Hyzaar
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Questions & Answers
Side Effects & Adverse Reactions
Drugs that act directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered to pregnant women. Several dozen cases have been reported in the world literature in patients who were taking angiotensin converting enzyme inhibitors. When pregnancy is detected, HYZAAR should be discontinued as soon as possible.
The use of drugs that act directly on the renin-angiotensin system during the second and third trimesters of pregnancy has been associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Oligohydramnios has also been reported, presumably resulting from decreased fetal renal function; oligohydramnios in this setting has been associated with fetal limb contractures, craniofacial deformation, and hypoplastic lung development. Prematurity, intrauterine growth retardation, and patent ductus arteriosus have also been reported, although it is not clear whether these occurrences were due to exposure to the drug.
These adverse effects do not appear to have resulted from intrauterine drug exposure that has been limited to the first trimester.
Mothers whose embryos and fetuses are exposed to an angiotensin II receptor antagonist only during the first trimester should be so informed. Nonetheless, when patients become pregnant, physicians should have the patient discontinue the use of HYZAAR as soon as possible.
Rarely (probably less often than once in every thousand pregnancies), no alternative to an angiotensin II receptor antagonist will be found. In these rare cases, the mothers should be apprised of the potential hazards to their fetuses, and serial ultrasound examinations should be performed to assess the intra-amniotic environment.
If oligohydramnios is observed, HYZAAR should be discontinued unless it is considered life-saving for the mother. Contraction stress testing (CST), a non-stress test (NST), or biophysical profiling (BPP) may be appropriate, depending upon the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury.
Infants with histories of in utero exposure to an angiotensin II receptor antagonist should be closely observed for hypotension, oliguria, and hyperkalemia. If oliguria occurs, attention should be directed toward support of blood pressure and renal perfusion. Exchange transfusion or dialysis may be required as means of reversing hypotension and/or substituting for disordered renal function.
There was no evidence of teratogenicity in rats or rabbits treated with a maximum losartan potassium dose of 10 mg/kg/day in combination with 2.5 mg/kg/day of hydrochlorothiazide. At these dosages, respective exposures (AUCs) of losartan, its active metabolite, and hydrochlorothiazide in rabbits were approximately 5, 1.5, and 1.0 times those achieved in humans with 100 mg losartan in combination with 25 mg hydrochlorothiazide. AUC values for losartan, its active metabolite and hydrochlorothiazide, extrapolated from data obtained with losartan administered to rats at a dose of 50 mg/kg/day in combination with 12.5 mg/kg/day of hydrochlorothiazide, were approximately 6, 2, and 2 times greater than those achieved in humans with 100 mg of losartan in combination with 25 mg of hydrochlorothiazide. Fetal toxicity in rats, as evidenced by a slight increase in supernumerary ribs, was observed when females were treated prior to and throughout gestation with 10 mg/kg/day losartan in combination with 2.5 mg/kg/day hydrochlorothiazide. As also observed in studies with losartan alone, adverse fetal and neonatal effects, including decreased body weight, renal toxicity, and mortality, occurred when pregnant rats were treated during late gestation and/or lactation with 50 mg/kg/day losartan in combination with 12.5 mg/kg/day hydrochlorothiazide. Respective AUCs for losartan, its active metabolite and hydrochlorothiazide at these dosages in rats were approximately 35, 10 and 10 times greater than those achieved in humans with the administration of 100 mg of losartan in combination with 25 mg hydrochlorothiazide. When hydrochlorothiazide was administered without losartan to pregnant mice and rats during their respective periods of major organogenesis, at doses up to 3000 and 1000 mg/kg/day, respectively, there was no evidence of harm to the fetus.
Thiazides cross the placental barrier and appear in cord blood. There is a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.
In patients who are intravascularly volume-depleted (e.g., those treated with diuretics), symptomatic hypotension may occur after initiation of therapy with HYZAAR. This condition should be corrected prior to administration of HYZAAR (see DOSAGE AND ADMINISTRATION).
HYZAAR is not recommended for patients with hepatic impairment who require titration with losartan. The lower starting dose of losartan recommended for use in patients with hepatic impairment cannot be given using HYZAAR.
Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history.
Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.
Lithium generally should not be given with thiazides (see PRECAUTIONS, Drug Interactions, Hydrochlorothiazide, Lithium).
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
HYZAAR is indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy of hypertension, except when the hypertension is severe enough that the value of achieving prompt blood pressure control exceeds the risk of initiating combination therapy in these patients (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, and DOSAGE AND ADMINISTRATION).
HYZAAR is indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients. (See PRECAUTIONS, Race, CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Losartan Potassium, Reduction in the Risk of Stroke,Race, and DOSAGE AND ADMINISTRATION.)
History
There is currently no drug history available for this drug.
Other Information
HYZAAR1 50-12.5 (losartan potassium-hydrochlorothiazide), HYZAAR2 100-12.5 (losartan potassium-hydrochlorothiazide) and HYZAAR3 100-25 (losartan potassium-hydrochlorothiazide) combine an angiotensin II receptor (type AT1) antagonist and a diuretic, hydrochlorothiazide.
Losartan potassium, a 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 is a white to off-white free-flowing 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 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 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.
HYZAAR is available for oral administration in three tablet combinations of losartan and hydrochlorothiazide. HYZAAR 50-12.5 contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. HYZAAR 100-12.5 contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. HYZAAR 100-25 contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide. Inactive ingredients are microcrystalline cellulose, lactose hydrous, pregelatinized starch, magnesium stearate, hydroxypropyl cellulose, hypromellose, and titanium dioxide. HYZAAR 50-12.5 and HYZAAR 100-25 also contain D&C yellow No. 10 aluminum lake. HYZAAR 50-12.5, HYZAAR 100-12.5, and HYZAAR 100-25 may also contain carnauba wax.
HYZAAR 50-12.5 contains 4.24 mg (0.108 mEq) of potassium, HYZAAR 100-12.5 contains 8.48 mg (0.216 mEq) of potassium, and HYZAAR 100-25 contains 8.48 mg (0.216 mEq) of potassium.
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Registered trademark of E.I. du Pont de Nemours and Company, Wilmington, Delaware, USA
Copyright © 1995, 2005 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved - 2
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Registered trademark of E.I. du Pont de Nemours and Company, Wilmington, Delaware, USA
Copyright © 1995, 2005 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved - 3
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Registered trademark of E.I. du Pont de Nemours and Company, Wilmington, Delaware, USA
Copyright © 1995, 2005 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved
Sources
Hyzaar Manufacturers
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Rebel Distributors Corp
![Hyzaar (Losartan Potassium And Hydrochlorothiazide) Tablet, Film Coated [Rebel Distributors Corp]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Hyzaar | Rebel Distributors Corp
HypertensionDosing must be individualized. The usual starting dose of losartan is 50 mg once daily, with 25 mg recommended for patients with intravascular volume depletion (e.g., patients treated with diuretics) (see WARNINGS, Hypotension — Volume-Depleted Patients) and patients with a history of hepatic impairment (see WARNINGS, Impaired Hepatic Function). Losartan can be administered once or twice daily at total daily doses of 25 to 100 mg. If the antihypertensive effect measured at trough using once-a-day dosing is inadequate, a twice-a-day regimen at the same total daily dose or an increase in dose may give a more satisfactory response.
Hydrochlorothiazide is effective in doses of 12.5 to 50 mg once daily and can be given at doses of 12.5 to 25 mg as HYZAAR.
To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed 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 a mixture of dose-dependent (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter. Therapy with any combination of losartan and hydrochlorothiazide will be associated 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 with losartan monotherapy (see above) or hydrochlorothiazide alone may be switched to HYZAAR 50-12.5 (losartan 50 mg/hydrochlorothiazide 12.5 mg) once daily. If blood pressure remains uncontrolled after about 3 weeks of therapy, the dose may be increased to two tablets of HYZAAR 50-12.5 once daily or one tablet of HYZAAR 100-25 (losartan 100 mg/hydrochlorothiazide 25 mg) once daily. A patient whose blood pressure is not adequately controlled with losartan 100 mg monotherapy (see above) may be switched to HYZAAR 100-12.5 once daily. If blood pressure remains uncontrolled after about 3 weeks of therapy, the dose may be increased to two tablets of HYZAAR 50-12.5 once daily or one tablet of HYZAAR 100-25 (losartan 100 mg/hydrochlorothiazide 25 mg) once daily.
