Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

•Rosuvastatin calcium tablets can be taken with or without food, at any time of day. ( 2.1 ) •Dose range: 5 to 40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg. ( 2.1 ) •Adult HoFH: Starting dose 20 mg/day ( 2.1 )

Rosuvastatin Calcium Tablets are supplied as: 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. They are supplied as follows. 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. 55700-574-30 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. 55700-575-30 55700-575-90 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. They are supplied as follows. Storage Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from moisture.

Rosuvastatin calcium tablets are contraindicated in the following conditions: •Patients with a known hypersensitivity to any component of this product. Hypersensitivity reactions including rash, pruritus, urticaria, and angioedema have been reported with rosuvastatin calcium tablets [ see Adverse Reactions (6.1 )]. •Patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels [ see Warnings and Precautions (5.2 )]. •Pregnancy [ see Use in Specific Populations (8.1, 8.3 )]. •Lactation. Limited data indicate that rosuvastatin calcium is present in human milk. Because statins have the potential for serious adverse reactions in nursing infants, women who require rosuvastatin calcium tablets treatment should not breastfeed their infants [see Use in Specific Populations (8.2 )].

Rosuvastatin calcium is a synthetic lipid-lowering agent for oral administration. 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 22 H 27 FN 3 O 6 S) 2 Ca and the molecular weight is 1001.14. Rosuvastatin calcium is a white to almost white powder that is sparingly soluble in methanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient of 1.14 by HPLC. Rosuvastatin calcium tablets 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.

• Cyclosporine: Combination increases rosuvastatin exposure. Limit rosuvastatin calcium tablets dose to 5 mg once daily. ( 2.4 , 5.1 , 7.1 , 12.3 ) • Gemfibrozil: Combination should be avoided. If used together, limit rosuvastatin calcium tablets dose to 10 mg once daily. (2.4 , 5.1 , 7.2 ) • Atazanavir/ritonavir, lopinavir/ritonavir, or simeprevir: Combination increases rosuvastatin exposure. Limit rosuvastatin calcium tablets dose to 10 mg once daily. ( 2.4 , 5.1 , 7.3 , 12.3 ) • Coumarin anticoagulants: Combination prolongs INR. Achieve stable INR prior to starting rosuvastatin calcium tablets. Monitor INR frequently until stable upon initiation or alteration of rosuvastatin calcium tablets therapy. ( 5.3 , 7.4 ) • Concomitant lipid-lowering therapies: Use with fibrates or lipid-modifying doses (≥1 g/day) of niacin increases the risk of adverse skeletal muscle effects. Caution should be used when prescribing with rosuvastatin calcium tablets. ( 5.1 , 7.5 , 7.6 )

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. 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. [ see Contraindications (4) and Use in Specific Populations (8.1 , 8.3 )]. Lactation Advise women not to breastfeed during treatment with rosuvastatin calcium tablets [ see Contraindications (4) and Use in Specific Populations (8.2 )]. 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. Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 Manufactured by: HETERO TM HETERO LABS LIMITED                2038142 Unit V, Polepally, Jadcherla,                                           Mahaboob Nagar-509 301, India.                           Barcode Revised: July 2016

Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca's CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Of the 10,275 patients in clinical studies with rosuvastatin calcium tablets, 3159 (31%) were 65 years and older, and 698 (6.8%) were 75 years and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Elderly patients are at higher risk of myopathy and rosuvastatin calcium tablets should be prescribed with caution in the elderly [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ].

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 typhimurium and Escherichia coli , the mouse lymphoma assay, and the chromosomal aberration assay in Chinese hamster lung cells. Rosuvastatin was negative in the in vivo mouse 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.

The following serious adverse reactions are discussed in greater detail in other sections of the label: •Rhabdomyolysis with myoglobinuria and acute renal failure and myopathy (including myositis) [ see Warnings and Precautions (5.1) ] •Liver enzyme abnormalities [ see Warnings and Precautions (5.2 )]

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.

Central Nervous System Toxicity CNS vascular lesions, characterized by perivascular hemorrhages, edema, and mononuclear cell infiltration of perivascular spaces, have been observed in dogs treated with several other members of this drug class. A chemically similar drug in this class produced dose-dependent optic nerve degeneration (Wallerian degeneration of retinogeniculate fibers) in dogs, at a dose that produced plasma drug levels about 30 times higher than the mean drug level in humans taking the highest recommended dose. Edema, hemorrhage, and partial necrosis in the interstitium of the choroid plexus was observed in a female dog sacrificed moribund at day 24 at 90 mg/kg/day by oral gavage (systemic exposures 100 times the human exposure at 40 mg/day based on AUC). Corneal opacity was seen in dogs treated for 52 weeks at 6 mg/kg/day by oral gavage (systemic exposures 20 times the human exposure at 40 mg/day based on AUC). Cataracts were seen in dogs treated for 12 weeks by oral gavage at 30 mg/kg/day (systemic exposures 60 times the human exposure at 40 mg/day based on AUC). Retinal dysplasia and retinal loss were seen in dogs treated for 4 weeks by oral gavage at  90 mg/kg/day (systemic exposures 100 times the human exposure at 40 mg/day based on AUC). Doses ≤30 mg/kg/day (systemic exposures ≤60 times the human exposure at  40 mg/day based on AUC) did not reveal retinal findings during treatment for up to one year. Juvenile Toxicology Study In a juvenile study, rats were dosed by oral gavage with 10 or 50 mg/kg/day from weaning for 9 weeks prior to pairing, throughout pairing and up to the day before necropsy for males or up to gestation day 7 for females. No effects on sexual development, testicular and epididymal appearance or fertility were observed at either dose level. Pediatric information is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca's marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Risk Summary Rosuvastatin calcium tablets are contraindicated for use in pregnant women since safety in pregnant women has not been established and there is no apparent benefit to therapy with rosuvastatin calcium tablets during pregnancy. Because HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, rosuvastatin calcium tablets may cause fetal harm when administered to pregnant women. Rosuvastatin calcium tablets should be discontinued as soon as pregnancy is recognized [ see Contraindications (4) ]. Limited published data on the use of rosuvastatin are insufficient to determine a drug-associated risk of major congenital malformations or miscarriage. In animal reproduction studies, there were no adverse developmental effects with oral administration of rosuvastatin during organogenesis at systemic exposures equivalent to a maximum recommended human dose (MRHD) of 40 mg/day in rats or rabbits (based on AUC and body surface area, respectively). In rats and rabbits, decreased pup/fetal survival occurred at 12 times and equivalent, respectively, to the MRHD of 40 mg/day [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 Limited published data on rosuvastatin have not shown an increased risk of major congenital malformations or miscarriage. Rare reports of congenital anomalies have been received following intrauterine exposure to other statins. In a review of approximately 100 prospectively followed pregnancies in women exposed to simvastatin or lovastatin, the incidences of congenital anomalies, spontaneous abortions, and fetal deaths/stillbirths did not exceed what would be expected in the general population. The number of cases is adequate to exclude a ≥3 to 4-fold increase in congenital anomalies over the background incidence. In 89% of the prospectively followed pregnancies, drug treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified. Animal Data Rosuvastatin crosses the placenta in rats and rabbits and is found in fetal tissue and amniotic fluid at 3% and 20%, respectively, of the maternal plasma concentration following a single 25 mg/kg oral gavage dose on gestation day 16 in rats. A higher fetal tissue distribution (25% maternal plasma concentration) was observed in rabbits after a single oral gavage dose of 1 mg/kg on gestation day 18. Rosuvastatin administration did not indicate a teratogenic effect in rats at ≤25 mg/kg/day or in rabbits ≤3 mg/kg/day (doses equivalent to the MRHD of 40 mg/day based on AUC and body surface area, respectively). 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 calcium tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia.

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.

Rosuvastatin calcium tablets are a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a precursor of cholesterol. In vivo studies in animals, and in vitro studies in cultured animal and human cells have shown rosuvastatin to have a high uptake into, and selectivity for, action in the liver, the target organ for cholesterol lowering. In   in vivo and in vitro studies, rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell-surface to enhance uptake and catabolism of LDL. Second, rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.

