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:
o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia.
o Reduce LDL-C and slow the progression of atherosclerosis in adults.
o 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:
o Primary dysbetalipoproteinemia.
o Hypertriglyceridemia.

Rosuvastatin tablets, USP

• 5 mg: Yellow, round, biconvex, film-coated tablets, debossed with “CL” on one side and “86” on the other side.
• 10 mg: Pink, round, biconvex, film-coated tablets, debossed with “CL87” on one side and plain on the other side.
• 20 mg: Pink, round, biconvex, film-coated tablets, debossed with “CL88” on one side and plain on the other side.
• 40 mg: Pink, oval, biconvex, film-coated tablets, debossed with “CL89” on one side and plain on the other side.

Rosuvastatin tablets  are 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 tablets. Hypersensitivity reactions including rash, pruritus, urticaria, and angioedema have been reported with rosuvastatin tablets [see Adverse Reactions (6.1)].

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)] 

No specific antidotes for rosuvastatin tablets 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.

Rosuvastatin calcium, USP is a synthetic lipid-lowering agent for oral administration.
The chemical name for rosuvastatin calcium, USP 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 USP, is (C22H27FN3O6S)2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium, USP is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium, USP is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0.
Rosuvastatin tablets, USP for oral administration contain 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: anhydrous dibasic calcium phosphate, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin. The 5 mg tablets contain iron oxide yellow and 10 mg, 20 mg and 40 mg tablets contain iron oxide red.
FDA approved dissolution method differs from the current USP monograph dissolution methods.

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 tablets 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 tablets 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 tablets -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 tablets 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 tablets significantly reduced the risk of nonfatal myocardial infarction, nonfatal stroke, and arterial revascularization procedures. There were no significant treatment differences between the rosuvastatin tablets and placebo groups for death due to CV causes or hospitalizations for unstable angina.
Rosuvastatin tablets 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 tablets -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 tablets -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 tablets treatment.

Figure 2. Major CV Events by Treatment Group in JUPITER

 
At one year, rosuvastatin tablets 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 tablets 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 tablets 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 Tablets in Adult Patients with Hyperlipidemia (Adjusted Mean % Change from Baseline at Week 6)

Rosuvastatin tablets 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 randomization, patients were treated for 6 weeks with a single daily dose of either rosuvastatin tablets, atorvastatin, simvastatin, or pravastatin (see Figure 3 and Table 11).

Figure 3. Percent LDL-C Change by Dose of Rosuvastatin, Atorvastatin, Simvastatin, and Pravastatin at Week 6 in Adult Patients with Hyperlipidemia or Mixed Dyslipidemia

Box plots are a representation of the 25th, 50th, and 75th percentile values, with whiskers representing the 10th and 90th percentile values. Mean baseline LDL-C: 189 mg/dL

Table 11: Percent Change in LDL-C by Dose of Rosuvastatin Tablets, Atorvastatin, Simvastatin, and Pravastatin From Baseline to Week 6 (LS Mean1) in Adult Patients with Hyperlipidemia or Mixed Dyslipidemia (Sample Sizes Ranging from 156–167 Patients Per Group)

1Corresponding standard errors are approximately 1.00. 

2 Rosuvastatin 10 mg reduced LDL-C significantly more than atorvastatin 10 mg; pravastatin 10 mg, 20 mg, and 40 mg; simvastatin 10 mg, 20 mg, and 40 mg. (p<0.002) 
3 Rosuvastatin 20 mg reduced LDL-C significantly more than atorvastatin 20 mg and 40 mg; pravastatin 20 mg and 40 mg; simvastatin 20 mg, 40 mg, and 80 mg. (p<0.002) 
4 Rosuvastatin 40 mg reduced LDL-C significantly more than atorvastatin 40 mg; pravastatin 40 mg; simvastatin 40 mg, and 80 mg. (p<0.002) 