A patient whose blood pressure is inadequately controlled by 25 mg once daily of hydrochlorothiazide, or is controlled but who experiences hypokalemia with this regimen, may be switched to HYZAAR 50-12.5 (losartan 50 mg/hydrochlorothiazide 12.5 mg) once daily, reducing the dose of hydrochlorothiazide without reducing the overall expected antihypertensive response. The clinical response to HYZAAR 50-12.5 should be subsequently evaluated, and if blood pressure remains uncontrolled after about 3 weeks of therapy, the dose may be increased to two tablets of HYZAAR 50-12.5 once daily or one tablet of HYZAAR 100-25 (losartan 100 mg/hydrochlorothiazide 25 mg) once daily.
The usual dose of HYZAAR is one tablet of HYZAAR 50-12.5 once daily. More than two tablets of HYZAAR 50-12.5 once daily or more than one tablet of HYZAAR 100-25 once daily is not recommended. The maximal antihypertensive effect is attained about 3 weeks after initiation of therapy.
Use in Patients with Renal Impairment: The usual regimens of therapy with HYZAAR may be followed as long as the patient's creatinine clearance is >30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so HYZAAR is not recommended.
Patients with Hepatic Impairment: HYZAAR is 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 HypertensionThe starting dose of HYZAAR for initial treatment of severe hypertension is one tablet of HYZAAR 50-12.5 once daily (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects). For patients who do not respond adequately to HYZAAR 50-12.5 after 2 to 4 weeks of therapy, the dosage may be increased to one tablet of HYZAAR 100-25 once daily. The maximum dose is one tablet of HYZAAR 100-25 once daily. HYZAAR is not recommended as initial therapy in patients with hepatic impairment (see WARNINGS, Impaired Hepatic Function) because the appropriate 25 mg starting dose of losartan cannot be given. It is also not recommended for use as initial therapy in patients with intravascular volume depletion (e.g., patients treated with diuretics, see WARNINGS, Hypotension — Volume-Depleted Patients).
Hypertensive Patients with Left Ventricular HypertrophyTreatment should be initiated with COZAAR 50 mg once daily. Hydrochlorothiazide 12.5 mg should be added or HYZAAR 50-12.5 substituted if the blood pressure reduction is inadequate. If additional blood pressure reduction is needed, COZAAR 100 mg and hydrochlorothiazide 12.5 mg or HYZAAR 100-12.5 may be substituted, followed by COZAAR 100 mg and hydrochlorothiazide 25 mg or HYZAAR 100-25. For further blood pressure reduction other antihypertensives should be added (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Losartan Potassium, Reduction in the Risk of Stroke).
HYZAAR may be administered with other antihypertensive agents.
HYZAAR may be administered with or without food.
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Pd-rx Pharmaceuticals, Inc.
Hyzaar | Pd-rx Pharmaceuticals, Inc.
HypertensionDosing must be individualized. The usual starting dose of losartan is 50 mg once daily, with 25 mg recommended for patients with intravascular volume depletion (e.g., patients treated with diuretics) (see WARNINGS, Hypotension — Volume-Depleted Patients) and patients with a history of hepatic impairment (see WARNINGS, Impaired Hepatic Function). Losartan can be administered once or twice daily at total daily doses of 25 to 100 mg. If the antihypertensive effect measured at trough using once-a-day dosing is inadequate, a twice-a-day regimen at the same total daily dose or an increase in dose may give a more satisfactory response.
Hydrochlorothiazide is effective in doses of 12.5 to 50 mg once daily and can be given at doses of 12.5 to 25 mg as HYZAAR.
To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed 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 a mixture of dose-dependent (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter. Therapy with any combination of losartan and hydrochlorothiazide will be associated 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 with losartan monotherapy (see above) or hydrochlorothiazide alone may be switched to HYZAAR 50/12.5 (losartan 50 mg/hydrochlorothiazide 12.5 mg) once daily. If blood pressure remains uncontrolled after about 3 weeks of therapy, the dose may be increased to two tablets of HYZAAR 50/12.5 once daily or one tablet of HYZAAR 100/25 (losartan 100 mg/hydrochlorothiazide 25 mg) once daily. A patient whose blood pressure is not adequately controlled with losartan 100 mg monotherapy (see above) may be switched to HYZAAR 100/12.5 once daily. If blood pressure remains uncontrolled after about 3 weeks of therapy, the dose may be increased to two tablets of HYZAAR 50/12.5 once daily or one tablet of HYZAAR 100/25 (losartan 100 mg/hydrochlorothiazide 25 mg) once daily.
