Rosuvastatin Calcium (Crestor)

Trade Name : CRESTOR

AstraZeneca Pharmaceuticals LP

TABLET, FILM COATED

Strength 10 mg/1

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

Delivery Process

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You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

About GNH

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

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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.

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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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