Losartan Potassium

WARNING: FETAL TOXICITY

BOXED WARNING SECTION

When pregnancy is detected, discontinue losartan potassium as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) ].

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

Losartan Potassium Tablets USP, 25 mg are green colored, oval shaped, biconvex film-coated tablets debossed with ‘E’ on one side and ‘45’ on other side. Losartan Potassium Tablets USP, 50 mg are green colored, oval shaped, biconvex film-coated tablets debossed with ‘E’ on one side and ‘4’ and ‘6’ separated by scoreline on other side. Losartan Potassium Tablets USP, 100 mg are green colored, oval shaped, biconvex film-coated tablets debossed with ‘E’ on one side and ‘47’ on other side.

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Losartan potassium tablets are contraindicated: In patients who are hypersensitive to any component of this product. For coadministration with aliskiren in patients with diabetes.

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

7 DRUG INTERACTIONS

DRUG INTERACTIONS SECTION

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

10 OVERDOSAGE

OVERDOSAGE SECTION

Significant lethality was observed in mice and rats after oral administration of 1000 mg/kg and 2000 mg/kg, respectively, about 44 and 170 times the maximum recommended human dose on a mg/m 2 basis. Limited data are available in regard to overdosage in humans. The most likely manifestation of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Neither losartan nor its active metabolite can be removed by hemodialysis.

11 DESCRIPTION

DESCRIPTION SECTION

Losartan potassium tablets are an angiotensin II receptor blocker acting on the AT 1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p -( o -1 H- tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C 22 H 22 ClKN 6 O, and its structural formula is: Losartan potassium USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch (maize), low substituted hydroxypropyl cellulose, magnesium stearate, hydroxypropyl cellulose, hypromellose 6 cP, titanium dioxide, FD&C blue #2/indigo carmine aluminum lake, D&C yellow #10 aluminum lake, and purified water. Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.

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

Product: 53002-5624 NDC: 53002-5624-9 90 TABLET, FILM COATED in a BOTTLE NDC: 53002-5624-0 100 TABLET, FILM COATED in a BOTTLE NDC: 53002-5624-3 30 TABLET, FILM COATED in a BOTTLE

17 PATIENT COUNSELING INFORMATION

INFORMATION FOR PATIENTS SECTION

Advise the patient to read the FDA-approved patient labeling (Patient Information). Pregnancy Advise female patients of childbearing age about the consequences of exposure to losartan potassium during pregnancy. Discuss treatment options with women planning to become pregnant. Tell patients to report pregnancies to their physicians as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ]. Potassium Supplements Advise patients receiving losartan potassium not to use potassium supplements or salt substitutes containing potassium without consulting their healthcare provider [see Drug Interactions (7.1) ] .

Patient Information

SPL PATIENT PACKAGE INSERT SECTION

Losartan Potassium Tablets USP (loe sar' tan poe tas' ee um) 25 mg, 50 mg, 100 mg Rx only Read the Patient Information that comes with losartan potassium tablets before you start taking them and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition and treatment. What is the most important information I should know about losartan potassium tablets? Losartan potassium tablets can cause harm or death to an unborn baby. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. If you get pregnant while taking losartan potassium tablets, tell your doctor right away. What are losartan potassium tablets? Losartan potassium tablets is a prescription medicine called an angiotensin receptor blocker (ARB). It is used: alone or with other blood pressure medicines to lower high blood pressure (hypertension). to lower the chance of stroke in patients with high blood pressure and a heart problem called left ventricular hypertrophy. Losartan potassium tablets may not help Black patients with this problem. to slow the worsening of diabetic kidney disease (nephropathy) in patients with type 2 diabetes who have or had high blood pressure. Losartan potassium tablets have not been studied in children less than 6 years old or in children with certain kidney problems. High Blood Pressure (hypertension). Blood pressure is the force in your blood vessels when your heart beats and when your heart rests. You have high blood pressure when the force is too much. Losartan potassium tablets can help your blood vessels relax so your blood pressure is lower. Left Ventricular Hypertrophy (LVH) is an enlargement of the walls of the left chamber of the heart (the heart’s main pumping chamber). LVH can happen from several things. High blood pressure is the most common cause of LVH. Type 2 Diabetes with Nephropathy. Type 2 diabetes is a type of diabetes that happens mainly in adults. If you have diabetic nephropathy it means that your kidneys do not work properly because of damage from the diabetes. Who should not take losartan potassium tablets? Do not take losartan potassium tablets if you are allergic to any of the ingredients in losartan potassium tablets. See the end of this leaflet for a complete list of ingredients in losartan potassium tablets. Do not take losartan potassium tablets if you have diabetes and are taking a medicine called aliskiren to reduce blood pressure. What should I tell my doctor before taking losartan potassium tablets? Tell your doctor about all of your medical conditions including if you: are pregnant or planning to become pregnant. See “What is the most important information I should know about losartan potassium tablets?” are breastfeeding. It is not known if losartan potassium passes into your breast milk. You should choose either to take losartan potassium tablets or breastfeed, but not both. are vomiting a lot or having a lot of diarrhea have liver problems have kidney problems Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Losartan potassium tablets and certain other medicines may interact with each other. Especially tell your doctor if you are taking: potassium supplements salt substitutes containing potassium other medicines that may increase serum potassium water pills (diuretics) lithium (a medicine used to treat a certain kind of depression) medicines used to treat pain and arthritis, called non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors other medicines to reduce blood pressure How should I take losartan potassium tablets? Take losartan potassium tablets exactly as prescribed by your doctor. Your doctor may change your dose if needed. Losartan potassium tablets can be taken with or without food. If you miss a dose, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Just take the next dose at your regular time. If you take too much losartan potassium, call your doctor or Poison Control Center, or go to the nearest hospital emergency room right away. What are the possible side effects of losartan potassium tablets? Losartan potassium tablets may cause the following side effects that may be serious: Injury or death of unborn babies. See “What is the most important information I should know about losartan potassium tablets?” Allergic reaction. Symptoms of an allergic reaction are swelling of the face, lips, throat or tongue. Get emergency medical help right away and stop taking losartan potassium tablets. Low blood pressure (hypotension). Low blood pressure may cause you to feel faint or dizzy. Lie down if you feel faint or dizzy. Call your doctor right away. For people who already have kidney problems, you may see a worsening in how well your kidneys work. Call your doctor if you get swelling in your feet, ankles, or hands, or unexplained weight gain. High blood levels of potassium The most common side effects of losartan potassium tablets in people with high blood pressure are: “colds” (upper respiratory infection) dizziness stuffy nose back pain The most common side effects of losartan potassium tablets in people with type 2 diabetes with diabetic kidney disease are: diarrhea tiredness low blood sugar chest pain high blood potassium low blood pressure Tell your doctor if you get any side effect that bothers you or that won’t go away. This is not a complete list of side effects. For a complete list, ask your doctor or pharmacist. How do I store losartan potassium tablets? Store losartan potassium tablets at 59°F to 86°F (15°C to 30°C). Keep losartan potassium tablets in a tightly closed container that protects the medicine from light. Keep losartan potassium tablets and all medicines out of the reach of children. General information about losartan potassium tablets Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use losartan potassium tablets for a condition for which it was not prescribed. Do not give losartan potassium tablets to other people, even if they have the same symptoms that you have. They may harm them. This leaflet summarizes the most important information about losartan potassium tablets. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about losartan potassium tablets that is written for health professionals. What are the ingredients in losartan potassium tablets? Active ingredient: losartan potassium Inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch (maize), low substituted hydroxypropyl cellulose, magnesium stearate, hydroxypropyl cellulose, hypromellose 6 cP, titanium dioxide, FD&C blue #2/indigo carmine aluminum lake, D&C yellow #10 aluminum lake, and purified water. Ora-Plus™ and Ora-Sweet SF™ are the trademarks of Paddock Laboratories, Inc. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 12/2021

Losartan Potassium 25mg Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL