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Rosuvastatin Calcium (Rosuvastatin Calcium)

Trade Name : Rosuvastatin Calcium

Major Pharmaceuticals

TABLET, COATED

Strength 5 mg/1

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

Delivery Process

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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

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Rosuvastatin Calcium (Rosuvastatin Calcium) which is also known as Rosuvastatin Calcium and Manufactured by Major Pharmaceuticals. It is available in strength of 5 mg/1 per ml. Read more

Rosuvastatin Calcium (Rosuvastatin Calcium) 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

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.

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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.

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About GNH

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.

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.

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  • No data
  • Rosuvastatin tablets are an HMG Co-A reductase inhibitor indicated for:
  • No data
  • 2.1
  • 2.1
  • 2.1
  • 5 mg: Yellow colored, round, biconvex, film coated tablets debossed with '79' on one side and plain on other side.
  • 10 mg: Light pink colored, round, biconvex, film coated tablets debossed with '1180' on one side and plain on other side.
  • 20 mg: Light pink colored, round, biconvex, film coated tablets debossed with '1181' on one side and plain on other side.
  • 40 mg: Light pink colored, oval shape, biconvex, beveled edge, film coated tablets debossed with '1182' on one side and plain on other side.
  • Tablets: 5 mg, 10 mg, 20 mg, and 40 mg ()
  • Rosuvastatin is contraindicated in the following conditions:
  • 4
  • 4
  • 4n- 8.1n- 8.3
  • 4n- 8.2
  • No data
  • Skeletal muscle effects (e.g., myopathy and rhabdomyolysis)n- 5.1n- 7.5n- 7.6
  • Liver enzyme abnormalities: n- 5.2
  • Most frequent adverse reactions (rate u22652%) are headache, myalgia, abdominal pain, asthenia, and nausea. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc. at 1-800-912-9561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • Cyclosporinen- 2.4n- 5.1n- 7.1n- 12.3
  • Gemfibroziln- 2.4n- 5.1n- 7.2
  • Atazanavir/ritonavir, lopinavir/ritonavir, or simeprevir: n- 2.4n- 5.1n- 7.3n- 12.3
  • Coumarin anticoagulants: n- 5.3n- 7.4
  • Concomitant lipid-lowering therapies: n- 5.1n- 7.5n- 7.6
  • 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.
  • Females of reproductive potential: n- (8.3)
  • Severe renal impairment (not on hemodialysis)n- 2.5n- 5.1n- 8.6
  • Asian populationn- 2.3n- 8.8
  • 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.
  • Rosuvastatin calcium USP is a synthetic lipid-lowering agent for oral administration.
  • The chemical name for rosuvastatin calcium USP is bis[(E)-7-[4-u00a0(4-fluorophenyl)-6-isopropyl-2u00a0[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)u00a0-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula:
  • The empirical formula for rosuvastatin calcium USP is (CHFNOS)Ca and the molecular weight is 1001.14. Rosuvastatin calcium USP 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.
  • Rosuvastatin Calcium USP for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin. Additionally, the 5 mg tablet contains ferric oxide yellow and the 10 mg, 20 mg and 40 mg tablets contain ferric oxide red.
  • No data
  • No data
  • No data
  • Rosuvastatin tablets USP are supplied as:
  • Rosuvastatin tablets USP 5 mg are yellow colored, round, biconvex, film coated tablets debossed with '79' on one side and plain on other side.
  • Cartons of 100 tablet (10 tablets each blister pack x 10), NDC 0904-6778-61
  • Rosuvastatin tablets USP 10 mg are light pink colored, round, biconvex, film coated tablets debossed with '1180' on one side and plain on other side.
  • Cartons of 100 tablet (10 tablets each blister pack x 10), NDC 0904-6779-61
  • Rosuvastatin tablets USP 20 mg are light pink colored, round, biconvex, film coated tablets debossed with '1181' on one side and plain on other side.
  • Cartons of 100 tablet (10 tablets each blister pack x 10), NDC 0904-6780-61
  • Rosuvastatin tablets USP 40 mg are light pink colored, oval shape, biconvex, beveled edge, film coated tablets debossed with '1182' on one side and plain on other side.
  • Cartons of 100 tablet (10 tablets each blister pack x 10), NDC 0904-6781-61
  • Storage
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F), excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [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 rosuvastatin tablets 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 rosuvastatin.
  • Concomitant Use of Antacids
  • When taking rosuvastatin with an aluminum and magnesium hydroxide combination antacid, the antacid should be taken at least 2 hours after rosuvastatin 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..
  • Lactation
  • Advise women not to breastfeed during treatment with rosuvastatin n
  • Liver Enzymes
  • It is recommended that liver enzyme tests be performed before the initiation of rosuvastatin and if signs or symptoms of liver injury occur. All patients treated with rosuvastatin should be advised to promptly report any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice.
  • Manufactured by:
  • TORRENT PHARMACEUTICALS LTD., INDIA.
  • Manufactured for:
  • TORRENT PHARMA INC., Basking Ridge, NJ 07920.
  • Distributed By:
  • MAJORu00ae PHARMACEUTICALS
  • 17177 N Laurel Park Dr., Suite 233
  • Livonia, MI 48152
  • 8072586 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Revised December 2018
  • This Patient Information has been approved by the U.S. Food and Drug Administration.
  • Rosuvastatin Calcium Tablets
  • 5 mg*
  • 100 Tablets
  • Rosuvastatin Calcium Tablets
  • 10 mg*
  • 100 Tablets
  • Rosuvastatin Calcium Tablets
  • 20 mg*
  • 100 Tablets
  • Rosuvastatin Calcium Tablets
  • 40 mg*
  • 100 Tablets

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