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Rosuvastatin 10 mg Tablet, Film Coated — NDC 55154-0158-0 (Billing 55154-0158-00)

by Cardinal Health 107, LLC · 10 BLISTER PACK in 1 BAG / 1 TABLET, FILM COATED in 1 BLISTER PACK

This is a package of Rosuvastatin 10 mg Tablet, Film Coated from Cardinal Health 107, LLC, marketed since Jul 2025 and currently FDA-listed. It is this product's only package size.

NDC 55154-0158-00
🏷️ FDA NDC (as labeled) 55154-0158-0 billing pads the package segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 55154-0158-0 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
55154 labeler · 0158 product · 0 package
Package marketed since
Jul 14, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5515401580 7
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Rosuvastatin (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Dec 31, 2025 — Out of specification for dissolution. (AvKARE) · FDA recall D-0292-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 55154-0158-0
Product NDC 55154-0158
11-digit billing NDC 55154015800
RxCUI 859747, 859751
UNII 83MVU38M7Q
Application # ANDA207616
SPL Set ID 0f7fad2c-fc46-4ebc-b55b-6534da99e053
Established class (EPC) HMG-CoA Reductase Inhibitor
Mechanism of action Hydroxymethylglutaryl-CoA Reductase Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-07-14
Route ORAL
Dosage form TABLET, FILM COATED
Substance ROSUVASTATIN CALCIUM
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 859747
Why two NDCs? The FDA registers this code as 55154-0158-0 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 55154-0158-00. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the HMG-CoA Reductase Inhibitor class.

Pharmacologic class HMG-CoA Reductase Inhibitor
Drug family (ATC) HMG CoA reductase inhibitors
How it works Hydroxymethylglutaryl-CoA Reductase Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It lowers cholesterol and triglycerides when diet alone isn’t enough. Some tablet labels also include slowing atherosclerosis and lowering the risk of heart attack and stroke in ad...
  • Take one tablet by mouth once a day, at any time, with or without food. Swallow it whole. If you miss a dose, skip it and take your next one as usual, without doubling up.
  • The most common are headache, nausea, muscle aches, tiredness, constipation and joint pain. Most people tolerate it well. Call your doctor if muscle pain, tenderness or weakness is...
  • Some medicines raise rosuvastatin levels and muscle risk, including cyclosporine, gemfibrozil and many antivirals. Tell me about everything you take. If you use an aluminum and mag...
📖 Read our full Rosuvastatin guide →
1
Nutrient depletion considerations

Rosuvastatin may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Rosuvastatin nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.1900 $1.90 / 10 tablet
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
55154-0158-00 You're viewing this Main listing 10 BLISTER PACK in 1 BAG / 1 TABLET, FILM COATED in 1 BLISTER PACK 2025-07-14 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Rosuvastatin 10 mg 11788-0131-05 AiPing 500 tablets $0.036 AB Availability likely —
Rosuvastatin Calcium 10 mg 13668-0180-05 Torrent 500 tablets $0.036 AB Availability likely —
Rosuvastatin Calcium 10 mg 13668-0721-05 TORRENT 500 tablets $0.036 AB Availability likely —
Rosuvastatin Calcium 10 mg 16714-0989-01 NorthStar 90 tablets $0.036 AB Availability likely —
Rosuvastatin Calcium 10 mg 24658-0262-45 PURACAP 45 tablets $0.036 AB Availability likely —
Rosuvastatin Calcium 10 mg 27808-0156-01 Cranbury 90 tablets $0.036 AB Availability likely —
Rosuvastatin 10 mg 50228-0117-10 ScieGen 1000 tablets $0.036 AB Availability likely —
Rosuvastatin 10 mg 50268-0709-15 AvPAK 1 tablet $0.036 AB Availability likely —
Rosuvastatin Calcium 10 mg 60687-0245-01 American 1 tablet $0.036 AB Availability likely —
Rosuvastatin Calcium 10 mg 67877-0440-05 Ascend 500 tablets $0.036 AB Availability likely —
Rosuvastatin Calcium 10 mg 72603-0365-01 NorthStar 90 tablets $0.036 AB Availability likely —
Rosuvastatin Calcium 10 mg 82009-0018-10 Quallent 1000 tablets $0.036 AB Availability likely —
Rosuvastatin 10 mg 16729-0285-15 Accord 90 tablets $0.049 AB FDA listed —
Crestor 10 mg 00310-7570-90 AstraZeneca 90 tablets $8.811 AB Availability likely —
Rosuvastatin Calcium 10 mg 00615-8533-39 NCS 30 tablets — AB FDA listed —
Rosuvastatin 10 mg 31722-0883-31 Camber 100 tablets — AB FDA listed —
Rosuvastatin 10 mg 33342-0262-07 Macleods 30 tablets — — FDA listed —
Rosuvastatin Calcium 10 mg 42677-0302-01 Shandong 90 tablets — AB FDA listed —
Rosuvastatin calcium 10 mg 42708-0190-30 QPharma, 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-2451-00 A-S 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-4738-00 A-S 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-5188-00 A-S 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-5189-00 A-S 90 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-5745-00 A-S 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-5746-00 A-S 90 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-5770-00 A-S 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-5771-00 A-S 90 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-6637-00 A-S 90 tablets — AB FDA listed —
Rosuvastatin 10 mg 50090-7430-00 A-S 30 tablets — AB FDA listed —
Rosuvastatin 10 mg 50090-7431-00 A-S 90 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-7486-00 A-S 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-7487-00 A-S 90 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-7492-00 A-S 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-7493-00 A-S 90 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-7967-00 A-S 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-7968-00 A-S 90 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 51407-0154-90 Golden 90 tablets — AB Discontinued —
Rosuvastatin 10 mg 51407-0849-10 Golden 1000 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 51655-0062-52 Northwind 30 tablets — AB FDA listed —
Rosuvastatin calcium 10 mg 51655-0256-52 Northwind 30 tablets — AB FDA listed —
Rosuvastatin 10 mgthis 55154-0158-00 Cardinal 1 tablet — AB FDA listed —
Rosuvastatin calcium 10 mg 55700-0998-30 Quality 30 tablets — AB Discontinued —
Rosuvastatin Calcium 10 mg 57237-0169-05 Rising 500 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 60290-0044-01 Umedica 30 tablets — AB FDA listed —
Rosuvastain Calcium 10 mg 62135-0691-90 Chartwell 90 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 63187-0864-30 Proficient 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 63629-7157-01 Bryant 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 65862-0294-05 Aurobindo 500 tablets — AB FDA listed —
Rosuvastatin 10 mg 67046-1627-03 Coupler 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 68071-2407-09 NuCare 90 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 68071-3623-09 NuCare 90 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 68071-3722-09 NuCare 90 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 68071-5176-09 NuCare 90 tablets — AB FDA listed —
Rosuvastatin calcium 10 mg 68462-0262-01 Glenmark 100 tablets — AB FDA listed —
Rosuvastatin 10 mg 68788-4057-02 Preferred 20 tablets — AB FDA listed —
Rosuvastatin calcium 10 mg 68788-7086-02 Preferred 20 tablets — AB Discontinued —
Rosuvastatin Calcium 10 mg 68788-8384-02 Preferred 20 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 68788-8775-02 Preferred 20 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 69367-0360-01 Westminster 100 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 69434-0006-02 Zhejiang 90 tablets — AB FDA listed —
Rosuvastatin calcium 10 mg 70377-0007-11 Biocon 30 tablets — AB FDA listed —
Rosuvastatin calcium 10 mg 70518-4143-02 REMEDYREPACK 90 tablets — AB FDA listed —
Rosuvastatin 10 mg 70518-4303-00 REMEDYREPACK 90 tablets — AB FDA listed —
rosuvstatin 10 mg 70756-0054-12 Lifestar 1000 tablets — — FDA listed —
Rosuvastatin calcium 10 mg 71205-0008-30 Proficient 30 tablets — AB FDA listed —
Rosuvastatin calcium 10 mg 71205-0052-30 Proficient 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 71205-0820-30 Proficient 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 71209-0044-04 Cadila 90 tablets — AB FDA listed —
Rosuvastatin 10 mg 71335-0606-01 Bryant 30 tablets — AB Discontinued —
Rosuvastatin Calcium 10 mg 71335-1733-01 Bryant 30 tablets — AB FDA listed —
Rosuvastatin calcium 10 mg 71335-1890-01 Bryant 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 71335-2035-01 Bryant 30 tablets — AB FDA listed —
Rosuvastatin 10 mg 71335-2539-01 Bryant 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 71335-9640-01 Bryant 30 tablets — AB FDA listed —
Rosuvastatin calcium 10 mg 71610-0215-45 Aphena 45 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 71610-0233-15 Aphena 15 tablets — AB FDA listed —
Rosuvastatin 10 mg 71610-0797-15 Aphena 15 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 71610-0801-45 Aphena 45 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 72205-0003-05 Novadoz 500 tablets — AB FDA listed —
Rosuvastatin 10 mg 82009-0189-05 Quallent 500 tablets — AB FDA listed —
Rosuvastatin calcium 10 mg 82804-0291-30 Proficient 30 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2025
On the market since
Jul 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color pink
ShapeRound
ImprintH;R5
Size8 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerCardinal Health 107, LLC
Application holderHETERO LABS LTD UNIT V
FDA applicationANDA207616 (ANDA)
Labeler code55154
First marketedJul 2025
Product typeHuman Prescription Drug
Portfolio477 products on file

More NDCs from Cardinal Health 107, LLC labeler code 55154

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS & USAGE Rosuvastatin tablets are indicated: • To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. • As an adjunct to diet to: • Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. • Reduce LDL-C and slow the progression of atherosclerosis in adults. • Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). • As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). • As an adjunct to diet for the treatment of adults with: • Primary dysbetalipoproteinemia. • Hypertriglyceridemia.

