Benicar Hct
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Questions & Answers
Side Effects & Adverse Reactions
Fetal/Neonatal Morbidity and Mortality
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 of patients who were taking angiotensin converting enzyme inhibitors. When pregnancy is detected, BENICAR HCT® 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 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 BENICAR HCT® as soon as possible.
Rarely (probably less often than once in every thousand pregnancies), no alternative to a drug acting on the renin-angiotensin system 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, BENICAR HCT® should be discontinued unless it is considered life-saving for the mother. Contraction stress testing (CST), a nonstress 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 is no clinical experience with the use of BENICAR HCT® in pregnant women. No teratogenic effects were observed when 1.6:1 combinations of olmesartan medoxomil and hydrochlorothiazide were administered to pregnant mice at oral doses up to 1625 mg/kg/day (122 times the maximum recommended human dose [MRHD] on a mg/m2 basis) or pregnant rats at oral doses up to 1625 mg/kg/day (280 times the MRHD on a mg/m2 basis). In rats, however, fetal body weights at 1625 mg/kg/day (a toxic, sometimes lethal dose in the dams) were significantly lower than control. The no observed effect dose for developmental toxicity in rats, 162.5 mg/kg/day, is about 28 times, on a mg/m2 basis, the MRHD of BENICAR HCT® (40 mg olmesartan medoxomil /25 mg hydrochlorothiazide/day).
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.
Hypotension in Volume- or Salt-Depleted PatientsIn patients with an activated renin-angiotensin system, such as volume- or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with BENICAR HCT®, as with any angiotensin receptor blocker. Treatment should start under close medical supervision. If hypotension does occur, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline (See DOSAGE AND ADMINISTRATION). When electrolyte and fluid imbalances have been corrected, therapy usually can be continued without difficulty. A transient hypotensive response is not a contraindication to further treatment.
Hydrochlorothiazide Hepatic ImpairmentThiazides 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 ReactionHypersensitivity 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.
Systemic Lupus ErythematosusThiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.
Lithium InteractionLithium 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
BENICAR HCT® is indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).
History
There is currently no drug history available for this drug.
Other Information
BENICAR HCT® (olmesartan medoxomil-hydrochlorothiazide) is a combination of an angiotensin II receptor antagonist (AT1 subtype), olmesartan medoxomil, and a thiazide diuretic, hydrochlorothiazide (HCTZ).
Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract.
Olmesartan medoxomil is 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate.
Its empirical formula is C29H30N6O6 and its structural formula is:
Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.6. It is practically insoluble in water and sparingly soluble in methanol.
Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiadiazine-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 297.7. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution.
BENICAR HCT® is available for oral administration in tablets containing 20 mg or 40 mg of olmesartan medoxomil combined with 12.5 mg of hydrochlorothiazide, or 40 mg of olmesartan medoxomil combined with 25 mg of hydrochlorothiazide. Inactive ingredients include: hydroxypropylcellulose, hypromellose, lactose, low-substituted hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, red iron oxide, talc, titanium dioxide and yellow iron oxide.
Sources
Benicar Hct Manufacturers
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Physicians Total Care, Inc.
![Benicar Hct (Olmesartan Medoxomil And Hydrochlorothiazide) Tablet, Film Coated [Physicians Total Care, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Benicar Hct | Physicians Total Care, Inc.
The usual recommended starting dose of BENICAR® (olmesartan medoxomil) is 20 mg once daily when used as monotherapy in patients who are not volume-contracted. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose may be increased to 40 mg. Doses above 40 mg do not appear to have greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily. No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40mL/min) or with moderate to marked hepatic dysfunction (see CLINICAL PHARMACOLOGY, Special Populations). For patients with possible depletion of intravascular volume (e.g., patients treated with diuretics, particularly those with impaired renal function), BENICAR® should be initiated under close medical supervision and consideration should be given to use of a lower starting dose (see WARNINGS, Hypotension in Volume- or Salt-Depleted Patients).
Hydrochlorothiazide is effective in doses between 12.5 mg and 50 mg once daily.
The side effects (see WARNINGS) of BENICAR® are generally rare and independent of dose; those of hydrochlorothiazide are most typically dose-dependent (primarily hypokalemia). Some dose-independent phenomena (e.g., pancreatitis) do occur with hydrochlorothiazide. Therapy with any combination of olmesartan medoxomil and hydrochlorothiazide will be associated with both sets of dose-independent side effects.
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.
Replacement TherapyBENICAR HCT® (olmesartan medoxomil-hydrochlorothiazide) may be substituted for its titrated components.
Dose Titration by Clinical EffectBENICAR HCT® is available in strengths of 20 mg/12.5 mg, 40 mg/12.5 mg and 40 mg/25 mg. A patient whose blood pressure is inadequately controlled by BENICAR® or hydrochlorothiazide alone may be switched to once daily BENICAR HCT® (olmesartan medoxomil-hydrochlorothiazide).
Dosing should be individualized. Depending on the blood pressure response, the dose may be titrated at intervals of 2-4 weeks.
If blood pressure is not controlled by BENICAR® alone, hydrochlorothiazide may be added starting with a dose of 12.5 mg and later titrated to 25 mg once daily.
