Prescription Drug Name:

Losartan Potassium and Hydrochlorothiazide Tablets USP

ID:

b125e99c-f968-4ece-9c23-64aa5b1e4986

Code:

34391-3

DESCRIPTION


id: 6e84c40b-34f7-47ee-af73-041b7071dbff
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Losartan Potassium and Hydrochlorothiazide Tablets USP combine an angiotensin II receptor (type AT1) antagonist and a diuretic, hydrochlorothiazide. Losartan potassium, a non­peptide molecule, is chemically described as 2­butyl­4­chloro­1­[p­(o­1H­tetrazol-5­ylphenyl)benzyl]imidazole­5­methanol monopotassium salt. Its molecular formula is C22H22ClKN6O, and its structural formula is: Losartan potassium is a white to off­white free­flowing crystalline 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 5­hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Hydrochlorothiazide is 6­chloro­3,4­dihydro­2H­1,2,4­benzothiadiazine­7­sulfonamide 1,1­dioxide. Its molecular formula is C7H8ClN3O4S2 and its structural formula is: Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Losartan Potassium and Hydrochlorothiazide Tablets USP are available for oral administration in three tablet combinations of losartan and hydrochlorothiazide. Losartan Potassium and Hydrochlorothiazide Tablets USP 50­12.5 contains 50 mg of losartan potassium USP and 12.5 mg of hydrochlorothiazide USP. Losartan Potassium and Hydrochlorothiazide Tablets USP 100­12.5 contains 100 mg of losartan potassium USP and 12.5 mg of hydrochlorothiazide USP. Losartan Potassium and Hydrochlorothiazide Tablets USP 100­25 contains 100 mg of losartan potassium USP and 25 mg of hydrochlorothiazide USP. Inactive ingredients are lactose, magnesium stearate, microcrystalline cellulose and pregelatinized starch. In addition to these ingredients the 50-12.5 mg and 100-25 mg tablets also contain Opadry II (Yellow), and the 100-12.5 mg tablet contains Opadry II (White). Opadry II (Yellow) contains D&C yellow #10 aluminum lake, hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide and triacetin. Opadry II (White) contains hypromellose, polyethylene glycol, polydextrose, titanium dioxide and triacetin. Losartan Potassium and Hydrochlorothiazide Tablets USP 50­12.5 contains 4.24 mg (0.108 mEq) of potassium, Losartan Potassium and Hydrochlorothiazide Tablets USP 100­12.5 contains 8.48 mg (0.216 mEq) of potassium, and Losartan Potassium and Hydrochlorothiazide Tablets USP 100­25 contains 8.48 mg (0.216 mEq) of potassium.

CONTRAINDICATIONS


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displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Losartan Potassium and Hydrochlorothiazide Tablets USP are contraindicated in patients who are hypersensitive to any component of this product. Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide­derived drugs. Do not co-administer aliskiren with Losartan Potassium and Hydrochlorothialzide Tablets USP in patients with diabetes.

ADVERSE REACTIONS


id: 392c8717-9b1b-4679-9d67-ef1080dda812
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

Losartan potassium and hydrochlorothiazide has been evaluated for safety in 858 patients treated for essential hypertension and 3889 patients treated for hypertension and left ventricular hypertrophy. In clinical trials with losartan potassium and hydrochlorothiazide, no adverse experiences peculiar to this combination have been observed. Adverse experiences have been limited to those that were reported previously with losartan potassium and/or hydrochlorothiazide. The overall incidence of adverse experiences reported with the combination was comparable to placebo. In general, treatment with losartan potassium and hydrochlorothiazide was well tolerated. For the most part, adverse experiences have been mild and transient in nature and have not required discontinuation of therapy. In controlled clinical trials, discontinuation of therapy due to clinical adverse experiences was required in only 2.8% and 2.3% of patients treated with the combination and placebo, respectively. In these double­blind controlled clinical trials, the following adverse experiences reported with losartan potassium and hydrochlorothiazide occurred in ≥1 percent of patients, and more often on drug than placebo, regardless of drug relationship:

   Losartan Potassium and Hydrochlorothiazide
(N=858)		  Placebo
(N=173)
 Body as a Whole    
    Abdominal Pain  1.2  0.6
    Edema/Swelling  1.3  1.2
 Cardiovascular    
    Palpitation  1.4  0.0
 Musculoskeletal    
    Back Pain  2.1  0.6
 Nervous/Psychiatric    
    Dizziness  5.7  2.9
 Respiratory    
    Cough  2.6  2.3
    Sinusitis  1.2  0.6
  Upper Respiratory Infection  6.1  4.6
 Skin    
    Rash  1.4  0.0
The following adverse events were also reported at a rate of 1% or greater, but were as, or more, common in the placebo group in studies of essential hypertension: asthenia/fatigue, diarrhea, nausea, headache, bronchitis, pharyngitis. Adverse events occurred at about the same rates in men and women. Adverse events were somewhat more frequent in the elderly compared to non-elderly patients and somewhat more frequent in Blacks compared to non-Blacks for both losartan and hydrochlorothiazide and the control groups. A patient with known hypersensitivity to aspirin and penicillin, when treated with losartan potassium, was withdrawn from study due to swelling of the lips and eyelids and facial rash, reported as angioedema, which returned to normal 5 days after therapy was discontinued. Superficial peeling of palms and hemolysis was reported in one subject treated with losartan potassium.

HOW SUPPLIED


id: effb88aa-1d59-4073-89dd-021519900865
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Losartan Potassium and Hydrochlorothiazide Tablets USP, 100-25 mg are supplied as round, yellow film coated, biconvex, beveled-edge tablets. The 100-25 mg tablets are debossed with product identification “54 557” on one side and plain on the other side.

33261-0904-30  100 mg/25 mg, yellow tablet, bottle of 30
33261-0904-90  100 mg/25 mg, yellow tablet, bottle of 90

PATIENT INFORMATION


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displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5

Read the Patient Information that comes with Losartan Potassium and Hydrochlorothiazide Tablets USP before you start taking it 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 and hydrochlorothiazide tablets USP? Do not take losartan potassium and hydrochlorothiazide USP if you are pregnant or plan to become pregnant. Losartan potassium and hydrochlorothiazide tablets USP can harm your unborn baby causing injury
and even death. Stop taking losartan potassium and hydrochlorothiazide tablets USP if you become pregnant and call your doctor right away. If you plan to become pregnant, talk to your doctor about other treatment options before taking losartan potassium and hydrochlorothiazide tablets USP. What is losartan potassium and hydrochlorothiazide tablets USP? Losartan potassium and hydrochlorothiazide tablets USP contains 2 prescription medicines, an angiotensin receptor blocker (ARB) and a diuretic (water pill). It is used to: • lower high blood pressure (hypertension). Losartan potassium and hydrochlorothiazide tablets USP is not usually the first medicine used to treat high blood pressure. • lower the chance of stroke in patients with high blood pressure and a heart problem called left ventricular hypertrophy (LVH). Losartan potassium and hydrochlorothiazide tablets USP may not help Black patients with this problem.
Losartan potassium and hydrochlorothiazide tablets USP has not been studied in children less than 18 years old. 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. The losartan ingredient in losartan potassium and hydrochlorothiazide tablets USP can help your blood vessels relax so your blood pressure is lower. The hydrochlorothiazide ingredient in losartan potassium and hydrochlorothiazide tablets works by making your kidneys pass more water and salt. 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. Who should not take losartan potassium and hydrochlorothiazide tablets USP? Do not take losartan potassium and hydrochlorothiazide tablets USP if you: • are allergic to any ingredients in losartan potassium and hydrochlorothiazide tablets USP. See a complete list of ingredients in losartan potassium and hydrochlorothiazide tablets USP at the end of this leaflet. • are allergic to any sulfonamide-containing (“sulfa”) medicines. Ask your doctor if you are not sure what sulfonamide-containing (“sulfa”) medicines are. • are not passing urine What should I tell my doctor before taking losartan potassium and hydrochlorothiazide tablets USP? Tell your doctor about all 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 and hydrochlorothiazide tablets USP?” • are breast-feeding or plan to breast-feed. Losartan potassium and hydrochlorothiazide tablets USP can pass into your milk and may harm your baby. You and your doctor should decide if you will take losartan potassium and hydrochlorothiazide tablets or breast-feed. You should not do both. • have been vomiting (throwing up), having diarrhea, sweating a lot, or not drinking enough fluids. These could cause you to have low blood pressure. • have liver problems • have kidney problems • have systemic lupus erythematosus (Lupus; SLE) • have diabetes • have asthma • have gout • have any allergies Tell your doctor about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and
herbal supplements. Losartan potassium and hydrochlorothiazide tablets USP and certain other medicines may interact with each other. Especially tell your doctor if you are taking: • potassium supplements • salt substitutes containing 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. Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine. How should I take losartan potassium and hydrochlorothiazide tablets USP? • Take losartan potassium and hydrochlorothiazide tablets USP exactly as prescribed by your doctor. Your doctor may change your dose if needed. • Losartan potassium and hydrochlorothiazide tablets USP 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 and hydrochlorothiazide tablets USP, call your doctor or Poison Control Center, or go to the nearest hospital emergency room right away. • Your doctor may do blood tests from time to time while you are taking losartan potassium and hydrochlorothiazide tablets USP. What are the possible side effects of losartan potassium and hydrochlorothiazide tablets USP? Losartan potassium and hydrochlorothiazide tablets USP 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 and hydrochlorothiazide tablets USP?” • 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 and hydrochlorothiazide tablets USP. • 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. • a new or worsening condition called systemic lupus erythematosus (Lupus; SLE) • if you 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. • If you have liver problems, you may see a worsening in how well your liver works. Call your doctor if you get nausea, pain in the right upper stomach area (abdomen), yellow eyes or skin (which can be itchy). The most common side effects of losartan potassium and hydrochlorothiazide tablets USP in people with high blood pressure are: • “colds” (upper respiratory infection) • dizziness • stuffy nose • back pain • fast or irregular heartbeat (palpitations) • rash 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 should I store losartan potassium and hydrochlorothiazide tablets USP? • Store losartan potassium and hydrochlorothiazide tablets USP at 20º to 25ºC (68º to 77ºF) (See USP controlled room temperature). • Keep losartan potassium and hydrochlorothiazide tablets USP in a tightly closed container, and keep losartan potassium and hydrochlorothiazide tablets USP out of the light. • Keep losartan potassium and hydrochlorothiazide tablets USP and all medicines out of the reach of children. General information about losartan potassium and hydrochlorothiazide tablets USP
 Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use losartan potassium and hydrochlorothiazide tablets USP for a condition for which it was not prescribed. Do not give losartan potassium and hydrochlorothiazide tablets USP to other people, even if they have the same symptoms that you have. It may harm them. This leaflet summarizes the most important information about losartan potassium and hydrochlorothiazide tablets USP. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information that is written for health professionals. What are the ingredients in losartan potassium and hydrochlorothiazide tablets USP? Active ingredients: losartan potassium USP, hydrochlorothiazide USP Inactive ingredients: lactose, magnesium stearate, microcrystalline cellulose and pregelatinized starch. In addition to these ingredients the 50-12.5 mg and 100-25 mg tablets also contain Opadry II (Yellow), and the 100-12.5 mg tablet contains Opadry II (White). Opadry II (Yellow) contains D&C yellow #10 aluminum lake, hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide and triacetin. Opadry II (White) contains hypromellose, polyethylene glycol, polydextrose, titanium dioxide and triacetin. 10004305/05 Revised November 2012 © RLI, 2012

PRINCIPAL DISPLAY PANEL


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displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880 Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg NDC 33261-0904-90