Rosuvastatin tablets are an HMG Co-A reductase inhibitor (statin) indicated: ( 1) • To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. • As an adjunct to diet to: • reduce LDL-C in adults with primary hyperlipidemia. • reduce LDL-C and slow the progression of atherosclerosis in adults. • reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). • As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). • As an adjunct to diet for the treatment of adults with: • Primary dysbetalipoproteinemia. • Hypertriglyceridemia.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE & ADMINISTRATION Take orally with or without food, at any time of day. ( 2.1) Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating rosuvastatin tablets, and adjust dosage if necessary. ( 2.1) Adults: Recommended dosage range is 5 to 40 mg once daily.

( 2.1) Pediatric Patients with HeFH:Recommended dosage range is 5 to 10 mg once daily for patients aged 8 to less than 10 years of age, and 5 to 20 mg once daily for patients aged 10 years and older. ( 2.2) Pediatric Patients with HoFH:Recommended dosage is 20 mg once daily for patients aged 7 years and older. ( 2.2) Asian Patients:Initiate at 5 mg once daily.

Consider risks and benefits of treatment if not adequately controlled at doses up to 20 mg once daily. ( 2.4)

2.1General Dosing Information • Administer rosuvastatin tablets orally as a single dose at any time of day, with or without food. Swallow the tablets whole. • Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating rosuvastatin tablets, and adjust the dosage if necessary. • If a dose is missed, advise patients not to take an extra dose. Resume treatment with the next dose. • When taking rosuvastatin tablets with an aluminum and magnesium hydroxide combination antacid, administer rosuvastatin tablets at least 2 hours before the antacid [see Drug Interactions ( 7.2)].

2.2Recommended Dosage in Adult Patients • The dosage range for rosuvastatin tablets is 5 to 40 mg orally once daily. • The recommended dose of rosuvastatin tablets depends on a patient’s indication for usage, LDLC, and individual risk for CV events.

2.3Recommended Dosage in Pediatric Patients Dosage in Pediatric Patients 8 Years of Age and Older with HeFH The recommended dosage range is 5 mg to 10 mg orally once daily in patients aged 8 years to less than 10 years and 5 mg to 20 mg orally once daily in patients aged 10 years and older. Dosage in Pediatric Patients 7 Years of Age and Older with HoFH The recommended dosage is 20 mg orally once daily.

2.4Dosing in Asian Patients Initiate rosuvastatin tablets at 5 mg once daily due to increased rosuvastatin plasma concentrations. Consider the risks and benefits of rosuvastatin tablets when treating Asian patients not adequately controlled at doses up to 20 mg once daily [see Warnings and Precautions (5.1), Use in Specific Populations (8.8), and Clinical Pharmacology (12.3)].

2.5Dosing in Patients with Severe Renal Impairment In patients with severe renal impairment (CL crless than 30 mL/min/1.73 m 2) not on hemodialysis, the recommended starting dosage is 5 mg once daily and should not exceed 10 mg once daily [see Warnings and Precautions (5.1) and Use in Specific Populations (8.6)]. There are no dosage adjustment recommendations for patients with mild and moderate renal impairment.

2.8Dosage Modifications Due to Drug Interactions Table 1 displays dosage modifications for rosuvastatin tablets due to drug interactions [see Warnings and Precautions (5.1) and Drug Interactions (7.1)]. 1

2.2Recommended Dosage in Adult Patients • The dosage range for rosuvastatin tablets is 5 to 40 mg orally once daily. • The recommended dose of rosuvastatin tablets depends on a patient’s indication for usage, LDLC, and individual risk for CV events.

2.3Recommended Dosage in Pediatric Patients Dosage in Pediatric Patients 8 Years of Age and Older with HeFH The recommended dosage range is 5 mg to 10 mg orally once daily in patients aged 8 years to less than 10 years and 5 mg to 20 mg orally once daily in patients aged 10 years and older. Dosage in Pediatric Patients 7 Years of Age and Older with HoFH The recommended dosage is 20 mg orally once daily.

2.8Dosage Modifications Due to Drug Interactions Table 1 displays dosage modifications for rosuvastatin tablets due to drug interactions [see Warnings and Precautions (5.1) and Drug Interactions (7.1)]. 1

💊 Dosage Forms and Strengths 116 words ▾

3 DOSAGE FORMS & STRENGTHS 5 mg: Light yellow to yellow, round, bevel edged biconvex film coated tablets debossed with "H" on one side and "R3" on the other side. 10 mg: Light pink to pink, round, bevel edged biconvex film coated tablets debossed with "H" on one side and "R4" on the other side. 20 mg: Light pink to pink, round, bevel edged biconvex film coated tablets debossed with "H" on one side and "R5" on the other side.