Absorption In clinical pharmacology studies in man, peak plasma concentrations of rosuvastatin were reached 3 to 5 hours following oral dosing. Both Cmax and AUC increased in approximate proportion to rosuvastatin calcium tablets dose. The absolute bioavailability of rosuvastatin is approximately 20%. Administration of rosuvastatin calcium tablets with food did not affect the AUC of rosuvastatin. The AUC of rosuvastatin does not differ following evening or morning drug administration. 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. 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 vitro studies 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%). The elimination half-life (t 1/2 ) of rosuvastatin is approximately 19 hours. After an intravenous dose, approximately 28% of total body clearance was via the renal route, and 72% by the hepatic route. Specific Populations Race A population pharmacokinetic analysis revealed no clinically relevant differences in pharmacokinetics among Caucasian, Hispanic, 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 Caucasian control group. Gender There were no differences in plasma concentrations of rosuvastatin between men and women. Pediatric use information for patients ages 8 to less than 10 years is approved for AstraZeneca's CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Geriatric There were no differences in plasma concentrations of rosuvastatin between the nonelderly and elderly populations (age ≥65 years). Renal Impairment Mild to moderate renal impairment (CLcr ≥30 mL/min/1.73 m2) 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 (CLcr < 30 mL/min/1.73 m2) not receiving hemodialysis compared with healthy subjects (CLcr > 80 mL/min/1.73 m 2 ). Hemodialysis Steady-state plasma concentrations of rosuvastatin in patients on chronic hemodialysis were approximately 50% greater compared with healthy volunteer subjects with normal renal function. Hepatic Impairment In patients with chronic alcohol liver disease, plasma concentrations of rosuvastatin were modestly increased. In patients with Child-Pugh A disease, C max and AUC were increased by 60% and 5%, respectively, as compared with patients with normal liver function. In patients with Child-Pugh B disease, C max and AUC were increased 100% and 21%, respectively, compared with patients with normal liver function. Drug-Drug Interactions Rosuvastatin clearance is not dependent on metabolism by cytochrome P450 3A4 to a clinically significant extent. Rosuvastatin is a substrate for certain transporter proteins including the hepatic uptake transporter organic anion-transporting polyprotein 1B1 (OATP1B1) and efflux transporter breast cancer resistance protein (BCRP). Concomitant administration of rosuvastatin calcium tablets with medications that are inhibitors of these transporter proteins (e.g. cyclosporine, certain HIV protease inhibitors) may result in increased rosuvastatin plasma concentrations and an increased risk of myopathy [ see Dosage and Administration (2.4) ]. It is recommended that prescribers consult the relevant product information when considering administration of such products together with rosuvastatin calcium tablets. Table 4. Effect of Coadministered Drugs on Rosuvastatin Systemic Exposure Coad m i n i st e r ed drug and   dos i ng reg imen R o s uvas t a t in Mean Ratio (ratio with/without) coadministered drug) No Effect=1 Dos e   (m g ) 1 Chang e in AUC Chang e in C max   C y closporine  –   stab le   d o se   required  (75  mg  –  200   mg  B ID)   10   mg   QD for  10  d a ys   7.1 2  11 2  At a z an avi r/ riton avir   co mbin ation   300   m g /100   mg   QD   for  8 d a ys  10  mg  3.1 2  7 2   Simeprevir  150   mg   QD, 7   days  10  mg , single dose  2.8 2  (2.3-3.4) 3  3.2 2  (2.6-3.9) 3   L opinavir/ritonav ir   com b ination  400  m g/100  mg  B ID  for 17  d a ys   20   mg   QD for  7  d a ys  2.1 2  (1.7-2.6) 3  5 2  (3.4-6.4) 3   Gemfibro z il   600   mg   B ID   for  7   d a ys  80  mg  1.9 2   (1.6-2.2) 3  2.2­ 2   (1.8-2.7) 3  Eltrombopag  75   mg  QD,  5  d a ys  10  mg   1.6  (1.4-1.7) 3   2   (1.8-2.3) 3   Darunavir   600   m g /riton a vir   100   mg B ID,                7   d a ys   10   mg   QD for  7  d a ys  1.5   (1-2.1) 3  2.4   (1.6-3.6) 3  Tip ran avi r/ riton avir   combin ation  500  m g/200 mg  B ID  for   11  d a ys  10  mg  1.4   (1.2-1.6) 3  2.2   (1.8-2.7) 3   Droned a rone   400   mg   BID   10   mg   1.4   It r aco n a z ole   200   mg   QD,  5   d a ys  10  mg  or 80  mg  1.4   (1.2-1.6) 3  1.3   (1.1-1.4) 3  1.4   (1.2-1.5) 3  1.2   (0.9-1.4) 3  Ez etimibe  10  mg  QD,  14  da ys  10  mg  QD for  14  d a ys  1.2   (0.9-1.6) 3  1.2   (0.8-1.6) 3   Fo sampre n avir/ritonavir  700  m g/100  mg  B ID  for 7  d a ys  10  mg  1.1  1.5   F enofib r ate   67   mg   T ID   f or  7 d a ys   10   mg  ↔  1.2   (1.1-1.3) 3 Coad m i n i st e r ed drug and   dos i ng reg imen R o s uvas t a t in  Rifampicin  450  mg  QD,  7  d a ys  20  mg  ↔  Aluminum   &  m a g n esium   h yd ro xide combin ati on   ant acid  Administ ered  simult an eous ly   Administered  2   hours   a p art  40  mg  40  mg  0.5 2   (0.4-0.5) 3  0.8   (0.7-0.9) 3  0.5 2   (0.4-0.6) 3  0.8   (0.7-1) 3   Ketocona z ole   200   mg   B ID   for 7  d a ys  80  mg  1   (0.8-1.2) 3  1   (0.7-1.3) 3   Fl ucona zo le   200   mg   QD for   11 days   80   mg  1.1   (1-1.3) 3  1.1   (0.9-1.4) 3   E r yt hro m y cin   500   mg   Q ID   for  7  d a ys  80  mg  0.8   (0.7-0.9) 3  0.7   (0.5-0.9) 3 1 Single dose unless otherwise noted. 2 Clinically significant [ see Dosage and Administration (2) and Warnings and Precautions (5) ] 3 Mean ratio with 90% CI (with/without coadministered drug, e.g., 1= no change, 0.7 = 30% decrease, 11=11 fold increase in exposure) Table 5. Effect of Rosuvastatin Coadministration on Systemic Exposure to Other Drugs Rosuvas t a t i n Dos a ge Re g i men Coadmi n i ste red Drug Mean Ratio (ratio with/without coadministered drug) No Effect = 1 Na me and D ose Chang e in AUC Chang e   in   C max   40   mg   QD   for   10   d a ys   W arfarin 1  25  mg  si n gle dose  R - W arfarin  1  (1-1.1) 2  S - W arfarin  1.1  (1-1.1) 2  R - W arfarin   1  (0.9-1) 2  S - W arfarin   1  (0.9-1.1) 2  40  mg  QD  for  12  d a ys  Di go xin  0.5  mg sin gle dose  1  (0.9-1.2) 2  1  (0.9-1.2) 2   40   mg   QD   for   28   d a ys   Oral   Contra c eptive   (ethi n yl est radiol   0.035   mg   &   n o r g estrel 0.180, 0.215 and 0.250 mg) QD for 21 Days  EE 1.3  (1.2-1.3) 2  NG 1.3  (1.3-1.4) 2  EE 1.3  (1.2-1.3 )2  NG 1.2  (1.1-1.3) 2  EE = ethinyl estradiol, NG = norgestrel 1 Clinically significant pharmacodynamic effects [ see Warnings and Precautions (5.3) ] 2 Mean ratio with 90% CI (with/without coadministered drug, e.g., 1= no change, 0.7=30% decrease, 11=11-fold increase in exposure)