A patient whose blood pressure is inadequately controlled by 25 mg once daily of hydrochlorothiazide, or is controlled but who experiences hypokalemia with this regimen, may be switched to HYZAAR 50/12.5 (losartan 50 mg/hydrochlorothiazide 12.5 mg) once daily, reducing the dose of hydrochlorothiazide without reducing the overall expected antihypertensive response. The clinical response to HYZAAR 50/12.5 should be subsequently evaluated, and if blood pressure remains uncontrolled after about 3 weeks of therapy, the dose may be increased to two tablets of HYZAAR 50/12.5 once daily or one tablet of HYZAAR 100/25 (losartan 100 mg/hydrochlorothiazide 25 mg) once daily.
The usual dose of HYZAAR is one tablet of HYZAAR 50/12.5 once daily. More than two tablets of HYZAAR 50/12.5 once daily or more than one tablet of HYZAAR 100/25 once daily is not recommended. The maximal antihypertensive effect is attained about 3 weeks after initiation of therapy.
Use in Patients with Renal Impairment: The usual regimens of therapy with HYZAAR may be followed as long as the patient's creatinine clearance is >30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so HYZAAR is not recommended.
Patients with Hepatic Impairment: HYZAAR is 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 HypertensionThe starting dose of HYZAAR for initial treatment of severe hypertension is one tablet of HYZAAR 50/12.5 once daily (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects). For patients who do not respond adequately to HYZAAR 50/12.5 after 2 to 4 weeks of therapy, the dosage may be increased to one tablet of HYZAAR 100/25 once daily. The maximum dose is one tablet of HYZAAR 100/25 once daily. HYZAAR is not recommended as initial therapy in patients with hepatic impairment (see WARNINGS, Impaired Hepatic Function) because the appropriate 25 mg starting dose of losartan cannot be given. It is also not recommended for use as initial therapy in patients with intravascular volume depletion (e.g., patients treated with diuretics, see WARNINGS, Hypotension — Volume-Depleted Patients).
Hypertensive Patients with Left Ventricular HypertrophyTreatment should be initiated with COZAAR 50 mg once daily. Hydrochlorothiazide 12.5 mg should be added or HYZAAR 50/12.5 substituted if the blood pressure reduction is inadequate. If additional blood pressure reduction is needed, COZAAR 100 mg and hydrochlorothiazide 12.5 mg or HYZAAR 100/12.5 may be substituted, followed by COZAAR 100 mg and hydrochlorothiazide 25 mg or HYZAAR 100/25. For further blood pressure reduction other antihypertensives should be added (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Losartan Potassium, Reduction in the Risk of Stroke).
HYZAAR may be administered with other antihypertensive agents.
HYZAAR may be administered with or without food.
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Physicians Total Care, Inc.
Hyzaar | Physicians Total Care, Inc.
HypertensionDosing must be individualized. The usual starting dose of losartan is 50 mg once daily, with 25 mg recommended for patients with intravascular volume depletion (e.g., patients treated with diuretics) (see WARNINGS, Hypotension — Volume-Depleted Patients) and patients with a history of hepatic impairment (see WARNINGS, Impaired Hepatic Function). Losartan can be administered once or twice daily at total daily doses of 25 to 100 mg. If the antihypertensive effect measured at trough using once-a-day dosing is inadequate, a twice-a-day regimen at the same total daily dose or an increase in dose may give a more satisfactory response.
Hydrochlorothiazide is effective in doses of 12.5 to 50 mg once daily and can be given at doses of 12.5 to 25 mg as HYZAAR.