40 mg: Light pink to pink, oval, bevel edged biconvex film coated tablets debossed with "H" on one side and "R6" on the other side. Tablets: 5 mg, 10 mg, 20 mg, and 40 mg (3)

⛔ Contraindications 63 words ▾

4 CONTRAINDICATIONS Rosuvastatin is contraindicated in the following conditions: • Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3)]. • Hypersensitivity to rosuvastatin or any excipients in rosuvastatin. Hypersensitivity reactions including rash, pruritus, urticaria, and angioedema have been reported with rosuvastatin [see Adverse Reactions (6.1)]. Acute liver failure or decompensated cirrhosis.

(4) Hypersensitivity to rosuvastatin or any excipients in rosuvastatin. (4)

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS

5.1Myopathy and Rhabdomyolysis Rosuvastatin may cause myopathy [muscle pain, tenderness, or weakness associated with elevated creatine kinase (CK)] and rhabdomyolysis. Acute kidney injury secondary to myoglobinuria and rare fatalities have occurred as a result of rhabdomyolysis with statins, including rosuvastatin. Risk Factors for Myopathy Risk factors for myopathy include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs (including other lipidlowering therapies), and higher rosuvastatin dosage.

Asian patients on rosuvastatin may be at higher risk for myopathy [see Drug Interactions (7.1) and Use in Specific Populations (8.8)]. The myopathy risk is greater in patients taking rosuvastatin 40 mg daily compared with lower rosuvastatin dosages. Steps to Prevent or Reduce the Risk of Myopathy and Rhabdomyolysis The concomitant use of rosuvastatin with cyclosporine or gemfibrozil is not recommended. rosuvastatin dosage modifications are recommended for patients taking certain antiviral medications, darolutamide, and regorafenib [see Dosage and Administration (2.6)].

Niacin, fibrates, and colchicine may also increase the risk of myopathy and rhabdomyolysis [see Drug Interactions (7.1)]. Discontinue rosuvastatin if markedly elevated CK levels occur or if myopathy is either diagnosed or suspected. Muscle symptoms and CK elevations may resolve if rosuvastatin is discontinued.

Temporarily discontinue rosuvastatin in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis (e.g., sepsis; shock; severe hypovolemia; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; or uncontrolled epilepsy). Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing the rosuvastatin dosage. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.

5.2Immune-Mediated Necrotizing Myopathy There have been rare reports ofimmune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use, including reports of recurrence when the sameor a different statin was administered. IMNM is characterized by proximal muscle weakness and elevated serum creatine kinase that persist despitediscontinuation of statin treatment; positive anti-HMG CoA reductase antibody; muscle biopsy showing necrotizing myopathy; and improvement withimmunosuppressive agents.

Additional neuromuscular and serologic testing may be necessary. Treatment with immunosuppressive agents may be required.Discontinue rosuvastatin if IMNM is suspected.

5.3Hepatic Dysfunction Increases in serum transaminases have been reported with use of rosuvastatin [see Adverse Reactions (6.1)]. In most cases, these changes appeared soon after initiation, were transient, were not accompanied by symptoms, and resolved or improved on continued therapy or after a brief interruption in therapy. In a pooled analysis of placebocontrolled trials, increases in serum transaminases to more than three times the ULN occurred in 1.1% of patients taking rosuvastatin versus 0.5% of patients treated with placebo.

Marked persistent increases of hepatic transaminases have also occurred with rosuvastatin. There have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including rosuvastatin. Patients who consume substantial quantities of alcohol and/or have a history of liver disease may be at increased risk for hepatic injury [see Use in Specific Populations (8.7)] .

Consider liver enzyme testing before rosuvastatin initiation and when clinically indicated thereafter. Rosuvastatin is contraindicated in patients with acute liver failure or decompensated cirrhosis [see Contraindications (4)] . If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice o… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.1)] Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions (5.2)] Hepatic Dysfunction [see Warnings and Precautions (5.3)] Proteinuria and Hematuria [see Warnings and Precautions (5.4)] Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions (5.5)]

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Adverse reactions reported in ≥2% of patients in placebo-controlled clinical studies and at a rate greater than placebo are shown in Table 2. These studies had a treatment duration of up to 12 weeks.

Table 2: Adverse Reactions Reported in ≥2% of Patients Treated with Rosuvastatin and > Placebo in Placebo-Controlled Trials Other adverse reactions reported in clinical studies were abdominal pain, dizziness, hypersensitivity (including rash, pruritus, urticaria, and angioedema) and pancreatitis. The following laboratory abnormalities have also been reported: dipstick-positive proteinuria and microscopic hematuria; elevated creatine phosphokinase, transaminases, glucose, glutamyl transpeptidase, alkaline phosphatase, and bilirubin; and thyroid function abnormalities.