Slowing of the Progression of Atherosclerosis
In the Measuring Effects on Intima Media Thickness: an Evaluation Of Rosuvastatin 40 mg (METEOR) study, the effect of therapy with rosuvastatin tablets on carotid atherosclerosis was assessed by B-mode ultrasonography in patients with elevated LDL-C, at low risk (Framingham risk <10% over ten years) for symptomatic coronary artery disease and with subclinical atherosclerosis as evidenced by carotid intimal-medial thickness (cIMT). In this double-blind, placebo-controlled clinical study 984 adult patients were randomized (of whom 876 were analyzed) in a 5:2 ratio to rosuvastatin tablets 40 mg or placebo once daily. Ultrasonograms of the carotid walls were used to determine the annualized rate of change per patient from baseline to two years in mean maximum cIMT of 12 measured segments. The estimated difference in the rate of change in the maximum cIMT analyzed over all 12 carotid artery sites between patients treated with rosuvastatin tablets and placebo-treated patients was -0.0145 mm/year (95% CI –0.0196, – 0.0093; p<0.0001). 
The annualized rate of change from baseline for the placebo group was +0.0131 mm/year (p<0.0001). The annualized rate of change from baseline for the group treated with rosuvastatin tablets was -0.0014 mm/year (p=0.32).  At an individual patient level in the group treated with rosuvastatin tablets, 52.1% of patients demonstrated an absence of disease progression (defined as a negative annualized rate of change), compared to 37.7% of patients in the placebo group.
HeFH in Adults
In a study of adult patients with HeFH (baseline mean LDL of 291 mg/dL), patients were randomized to rosuvastatin tablets 20 mg or atorvastatin 20 mg. The dose was increased at 6-week intervals. Significant LDL-C reductions from baseline were seen at each dose in both treatment groups (see Table 12).

Table 12:  LDL-C Percent Change from Baseline

1 LS Means are least square means adjusted for baseline LDL-C

HeFH in Pediatric Patients
In a double-blind, randomized, multicenter, placebo-controlled, 12-week study, 176 (97 male and 79 female) pediatric patients with HeFH  were randomized to rosuvastatin 5 mg, 10 mg or 20 mg or placebo daily. Patients ranged in age from 10 to 17 years (median age of 14 years) with approximately 30% of the patients 10 to 13 years and approximately 17%, 18%, 40%, and 25% at Tanner stages II, III, IV, and V, respectively. Females were at least 1-year postmenarche. Mean LDL-C at baseline was 233 mg/dL (range of 129 to 399). The 12-week double-blind phase was followed by a 40-week open-label dose-titration phase, where all patients (n=173) received 5 mg, 10 mg or 20 mg rosuvastatin daily. 
Rosuvastatin significantly reduced LDL-C (primary end point), total cholesterol and ApoB levels at each dose compared to placebo. Results are shown in Table 13 below.

Table 13: Lipid-Modifying Effects of Rosuvastatin Tablets in Pediatric Patients 10 to 17 years of Age with HeFH (Least-Squares Mean Percent Change from Baseline To Week 12)

1 Median percent change 

2 Difference from placebo not statistically significant

Rosuvastatin was also studied in a two-year open-label, uncontrolled, titration-to-goal trial that included 175 pediatric patients with HeFH who were 8 to 17 years old (79 males and 96 females). All patients had a documented genetic defect in the LDL receptor or in ApoB. Approximately 89% were White, 7% were Asian, 1% were Black or African American, and fewer than 1% were Hispanic or Latino ethnicity.  Mean LDL-C at baseline was 236 mg/dL. Fifty-eight (33%) patients were prepubertal at baseline. The starting rosuvastatin dosage for all pediatric patients was 5 mg once daily. Pediatric patients aged 8 to less than 10 years (n=41 at baseline) could titrate to a maximum dosage of 10 mg once daily, and pediatric patients aged 10 to 17 years could titrate to a maximum dosage of 20 mg once daily.
The reductions in LDL-C from baseline were generally consistent across age groups within the trial as well as with previous experience in both adult and pediatric controlled trials.
HoFH in Adult and Pediatric Patients

In an open-label, forced-titration study, HoFH patients (n=40, 8-63 years) were evaluated for their response to rosuvastatin tablets 20 to 40 mg titrated at a 6-week interval. In the overall population, the mean LDL-C reduction from baseline was 22%. About one-third of the patients benefited from increasing their dose from 20 mg to 40 mg with further LDL-C lowering of greater than 6%. In the 27 patients with at least a 15% reduction in LDL-C, the mean LDL-C reduction was 30% (median 28% reduction). Among 13 patients with an LDL-C reduction of <15%, 3 had no change or an increase in LDL-C. Reductions in LDL-C of 15% or greater were observed in 3 of 5 patients with known receptor negative status.