• Females of reproductive potential: Advise females of reproductive potential to use effective contraception during treatment with rosuvastatin calcium tablets ( 8.3 ) • Severe renal impairment (not on hemodialysis): Starting dose is 5 mg, not to exceed 10 mg. ( 2.5 , 5.1 , 8.6 ) • Asian population: Consider 5 mg starting dose. ( 2.3 , 8.8 ) See 17 for PATIENT COUNSELING INFORMATION and FDA- approved patient labeling. Pediatric use information for patients ages 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (≥65), hypothyroidism, renal impairment, and combination use with cyclosporine, atazanavir/ritonavir, lopinavir/ritonavir, or simeprevir. Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported. Advise patients to promptly report to their physician unexplained and/or persistent muscle pain, tenderness, or weakness and discontinue rosuvastatin calcium tablets if signs or symptoms appear. ( 5.1 , 7.5 , 7.6 ) • Liver enzyme abnormalities: Persistent elevations in hepatic transaminases can occur. Perform liver enzyme tests before initiating therapy and as clinically indicated thereafter. ( 5.2 )

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Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

•Rosuvastatin calcium tablets can be taken with or without food, at any time of day. ( 2.1 ) •Dose range: 5 to 40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg. ( 2.1 ) •Adult HoFH: Starting dose 20 mg/day ( 2.1 )

Rosuvastatin Calcium Tablets are supplied as: 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. They are supplied as follows. 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. 55700-574-30 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. 55700-575-30 55700-575-90 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. They are supplied as follows. Storage Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from moisture.

Rosuvastatin calcium tablets are contraindicated in the following conditions: •Patients with a known hypersensitivity to any component of this product. Hypersensitivity reactions including rash, pruritus, urticaria, and angioedema have been reported with rosuvastatin calcium tablets [ see Adverse Reactions (6.1 )]. •Patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels [ see Warnings and Precautions (5.2 )]. •Pregnancy [ see Use in Specific Populations (8.1, 8.3 )]. •Lactation. Limited data indicate that rosuvastatin calcium is present in human milk. Because statins have the potential for serious adverse reactions in nursing infants, women who require rosuvastatin calcium tablets treatment should not breastfeed their infants [see Use in Specific Populations (8.2 )].

• Cyclosporine: Combination increases rosuvastatin exposure. Limit rosuvastatin calcium tablets dose to 5 mg once daily. ( 2.4 , 5.1 , 7.1 , 12.3 ) • Gemfibrozil: Combination should be avoided. If used together, limit rosuvastatin calcium tablets dose to 10 mg once daily. (2.4 , 5.1 , 7.2 ) • Atazanavir/ritonavir, lopinavir/ritonavir, or simeprevir: Combination increases rosuvastatin exposure. Limit rosuvastatin calcium tablets dose to 10 mg once daily. ( 2.4 , 5.1 , 7.3 , 12.3 ) • Coumarin anticoagulants: Combination prolongs INR. Achieve stable INR prior to starting rosuvastatin calcium tablets. Monitor INR frequently until stable upon initiation or alteration of rosuvastatin calcium tablets therapy. ( 5.3 , 7.4 ) • Concomitant lipid-lowering therapies: Use with fibrates or lipid-modifying doses (≥1 g/day) of niacin increases the risk of adverse skeletal muscle effects. Caution should be used when prescribing with rosuvastatin calcium tablets. ( 5.1 , 7.5 , 7.6 )

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. 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. [ see Contraindications (4) and Use in Specific Populations (8.1 , 8.3 )]. Lactation Advise women not to breastfeed during treatment with rosuvastatin calcium tablets [ see Contraindications (4) and Use in Specific Populations (8.2 )]. 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. Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 Manufactured by: HETERO TM HETERO LABS LIMITED                2038142 Unit V, Polepally, Jadcherla,                                           Mahaboob Nagar-509 301, India.                           Barcode Revised: July 2016

Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca's CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Of the 10,275 patients in clinical studies with rosuvastatin calcium tablets, 3159 (31%) were 65 years and older, and 698 (6.8%) were 75 years and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Elderly patients are at higher risk of myopathy and rosuvastatin calcium tablets should be prescribed with caution in the elderly [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ].

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 typhimurium and Escherichia coli , the mouse lymphoma assay, and the chromosomal aberration assay in Chinese hamster lung cells. Rosuvastatin was negative in the in vivo mouse 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.

The following serious adverse reactions are discussed in greater detail in other sections of the label: •Rhabdomyolysis with myoglobinuria and acute renal failure and myopathy (including myositis) [ see Warnings and Precautions (5.1) ] •Liver enzyme abnormalities [ see Warnings and Precautions (5.2 )]

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 (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 22 H 27 FN 3 O 6 S) 2 Ca and the molecular weight is 1001.14. Rosuvastatin calcium is a white to almost white powder that is sparingly soluble in methanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient of 1.14 by HPLC. Rosuvastatin calcium tablets 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.

Central Nervous System Toxicity CNS vascular lesions, characterized by perivascular hemorrhages, edema, and mononuclear cell infiltration of perivascular spaces, have been observed in dogs treated with several other members of this drug class. A chemically similar drug in this class produced dose-dependent optic nerve degeneration (Wallerian degeneration of retinogeniculate fibers) in dogs, at a dose that produced plasma drug levels about 30 times higher than the mean drug level in humans taking the highest recommended dose. Edema, hemorrhage, and partial necrosis in the interstitium of the choroid plexus was observed in a female dog sacrificed moribund at day 24 at 90 mg/kg/day by oral gavage (systemic exposures 100 times the human exposure at 40 mg/day based on AUC). Corneal opacity was seen in dogs treated for 52 weeks at 6 mg/kg/day by oral gavage (systemic exposures 20 times the human exposure at 40 mg/day based on AUC). Cataracts were seen in dogs treated for 12 weeks by oral gavage at 30 mg/kg/day (systemic exposures 60 times the human exposure at 40 mg/day based on AUC). Retinal dysplasia and retinal loss were seen in dogs treated for 4 weeks by oral gavage at  90 mg/kg/day (systemic exposures 100 times the human exposure at 40 mg/day based on AUC). Doses ≤30 mg/kg/day (systemic exposures ≤60 times the human exposure at  40 mg/day based on AUC) did not reveal retinal findings during treatment for up to one year. Juvenile Toxicology Study In a juvenile study, rats were dosed by oral gavage with 10 or 50 mg/kg/day from weaning for 9 weeks prior to pairing, throughout pairing and up to the day before necropsy for males or up to gestation day 7 for females. No effects on sexual development, testicular and epididymal appearance or fertility were observed at either dose level. Pediatric information is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca's marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Risk Summary Rosuvastatin calcium tablets are contraindicated for use in pregnant women since safety in pregnant women has not been established and there is no apparent benefit to therapy with rosuvastatin calcium tablets during pregnancy. Because HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, rosuvastatin calcium tablets may cause fetal harm when administered to pregnant women. Rosuvastatin calcium tablets should be discontinued as soon as pregnancy is recognized [ see Contraindications (4) ]. Limited published data on the use of rosuvastatin are insufficient to determine a drug-associated risk of major congenital malformations or miscarriage. In animal reproduction studies, there were no adverse developmental effects with oral administration of rosuvastatin during organogenesis at systemic exposures equivalent to a maximum recommended human dose (MRHD) of 40 mg/day in rats or rabbits (based on AUC and body surface area, respectively). In rats and rabbits, decreased pup/fetal survival occurred at 12 times and equivalent, respectively, to the MRHD of 40 mg/day [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 Limited published data on rosuvastatin have not shown an increased risk of major congenital malformations or miscarriage. Rare reports of congenital anomalies have been received following intrauterine exposure to other statins. In a review of approximately 100 prospectively followed pregnancies in women exposed to simvastatin or lovastatin, the incidences of congenital anomalies, spontaneous abortions, and fetal deaths/stillbirths did not exceed what would be expected in the general population. The number of cases is adequate to exclude a ≥3 to 4-fold increase in congenital anomalies over the background incidence. In 89% of the prospectively followed pregnancies, drug treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified. Animal Data Rosuvastatin crosses the placenta in rats and rabbits and is found in fetal tissue and amniotic fluid at 3% and 20%, respectively, of the maternal plasma concentration following a single 25 mg/kg oral gavage dose on gestation day 16 in rats. A higher fetal tissue distribution (25% maternal plasma concentration) was observed in rabbits after a single oral gavage dose of 1 mg/kg on gestation day 18. Rosuvastatin administration did not indicate a teratogenic effect in rats at ≤25 mg/kg/day or in rabbits ≤3 mg/kg/day (doses equivalent to the MRHD of 40 mg/day based on AUC and body surface area, respectively). 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 calcium tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia.

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.

Rosuvastatin calcium tablets are a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a precursor of cholesterol. In vivo studies in animals, and in vitro studies in cultured animal and human cells have shown rosuvastatin to have a high uptake into, and selectivity for, action in the liver, the target organ for cholesterol lowering. In   in vivo and in vitro studies, rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell-surface to enhance uptake and catabolism of LDL. Second, rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.