In the METEOR study, patients were treated with rosuvastatin 40 mg (n=700) or placebo (n=281) with a mean treatment duration of 1.7 years. Adverse reactions reported in ≥2% of patients and at a rate greater than placebo are shown in Table 3. Table 3: Adverse Reactions Reported in ≥2% of Patients Treated with Rosuvastatin and > Placebo in the METEOR Trial 1 Frequency recorded as abnormal laboratory value.

In the JUPITER study, patients were treated with rosuvastatin 20 mg (n=8,901) or placebo (n=8,901) for a mean duration of 2 years. In JUPITER, there was a significantly higher frequency of diabetes mellitus reported in patients taking rosuvastatin (2.8%) versus patients taking placebo (2.3%). Mean HbA1c was significantly increased by 0.1% in rosuvastatin-treated patients compared to placebo-treated patients.

The number of patients with a HbA1c >6.5% at the end of the trial was significantly higher in rosuvastatin-treated versus placebo-treated patients [see Clinical Studies (14)]. Adverse reactions reported in ≥2% of patients and at a rate greater than placebo are shown in Table 4. Table 4: Adverse Reactions Reported in ≥2% of Patients Treated with Rosuvastatin and > Placebo in the JUPITER Trial Pediatric Patients with HeFH In a 12-week controlled study in pediatric patients 10 to 17 years of age with HeFH with rosuvastatin 5 mg to 20 mg daily [see Use in Specific Populations (8.4) and Clinical Studies (14)],elevations in serum CK greater than 10 x ULN were observed more frequently in rosuvastatin-treated patients compared with patients receiving placebo.

Four of 130 (3%) patients treated with rosuvastatin (2 treated with 10 mg and 2 treated with 20 mg) had increased CK greater than 10 x ULN, compared to 0 of 46 patients on placebo.

6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of rosuvastatin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Blood Disorders:thrombocytopenia Hepatobiliary Disorders:hepatitis, jaundice, fatal and non-fatal hepatic failure Musculoskeletal Disorders:arthralgia, rare reports of immune-mediated necrotizing myopathy associated with statin use Nervous System Disorders:peripheral neuropathy, rare postmarketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS

7.1Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with Rosuvastatin Rosuvastatin is a substrate of CYP2C9 and transporters (such as OATP1B1, BCRP). Rosuvastatin plasma levels can be significantly increased with concomitant administration of inhibitors of CYP2C9 and transporters. Table 5 includes a list of drugs that increase the risk of myopathy and rhabdomyolysis when used concomitantly with rosuvastatin and instructions for preventing or managing them [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)].

Table 5: Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with Rosuvastatin

7.2Drug Interactions that Decrease the Efficacy of Rosuvastatin Table 6 presents drug interactions that may decrease the efficacy of rosuvastatin and instructions for preventing or managing them. Table 6: Drug Interactions that Decrease the Efficacy of Rosuvastatin

7.3Rosuvastatin Effects on Other Drugs Table 7 presents rosuvastatin’s effect on other drugs and instructions for preventing or managing them. Table 7: Rosuvastatin Effects on Other Drugs See full prescribing information for details regarding concomitant use of rosuvastatin with other drugs that increase the risk of myopathy and rhabdomyolysis. ( 7.1) Aluminum and Magnesium Hydroxide Combination Antacids:Administer rosuvastatin at least 2 hours before the antacid.

( 7.2) Warfarin:Obtain INR prior to starting rosuvastatin Monitor INR frequently until stable upon initiation, dose titration or discontinuation. ( 7.3) table 5, part 1 table 5, part 2 table 5; part 3 table 5, part 4 table 5; part 5 table 6 table 7

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Discontinue rosuvastatin when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Rosuvastatin decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, rosuvastatin may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology (12.1)].

In addition, treatment of hyperlipidemia is not generally necessary during pregnancy. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperlipidemia for most patients. Available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of major congenital malformations.

Published data from prospective and retrospective observational cohort studies with rosuvastatin use in pregnant women are insufficient to determine if there is a drug-associated risk of miscarriage (see Data). In animal reproduction studies, no adverse developmental effects were observed in pregnant rats or rabbits orally administered rosuvastatin during the period of organogenesis at doses that resulted in systemic exposures equivalent to human exposures at the maximum recommended human dose (MRHD) of 40 mg/day, based on AUC and body surface area (mg/m 2), respectively (see Data).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data A Medicaid cohort linkage study of 1,152 statin-exposed pregnant women compared to 886,996 controls did not find a significant teratogenic effect from maternal use of statins in the first trimester of pregnancy, after adjusting for potential confounders – including maternal age, diabetes mellitus, hypertension, obesity, and alcohol and tobacco use – using propensity scorebased methods.

