiation of CRESTOR 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) andClinical Pharmacology (12.3)].

    2.5 Use with Concomitant Therapy

    Patients taking cyclosporine

    The dose of CRESTOR should not exceed 5 mg once daily [seeWarnings and Precautions (5.1), Drug Interactions (7.1), and Clinical Pharmacology (12.3)]

    Patients taking gemfibrozil

    Initiate CRESTOR therapy with 5 mg once daily. The dose of CRESTOR should not exceed 10 mg once daily [see Warnings and Precautions (5.1) and Drug Interactions (7.2), and Clinical Pharmacology (12.3)].

    Patients taking lopinavir and ritonavir or atazanavir and ritonavir

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

    2.6 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 CRESTOR 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)].

  • Crestor | Basic Research
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    Crestor | Basic Research

    Crestor | Basic Research

    Directions

    Cleanse the skin thoroughly before applying this medication.

    Cover the entire affected area with a thin layer one to three times daily.

    Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three time daily if needed or as directed by a doctor.

    If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

    Inactive ingredients

    Water (Aqua), Butylene Glycol, Cetearyl Alcohol, Cetyl Alcohol, Glycerin, Caprylic/Capric Triglyceride, Steareth-2, Oleth-10, Octyldodecanol, Caprylyl Methicone, Bakuchiol, Allantoin, Bisabolol, Boerhavia Diffusia Root Extract, C18-21 Alkane, Caprylyl Glycol, Ceteth-10 Phosphate, Dicetyl Phophate, Disodium EDTA, Ethylhexylglycerin, Glyceryl Acrylate/Acrylic Acid Copolymer, Hydrolyzed Optunia Ficus-Indica Flower Extract, Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer, Magnesium Aluminum Silicate, Phenoxyethanol, Polyisobutene, Polysorbate 60, PVM/MA Copolymer, Sodium Benzoate, Sodium Hyaluronate, Sodium Hydroxide, Squalane, Titanium Dioxide (CI 77891), Tocopheryl Acetate, Xanthan Gum.

  • Crestor | Cardinal Health
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    Crestor | Cardinal Health

    Crestor | Cardinal Health
    2.1 General Dosing Information

    The dose range for CRESTOR is 5 to 40 mg orally once daily. The usual starting dose is 10‑20 mg.

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

    When initiating CRESTOR therapy or switching from another HMG‑CoA reductase inhibitor therapy, the appropriate CRESTOR 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 CRESTOR, lipid levels should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly.

    The 40 mg dose of CRESTOR should be used only for those patients who have not achieved their LDL‑C goal utilizing the 20 mg dose [seeWarnings and Precautions (5.1)].

    2.2 Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10 to 17 years of age)

    The usual dose range of CRESTOR is 5‑20 mg/day; the maximum recommended dose is 20 mg/day (doses greater than 20 mg have not been studied in this patient population). Doses should be individualized according to the recommended goal of therapy [seeClinical Pharmacology (12) and Indications and Usage (1.2)]. Adjustments should be made at intervals of 4 weeks or more.

    2.3 Homozygous Familial Hypercholesterolemia

    The recommended starting dose of CRESTOR is 20 mg once daily. Response to therapy should be estimated from preapheresis LDL‑C levels.

    2.4 Dosing in Asian Patients

    In Asian patients, consider initiation of CRESTOR 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. [seeUse in Specific Populations (8.8) andClinical Pharmacology (12.3)].

    2.5 Use with Concomitant Therapy

    Patients taking cyclosporine

    The dose of CRESTOR 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

    Initiate CRESTOR therapy with 5 mg once daily. The dose of CRESTOR should not exceed 10 mg once daily [seeWarnings and Precautions (5.1) and Drug Interactions (7.2), and Clinical Pharmacology (12.3)].

