Complete SPL Sections
1 INDICATIONS AND USAGE
INDICATIONS & USAGE SECTION
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.
2 DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
3 DOSAGE FORMS AND STRENGTHS
DOSAGE FORMS & STRENGTHS SECTION
Rosuvastatin tablets, USP: 5 mg tablets: Yellow colored, circular, biconvex, film-coated tablets with ‘S’ debossed on one side and plain on the other side of the tablet. 10 mg tablets: Pink colored, circular, biconvex, film-coated tablets with ‘583’ debossed on one side and plain on the other side of the tablet. 20 mg tablets: Pink colored, circular, biconvex, film-coated tablets with ‘584’ debossed on one side and plain on the other side of the tablet. 40 mg tablets: Pink colored, oval, biconvex, film-coated tablets with ‘585’ debossed on one side and plain on the other side of the tablet.
4 CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
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 tablet. Hypersensitivity reactions including rash, pruritus, urticaria, and angioedema have been reported with rosuvastatin [see Adverse Reactions (6.1)].
5 WARNINGS AND PRECAUTIONS
WARNINGS AND PRECAUTIONS SECTION
6 ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
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)]
7 DRUG INTERACTIONS
DRUG INTERACTIONS SECTION
8 USE IN SPECIFIC POPULATIONS
USE IN SPECIFIC POPULATIONS SECTION
10 OVERDOSAGE
OVERDOSAGE SECTION
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.
11 DESCRIPTION
DESCRIPTION SECTION
Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2- [methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula: 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, USP is a white to off-white amorphous powder that is slightly soluble in water, and practically insoluble in ethanol and methanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets, USP for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized maize starch, talc, titanium dioxide, iron oxide yellow (5 mg), iron oxide red (10 mg, 20 mg, 40 mg), and FD& C Red # 40 aluminum lake (10 mg, 20 mg, 40 mg). Meets USP dissolution test 2
12 CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY SECTION
13 NONCLINICAL TOXICOLOGY
NONCLINICAL TOXICOLOGY SECTION
14 CLINICAL STUDIES
CLINICAL STUDIES SECTION
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
16 HOW SUPPLIED/STORAGE AND HANDLING
HOW SUPPLIED SECTION
Rosuvastatin tablets, USP are available containing 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin. 5 mg tablets: Yellow colored, circular, biconvex, film-coated tablets with ‘S’ debossed on one side and plain on the other side of the tablet. Bottles of 30 with child-resistant closure..........................................................NDC 47335-582-83 Bottles of 90 with child-resistant closure..........................................................NDC 47335-582-81 Bottles of 1000..................................................................................................NDC 47335-582-18 10 mg tablets: Pink colored, circular, biconvex, film-coated tablets with ‘583’ debossed on one side and plain on the other side of the tablet. Bottles of 30 with child-resistant closure ….........................................................NDC 47335-583-83 Bottles of 90 with child-resistant closure ….........................................................NDC 47335-583-81 Bottles of 1000 ………………………… ….........................................................NDC 47335-583-18 20 mg tablets: Pink colored, circular, biconvex, film-coated tablets with ‘584’ debossed on one side and plain on the other side of the tablet. Bottles of 30 with child-resistant closure..............................................................NDC 47335-584-83 Bottles of 90 with child-resistant closure..............................................................NDC 47335-584-81 Bottles of 1000…………………………..............................................................NDC 47335-584-18 40 mg tablets: Pink colored, oval, biconvex, film-coated tablets with ‘585’ debossed on one side and plain on the other side of the tablet. Bottles of 30 with child-resistant closure.............................................................NDC 47335-585-83 Bottles of 90 with child-resistant closure.............................................................NDC 47335-585-81 Bottles of 1000 ………………………….............................................................NDC 47335-585-18 Storage Store rosuvastatin tablets at 20º to 25ºC (68º to 77ºF); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Protect from moisture.
17 PATIENT COUNSELING INFORMATION
INFORMATION FOR PATIENTS SECTION
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)] . Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 1012, Dadra-396 193, U.T. of D & NH and Daman & Diu, India.
SPL PATIENT PACKAGE INSERT SECTION
SPL PATIENT PACKAGE INSERT SECTION
Dispense with Patient Information available at: https://www.sunpharma.com/usa/products P ATIENT INFORMATION Rosuvastatin (roe-SOO-va-STAT-in) Tablets USP, for oral use 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 are right for you. W hat are rosuvastatin tablets? Rosuvastatin tablets are a prescription medicine that contains a cholesterol-lowering medicine called rosuvastatin. Rosuvastatin tablets are used: 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. along with diet to: lower the level of low-density lipoprotein (LDL-C) cholesterol or “bad” cholesterol in adults with primary hyperlipidemia. slow the buildup of fatty deposits (plaque) in the walls of blood vessels. 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). 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). along with diet for the treatment of adults with: primary dysbetalipoproteinemia (an inherited condition that causes high levels of cholesterol and fat). hypertriglyceridemia. It is not known if rosuvastatin tablets are 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 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 work. 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: lopinavir, ritonavir, fosamprenavir, tipranavir, atazanavir, simeprevir combination of sofosbuvir/velpatasvir/voxilaprevir dasabuvir/ombitasvir/paritaprevir/ritonavir elbasvir/grazoprevir sofosbuvir/velpatasvir glecaprevir/pibrentasvir and 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. W hat are the possible side effects of rosuvastatin tablets? Rosuvastatin tablets may cause serious side effects, including: M uscle 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: 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. 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: are taking certain other medicines while you take rosuvastatin tablets (see “Especially tell your healthcare provider if you take”) are 65 years of age or older are of Asian descent have thyroid problems (hypothyroidism) that are not controlled have kidney problems 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 ...
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Label 5 mg
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 47335-582-81 Rosuvastatin Tablets 5 mg PHARMACIST: Dispense with Patient Information Rx only 90 Tablets SUN PHARMA
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Label 10 mg
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 47335-583-81 Rosuvastatin Tablets 10 mg PHARMACIST: Dispense with Patient Information Rx only 90 Tablets SUN PHARMA
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Label 20 mg
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 47335-584-81 Rosuvastatin Tablets 20 mg PHARMACIST: Dispense with Patient Information Rx only 90 Tablets SUN PHARMA
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Label 40 mg
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 47335-585-81 Rosuvastatin Tablets 40 mg PHARMACIST: Dispense with Patient Information Rx only 90 Tablets SUN PHARMA