The relative risk of congenital malformations between the group with statin use and the group with no statin use in the first trimester was 1.07 (95% confidence interval 0.85 to 1.37) after controlling for confounders, particularly pre-existing diabetes mellitus. There were also no statistically significant increases in any of the organ-specific malformations assessed after accounting for confounders. In the majority of pregnancies, statin treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified.

Study limitations include reliance on physician coding to define the presence of a malformation, lack of control for certain confounders such as body mass index, use of prescription dispensing as verification for the use of a statin, and lack of information on non-live births. Animal Data In female rats given 5, 15 and 50 mg/kg/day before mating and continuing through to gestation day 7 resulted in decreased fetal body weight (female pups) and delayed ossification at 50 mg/kg/day (10 times the human exposure at the MRHD dose of 40 mg/day based on AUC).

In pregnant rats given 2, 10 and 50 mg/kg/day of rosuvastatin from gestation day 7 through lactation day 21 (weaning), decreased pup survival occurred at 50 mg/kg/day (dose equivalent to 12 times the MRHD of 40 mg/day based body surface area). In pregnant rabbits given 0.3, 1, and 3 mg/kg/day of rosuvastatin from gestation day 6 to day 18, decreased fetal viability and maternal mortality was observed at 3 mg/kg/day (dose equivalent to the MRHD of 40 mg/day based on body surface area). Rosuvastatin crosses the placenta in rats and rabbits and is found in fetal tissue and amniotic fluid a… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 38 words ▾

10 OVERDOSAGE No specific antidotes for rosuvastatin are known. Hemodialysis does not significantly enhance clearance of rosuvastatin. In the event of overdose, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Rosuvastatin is an inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a precursor of cholesterol.

12.2Pharmacodynamics Inhibition of HMG-CoA reductase by rosuvastatin accelerates the expression of LDL-receptors, followed by the uptake of LDL-C from blood to the liver, leading to a decrease in plasma LDL-C and total cholesterol. Sustained inhibition of cholesterol synthesis in the liver also decreases levels of very-low-density lipoproteins. The maximum LDL-C reduction of rosuvastatin is usually achieved by 4 weeks and is maintained after that.

12.3Pharmacokinetics Absorption In clinical pharmacology studies in man, peak plasma concentrations of rosuvastatin were reached 3 to 5 hours following oral dosing. Both C maxand AUC increased in approximate proportion to rosuvastatin dose. The absolute bioavailability of rosuvastatin is approximately 20%.

The AUC of rosuvastatin does not differ following evening or morning drug administration. Effect of food Administration of rosuvastatin with food did not affect the AUC of rosuvastatin. Distribution Mean volume of distribution at steady-state of rosuvastatin is approximately 134 liters.

Rosuvastatin is 88% bound to plasma proteins, mostly albumin. This binding is reversible and independent of plasma concentrations. Elimination Metabolism Rosuvastatin is not extensively metabolized; approximately 10% of a radiolabeled dose is recovered as metabolite.

The major metabolite is N-desmethyl rosuvastatin, which is formed principally by cytochrome P450 \ 2C9, and in vitrostudies have demonstrated that N-desmethyl rosuvastatin has approximately one-sixth to one-half the HMG-CoA reductase inhibitory activity of the parent compound. Overall, greater than 90% of active plasma HMG-CoA reductase inhibitory activity is accounted for by the parent compound. Excretion Following oral administration, rosuvastatin and its metabolites are primarily excreted in the feces (90%).

After an intravenous dose, approximately 28% of total body clearance was via the renal route, and 72% by the hepatic route. The elimination half-life of rosuvastatin is approximately 19 hours. Specific Populations Geriatric Patients There were no differences in plasma concentrations of rosuvastatin between the nonelderly and elderly populations (age ≥65 years).

Pediatric Patients In a population pharmacokinetic analysis of two pediatric trials involving patients with HeFH 10 to 17 years of age and 8 to 17 years of age, respectively, rosuvastatin exposure appeared comparable to or lower than rosuvastatin exposure in adult patients. Male and Female Patients There were no differences in plasma concentrations of rosuvastatin between males and females. Racial or Ethnic Groups A population pharmacokinetic analysis revealed no clinically relevant differences in pharmacokinetics among White, Hispanic, or Latino ethnicity, and Black or Afro-Caribbean groups.

However, pharmacokinetic studies, including one conducted in the US, have demonstrated an approximate 2-fold elevation in median exposure (AUC and C max) in Asian subjects when compared with a White control group. Patients with Renal Impairment Mild to moderate renal impairment (CL cr≥30 mL/min/1.73 m 2) had no influence on plasma concentrations of rosuvastatin. However, plasma concentrations of rosuvastatin increased to a clinically significant extent (about 3-fold) in patients with severe renal impairment (CL cr<30 mL/min/1.73 m 2) not receiving hemodialysis compared with healthy subjects (CLcr >80 mL/min/1.73 m 2).