To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed 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 a mixture of dose-dependent (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter. Therapy with any combination of losartan and hydrochlorothiazide will be associated 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 with losartan monotherapy (see above) or hydrochlorothiazide alone may be switched to HYZAAR 50/12.5 (losartan 50 mg/hydrochlorothiazide 12.5 mg) once daily. If blood pressure remains uncontrolled after about 3 weeks of therapy, the dose may be increased to two tablets of HYZAAR 50/12.5 once daily or one tablet of HYZAAR 100/25 (losartan 100 mg/hydrochlorothiazide 25 mg) once daily. A patient whose blood pressure is not adequately controlled with losartan 100 mg monotherapy (see above) may be switched to HYZAAR 100/12.5 once daily. If blood pressure remains uncontrolled after about 3 weeks of therapy, the dose may be increased to two tablets of HYZAAR 50/12.5 once daily or one tablet of HYZAAR 100/25 (losartan 100 mg/hydrochlorothiazide 25 mg) once daily.
A patient whose blood pressure is inadequately controlled by 25 mg once daily of hydrochlorothiazide, or is controlled but who experiences hypokalemia with this regimen, may be switched to HYZAAR 50/12.5 (losartan 50 mg/hydrochlorothiazide 12.5 mg) once daily, reducing the dose of hydrochlorothiazide without reducing the overall expected antihypertensive response. The clinical response to HYZAAR 50/12.5 should be subsequently evaluated, and if blood pressure remains uncontrolled after about 3 weeks of therapy, the dose may be increased to two tablets of HYZAAR 50/12.5 once daily or one tablet of HYZAAR 100/25 (losartan 100 mg/hydrochlorothiazide 25 mg) once daily.
The usual dose of HYZAAR is one tablet of HYZAAR 50/12.5 once daily. More than two tablets of HYZAAR 50/12.5 once daily or more than one tablet of HYZAAR 100/25 once daily is not recommended. The maximal antihypertensive effect is attained about 3 weeks after initiation of therapy.
Use in Patients with Renal Impairment: The usual regimens of therapy with HYZAAR may be followed as long as the patient's creatinine clearance is >30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so HYZAAR is not recommended.
Patients with Hepatic Impairment: HYZAAR is 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 HypertensionThe starting dose of HYZAAR for initial treatment of severe hypertension is one tablet of HYZAAR 50/12.5 once daily (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects). For patients who do not respond adequately to HYZAAR 50/12.5 after 2 to 4 weeks of therapy, the dosage may be increased to one tablet of HYZAAR 100/25 once daily. The maximum dose is one tablet of HYZAAR 100/25 once daily. HYZAAR is not recommended as initial therapy in patients with hepatic impairment (see WARNINGS, Impaired Hepatic Function) because the appropriate 25 mg starting dose of losartan cannot be given. It is also not recommended for use as initial therapy in patients with intravascular volume depletion (e.g., patients treated with diuretics, see WARNINGS, Hypotension — Volume-Depleted Patients).
Hypertensive Patients with Left Ventricular HypertrophyTreatment should be initiated with COZAAR 50 mg once daily. Hydrochlorothiazide 12.5 mg should be added or HYZAAR 50/12.5 substituted if the blood pressure reduction is inadequate. If additional blood pressure reduction is needed, COZAAR 100 mg and hydrochlorothiazide 12.5 mg or HYZAAR 100/12.5 may be substituted, followed by COZAAR 100 mg and hydrochlorothiazide 25 mg or HYZAAR 100/25. For further blood pressure reduction other antihypertensives should be added (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Losartan Potassium, Reduction in the Risk of Stroke).
HYZAAR may be administered with other antihypertensive agents.
HYZAAR may be administered with or without food.
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Aphena Pharma Solutions – Tennessee, Llc
Hyzaar | Aphena Pharma Solutions - Tennessee, Llc
HypertensionDosing must be individualized. The usual starting dose of losartan is 50 mg once daily, with 25 mg recommended for patients with intravascular volume depletion (e.g., patients treated with diuretics) (see WARNINGS, Hypotension — Volume-Depleted Patients) and patients with a history of hepatic impairment (see WARNINGS, Impaired Hepatic Function). Losartan can be administered once or twice daily at total daily doses of 25 to 100 mg. If the antihypertensive effect measured at trough using once-a-day dosing is inadequate, a twice-a-day regimen at the same total daily dose or an increase in dose may give a more satisfactory response.
Hydrochlorothiazide is effective in doses of 12.5 to 50 mg once daily and can be given at doses of 12.5 to 25 mg as HYZAAR.
To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed 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 a mixture of dose-dependent (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter. Therapy with any combination of losartan and hydrochlorothiazide will be associated 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 with losartan monotherapy (see above) or hydrochlorothiazide alone may be switched to HYZAAR 50/12.5 (losartan 50 mg/hydrochlorothiazide 12.5 mg) once daily. If blood pressure remains uncontrolled after about 3 weeks of therapy, the dose may be increased to two tablets of HYZAAR 50/12.5 once daily or one tablet of HYZAAR 100/25 (losartan 100 mg/hydrochlorothiazide 25 mg) once daily. A patient whose blood pressure is not adequately controlled with losartan 100 mg monotherapy (see above) may be switched to HYZAAR 100/12.5 once daily. If blood pressure remains uncontrolled after about 3 weeks of therapy, the dose may be increased to two tablets of HYZAAR 50/12.5 once daily or one tablet of HYZAAR 100/25 (losartan 100 mg/hydrochlorothiazide 25 mg) once daily.
A patient whose blood pressure is inadequately controlled by 25 mg once daily of hydrochlorothiazide, or is controlled but who experiences hypokalemia with this regimen, may be switched to HYZAAR 50/12.5 (losartan 50 mg/hydrochlorothiazide 12.5 mg) once daily, reducing the dose of hydrochlorothiazide without reducing the overall expected antihypertensive response. The clinical response to HYZAAR 50/12.5 should be subsequently evaluated, and if blood pressure remains uncontrolled after about 3 weeks of therapy, the dose may be increased to two tablets of HYZAAR 50/12.5 once daily or one tablet of HYZAAR 100/25 (losartan 100 mg/hydrochlorothiazide 25 mg) once daily.
The usual dose of HYZAAR is one tablet of HYZAAR 50/12.5 once daily. More than two tablets of HYZAAR 50/12.5 once daily or more than one tablet of HYZAAR 100/25 once daily is not recommended. The maximal antihypertensive effect is attained about 3 weeks after initiation of therapy.
Use in Patients with Renal Impairment: The usual regimens of therapy with HYZAAR may be followed as long as the patient's creatinine clearance is greater than 30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so HYZAAR is not recommended.
Patients with Hepatic Impairment: HYZAAR is 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 HypertensionThe starting dose of HYZAAR for initial treatment of severe hypertension is one tablet of HYZAAR 50/12.5 once daily (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects). For patients who do not respond adequately to HYZAAR 50/12.5 after 2 to 4 weeks of therapy, the dosage may be increased to one tablet of HYZAAR 100/25 once daily. The maximum dose is one tablet of HYZAAR 100/25 once daily. HYZAAR is not recommended as initial therapy in patients with hepatic impairment (see WARNINGS, Impaired Hepatic Function) because the appropriate 25 mg starting dose of losartan cannot be given. It is also not recommended for use as initial therapy in patients with intravascular volume depletion (e.g., patients treated with diuretics, see WARNINGS, Hypotension — Volume-Depleted Patients).
Hypertensive Patients with Left Ventricular HypertrophyTreatment should be initiated with COZAAR 50 mg once daily. Hydrochlorothiazide 12.5 mg should be added or HYZAAR 50/12.5 substituted if the blood pressure reduction is inadequate. If additional blood pressure reduction is needed, COZAAR 100 mg and hydrochlorothiazide 12.5 mg or HYZAAR 100/12.5 may be substituted, followed by COZAAR 100 mg and hydrochlorothiazide 25 mg or HYZAAR 100/25. For further blood pressure reduction other antihypertensives should be added (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Losartan Potassium, Reduction in the Risk of Stroke).
HYZAAR may be administered with other antihypertensive agents.
HYZAAR may be administered with or without food.
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Bryant Ranch Prepack
Hyzaar | Bryant Ranch Prepack
HypertensionDosing must be individualized. The usual starting dose of losartan is 50 mg once daily, with 25 mg recommended for patients with intravascular volume depletion (e.g., patients treated with diuretics) (see WARNINGS, Hypotension — Volume-Depleted Patients) and patients with a history of hepatic impairment (see WARNINGS, Impaired Hepatic Function). Losartan can be administered once or twice daily at total daily doses of 25 to 100 mg. If the antihypertensive effect measured at trough using once-a-day dosing is inadequate, a twice-a-day regimen at the same total daily dose or an increase in dose may give a more satisfactory response.