HoFH in Pediatric Patients

Rosuvastatin tablet was studied in a randomized, double-blind, placebo-controlled, multicenter, crossover study in 14 pediatric patients with HoFH. The study included a 4-week dietary lead-in phase during which patients received rosuvastatin tablets 10 mg daily, a cross-over phase that included two 6-week treatment periods with either rosuvastatin tablets 20 mg or placebo in random order, followed by a 12-week open-label phase during which all patients received rosuvastatin tablets  20 mg. Patients ranged in age from 7 to 15 years of age (median 11 years), 50% were male, 71% were White, 21% were Asian, 7% were Black or African American, and no patients were of Hispanic or Latino ethnicity. Fifty percent were on apheresis therapy and 57% were taking ezetimibe. Patients who entered the study on apheresis therapy or ezetimibe continued the treatment throughout the entire study. Mean LDL-C at baseline was 416 mg/dL (range 152 to 716 mg/dL). A total of 13 patients completed both treatment periods of the randomized cross-over phase; one patient withdrew consent due to inability to have blood drawn during the cross-over phase.
Rosuvastatin tablets 20 mg significantly reduced LDL-C, total cholesterol, ApoB, and non-HDL-C compared to placebo (see Table 14).

Table 14: Lipid-Modifying Effects of Rosuvastatin Tablets in Pediatric Patients 7 to 15 years of Age with HoFH After 6 Weeks 

% Difference estimates are based on transformations of the estimated mean difference in log LDL measurements between Rosuvastatin tablets and placebo using a mixed model adjusted for study period 1 p=0.005, 2 p=0.003, 3 p=0.024

 Primary Dysbetalipoproteinemia in Adults 
In a randomized, multicenter, double-blind cross-over study, 32 adult patients (27 with є2/є2 and 4 with apo E mutation [Arg145Cys] with primary dysbetalipoproteinemia entered a 6-week dietary lead-in period on the NCEP Therapeutic Lifestyle Change (TLC) diet. Following dietary lead-in, patients were randomized to a sequence of treatments for 6 weeks each: rosuvastatin 10 mg followed by rosuvastatin 20 mg or rosuvastatin 20 mg followed by rosuvastatin 10 mg. Rosuvastatin tablets reduced non-HDL-C (primary end point) and circulating remnant lipoprotein levels. Results are shown in the table below.

Table 15: Lipid-Modifying Effects of Rosuvastatin Tablets 10 mg and 20 mg in Adult Patients with Primary Dysbetalipoproteinemia (Type III hyperlipoproteinemia) After Six Weeks by Median Percent Change (95% CI) from Baseline (N=32)

Hypertriglyceridemia in Adults
In a double-blind, placebo-controlled study in adult patients with baseline TG levels from 273 to 817 mg/dL, Rosuvastatin tablets given as a single daily dose (5 to 40 mg) over 6 weeks significantly reduced serum TG levels (see Table 16).

Table 16: Lipid-Modifying Effect of Rosuvastatin Tablets in Adult Patients with Primary Hypertriglyceridemia After Six Weeks by Median (Min, Max) Percent Change from Baseline to Week 6

Rosuvastatin tablets, USP are supplied as:

• 5 mg: Yellow, round, biconvex, film-coated tablets, debossed with “CL” on one side and “86” on the other side
    NDC 33342-261-07 bottle of 30 tablets
    NDC 33342-261-10 bottle of 90 tablets
    NDC 33342-261-44 bottle of 1000 tablets
    NDC 33342-261-12 blister pack of 100 tablets (10×10 unit-dose)
• 10 mg. Pink, round, biconvex, film-coated tablets, debossed with “CL87” on one side and plain on the other side
    NDC 33342-262-07 bottle of 30 tablets
    NDC 33342-262-10 bottle of 90 tablets
    NDC 33342-262-44 bottle of 1000 tablets
    NDC 33342-262-12 blister pack of 100 tablets (10×10 unit-dose)
• 20 mg. Pink, round, biconvex, film-coated tablets, debossed with “CL88” on one side and plain on the other side
    NDC 33342-263-07 bottle of 30 tablets
    NDC 33342-263-10 bottle of 90 tablets
    NDC 33342-263-44 bottle of 1000 tablets
    NDC 33342-263-12 blister pack of 100 tablets (10×10 unit-dose)
• 40 mg. Pink, oval, biconvex, film-coated tablets, debossed with “CL89” on one side and plain on the other side
    NDC 33342-264-07 bottle of 30 tablets
    NDC 33342-264-10 bottle of 90 tablets
    NDC 33342-264-44 bottle of 1000 tablets
    NDC 33342-264-12 blister pack of 100 tablets (10×10 unit-dose)

Storage
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.

Advise the patient to read the FDA-approved patient labeling (Patient Information).
Myopathy and Rhabdomyolysis
Advise patients that rosuvastatin tablets 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 tablets 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 tablets. 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 tablets should be discontinued [see Use in Specific Populations (8.1)].
Lactation
Advise patients that breastfeeding during treatment with rosuvastatin tablets is not recommended [see Use in Specific Populations (8.2)].
Concomitant Use of Antacids
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)].
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:

Macleods Pharma USA, Inc.
Princeton, NJ 08540

Manufactured by:
Macleods Pharmaceuticals Ltd.
Baddi, Himachal Pradesh-174101 INDIA

Rev. 11/2024

PATIENT INFORMATION
Rosuvastatin
(roe-SOO-va-STAT-in)
Tablets

Read this Patient Information carefully before you start taking rosuvastatin tablets and each time you get a refill. 
If you have any questions about rosuvastatin tablets, ask your healthcare provider. Only your healthcare provider can determine if rosuvastatin tablets is right for you. 

What are Rosuvastatin  tablets?
Rosuvastatin tablet is a prescription medicine that contains a cholesterol-lowering medicine called rosuvastatin. 
• Rosuvastatin tablets is used: 
o to reduce the risk of major adverse cardiovascular (CV) events, such as death from cardiovascular disease, heart attack, stroke, or the need for procedures to improve blood flow to the heart called arterial revascularization, in adults who do not have known heart disease but do have certain additional risk factors. 
o along with diet to: 
o lower the level of low-density lipoprotein (LDL-C) cholesterol or “bad” cholesterol in adults with primary hyperlipidemia. 
o slow the buildup of fatty deposits (plaque) in the walls of blood vessels. 
o treat adults and children 8 years of age and older with high blood cholesterol due to heterozygous familial hypercholesterolemia (HeFH) (an inherited condition that causes high levels of LDL-C).  
o along with other cholesterol lowering treatments or alone if such treatments are unavailable in adults and children 7 years of age and older with homozygous familial hypercholesterolemia (HoFH) (an inherited condition that causes high levels of LDL-C). 
o along with diet for the treatment of adults with:
o primary dysbetalipoproteinemia (an inherited condition that causes high levels of cholesterol and fat).
o hypertriglyceridemia.

It is not known if rosuvastatin tablets is safe and effective in children younger than 8 years of age with HeFH or children younger than 7 years of age with HoFH or in children with other types of hyperlipidemias (other than HeFH or HoFH).
Do not take Rosuvastatin tablets  if you: 
• have liver problems. 
• are allergic to rosuvastatin or any of the ingredients in rosuvastatin tablets . See the end of this leaflet for a complete list of ingredients in rosuvastatin tablets. 
Before you take rosuvastatin tablets, tell your healthcare provider about all of your medical conditions, including if you:
• have unexplained muscle aches or weakness. 
• have or have had kidney problems. 
• have or have had liver problems. 
• drink more than 2 glasses of alcohol daily. 
• have thyroid problems. 
• are of Asian descent. 
• are pregnant or think you may be pregnant, or are planning to become pregnant. If you become pregnant while taking rosuvastatin tablets, call your healthcare provider right away to discuss your rosuvastatin tablets treatment. 
• are breastfeeding. rosuvastatin tablets can pass into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take rosuvastatin tablets. Do not breastfeed while taking rosuvastatin tablets.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Tell your healthcare provider who prescribes rosuvastatin tablets if another healthcare provider increases the dose of another medicine you are taking. rosuvastatin tablets may affect the way other medicines work, and other medicines may affect how rosuvastatin tablets works.

Especially tell your healthcare provider if you take: 
• coumarin anticoagulants (medicines that prevent blood clots, such as warfarin) 
• antacids (medicines you take for heartburn that contain aluminum and magnesium hydroxide Taking rosuvastatin tablets with certain medicines may increase the risk of muscle problems.
Especially tell your healthcare provider if you take:
• cyclosporine (a medicine for your immune system) 
• teriflunomide (a medicine used to treat relapsing remitting multiple sclerosis) 
• enasidenib (a medicine used to treat acute myeloid leukemia)
• capmatinib (a medicine for the treatment of non-small cell lung cancer) 
• fostamatinib (a medicine used to treat low platelet counts) 
• febuxostat (a medicine used to treat and prevent high blood levels of uric acid) 
• gemfibrozil (a fibric acid medicine for lowering cholesterol)
• tafamidis [used to treat cardiomyopathy (enlarged and thickened heart muscle)]
• anti-viral medicines including certain HIV or hepatitis C virus drugs such as: 
o lopinavir, ritonavir, fosamprenavir, tipranavir, atazanavir, simeprevir 
o combination of
• sofosbuvir/velpatasvir/voxilaprevir 
• dasabuvir/ombitasvir/paritaprevir/ritonavir 
• elbasvir/grazoprevir 
• sofosbuvir/velpatasvir 
• glecaprevir/pibrentasvir and
o all other combinations with ledipasvir including ledipasvir/sofosbuvir 
• darolutamide (a medicine for the treatment of prostate cancer)
• regorafenib (a medicine used to treat cancer of the colon and rectum)
• fibric acid derivatives (such as fenofibrate) 
• ticagrelor (helps reduce the chance of a blood clot formation that can block a blood vessel)
• niacin or nicotinic acid
• colchicine (a medicine used to treat gout) 
Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get new medicine. 
How should I take Rosuvastatin tablets?
• Take rosuvastatin tablets exactly as your healthcare provider tells you to take it. 
• Take rosuvastatin tablets, by mouth, 1 time each day, with or without food. Swallow the tablet whole. 
• Rosuvastatin tablets can be taken at any time of day, with or without food. 
• Do not change your dose or stop rosuvastatin tablets without talking to your healthcare provider, even if you are feeling well. 
• Your healthcare provider may do blood tests to check your cholesterol levels before and during your treatment with rosuvastatin tablets. Your healthcare provider may change your dose of rosuvastatin tablets if needed. 
• While taking rosuvastatin tablets, continue to follow your cholesterol-lowering diet and to exercise as your healthcare provider told you to.
• If you take a medicine called an antacid that contains a combination of aluminum and magnesium hydroxide, take rosuvastatin tablets at least 2 hours before you take the antacid. 
• If you miss a dose of rosuvastatin tablets, take your next dose at your normal scheduled time. Do not take an extra dose of rosuvastatin tablets.
• In case of an overdose, get medical help or contact a live Poison Center expert right away at 1-800-222-1222. Advice is also available online at poisonhelp.org.
What are the possible side effects of Rosuvastatin tablets?
Rosuvastatin tablets may cause serious side effects, including: 
•       Muscle pain, tenderness and weakness (myopathy). Muscle problems, including muscle breakdown, can be serious in some people and rarely cause kidney damage that can lead to death. Tell your healthcare provider right away if:
o you have unexplained muscle pain, tenderness, or weakness, especially if you have a fever or feel more tired than usual, while you take rosuvastatin tablets. 
o you have muscle problems that do not go away even after your healthcare provider has told you to stop taking rosuvastatin tablets. Your healthcare provider may do further tests to diagnose the cause of your muscle problems. 
Your chances of getting muscle problems are higher if you:
o are taking certain other medicines while you take rosuvastatin tablets (see “Especially tell your healthcare provider if you take”)
o are 65 years of age or older 
o are of Asian descent
o have thyroid problems (hypothyroidism) that are not controlled 
o have kidney problems 
o are taking higher doses of rosuvastatin tablets 
• Liver problems. Your healthcare provider may do blood tests to check your liver before you start taking rosuvastatin tablets and if you have symptoms of liver problems while you take rosuvastatin tablets. Call your healthcare provider right away if you have any of the following symptoms of liver problems: 
o feel unusually tired or weak 
o loss of appetite 
o upper belly pain 
o dark urine 
o yellowing of your skin or the whites of your eyes
• Protein and blood in the urine. Rosuvastatin tablets  may cause you to have protein and blood in your urine. If you develop protein or blood in your urine, your healthcare provider may decrease your dose of rosuvastatin tablets.
• Increase in blood sugar (glucose) levels. rosuvastatin tablets may cause an increase in your blood sugar levels. 
The most common side effects may include headache, nausea, muscle aches and pains, weakness, and constipation. 
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. 
For more information, ask your healthcare provider or pharmacist. 
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. 