Absorption In clinical pharmacology studies in man, peak plasma concentrations of rosuvastatin were reached 3 to 5 hours following oral dosing. Both Cmax and AUC increased in approximate proportion to rosuvastatin calcium tablets dose. The absolute bioavailability of rosuvastatin is approximately 20%. Administration of rosuvastatin calcium tablets with food did not affect the AUC of rosuvastatin. The AUC of rosuvastatin does not differ following evening or morning drug administration. 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. 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 vitro studies 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%). The elimination half-life (t 1/2 ) of rosuvastatin is approximately 19 hours. After an intravenous dose, approximately 28% of total body clearance was via the renal route, and 72% by the hepatic route. Specific Populations Race A population pharmacokinetic analysis revealed no clinically relevant differences in pharmacokinetics among Caucasian, Hispanic, 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 Caucasian control group. Gender There were no differences in plasma concentrations of rosuvastatin between men and women. Pediatric use information for patients ages 8 to less than 10 years is approved for AstraZeneca's CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Geriatric There were no differences in plasma concentrations of rosuvastatin between the nonelderly and elderly populations (age ≥65 years). Renal Impairment Mild to moderate renal impairment (CLcr ≥30 mL/min/1.73 m2) 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 (CLcr < 30 mL/min/1.73 m2) not receiving hemodialysis compared with healthy subjects (CLcr > 80 mL/min/1.73 m 2 ). Hemodialysis Steady-state plasma concentrations of rosuvastatin in patients on chronic hemodialysis were approximately 50% greater compared with healthy volunteer subjects with normal renal function. Hepatic Impairment In patients with chronic alcohol liver disease, plasma concentrations of rosuvastatin were modestly increased. In patients with Child-Pugh A disease, C max and AUC were increased by 60% and 5%, respectively, as compared with patients with normal liver function. In patients with Child-Pugh B disease, C max and AUC were increased 100% and 21%, respectively, compared with patients with normal liver function. Drug-Drug Interactions Rosuvastatin clearance is not dependent on metabolism by cytochrome P450 3A4 to a clinically significant extent. Rosuvastatin is a substrate for certain transporter proteins including the hepatic uptake transporter organic anion-transporting polyprotein 1B1 (OATP1B1) and efflux transporter breast cancer resistance protein (BCRP). Concomitant administration of rosuvastatin calcium tablets with medications that are inhibitors of these transporter proteins (e.g. cyclosporine, certain HIV protease inhibitors) may result in increased rosuvastatin plasma concentrations and an increased risk of myopathy [ see Dosage and Administration (2.4) ]. It is recommended that prescribers consult the relevant product information when considering administration of such products together with rosuvastatin calcium tablets. Table 4. Effect of Coadministered Drugs on Rosuvastatin Systemic Exposure Coad m i n i st e r ed drug and   dos i ng reg imen R o s uvas t a t in Mean Ratio (ratio with/without) coadministered drug) No Effect=1 Dos e   (m g ) 1 Chang e in AUC Chang e in C max   C y closporine  –   stab le   d o se   required  (75  mg  –  200   mg  B ID)   10   mg   QD for  10  d a ys   7.1 2  11 2  At a z an avi r/ riton avir   co mbin ation   300   m g /100   mg   QD   for  8 d a ys  10  mg  3.1 2  7 2   Simeprevir  150   mg   QD, 7   days  10  mg , single dose  2.8 2  (2.3-3.4) 3  3.2 2  (2.6-3.9) 3   L opinavir/ritonav ir   com b ination  400  m g/100  mg  B ID  for 17  d a ys   20   mg   QD for  7  d a ys  2.1 2  (1.7-2.6) 3  5 2  (3.4-6.4) 3   Gemfibro z il   600   mg   B ID   for  7   d a ys  80  mg  