Rosuvastatin Calcium (Crestor)

Trade Name

CRESTOR

Active Ingredient

Power

10 mg/1

Type / form

Tablets

Status

Manufacturer

AstraZeneca Pharmaceuticals LP

Storage and handling for CRESTOR

ROSUVASTATIN CALCIUM HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

Disclaimer

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Rosuvastatin Calcium (Crestor) which is also known as CRESTOR and Manufactured by AstraZeneca Pharmaceuticals LP. It is available in strength of 10 mg/1 per ml. Read more

Rosuvastatin Calcium (Crestor) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

About GNH

GNH India a Global Orphan Drug specialist renowned for its adherence to stringent quality standards. GNH India holds ISO 9001:2015 certification and WHO Good Storage and Distribution Practices (GSDP) compliance, ensuring the highest levels of safety and reliability in our operations.

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  • No data
  • CRESTOR is an HMG Co-A reductase inhibitor indicated for:
  • Limitations of use
  • No data
  • 5u00a0mg: Yellow, round, biconvex, coated tablets. Debossed u201cCRESTORu201d and u201c5u201d on one side of the tablet.
  • 10u00a0mg: Pink, round, biconvex, coated tablets. Debossed u201cCRESTORu201d and u201c10u201d on one side of the tablet.
  • 20u00a0mg: Pink, round, biconvex, coated tablets. Debossed u201cCRESTORu201d and u201c20u201d on one side of the tablet.
  • 40u00a0mg: Pink, oval, biconvex, coated tablets. Debossed u201cCRESTORu201d on one side and u201c40u201d on the other side of the tablet.
  • Tablets: 5u00a0mg, 10u00a0mg, 20u00a0mg, and 40u00a0mg n
  • CRESTOR is contraindicated in the following conditions:
  • 4n- 8.1n- 8.3
  • 4n- 8.2
  • No data
  • Skeletal muscle effects (e.g., myopathy and rhabdomyolysis):
  • Liver enzyme abnormalities:
  • The following serious adverse reactions are discussed in greater detail in other sections of the label:
  • Most frequent adverse reactions (rate >2%) are headache, myalgia, abdominal pain, asthenia, and nausea. n
  • To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or n
  • No data
  • Cyclosporine:
  • Gemfibrozil:
  • Atazanavir/ritonavir, lopinavir/ritonavir, or simeprevir:
  • Coumarin anticoagulants:
  • Concomitant lipid-lowering therapies:
  • No data
  • Females of reproductive potential:
  • Severe renal impairment (not on hemodialysis):
  • Asian population:
  • There is no specific treatment in the event of overdose. In the event of overdose, the patient should be treated symptomatically and supportive measures instituted as required. Hemodialysis does not significantly enhance clearance of rosuvastatin.
  • 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 (CHFNOS)Ca and the molecular weight isu00a01001.14. 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) ofu00a00.13 at pH ofu00a07.0.
  • CRESTOR Tablets for oral administration contain 5, 10, 20, or 40u00a0mg 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.
  • No data
  • No data
  • No data
  • CRESTOR (rosuvastatin calcium) Tablets are supplied as:
  • Storage
  • Store at controlled room temperature, 20u201125u00baC (68-77u00baF) [see USP Controlled Room Temperature]. Protect from moisture.
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Patients should be instructed not to take 2 doses of CRESTOR within 12 hours of each other.
  • Skeletal Muscle Effects
  • Patients should be advised to report promptly unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever or if these muscle signs or symptoms persist after discontinuing CRESTOR.
  • Concomitant Use of Antacids
  • When taking CRESTOR with an aluminum and magnesium hydroxide combination antacid, the antacid should be taken at least 2 hours after CRESTOR administration.
  • Embryofetal Toxicity
  • Advise females of reproductive potential of the risk to a fetus, to use effective contraception during treatment, and to inform their healthcare provider of a known or suspected pregnancy n
  • Lactation
  • Advise women not to breastfeed during treatment with CRESTOR n
  • Liver Enzymes
  • It is recommended that liver enzyme tests be performed before the initiation of CRESTOR and if signs or symptoms of liver injury occur. All patients treated with CRESTOR should be advised to promptly report any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice.
  • CRESTOR is a trademark of the AstraZeneca group of companies.
  • u00a9 AstraZeneca 2018
  • Licensed from SHIONOGI & CO., LTD., Osaka, Japan
  • Distributed by:
  • AstraZeneca Pharmaceuticals LP
  • Wilmington, DE 19850
  • This Patient Information has been approved by the U.S. Food and Drug Administration u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Revised 11/2018
  • NDC 0310-0755-90u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a090 tablets
  • CRESTORu00ae
  • rosuvastatin calcium
  • 5 mg
  • Rx only
  • Mfd. for: AstraZeneca Pharmaceuticals LP
  • Wilmington, DE 19850
  • By: IPR Pharmaceuticals LP
  • Canu00f3vanas, PR 00729
  • Product of UK
  • AstraZeneca
  • NDC 0310-0751-90u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a090 tablets
  • CRESTORu00ae
  • rosuvastatin calcium
  • 10 mg tablets
  • Rx only
  • Mfd. for: AstraZeneca Pharmaceuticals LP
  • Wilmington, DE 19850
  • By: IPR Pharmaceuticals LP
  • Canu00f3vanas, PR 00729
  • Product of UK
  • AstraZeneca
  • NDC 0310-0752-90u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a090 tablets
  • CRESTORu00ae
  • rosuvastatin calcium
  • 20 mg tablets
  • Rx only
  • Mfd. for: AstraZeneca Pharmaceuticals LP
  • Wilmington, DE 19850
  • By: IPR Pharmaceuticals LP
  • Canu00f3vanas, PR 00729
  • Product of UK
  • AstraZeneca
  • NDC 0310-0754-30u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a030 tablets
  • CRESTORu00ae
  • rosuvastatin calcium
  • 40 mg tablets
  • Rx only
  • Mfd. for: AstraZeneca Pharmaceuticals LP
  • Wilmington, DE 19850
  • By: IPR Pharmaceuticals LP
  • Canu00f3vanas, PR 00729
  • Product of UK
  • AstraZeneca

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