How should I store Rosuvastatin tablets?
• Store rosuvastatin tablets at room temperature, between 68°F to 77°F (20°C to 25°C) and in a dry place. 
Keep Rosuvastatin tablets and all medicines out of the reach of children. 

General Information about the safe and effective use of Rosuvastatin tablets  
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use rosuvastatin tablets for a condition for which it was not prescribed. Do not give rosuvastatin tablets to other people, even if they have the same medical condition you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about rosuvastatin tablets that is written for health professionals. 
What are the Ingredients in Rosuvastatin tablets?
Active Ingredient: rosuvastatin as rosuvastatin calcium 
Inactive Ingredients: anhydrous dibasic calcium phosphate, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin. The 5 mg tablets contain iron oxide yellow and 10 mg, 20 mg and 40 mg tablets contain iron oxide red.

Manufactured for:
Macleods Pharma USA, Inc.
Princeton, NJ 08540

Manufactured by:
Macleods Pharmaceuticals Ltd.
Baddi, Himachal Pradesh- 174101 INDIA

This Patient Information has been approved by the U.S. Food and Drug Administration 

Revised 11/2024

Rosuvastatin Tablets, USP 5mg
30's Container
NDC.No.33342-261-07

Rosuvastatin Tablets, USP 5mg
90's Container
NDC.No.33342-261-10    

Rosuvastatin Tablets, USP 5mg
1000's Container
NDC.No.33342-261-44

Rosuvastatin Tablets, USP 5mg
100's Carton
NDC.No.33342-261-12

Rosuvastatin Tablets, USP 10mg
30's Container

NDC.No.33342-262-07        

Rosuvastatin Tablets, USP 10mg
90's Container

NDC.No.33342-262-10

Rosuvastatin Tablets, USP 10mg
1000's Container

NDC.No.33342-262-44

Rosuvastatin Tablets, USP 10mg
100's Carton
NDC.No.33342-262-12

Rosuvastatin Tablets, USP 20mg
30's Container
NDC.No.33342-263-07

Rosuvastatin Tablets, USP 20mg
90's Container
NDC.No.33342-263-10

Rosuvastatin Tablets, USP 20mg
1000's Container
NDC.No.33342-263-44

Rosuvastatin Tablets, USP 20mg
100's Carton
NDC.No.33342-263-12

Rosuvastatin Tablets, USP 40mg
30's Container
NDC.No.33342-264-07

Rosuvastatin Tablets, USP 40mg
90's Container
NDC.No.33342-264-10

Rosuvastatin Tablets, USP 40mg
1000's Container
NDC.No.33342-264-44

Rosuvastatin Tablets, USP 40mg
100's Carton
NDC.No.33342-264-12