Hydrochlorothiazide is effective in doses of 12.5 to 50 mg once daily and can be given at doses of 12.5 to 25 mg as HYZAAR.
To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed 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 a mixture of dose-dependent (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter. Therapy with any combination of losartan and hydrochlorothiazide will be associated 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 with losartan monotherapy (see above) or hydrochlorothiazide alone may be switched to HYZAAR 50/12.5 (losartan 50 mg/hydrochlorothiazide 12.5 mg) once daily. If blood pressure remains uncontrolled after about 3 weeks of therapy, the dose may be increased to two tablets of HYZAAR 50/12.5 once daily or one tablet of HYZAAR 100/25 (losartan 100 mg/hydrochlorothiazide 25 mg) once daily. A patient whose blood pressure is not adequately controlled with losartan 100 mg monotherapy (see above) may be switched to HYZAAR 100/12.5 once daily. If blood pressure remains uncontrolled after about 3 weeks of therapy, the dose may be increased to two tablets of HYZAAR 50/12.5 once daily or one tablet of HYZAAR 100/25 (losartan 100 mg/hydrochlorothiazide 25 mg) once daily.
A patient whose blood pressure is inadequately controlled by 25 mg once daily of hydrochlorothiazide, or is controlled but who experiences hypokalemia with this regimen, may be switched to HYZAAR 50/12.5 (losartan 50 mg/hydrochlorothiazide 12.5 mg) once daily, reducing the dose of hydrochlorothiazide without reducing the overall expected antihypertensive response. The clinical response to HYZAAR 50/12.5 should be subsequently evaluated, and if blood pressure remains uncontrolled after about 3 weeks of therapy, the dose may be increased to two tablets of HYZAAR 50/12.5 once daily or one tablet of HYZAAR 100/25 (losartan 100 mg/hydrochlorothiazide 25 mg) once daily.
The usual dose of HYZAAR is one tablet of HYZAAR 50/12.5 once daily. More than two tablets of HYZAAR 50/12.5 once daily or more than one tablet of HYZAAR 100/25 once daily is not recommended. The maximal antihypertensive effect is attained about 3 weeks after initiation of therapy.
Use in Patients with Renal Impairment: The usual regimens of therapy with HYZAAR may be followed as long as the patient's creatinine clearance is >30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so HYZAAR is not recommended.
Patients with Hepatic Impairment: HYZAAR is 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 HypertensionThe starting dose of HYZAAR for initial treatment of severe hypertension is one tablet of HYZAAR 50/12.5 once daily (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects). For patients who do not respond adequately to HYZAAR 50/12.5 after 2 to 4 weeks of therapy, the dosage may be increased to one tablet of HYZAAR 100/25 once daily. The maximum dose is one tablet of HYZAAR 100/25 once daily. HYZAAR is not recommended as initial therapy in patients with hepatic impairment (see WARNINGS, Impaired Hepatic Function) because the appropriate 25 mg starting dose of losartan cannot be given. It is also not recommended for use as initial therapy in patients with intravascular volume depletion (e.g., patients treated with diuretics, see WARNINGS, Hypotension — Volume-Depleted Patients).
Hypertensive Patients with Left Ventricular HypertrophyTreatment should be initiated with COZAAR 50 mg once daily. Hydrochlorothiazide 12.5 mg should be added or HYZAAR 50/12.5 substituted if the blood pressure reduction is inadequate. If additional blood pressure reduction is needed, COZAAR 100 mg and hydrochlorothiazide 12.5 mg or HYZAAR 100/12.5 may be substituted, followed by COZAAR 100 mg and hydrochlorothiazide 25 mg or HYZAAR 100/25. For further blood pressure reduction other antihypertensives should be added (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Losartan Potassium, Reduction in the Risk of Stroke).
HYZAAR may be administered with other antihypertensive agents.
HYZAAR may be administered with or without food.
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Merck Sharp & Dohme Corp.
Hyzaar | Merck Sharp & Dohme Corp.
