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Rosuvastatin Calcium (Rosuvastatin Calcium)

Trade Name : Rosuvastatin Calcium

Sun Pharmaceutical Industries, Inc.

TABLET, FILM COATED

Strength 5 mg/1

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

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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 Sun Pharmaceutical Industries, Inc.. 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.

Read more
  • No data
  • Pediatric use information for patients 7 to 17 years of age is approved for AstraZenecau2019s . However, due to AstraZenecau2019s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
  • Rosuvastatin is an HMG Co-A reductase inhibitor indicated for:
  • Limitations of use
  • adult patients with hypertriglyceridemia as an adjunct to diet ()
  • adult patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet ()
  • adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total-C, and ApoB ()
  • No data
  • Rosuvastatin calcium tablets can be taken with or without food, at any time of day. ()
  • Dose range: 5 mg to 40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg. ()
  • Adult HoFH: Starting dose 20 mg/day. ()
  • 5 mg tablets: Yellow colored, circular, biconvex, film-coated tablets with u2018Su2019 debossed on one side and plain on the other side of the tablet.
  • 10 mg tablets: Pink colored, circular, biconvex, film-coated tablets with u2018583u2019 debossed on one side and plain on the other side of the tablet.
  • 20 mg tablets: Pink colored, circular, biconvex, film-coated tablets with u2018584u2019 debossed on one side and plain on the other side of the tablet.
  • 40 mg tablets: Pink colored, oval, biconvex, film-coated tablets with u2018585u2019 debossed on one side and plain on the other side of the tablet.
  • Tablets: 5 mg, 10 mg, 20 mg, and 40 mg ()
  • Rosuvastatin is contraindicated in the following conditions:
  • Known hypersensitivity to product components ()
  • Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels ()
  • Pregnancy (, , )
  • Lactation (, )
  • 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 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.
  • 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:
  • Rosuvastatin calcium tablets for oral administration contain 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin and the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized maize starch, talc, titanium dioxide, iron oxide yellow (5 mg), iron oxide red (10 mg, 20 mg, 40 mg), and FD& C Red # 40 aluminum lake (10 mg, 20 mg, 40 mg).
  • No data
  • No data
  • No data
  • Rosuvastatin calcium tablets are available containing 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin.
  • 5 mg tablets: Yellow colored, circular, biconvex, film-coated tablets with u2018Su2019 debossed on one side and plain on the other side of the tablet.
  • Bottles of 30u2019s with Child Resistant Capu2026.............................................................NDC 47335-582-83
  • Bottles of 90's with Child Resistant Capu2026..............................................................NDC 47335-582-81
  • Bottles of 100u2019s with Child Resistant Capu2026...........................................................NDC 47335-582-88
  • Bottles of 100u2019s with Non Child Resistant Capu2026...................................................NDC 47335-582-08
  • Bottles of 500's with Non Child Resistant Capu2026....................................................NDC 47335-582-13
  • Bottles of 1000u2019s with Non Child Resistant Capu2026.................................................NDC 47335-582-18
  • 10 mg tablets: Pink colored, circular, biconvex, film-coated tablets with u2018583u2019 debossed on one side and plain on the other side of the tablet.
  • Bottles of 30u2019s with Child Resistant Capu2026.............................................................NDC 47335-583-83
  • Bottles of 90's with Child Resistant Capu2026..............................................................NDC 47335-583-81
  • Bottles of 100u2019s with Child Resistant Capu2026...........................................................NDC 47335-583-88
  • Bottles of 100u2019s with Non Child Resistant Capu2026...................................................NDC 47335-583-08
  • Bottles of 500's with Non Child Resistant Capu2026u2026................................................NDC 47335-583-13
  • Bottles of 1000u2019s with Non Child Resistant Capu2026.................................................NDC 47335-583-18
  • 20 mg tablets: Pink colored, circular, biconvex, film-coated tablets with u2018584u2019 debossed on one side and plain on the other side of the tablet.
  • Bottles of 30u2019s with Child Resistant Capu2026.............................................................NDC 47335-584-83
  • Bottles of 90's with Child Resistant Capu2026..............................................................NDC 47335-584-81
  • Bottles of 100u2019s with Child Resistant Capu2026...........................................................NDC 47335-584-88
  • Bottles of 100u2019s with Non Child Resistant Capu2026...................................................NDC 47335-584-08
  • Bottles of 500's with Non Child Resistant Capu2026u2026................................................NDC 47335-584-13
  • Bottles of 1000u2019s with Non Child Resistant Capu2026.................................................NDC 47335-584-18
  • 40 mg tablets: Pink colored, oval, biconvex, film-coated tablets with u2018585u2019 debossed on one side and plain on the other side of the tablet.
  • Bottles of 30u2019s with Child Resistant Capu2026.............................................................NDC 47335-585-83
  • Bottles of 90's with Child Resistant Capu2026..............................................................NDC 47335-585-81
  • Bottles of 100u2019s with Child Resistant Capu2026...........................................................NDC 47335-585-88
  • Bottles of 100u2019s with Non Child Resistant Capu2026...................................................NDC 47335-585-08
  • Bottles of 500's with Non Child Resistant Capu2026u2026................................................NDC 47335-585-13
  • Bottles of 1000u2019s with Non Child Resistant Capu2026.................................................NDC 47335-585-18
  • Storage
  • Store rosuvastatin calcium tablets at 20u00ba to 25u00baC (68u00ba to 77u00baF); excursions permitted between 15u00b0 and 30u00b0C (59u00b0 and 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 calcium tablets within 12 hours of each other.n
  • 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 calcium tablets.
  • Concomitant Use of Antacids
  • When taking rosuvastatin calcium tablets with an aluminum and magnesium hydroxide combination antacid, the antacid should be taken at least 2 hours after rosuvastatin calcium tablets 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 rosuvastatin calcium tablets n
  • Liver Enzymes
  • It is recommended that liver enzyme tests be performed before the initiation of rosuvastatin calcium tablets and if signs or symptoms of liver injury occur. All patients treated with rosuvastatin calcium tablets should be advised to promptly report any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice.
  • This Patient Information has been approved by the U.S. Food and Drug Administration.u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0ISS. 11/2019
  • NDC 47335-582-83 Rosuvastatin Calcium Tablets 5 mg* PHARMACIST: Please dispense with Patient Information provided separately to each patient. Rx only 30 Tablets SUN PHARMAn n
  • NDC 47335-583-83 Rosuvastatin Calcium Tabletsu00a0 10 mg* PHARMACIST: Please dispense with Patient Information provided separately to each patient. Rx only 30 Tablets SUN PHARMAn n
  • NDC 47335-584-83 Rosuvastatin Calcium Tablets 20 mg* PHARMACIST: Please dispense with Patient Information provided separately to each patient. Rx only 30 Tablets SUN PHARMAn n
  • NDC 47335-585-83 Rosuvastatin Calcium Tablets 40 mg* PHARMACIST: Please dispense with Patient Information provided separately to each patient. Rx only 30 Tablets SUN PHARMAn n

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