    Patients taking lopinavir and ritonavir or atazanavir and ritonavir

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

    2.6 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 CRESTOR should be started at 5 mg once daily and not exceed 10 mg once daily [seeUse in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

  • Astrazeneca Pharmaceuticals Lp
    Crestor | Astrazeneca Pharmaceuticals Lp
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    Crestor | Astrazeneca Pharmaceuticals Lp

    Crestor | Astrazeneca Pharmaceuticals Lp
    2.1 General Dosing Information

    The dose range for CRESTOR is 5 to 40 mg orally once daily. The usual starting dose is 10‑20 mg.

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

    When initiating CRESTOR therapy or switching from another HMG‑CoA reductase inhibitor therapy, the appropriate CRESTOR 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 CRESTOR, lipid levels should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly.

    The 40 mg dose of CRESTOR should be used only for those patients who have not achieved their LDL‑C goal utilizing the 20 mg dose [seeWarnings and Precautions (5.1)].

    2.2 Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10 to 17 years of age)

    The usual dose range of CRESTOR is 5‑20 mg/day; the maximum recommended dose is 20 mg/day (doses greater than 20 mg have not been studied in this patient population). Doses should be individualized according to the recommended goal of therapy [seeClinical Pharmacology (12) and Indications and Usage (1.2)]. Adjustments should be made at intervals of 4 weeks or more.

    2.3 Homozygous Familial Hypercholesterolemia

    The recommended starting dose of CRESTOR is 20 mg once daily. Response to therapy should be estimated from preapheresis LDL‑C levels.

    2.4 Dosing in Asian Patients

    In Asian patients, consider initiation of CRESTOR 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. [seeUse in Specific Populations (8.8) andClinical Pharmacology (12.3)].

    2.5 Use with Concomitant Therapy

    Patients taking cyclosporine

    The dose of CRESTOR 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

    Initiate CRESTOR therapy with 5 mg once daily. The dose of CRESTOR should not exceed 10 mg once daily [seeWarnings and Precautions (5.1) and Drug Interactions (7.2), and Clinical Pharmacology (12.3)].

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

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

    2.6 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 CRESTOR should be started at 5 mg once daily and not exceed 10 mg once daily [seeUse in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

  • Bryant Ranch Prepack
    Crestor | Bryant Ranch Prepack
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    Crestor | Bryant Ranch Prepack

    Crestor | Bryant Ranch Prepack
    2.1 General Dosing Information

    The dose range for CRESTOR is 5 to 40 mg orally once daily. The usual starting dose is 10‑20 mg.

    CRESTOR can be administered as a single dose at any time of day, with or without food.

    When initiating CRESTOR therapy or switching from another HMG‑CoA reductase inhibitor therapy, the appropriate CRESTOR 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 CRESTOR, lipid levels should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly.

    The 40 mg dose of CRESTOR 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)].

    2.2 Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10 to 17 years of age)

    The usual dose range of CRESTOR is 5‑20 mg/day; the maximum recommended dose is 20 mg/day (doses greater than 20 mg have not been studied in this patient population). Doses should be individualized according to the recommended goal of therapy [see Clinical Pharmacology (12) and Indications and Usage (1.2)]. Adjustments should be made at intervals of 4 weeks or more.

    2.3 Homozygous Familial Hypercholesterolemia

    The recommended starting dose of CRESTOR is 20 mg once daily. Response to therapy should be estimated from preapheresis LDL‑C levels.

    2.4 Dosing in Asian Patients

    In Asian patients, consider initiation of CRESTOR 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) andClinical Pharmacology (12.3)].

    2.5 Use with Concomitant Therapy

    Patients taking cyclosporine

    The dose of CRESTOR should not exceed 5 mg once daily [seeWarnings and Precautions (5.1), Drug Interactions (7.1), and Clinical Pharmacology (12.3)]

    Patients taking gemfibrozil

    Initiate CRESTOR therapy with 5 mg once daily. The dose of CRESTOR should not exceed 10 mg once daily [see Warnings and Precautions (5.1) and Drug Interactions (7.2), and Clinical Pharmacology (12.3)].

    Patients taking lopinavir and ritonavir or atazanavir and ritonavir

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

    2.6 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 CRESTOR 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)].

  • Crestor | Carilion Materials Management
    No Recall

    Crestor | Carilion Materials Management

    Crestor | Carilion Materials Management
    2.1 General Dosing Information

    The dose range for CRESTOR is 5 to 40 mg orally once daily. The usual starting dose is 10‑20 mg.

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

    When initiating CRESTOR therapy or switching from another HMG‑CoA reductase inhibitor therapy, the appropriate CRESTOR 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 CRESTOR, lipid levels should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly.

    The 40 mg dose of CRESTOR 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)

    2.2 Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10 to 17 years of age)

    The usual dose range of CRESTOR is 5‑20 mg/day; the maximum recommended dose is 20 mg/day (doses greater than 20 mg have not been studied in this patient population). Doses should be individualized according to the recommended goal of therapy [see and ]. Adjustments should be made at intervals of 4 weeks or more. Clinical Pharmacology (12)Indications and Usage (1.2)

    2.3 Homozygous Familial Hypercholesterolemia

    The recommended starting dose of CRESTOR is 20 mg once daily. Response to therapy should be estimated from preapheresis LDL‑C levels.

    2.4 Dosing in Asian Patients

    In Asian patients, consider initiation of CRESTOR 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 and ]. Use in Specific Populations (8.8)Clinical Pharmacology (12.3)

    2.5 Use with Concomitant Therapy

    Patients taking cyclosporine

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

    Patients taking gemfibrozil

    Initiate CRESTOR therapy with 5 mg once daily. The dose of CRESTOR should not exceed 10 mg once daily [see and , and ]. Warnings and Precautions (5.1)Drug Interactions (7.2)Clinical Pharmacology (12.3)

    Patients taking lopinavir and ritonavir or atazanavir and ritonavir

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

    2.6 Dosing in Patients with Severe Renal Impairment

    For patients with severe renal impairment (CL  <30 mL/min/1.73 m ) not on hemodialysis, dosing of CRESTOR should be started at 5 mg once daily and not exceed 10 mg once daily [see and ]. cr2Use in Specific Populations (8.6)Clinical Pharmacology (12.3)

  • Medsource Pharmaceuticals
    Crestor | Medsource Pharmaceuticals
    No Recall

    Crestor | Medsource Pharmaceuticals

    Crestor | Medsource Pharmaceuticals
    2.1 General Dosing Information

    The dose range for CRESTOR is 5 to 40 mg orally once daily. The usual starting dose is 10‑20 mg.

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

    When initiating CRESTOR therapy or switching from another HMG‑CoA reductase inhibitor therapy, the appropriate CRESTOR 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 CRESTOR, lipid levels should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly.

    The 40 mg dose of CRESTOR 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)].

    2.2 Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10 to 17 years of age)

    The usual dose range of CRESTOR is 5‑20 mg/day; the maximum recommended dose is 20 mg/day (doses greater than 20 mg have not been studied in this patient population). Doses should be individualized according to the recommended goal of therapy [see Clinical Pharmacology (12) and Indications and Usage (1.2)]. Adjustments should be made at intervals of 4 weeks or more.

    2.3 Homozygous Familial Hypercholesterolemia

    The recommended starting dose of CRESTOR is 20 mg once daily. Response to therapy should be estimated from preapheresis LDL‑C levels.

    2.4 Dosing in Asian Patients

    In Asian patients, consider initiation of CRESTOR 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)].

    2.5 Use with Concomitant Therapy

    Patients taking cyclosporine

    The dose of CRESTOR 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

    Initiate CRESTOR therapy with 5 mg once daily. The dose of CRESTOR should not exceed 10 mg once daily [see Warnings and Precautions (5.1) and Drug Interactions (7.2), and Clinical Pharmacology (12.3)].

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

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

    2.6 Dosing in Patients with Severe Renal Impairment

    For patients with severe renal impairment (CL cr <30 mL/min/1.73 m 2) not on hemodialysis, dosing of CRESTOR 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)].