HypertensionDosing must be individualized. The usual starting dose of losartan is 50 mg once daily, with 25 mg recommended for patients with intravascular volume depletion (e.g., patients treated with diuretics) (see WARNINGS, Hypotension — Volume-Depleted Patients) and patients with a history of hepatic impairment (see WARNINGS, Impaired Hepatic Function). Losartan can be administered once or twice daily at total daily doses of 25 to 100 mg. If the antihypertensive effect measured at trough using once-a-day dosing is inadequate, a twice-a-day regimen at the same total daily dose or an increase in dose may give a more satisfactory response.
Hydrochlorothiazide is effective in doses of 12.5 to 50 mg once daily and can be given at doses of 12.5 to 25 mg as HYZAAR.
To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed 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 a mixture of dose-dependent (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter. Therapy with any combination of losartan and hydrochlorothiazide will be associated 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 with losartan monotherapy (see above) or hydrochlorothiazide alone may be switched to HYZAAR 50/12.5 (losartan 50 mg/hydrochlorothiazide 12.5 mg) once daily. If blood pressure remains uncontrolled after about 3 weeks of therapy, the dose may be increased to two tablets of HYZAAR 50/12.5 once daily or one tablet of HYZAAR 100/25 (losartan 100 mg/hydrochlorothiazide 25 mg) once daily. A patient whose blood pressure is not adequately controlled with losartan 100 mg monotherapy (see above) may be switched to HYZAAR 100/12.5 once daily. If blood pressure remains uncontrolled after about 3 weeks of therapy, the dose may be increased to two tablets of HYZAAR 50/12.5 once daily or one tablet of HYZAAR 100/25 (losartan 100 mg/hydrochlorothiazide 25 mg) once daily.
A patient whose blood pressure is inadequately controlled by 25 mg once daily of hydrochlorothiazide, or is controlled but who experiences hypokalemia with this regimen, may be switched to HYZAAR 50/12.5 (losartan 50 mg/hydrochlorothiazide 12.5 mg) once daily, reducing the dose of hydrochlorothiazide without reducing the overall expected antihypertensive response. The clinical response to HYZAAR 50/12.5 should be subsequently evaluated, and if blood pressure remains uncontrolled after about 3 weeks of therapy, the dose may be increased to two tablets of HYZAAR 50/12.5 once daily or one tablet of HYZAAR 100/25 (losartan 100 mg/hydrochlorothiazide 25 mg) once daily.
The usual dose of HYZAAR is one tablet of HYZAAR 50/12.5 once daily. More than two tablets of HYZAAR 50/12.5 once daily or more than one tablet of HYZAAR 100/25 once daily is not recommended. The maximal antihypertensive effect is attained about 3 weeks after initiation of therapy.
Use in Patients with Renal Impairment: The usual regimens of therapy with HYZAAR may be followed as long as the patient's creatinine clearance is greater than 30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so HYZAAR is not recommended.
Patients with Hepatic Impairment: HYZAAR is 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 HypertensionThe starting dose of HYZAAR for initial treatment of severe hypertension is one tablet of HYZAAR 50/12.5 once daily (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects). For patients who do not respond adequately to HYZAAR 50/12.5 after 2 to 4 weeks of therapy, the dosage may be increased to one tablet of HYZAAR 100/25 once daily. The maximum dose is one tablet of HYZAAR 100/25 once daily. HYZAAR is not recommended as initial therapy in patients with hepatic impairment (see WARNINGS, Impaired Hepatic Function) because the appropriate 25 mg starting dose of losartan cannot be given. It is also not recommended for use as initial therapy in patients with intravascular volume depletion (e.g., patients treated with diuretics, see WARNINGS, Hypotension — Volume-Depleted Patients).
Hypertensive Patients with Left Ventricular HypertrophyTreatment should be initiated with COZAAR 50 mg once daily. Hydrochlorothiazide 12.5 mg should be added or HYZAAR 50/12.5 substituted if the blood pressure reduction is inadequate. If additional blood pressure reduction is needed, COZAAR 100 mg and hydrochlorothiazide 12.5 mg or HYZAAR 100/12.5 may be substituted, followed by COZAAR 100 mg and hydrochlorothiazide 25 mg or HYZAAR 100/25. For further blood pressure reduction other antihypertensives should be added (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Losartan Potassium, Reduction in the Risk of Stroke).
HYZAAR may be administered with other antihypertensive agents.
HYZAAR may be administered with or without food.
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