1.9 2   (1.6-2.2) 3  2.2­ 2   (1.8-2.7) 3  Eltrombopag  75   mg  QD,  5  d a ys  10  mg   1.6  (1.4-1.7) 3   2   (1.8-2.3) 3   Darunavir   600   m g /riton a vir   100   mg B ID,                7   d a ys   10   mg   QD for  7  d a ys  1.5   (1-2.1) 3  2.4   (1.6-3.6) 3  Tip ran avi r/ riton avir   combin ation  500  m g/200 mg  B ID  for   11  d a ys  10  mg  1.4   (1.2-1.6) 3  2.2   (1.8-2.7) 3   Droned a rone   400   mg   BID   10   mg   1.4   It r aco n a z ole   200   mg   QD,  5   d a ys  10  mg  or 80  mg  1.4   (1.2-1.6) 3  1.3   (1.1-1.4) 3  1.4   (1.2-1.5) 3  1.2   (0.9-1.4) 3  Ez etimibe  10  mg  QD,  14  da ys  10  mg  QD for  14  d a ys  1.2   (0.9-1.6) 3  1.2   (0.8-1.6) 3   Fo sampre n avir/ritonavir  700  m g/100  mg  B ID  for 7  d a ys  10  mg  1.1  1.5   F enofib r ate   67   mg   T ID   f or  7 d a ys   10   mg  ↔  1.2   (1.1-1.3) 3 Coad m i n i st e r ed drug and   dos i ng reg imen R o s uvas t a t in  Rifampicin  450  mg  QD,  7  d a ys  20  mg  ↔  Aluminum   &  m a g n esium   h yd ro xide combin ati on   ant acid  Administ ered  simult an eous ly   Administered  2   hours   a p art  40  mg  40  mg  0.5 2   (0.4-0.5) 3  0.8   (0.7-0.9) 3  0.5 2   (0.4-0.6) 3  0.8   (0.7-1) 3   Ketocona z ole   200   mg   B ID   for 7  d a ys  80  mg  1   (0.8-1.2) 3  1   (0.7-1.3) 3   Fl ucona zo le   200   mg   QD for   11 days   80   mg  1.1   (1-1.3) 3  1.1   (0.9-1.4) 3   E r yt hro m y cin   500   mg   Q ID   for  7  d a ys  80  mg  0.8   (0.7-0.9) 3  0.7   (0.5-0.9) 3 1 Single dose unless otherwise noted. 2 Clinically significant [ see Dosage and Administration (2) and Warnings and Precautions (5) ] 3 Mean ratio with 90% CI (with/without coadministered drug, e.g., 1= no change, 0.7 = 30% decrease, 11=11 fold increase in exposure) Table 5. Effect of Rosuvastatin Coadministration on Systemic Exposure to Other Drugs Rosuvas t a t i n Dos a ge Re g i men Coadmi n i ste red Drug Mean Ratio (ratio with/without coadministered drug) No Effect = 1 Na me and D ose Chang e in AUC Chang e   in   C max   40   mg   QD   for   10   d a ys   W arfarin 1  25  mg  si n gle dose  R - W arfarin  1  (1-1.1) 2  S - W arfarin  1.1  (1-1.1) 2  R - W arfarin   1  (0.9-1) 2  S - W arfarin   1  (0.9-1.1) 2  40  mg  QD  for  12  d a ys  Di go xin  0.5  mg sin gle dose  1  (0.9-1.2) 2  1  (0.9-1.2) 2   40   mg   QD   for   28   d a ys   Oral   Contra c eptive   (ethi n yl est radiol   0.035   mg   &   n o r g estrel 0.180, 0.215 and 0.250 mg) QD for 21 Days  EE 1.3  (1.2-1.3) 2  NG 1.3  (1.3-1.4) 2  EE 1.3  (1.2-1.3 )2  NG 1.2  (1.1-1.3) 2  EE = ethinyl estradiol, NG = norgestrel 1 Clinically significant pharmacodynamic effects [ see Warnings and Precautions (5.3) ] 2 Mean ratio with 90% CI (with/without coadministered drug, e.g., 1= no change, 0.7=30% decrease, 11=11-fold increase in exposure)

• Females of reproductive potential: Advise females of reproductive potential to use effective contraception during treatment with rosuvastatin calcium tablets ( 8.3 ) • Severe renal impairment (not on hemodialysis): Starting dose is 5 mg, not to exceed 10 mg. ( 2.5 , 5.1 , 8.6 ) • Asian population: Consider 5 mg starting dose. ( 2.3 , 8.8 ) See 17 for PATIENT COUNSELING INFORMATION and FDA- approved patient labeling. Pediatric use information for patients ages 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (≥65), hypothyroidism, renal impairment, and combination use with cyclosporine, atazanavir/ritonavir, lopinavir/ritonavir, or simeprevir. Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported. Advise patients to promptly report to their physician unexplained and/or persistent muscle pain, tenderness, or weakness and discontinue rosuvastatin calcium tablets if signs or symptoms appear. ( 5.1 , 7.5 , 7.6 ) • Liver enzyme abnormalities: Persistent elevations in hepatic transaminases can occur. Perform liver enzyme tests before initiating therapy and as clinically indicated thereafter. ( 5.2 )

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