A3525-18/27 Combined Spinal/epidural 18g Epidural/27g High Flow Whitacre Spinal
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Questions & Answers
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Uses
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 nonpharmacological interventions alone has been inadequate.
Pediatric Patients 10 to 17 years of age with Heterozygous Familial Hypercholesterolemia (HeFH)
Adjunct to diet to reduce Total‑C, LDL‑C and ApoB levels in adolescent boys and girls, who are at least one year post-menarche, 10‑17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: LDL‑C > 190 mg/dL or > 160 mg/dL and there is a positive family history of premature cardiovascular disease (CVD) or two or more other CVD risk factors.
CRESTOR is indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia.
CRESTOR is indicated as an adjunct to diet for the treatment of patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia).
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.
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.
In individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease based on age ≥ 50 years old in men and ≥ 60 years old in women, hsCRP ≥ 2 mg/L, and the presence of at least one additional cardiovascular disease risk factor such as hypertension, low HDL‑C, smoking, or a family history of premature coronary heart disease, CRESTOR is indicated to:
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- reduce the risk of stroke
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- reduce the risk of myocardial infarction
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- reduce the risk of arterial revascularization procedures
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:
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.
CRESTOR Tablets for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following 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.
Sources
A3525-18/27 Combined Spinal/epidural 18g Epidural/27g High Flow Whitacre Spinal Manufacturers
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Smiths Medical Asd, Inc.
![A3525-18/27 Combined Spinal/epidural 18g Epidural/27g High Flow Whitacre Spinal () C47916 [Smiths Medical Asd, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
A3525-18/27 Combined Spinal/epidural 18g Epidural/27g High Flow Whitacre Spinal | Cardinal Health
2.1 General Dosing InformationThe 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 HypercholesterolemiaThe 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 PatientsIn 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 TherapyPatients 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 ImpairmentFor 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)].
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