Rosuvastatin

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

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.

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

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.

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Rosuvastatin 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 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 is present in human milk. Because statins have the potential for serious adverse reactions in nursing infants, women who require rosuvastatin treatment should not breastfeed their infants [see Use in Specific Populations ( 8.2 )].

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

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 )]

7 DRUG INTERACTIONS

DRUG INTERACTIONS SECTION

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

10 OVERDOSAGE

OVERDOSAGE SECTION

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.

11 DESCRIPTION

DESCRIPTION SECTION

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 empirical 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 or almost white hygroscopic powder that is sparingly soluble in methanol, slightly soluble in water, practically insoluble in anhydrous ethanol. Rosuvastatin tablets USP for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: crospovidone, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate, talc, titanium dioxide and triacetin. Additionally 5 mg tablets contain FD&C yellow #5/tartrazine aluminum lake and 10 mg, 20 mg and 40 mg tablets contain FD&C yellow #6/sunset yellow FCF aluminum lake. USP Dissolution test is pending.

12 CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

13 NONCLINICAL TOXICOLOGY

NONCLINICAL TOXICOLOGY SECTION

14 CLINICAL STUDIES

CLINICAL STUDIES SECTION

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

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. NDC 68071-2848-9 BOTTLES OF 90 Storage Store at 20º to 25ºC (68º to 77ºF) [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). Patients should be instructed not to take 2 doses of rosuvastatin 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 tablets. Concomitant Use of Antacids When taking rosuvastatin tablets with an aluminum and magnesium hydroxide combination antacid, the antacid should be taken at least 2 hours after rosuvastatin 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 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 tablets and if signs or symptoms of liver injury occur. All patients treated with rosuvastatin 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 By: HETERO TM Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahabubnagar - 509 301, India. Revised: 10/2019

PATIENT INFORMATION

SPL UNCLASSIFIED SECTION

Rosuvastatin Tablets, USP (roe-soo-va-STAT-in) 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 doctor. Only your doctor can determine if rosuvastatin tablets are right for you. What is rosuvastatin tablet? Rosuvastatin tablet is a prescription medicine that contains a cholesterol-lowering medicine called rosuvastatin calcium. Most of the cholesterol in your blood is made in the liver. Rosuvastatin tablets work by reducing cholesterol in two ways: rosuvastatin tablets block an enzyme in the liver causing the liver to make less cholesterol, and rosuvastatin tablets increase the uptake and breakdown by the liver of cholesterol already in the blood. • Rosuvastatin tablets are used along with diet to: o lower the level of your "bad" cholesterol (LDL) o increase the level of your "good" cholesterol (HDL) o lower the level of fat in your blood (triglycerides) • Rosuvastatin tablets are used to treat: o adults who cannot control their cholesterol levels by diet and exercise alone It is not known if rosuvastatin tablets are safe and effective in people who have Fredrickson Type I and V dyslipidemias. 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. Who should not take rosuvastatin tablets? Do not take rosuvastatin tablets if you: • are allergic to rosuvastatin calcium or any of the ingredients in rosuvastatin tablets. See the end of this leaflet for a complete list of ingredients in rosuvastatin tablets. • have liver problems. • are pregnant or think you may be pregnant, or are planning to become pregnant. Rosuvastatin tablets may harm your unborn baby. If you become pregnant, stop taking rosuvastatin tablets and call your doctor right away. If you are not planning to become pregnant you should use effective birth control (contraception) while you are taking rosuvastatin tablets. • are breastfeeding. Medicines like rosuvastatin calcium can pass into your breast milk and may harm your baby. What should I tell my doctor before and while taking rosuvastatin tablets? Tell your doctor 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 65 years of age or older • are of Asian descent • are pregnant or think you may be pregnant, or are planning to become pregnant • are breastfeeding Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Talk to your doctor before you start taking any new medicines. Taking rosuvastatin tablets with certain other medicines may affect each other causing side effects. Rosuvastatin tablets may affect the way other medicines work, and other medicines may affect how rosuvastatin tablets work. Especially tell your doctor if you take: • cyclosporine (a medicine for your immune system) • gemfibrozil (a fibric acid medicine for lowering cholesterol) • anti-viral medicines including HIV or hepatitis C protease inhibitors (such as lopinavir, ritonavir, fosamprenavir, tipranavir, atazanavir, or simeprevir) • certain anti-fungal medicines (such as itraconazole, ketoconazole and fluconazole) • coumarin anticoagulants (medicines that prevent blood clots, such as warfarin) • niacin or nicotinic acid • fibric acid derivatives (such as fenofibrate) • colchicine (a medicine used to treat gout) Ask your doctor or pharmacist for a list of these medicines if you are not sure. Know all of the medicines you take. Keep a list of them to show your doctor and pharmacist when you get new medicine. How should I take rosuvastatin tablets? • Take rosuvastatin tablets exactly as your doctor tells you to take them. • Take rosuvastatin tablets, by mouth, 1 time each day. 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 doctor, even if you are feeling well. • Your doctor may do blood tests to check your cholesterol levels before and during your treatment with rosuvastatin tablets. Your doctor may change your dose of rosuvastatin tablets if needed. • Your doctor may start you on a cholesterol lowering diet before giving you rosuvastatin tablets. Stay on this diet when you take rosuvastatin tablets. • Wait at least 2 hours after taking rosuvastatin tablets to take an antacid that contains a combination of aluminum and magnesium hydroxide. • If you miss a dose of rosuvastatin tablets, take it as soon as you remember. However, do not take 2 doses of rosuvastatin tablets within 12 hours of each other. • If you take too much rosuvastatin calcium or overdose, call your doctor or go to the nearest hospital emergency room right away. 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 doctor 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 doctor has told you to stop taking rosuvastatin tablets. Your doctor 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 o are 65 years of age or older o have thyroid problems (hypothyroidism) that are not controlled o have kidney problems o are taking higher doses of rosuvastatin tablets • Liver problems . Your doctor should 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 doctor 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 The most common side effects may include: headache, muscle aches and pains, abdominal pain, weakness, and nausea. Additional side effects that have been reported with rosuvastatin tablets include memory loss and confusion. Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of rosuvastatin tablets. For more information, ask your doctor 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. • Safely throw away medicine that is out of date or no longer needed. Keep rosuvastatin tablets and all medicines out of the reach of children. What are the Ingredients in rosuvastatin tablets? Active Ingredient: rosuvastatin as rosuvastatin calcium USP Inactive Ingredients: 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. General Information about the safe and effective use of rosuvastatin tablets Medicines are s...

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL