INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE. Hypertension LosartanPotassium and Hydrochlorothiazide Tablets are indicated for thetreatment of hypertension. This fixed dose combination is not indicatedfor initial therapy of hypertension, except when the hypertension issevere enough that the value of achieving prompt blood pressure controlexceeds the risk of initiating combination therapy in these patients(see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, and DOSAGE AND ADMINISTRATION). Hypertensive Patients with Left Ventricular Hypertrophy LosartanPotassium and Hydrochlorothiazide Tablets are indicated to reduce therisk of stroke in patients with hypertension and left ventricularhypertrophy, but there is evidence that this benefit does not apply toBlack patients. (See PRECAUTIONS, Race, CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Losartan Potassium, Reduction in the Risk of Stroke, Race, and DOSAGE AND ADMINISTRATION).

ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. Losartan potassium-hydrochlorothiazidehas been evaluated for safety in 858 patients treated for essentialhypertension and 3889 patients treated for hypertension and leftventricular hypertrophy. In clinical trials with losartanpotassium-hydrochlorothiazide, no adverse experiences peculiar to thiscombination have been observed. Adverse experiences have been limitedto those that were reported previously with losartan potassium and/orhydrochlorothiazide. The overall incidence of adverse experiencesreported with the combination was comparable to placebo. Ingeneral, treatment with losartan potassium-hydrochlorothiazide was welltolerated. For the most part, adverse experiences have been mild andtransient in nature and have not required discontinuation of therapy.In controlled clinical trials, discontinuation of therapy due toclinical adverse experiences was required in only 2.8% and 2.3% ofpatients treated with the combination and placebo, respectively. Inthese double-blind controlled clinical trials, the following adverseexperiences reported with losartan-hydrochlorothiazide occurred in >=1percent of patients, and more often on drug than placebo, regardless ofdrug relationship:Losartan Potassium-Hydrochlorothiazide(n=858) Placebo(n=173)Body as 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 alsoreported at rate of 1% or greater, but were as, or more, common inthe placebo group in studies of essential hypertension:asthenia/fatigue, diarrhea, nausea, headache, bronchitis, pharyngitis. Adverseevents occurred at about the same rates in men and women. Adverseevents were somewhat more frequent in the elderly compared tonon-elderly patients and somewhat more frequent in Blacks compared tonon-Blacks for both the losartan-hydrochlorothiazide and the controlgroups. patient with known hypersensitivity toaspirin and penicillin, when treated with losartan potassium, waswithdrawn from study due to swelling of the lips and eyelids and facialrash, reported as angioedema, which returned to normal days aftertherapy was discontinued. Superficial peeling of palms and hemolysis were reported in one subject treated with losartan potassium.

BOXED WARNING SECTION.

USE IN PREGNANCYWhenused in pregnancy during the second and third trimesters, drugs thatact directly on the renin-angiotensin system can cause injury and evendeath to the developing fetus. When pregnancy is detected, Losartan Potassium and Hydrochlorothiazide Tablets should be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal Morbidity and Mortality.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. Losartan Potassium and HydrochlorothiazideTablets are contraindicated in patients who are hypersensitive to anycomponent of this product. Because of thehydrochlorothiazide component, this product is contraindicated inpatients with anuria or hypersensitivity to other sulfonamide-deriveddrugs.

DESCRIPTION SECTION.

DESCRIPTION. Losartan Potassium and Hydrochlorothiazide 50 mg/12.5 mg, Losartan Potassium and Hydrochlorothiazide 100 mg/12.5 mg and Losartan Potassium and Hydrochlorothiazide 100 mg/25 mg combine an angiotensin II receptor (type AT1) antagonist and diuretic, hydrochlorothiazide. Losartan potassium, non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22ClKN6O, and its structural formula is: Losartan potassium, USP is white to off-white free-flowing crystalline powder with 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. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is: Hydrochlorothiazide, USP is white, or practically white, crystalline powder with 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 50 mg/12.5 mg contain 50 mg of losartan potassium USP and 12.5 mg of hydrochlorothiazide USP. Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg contain 100 mg of losartan potassium USP and 12.5 mg of hydrochlorothiazide USP. Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg contain 100 mg of losartan potassium USP and 25 mg of hydrochlorothiazide USP. Inactive ingredients are colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc and titanium dioxide. Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg and Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg also contain and yellow No. 10 lake. Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg contain 4.24 mg (0.108 mEq) of potassium, Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg contain 8.48 mg (0.216 mEq) of potassium, and Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg contain 8.48 mg (0.216 mEq) of potassium.. structural formula. structural formula.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. Hypertension Dosingmust be individualized. The usual starting dose of losartan is 50 mgonce daily, with 25 mg recommended for patients with intravascularvolume depletion (e.g., patients treated with diuretics) (see WARNINGS, Hypotension Volume-Depleted Patients) and patients with history of hepatic impairment (see WARNINGS, Impaired Hepatic Function).Losartan can be administered once or twice daily at total daily dosesof 25 to 100 mg. If the antihypertensive effect measured at troughusing once-a-day dosing is inadequate, twice-a-day regimen at thesame total daily dose or an increase in dose may give moresatisfactory response. Hydrochlorothiazide is effectivein doses of 12.5 to 50 mg once daily and can be given at doses of 12.5to 25 mg as Losartan Potassium and Hydrochlorothiazide Tablets. To minimize dose-independent side effects, it is usuallyappropriate to begin combination therapy only after patient hasfailed to achieve the desired effect with monotherapy. The side effects (see WARNINGS)of losartan are generally rare and apparently independent of dose;those of hydrochlorothiazide are mixture of dose-dependent (primarilyhypokalemia) and dose-independent phenomena (e.g.,pancreatitis), the former much more common than the latter. Therapywith any combination of losartan and hydrochlorothiazide will beassociated with both sets of dose-independent side effects. Replacement Therapy: The combination may be substituted for the titrated components. Dose Titration by Clinical Effect:A patient whose blood pressure is not adequately controlled withlosartan monotherapy (see above) or hydrochlorothiazide alone, may beswitched to Losartan Potassium and Hydrochlorothiazide Tablets 50mg/12.5 mg (losartan 50 mg/hydrochlorothiazide 12.5 mg) once daily. Ifblood pressure remains uncontrolled after about weeks of therapy, thedose may be increased to two tablets of Losartan Potassium andHydrochlorothiazide 50 mg/12.5 mg once daily or one tablet of LosartanPotassium and Hydrochlorothiazide 100 mg/25 mg (losartan 100mg/hydrochlorothiazide 25 mg) once daily. patient whose bloodpressure is not adequately controlled with losartan 100 mg monotherapy(see above) may be switched to Losartan Potassium andHydrochlorothiazide Tablets 100 mg/12.5 mg once daily. If bloodpressure remains uncontrolled after about weeks of therapy, the dosemay be increased to two tablets of Losartan Potassium andHydrochlorothiazide 50 mg/12.5 mg once daily or one tablet of LosartanPotassium and Hydrochlorothiazide 100 mg/25 mg (losartan 100mg/hydrochlorothiazide 25 mg) once daily. patient whoseblood pressure is inadequately controlled by 25 mg once daily ofhydrochlorothiazide, or is controlled but who experiences hypokalemiawith this regimen, may be switched to Losartan Potassium andHydrochlorothiazide Tablets 50 mg/12.5 mg (losartan 50mg/hydrochlorothiazide 12.5 mg) once daily, reducing the dose ofhydrochlorothiazide without reducing the overall expectedantihypertensive response. The clinical response to Losartan Potassiumand Hydrochlorothiazide Tablets 50 mg/12.5 mg should be subsequentlyevaluated, and if blood pressure remains uncontrolled after about 3weeks of therapy, the dose may be increased to two tablets of LosartanPotassium and Hydrochlorothiazide Tablets 50 mg/12.5 mg once daily orone tablet of Losartan Potassium and Hydrochlorothiazide Tablets 100mg/25 mg (losartan 100 mg/hydrochlorothiazide 25 mg) once daily. Theusual dose of Losartan Potassium and Hydrochlorothiazide is one tabletof Losartan Potassium and Hydrochlorothiazide 50 mg/12.5 mg once daily.More than two tablets of Losartan Potassium and Hydrochlorothiazide 50mg/12.5 mg once daily or more than one tablet of Losartan Potassium andHydrochlorothiazide 100 mg/25 mg once daily is not recommended. Themaximal antihypertensive effect is attained about weeks afterinitiation of therapy. Use in Patients with Renal Impairment:The usual regimens of therapy with Losartan Potassium andHydrochlorothiazide Tablets may be followed as long as the patientscreatinine clearance is >30 mL/min. In patients with more severerenal impairment, loop diuretics are preferred to thiazides, soLosartan Potassium and Hydrochlorothiazide Tablets are not recommended. Patients with Hepatic Impairment: Losartan Potassium and Hydrochlorothiazide Tablets are not recommended for titration in patients with hepatic impairment (see WARNINGS, Impaired Hepatic function) because the appropriate 25 mg starting dose of losartan cannot be given.Severe Hypertension The starting dose of Losartan Potassium and HydrochlorothiazideTablets for initial treatment of severe hypertension is one tablet ofLosartan Potassium and Hydrochlorothiazide 50 mg/12.5 mg once daily(see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects). Forpatients who do not respond adequately to Losartan Potassium andHydrochlorothiazide Tablets 50 mg/12.5 mg after to weeks oftherapy, the dosage may be increased to one tablet of LosartanPotassium and Hydrochlorothiazide 100 mg/25 mg once daily. The maximumdose is one tablet of Losartan Potassium and Hydrochlorothiazide 100mg/25 mg once daily. Losartan Potassium and Hydrochlorothiazide Tabletsare not recommended as initial therapy in patients with hepaticimpairment (see WARNINGS, Impaired Hepatic Function) becausethe appropriate 25 mg starting dose of losartan cannot be given. It isalso not recommended for use as initial therapy in patients withintravascular volume depletion (e.g., patients treated with diuretics, see WARNINGS, Hypotension Volume-Depleted Patients).. Hypertensive Patients with Left Ventricular Hypertrophy Treatmentshould be initiated with losartan potassium tablets 50 mg once daily.Hydrochlorothiazide 12.5 mg should be added or Losartan Potassium andHydrochlorothiazide Tablets 50 mg/12.5 mg substituted if the bloodpressure reduction is inadequate. If additional blood pressurereduction is needed, losartan potassium tablets 100 mg andhydrochlorothiazide 12.5 mg or Losartan Potassium andHydrochlorothiazide Tablets 100 mg/12.5 mg may be substituted, followedby losartan potassium tablets 100 mg and hydrochlorothiazide 25 mg orLosartan Potassium and Hydrochlorothiazide Tablets 100 mg/25 mg. Forfurther blood pressure reduction other antihypertensives should beadded (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Losartan Potassium, Reduction in the Risk of Stroke).Losartan Potassium and Hydrochlorothiazide Tablets may be administered with other antihypertensive agents. Losartan Potassium and Hydrochlorothiazide Tablets may be administered with or without food.

HOW SUPPLIED SECTION.

HOW SUPPLIED. LosartanPotassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg are whiteto off white colored, oval shaped, biconvex film coated tablets,debossed with 1117 on one side and plain on other side.Bottles of 90 NDC 68258-6031-09 Storage Store at 20 to 25C (68 to 77F) (See USP controlled room temperature). Protect from light.Keep container tightly closed.

OVERDOSAGE SECTION.

OVERDOSAGE. Losartan Potassium Significantlethality was observed in mice and rats after oral administration of1000 mg/kg and 2000 mg/kg, respectively, about 44 and 170 times themaximum recommended human dose on mg/m2 basis. Limiteddata are available in regard to overdosage in humans. The most likelymanifestation of overdosage would be hypotension and tachycardia;bradycardia could occur from parasympathetic (vagal) stimulation. Ifsymptomatic hypotension should occur, supportive treatment should beinstituted. Neither losartan nor its active metabolite can be removed by hemodialysis. Hydrochlorothiazide The oral LD50of hydrochlorothiazide is greater than 10 g/kg in both mice and rats.The most common signs and symptoms observed are those caused byelectrolyte depletion (hypokalemia, hypochloremia, hyponatremia) anddehydration resulting from excessive diuresis. If digitalis has alsobeen administered, hypokalemia may accentuate cardiac arrhythmias. Thedegree to which hydrochlorothiazide is removed by hemodialysis has notbeen established.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL. NDC 68258-6031-XXNDC 68258-6031-09 NDC 68258-6031-XX.

SPL PATIENT PACKAGE INSERT SECTION.

Patient Information Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg Rx onlyReadthe Patient Information that comes with Losartan Potassium andHydrochlorothiazide Tablets before you start taking it and each timeyou get refill. There may be new information. This leaflet does nottake the place of talking with your doctor about your condition andtreatment. What is the most important information should know about Losartan Potassium and Hydrochlorothiazide Tablets. Do not take Losartan Potassium andHydrochlorothiazide Tablets if you are pregnant or plan to becomepregnant. Losartan Potassium and Hydrochlorothiazide Tablets can harmyour unborn baby causing injury and even death. Stop taking LosartanPotassium and Hydrochlorothiazide Tablets if you become pregnant andcall your doctor right away. If you plan to become pregnant,talk to your doctor about other treatment options before takingLosartan Potassium and Hydrochlorothiazide Tablets.. What are Losartan Potassium and Hydrochlorothiazide Tablets. Losartan Potassium and HydrochlorothiazideTablets contain prescription medicines, an angiotensin receptorblocker (ARB) and diuretic (water pill). It is used to: lowerhigh blood pressure (hypertension). Losartan Potassium andHydrochlorothiazide Tablets are not usually the first medicine used totreat high blood pressure. lower the chance of stroke inpatients with high blood pressure and heart problem called leftventricular hypertrophy (LVH). Losartan Potassium andHydrochlorothiazide Tablets may not help Black patients with thisproblem. Losartan Potassium and Hydrochlorothiazide Tablets have not been studied in children less than 18 years old. High Blood Pressure (hypertension) Bloodpressure is the force in your blood vessels when your heart beats andwhen your heart rests. You have high blood pressure when the force istoo much. The losartan ingredient in Losartan Potassium andHydrochlorothiazide Tablets can help your blood vessels relax so yourblood pressure is lower. The hydrochlorothiazide ingredient in LosartanPotassium and Hydrochlorothiazide Tablets work by making your kidneyspass more water and salt. Left Ventricular Hypertrophy (LVH) is an enlargement ofthe walls of the left chamber of the heart (the hearts main pumpingchamber). LVH can happen from several things. High blood pressure isthe most common cause of LVH. lowerhigh blood pressure (hypertension). Losartan Potassium andHydrochlorothiazide Tablets are not usually the first medicine used totreat high blood pressure. lower the chance of stroke inpatients with high blood pressure and heart problem called leftventricular hypertrophy (LVH). Losartan Potassium andHydrochlorothiazide Tablets may not help Black patients with thisproblem. Who should not take Losartan Potassium and Hydrochlorothiazide Tablets. Do not take Losartan Potassium and Hydrochlorothiazide Tablets if you: areallergic to any ingredients in Losartan Potassium andHydrochlorothiazide Tablets. See complete list of ingredients inLosartan Potassium and Hydrochlorothiazide Tablets at the end of thisleaflet. are allergic to any sulfonamide-containing (sulfa)medicines. Ask your doctor if you are not sure whatsulfonamide-containing (sulfa) medicines are. are not passing urine. areallergic to any ingredients in Losartan Potassium andHydrochlorothiazide Tablets. See complete list of ingredients inLosartan Potassium and Hydrochlorothiazide Tablets at the end of thisleaflet. are allergic to any sulfonamide-containing (sulfa)medicines. Ask your doctor if you are not sure whatsulfonamide-containing (sulfa) medicines are. are not passing urine. What should tell my doctor before taking Losartan Potassium and Hydrochlorothiazide Tablets. 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 should know about Losartan Potassium and Hydrochlorothiazide Tablets arebreast-feeding or plan to breast-feed. Losartan potassium andhydrochlorothiazide tablets can pass into your milk and may harm yourbaby. You and your doctor should decide if you will take LosartanPotassium and Hydrochlorothiazide Tablets or breast-feed. You shouldnot do both. have been vomiting (throwing up), havingdiarrhea, sweating lot, or not drinking enough fluids. These couldcause 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 Tellyour doctor about all of the medicines you take, including prescriptionand non-prescription medicines, vitamins, and herbal supplements. LosartanPotassium and Hydrochlorothiazide Tablets and certain other medicinesmay interact with each other. Especially tell your doctor if you aretaking: potassium supplements salt substitutes containing potassium water pills (diuretics) lithium (a medicine used to treat 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.Knowthe medicines you take. Keep list of your medicines and show it toyour doctor and pharmacist when you get new medicine. are pregnant or planning to become pregnant. See What is the most important information should know about Losartan Potassium and Hydrochlorothiazide Tablets arebreast-feeding or plan to breast-feed. Losartan potassium andhydrochlorothiazide tablets can pass into your milk and may harm yourbaby. You and your doctor should decide if you will take LosartanPotassium and Hydrochlorothiazide Tablets or breast-feed. You shouldnot do both. have been vomiting (throwing up), havingdiarrhea, sweating lot, or not drinking enough fluids. These couldcause 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 potassium supplements salt substitutes containing potassium water pills (diuretics) lithium (a medicine used to treat 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 take Losartan Potassium and Hydrochlorothiazide Tablets. Take Losartan Potassium and HydrochlorothiazideTablets exactly as prescribed by your doctor. Your doctor may changeyour dose if needed. Losartan Potassium and Hydrochlorothiazide Tablets can be taken with or without food. Ifyou miss dose, take it as soon as you remember. If it is close toyour next dose, do not take the missed dose. Just take the next dose atyour regular time. If you take too much Losartan Potassiumand Hydrochlorothiazide Tablets, call your doctor or Poison ControlCenter, 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. What are the possible side effects of Losartan Potassium and Hydrochlorothiazide TabletsLosartan Potassium and Hydrochlorothiazide Tablets may cause the following side effects that may be serious: injury or death of unborn babies. See What is the most important information should know about Losartan Potassium and Hydrochlorothiazide Tablets allergicreaction. Symptoms of an allergic reaction are swelling of the face,lips, throat, or tongue. Get emergency medical help right away and stoptaking Losartan Potassium and Hydrochlorothiazide 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. new or worsening condition called systemic lupus erythematosus (Lupus; SLE) If you have kidney problems, you may see 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 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). Eye problems. Oneof the medicines in Losartan Potassium and Hydrochlorothiazide Tabletscan cause eye problems that, if left untreated, may lead to visionloss. Symptoms of eye problems can happen within hours to weeks ofstarting Losartan Potassium and Hydrochlorothiazide Tablets. Tell your doctor right away if you have: decrease in vision eye painThe most common side effects of Losartan Potassium and Hydrochlorothiazide Tablets 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 wont go away. This is not complete list of side effects. For complete list, 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.. Take Losartan Potassium and HydrochlorothiazideTablets exactly as prescribed by your doctor. Your doctor may changeyour dose if needed. Losartan Potassium and Hydrochlorothiazide Tablets can be taken with or without food. Ifyou miss dose, take it as soon as you remember. If it is close toyour next dose, do not take the missed dose. Just take the next dose atyour regular time. If you take too much Losartan Potassiumand Hydrochlorothiazide Tablets, call your doctor or Poison ControlCenter, 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. injury or death of unborn babies. See What is the most important information should know about Losartan Potassium and Hydrochlorothiazide Tablets allergicreaction. Symptoms of an allergic reaction are swelling of the face,lips, throat, or tongue. Get emergency medical help right away and stoptaking Losartan Potassium and Hydrochlorothiazide 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. a new or worsening condition called systemic lupus erythematosus (Lupus; SLE) If you have kidney problems, you may see 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 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). Eye problems. Oneof the medicines in Losartan Potassium and Hydrochlorothiazide Tabletscan cause eye problems that, if left untreated, may lead to visionloss. Symptoms of eye problems can happen within hours to weeks ofstarting Losartan Potassium and Hydrochlorothiazide Tablets.. colds (upper respiratory infection) dizziness stuffy nose back pain fast or irregular heartbeat (palpitations) rash How should store Losartan Potassium and Hydrochlorothiazide Tablets. Store Losartan Potassium and Hydrochlorothiazide Tablets at 20 to 25C (68 to 77F) (See USP controlled room temperature).KeepLosartan Potassium and Hydrochlorothiazide Tablets in tightly closedcontainer, and keep Losartan Potassium and Hydrochlorothiazide Tabletsout of the light. Keep Losartan Potassium and Hydrochlorothiazide Tablets and all medicines out of the reach of children. Store Losartan Potassium and Hydrochlorothiazide Tablets at 20 to 25C (68 to 77F) (See USP controlled room temperature).. KeepLosartan Potassium and Hydrochlorothiazide Tablets in tightly closedcontainer, and keep Losartan Potassium and Hydrochlorothiazide Tabletsout of the light. Keep Losartan Potassium and Hydrochlorothiazide Tablets and all medicines out of the reach of children. General information about Losartan Potassium and Hydrochlorothiazide Tablets. Medicines are sometimes prescribed forconditions that are not mentioned in patient information leaflets. Donot use Losartan Potassium and Hydrochlorothiazide Tablets for acondition for which it was not prescribed. Do not give LosartanPotassium and Hydrochlorothiazide Tablets to other people, even if theyhave the same symptoms that you have. It may harm them. Thisleaflet summarizes the most important information about LosartanPotassium and Hydrochlorothiazide Tablets. If you would like moreinformation, talk with your doctor. You can ask your pharmacist ordoctor for information that is written for health professionals. What are the ingredients in Losartan Potassium and Hydrochlorothiazide Tablets. Active ingredients: losartan potassium, USP and hydrochlorothiazide, USP Inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc and titanium dioxide. Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg and Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg also contain and yellow No. 10 lake.

SPL UNCLASSIFIED SECTION.

The following adverse events were alsoreported at rate of 1% or greater, but were as, or more, common inthe placebo group in studies of essential hypertension:asthenia/fatigue, diarrhea, nausea, headache, bronchitis, pharyngitis. Adverseevents occurred at about the same rates in men and women. Adverseevents were somewhat more frequent in the elderly compared tonon-elderly patients and somewhat more frequent in Blacks compared tonon-Blacks for both the losartan-hydrochlorothiazide and the controlgroups. patient with known hypersensitivity toaspirin and penicillin, when treated with losartan potassium, waswithdrawn from study due to swelling of the lips and eyelids and facialrash, reported as angioedema, which returned to normal days aftertherapy was discontinued. Superficial peeling of palms and hemolysis were reported in one subject treated with losartan potassium.