Steady-state plasma concentrations of rosuvastatin in patients on chronic hemodialysis were approximately 50% greater compared with healthy volunteer subjects with normal renal function. Patients with Hepatic Impairment In patients with chronic alcohol liver disease, plasma concentrations of rosuvastatin were modestly increased. In patients with Child-… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 144 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Rosuvastatin Tablets USP are supplied as: 10 mg: Light pink to pink, round, bevel edged biconvex film coated tablets, debossed with ‘H’ on one side and ‘R4’ on the other side. They are supplied as follows. Overbagged with 10 film coated tablets per bag, NDC 55154-0158-0 20 mg: Light pink to pink, round, bevel edged biconvex film coated tablets, debossed with ‘H’ on one side and ‘R5’ on the other side.

They are supplied as follows. Overbagged with 10 film coated tablets per bag, NDC 55154-0159-0 WARNING: These Unit Dose packages are not child resistant and are Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Dispensed in Unit Dose Package. For Institutional Use Only. Storage Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature].

Protect from moisture.

📋 Description 162 words ▾

11 DESCRIPTION Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is (3R, 5S, 6E) -7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid calcium salt with the following structural formula: : The molecular formula for rosuvastatin calcium is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium USP is a white or almost white hygroscopic powder that is sparingly soluble in methanol, slightly soluble in water, practically insoluble in anhydrous ethanol.

Rosuvastatin tablets USP for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: crospovidone, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate, talc, titanium dioxide and triacetin. Additionally 5 mg tablets contain FD&C yellow #5/tartrazine aluminum lake and 10 mg, 20 mg and 40 mg tablets contain FD&C yellow #6/sunset yellow FCF aluminum lake.

USP Dissolution test is pending. structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Myopathy and Rhabdomyolysis Advise patients that rosuvastatin may cause myopathy and rhabdomyolysis. Inform patients that the risk is also increased when taking certain types of medication and they should discuss all medication, both prescription and over-the-counter, with their healthcare provider.

Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever [see Warnings and Precautions (5.1), and Drug Interactions (7.1)]. Hepatic Dysfunction Inform patients that rosuvastatin may cause liver enzyme elevations and possibly liver failure. Advise patients to promptly report fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice [see Warnings and Precautions (5.3)].

Increases in HbA1c and Fasting Serum Glucose Levels Inform patients that increases in HbA1c and fasting serum glucose levels may occur with rosuvastatin. Encourage patients to optimize lifestyle measures, including regular exercise, maintaining a healthy body weight, and making healthy food choices [see Warnings and Precautions (5.5)]. Pregnancy Advise pregnant patients and patients who can become pregnant of the potential risk to a fetus.

Advise patients to inform their healthcare provider of a known or suspected pregnancy to discuss if rosuvastatin should be discontinued [see Use in Specific Populations (8.1)]. Lactation Advise patients that breastfeeding during treatment with rosuvastatin is not recommended [see Use in Specific Populations (8.2)]. Concomitant Use of Antacids When taking rosuvastatin with an aluminum and magnesium hydroxide combination antacid, administer rosuvastatin at least 2 hours before the antacid [see Drug Interactions (7.2)].

Missed Doses If a dose is missed, advise patients not to take an extra dose. Just resume the usual schedule [see Dosage and Administration (2.1)]. Manufactured for: AvKARE Pulaski, TN 38478 Distributed By: Cardinal Health Dublin, OH 43017 L59919711225 L60439620326 Mfg.

Rev. 11/24 AV Rev. 01/25 (M)

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES Primary Prevention of CV Disease In the Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) study, the effect of rosuvastatin on the occurrence of major CV disease events was assessed in 17,802 males (≥50 years) and females (≥60 years) who had no clinically evident CV disease, LDL-C levels <130 mg/dL and hsCRP levels ≥2 mg/L. The study population had an estimated baseline coronary heart disease risk of 11.6% over 10 years based on the Framingham risk criteria and included a high percentage of patients with additional risk factors such as hypertension (58%), low HDL-C levels (23%), cigarette smoking (16%), or a family history of premature CHD (12%).

Patients had a median baseline LDL-C of 108 mg/dL and hsCRP of 4.3 mg/L. Patients were randomly assigned to placebo (n=8901) or rosuvastatin 20 mg once daily (n=8901) and were followed for a mean duration of 2 years. The JUPITER study was stopped early by the Data Safety Monitoring Board due to meeting predefined stopping rules for efficacy in rosuvastatin-treated subjects.

The primary end point was a composite end point consisting of the time-to-first occurrence of any of the following major CV events: CV death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina or an arterial revascularization procedure. Rosuvastatin significantly reduced the risk of major CV events (252 events in the placebo group vs. 142 events in the rosuvastatin group) with a statistically significant (p<0.001) relative risk reduction of 44% and absolute risk reduction of 1.2% (see Figure 1).

The risk reduction for the primary end point was consistent across the following predefined subgroups: age, sex, race, smoking status, family history of premature CHD, body mass index, LDL-C, HDL-C, and hsCRP levels. Figure 1. Time to First Occurrence of Major CV Events in JUPITER The individual components of the primary end point are presented in Figure 3.

Rosuvastatin significantly reduced the risk of nonfatal myocardial infarction, nonfatal stroke, and arterial revascularization procedures. There were no significant treatment differences between the rosuvastatin and placebo groups for death due to CV causes or hospitalizations for unstable angina. Rosuvastatin significantly reduced the risk of myocardial infarction (6 fatal events and 62 nonfatal events in placebo-treated subjects vs.

9 fatal events and 22 nonfatal events in rosuvastatin-treated subjects) and the risk of stroke (6 fatal events and 58 nonfatal events in placebo-treated subjects vs. 3 fatal events and 30 nonfatal events in rosuvastatin-treated subjects). In a post-hoc subgroup analysis of JUPITER subjects (rosuvastatin=725, placebo=680) with a hsCRP ≥2 mg/L and no other traditional risk factors (smoking, BP ≥140/90 or taking antihypertensives, low HDL-C) other than age, after adjustment for high HDL-C, there was no significant treatment benefit with rosuvastatin treatment.

Figure 2. Major CV Events by Treatment Group in JUPITER At one year, rosuvastatin increased HDL-C and reduced LDL-C, hsCRP, total cholesterol and serum triglyceride levels (p<0.001 for all versus placebo). Primary Hyperlipidemia in Adults Rosuvastatin reduces Total-C, LDL-C, ApoB, non-HDL-C, and TG, and increases HDL-C, in adult patients with hyperlipidemia and mixed dyslipidemia.

In a multicenter, double-blind, placebo-controlled study in patients with hyperlipidemia, rosuvastatin given as a single daily dose (5 to 40 mg) for 6 weeks significantly reduced Total-C, LDL-C, non-HDL-C, and ApoB, across the dose range (Table 10). Table 10: Lipid-Modifying Effect of Rosuvastatin in Adult Patients with Hyperlipidemia (Adjusted Mean % Change from Baseline at Week 6) Rosuvastatin was compared with the statins (atorvastatin, simvastatin, and pravastatin) in a multicenter, open-label, dose-ranging study of 2,240 patients with hyperlipidemia or mixed dyslipidemia.

After randomizat… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a 104-week carcinogenicity study in rats at dose levels of 2, 20, 60, or 80 mg/kg/day by oral gavage, the incidence of uterine stromal polyps was significantly increased in females at 80 mg/kg/day at systemic exposure 20 times the human exposure at 40 mg/day based on AUC. Increased incidence of polyps was not seen at lower doses. In a 107-week carcinogenicity study in mice given 10, 60, or 200 mg/kg/day by oral gavage, an increased incidence of hepatocellular adenoma/carcinoma was observed at 200 mg/kg/day at systemic exposures 20 times the human exposure at 40 mg/day based on AUC.

An increased incidence of hepatocellular tumors was not seen at lower doses. Rosuvastatin was not mutagenic or clastogenic with or without metabolic activation in the Ames test with Salmonella typhimuriumand Escherichia coli,the mouse lymphoma assay, and the chromosomal aberration assay in Chinese hamster lung cells. Rosuvastatin was negative in the in vivomouse micronucleus test.

In rat fertility studies with oral gavage doses of 5, 15, 50 mg/kg/day, males were treated for 9 weeks prior to and throughout mating and females were treated 2 weeks prior to mating and throughout mating until gestation day 7. No adverse effect on fertility was observed at 50 mg/kg/day (systemic exposures up to 10 times the human exposure at 40 mg/day based on AUC). In testicles of dogs treated with rosuvastatin at 30 mg/kg/day for one month, spermatidic giant cells were seen.

Spermatidic giant cells were observed in monkeys after 6-month treatment at 30 mg/kg/day in addition to vacuolation of seminiferous tubular epithelium. Exposures in the dog were 20 times and in the monkey 10 times the human exposure at 40 mg/day based on body surface area. Similar findings have been seen with other drugs in this class.

📄 Package Label / Principal Display Panel 31 words ▾

Package/Label Display Panel NDC 55154-0158-0 Rosuvastatin Tablets, USP 10 mg 10 TABLETS 10mg bag label

Package/Label Display Panel NDC 55154-0159-0 Rosuvastatin Calcium Tablets, USP 20 mg 10 TABLETS 20mg bag label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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