If a patient is taking hydrochlorothiazide, BENICAR® may be added starting with a dose of 20 mg once daily and titrated to 40 mg, for inadequate blood pressure control. If large doses of hydrochlorothiazide have been used as monotherapy and volume depletion or hyponatremia is present, caution should be used when adding BENICAR® or switching to BENICAR HCT® as marked decreases in blood pressure may occur (see WARNINGS, Hypotension in Volume- or Salt-Depleted Patients). Consideration should be given to reducing the dose of hydrochlorothiazide to 12.5 mg before adding BENICAR®. The antihypertensive effect of BENICAR HCT® is related to the dose of both components over the range of 10 mg/12.5 mg to 40 mg/25 mg (see CLINICAL PHARMACOLOGY, Clinical Trials). The dose of BENICAR HCT® is one tablet once daily. More than one tablet daily is not recommended.
BENICAR HCT® may be administered with other antihypertensive agents.
Patients with Renal ImpairmentThe usual regimens of therapy with BENICAR HCT® may be followed provided the patient’s creatinine clearance is >30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so BENICAR HCT® is not recommended.
Patients with Hepatic ImpairmentNo dosage adjustment is necessary with hepatic impairment (see CLINICAL PHARMACOLOGY, Special Populations).
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Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
Benicar Hct | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
The usual recommended starting dose of BENICAR® (olmesartan medoxomil) is 20 mg once daily when used as monotherapy in patients who are not volume-contracted. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose may be increased to 40 mg. Doses above 40 mg do not appear to have greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily. No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40mL/min) or with moderate to marked hepatic dysfunction (see CLINICAL PHARMACOLOGY, Special Populations). For patients with possible depletion of intravascular volume (e.g., patients treated with diuretics, particularly those with impaired renal function), BENICAR® should be initiated under close medical supervision and consideration should be given to use of a lower starting dose (see WARNINGS, Hypotension in Volume- or Salt-Depleted Patients).
Hydrochlorothiazide is effective in doses between 12.5 mg and 50 mg once daily.
The side effects (see WARNINGS) of BENICAR® are generally rare and independent of dose; those of hydrochlorothiazide are most typically dose-dependent (primarily hypokalemia). Some dose-independent phenomena (e.g., pancreatitis) do occur with hydrochlorothiazide. Therapy with any combination of olmesartan medoxomil and hydrochlorothiazide will be associated with both sets of dose-independent side effects.
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.
Replacement TherapyBENICAR HCT® (olmesartan medoxomil-hydrochlorothiazide) may be substituted for its titrated components.
Dose Titration by Clinical EffectBENICAR HCT® is available in strengths of 20 mg/12.5 mg, 40 mg/12.5 mg and 40 mg/25 mg. A patient whose blood pressure is inadequately controlled by BENICAR® or hydrochlorothiazide alone may be switched to once daily BENICAR HCT® (olmesartan medoxomil-hydrochlorothiazide).
Dosing should be individualized. Depending on the blood pressure response, the dose may be titrated at intervals of 2-4 weeks.
If blood pressure is not controlled by BENICAR® alone, hydrochlorothiazide may be added starting with a dose of 12.5 mg and later titrated to 25 mg once daily.
If a patient is taking hydrochlorothiazide, BENICAR® may be added starting with a dose of 20 mg once daily and titrated to 40 mg, for inadequate blood pressure control. If large doses of hydrochlorothiazide have been used as monotherapy and volume depletion or hyponatremia is present, caution should be used when adding BENICAR® or switching to BENICAR HCT® as marked decreases in blood pressure may occur (see WARNINGS, Hypotension in Volume- or Salt-Depleted Patients). Consideration should be given to reducing the dose of hydrochlorothiazide to 12.5 mg before adding BENICAR®. The antihypertensive effect of BENICAR HCT® is related to the dose of both components over the range of 10 mg/12.5 mg to 40 mg/25 mg (see CLINICAL PHARMACOLOGY, Clinical Trials). The dose of BENICAR HCT® is one tablet once daily. More than one tablet daily is not recommended.
BENICAR HCT® may be administered with other antihypertensive agents.
Patients with Renal ImpairmentThe usual regimens of therapy with BENICAR HCT® may be followed provided the patient’s creatinine clearance is >30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so BENICAR HCT® is not recommended.
Patients with Hepatic ImpairmentNo dosage adjustment is necessary with hepatic impairment (see CLINICAL PHARMACOLOGY, Special Populations).
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Pd-rx Pharmaceuticals, Inc.
Benicar Hct | Pd-rx Pharmaceuticals, Inc.
The usual recommended starting dose of BENICAR® (olmesartan medoxomil) is 20 mg once daily when used as monotherapy in patients who are not volume-contracted. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose may be increased to 40 mg. Doses above 40 mg do not appear to have greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily. No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40mL/min) or with moderate to marked hepatic dysfunction (see CLINICAL PHARMACOLOGY, Special Populations). For patients with possible depletion of intravascular volume (e.g., patients treated with diuretics, particularly those with impaired renal function), BENICAR® should be initiated under close medical supervision and consideration should be given to use of a lower starting dose (see WARNINGS, Hypotension in Volume- or Salt-Depleted Patients).
Hydrochlorothiazide is effective in doses between 12.5 mg and 50 mg once daily.
The side effects (see WARNINGS) of BENICAR® are generally rare and independent of dose; those of hydrochlorothiazide are most typically dose-dependent (primarily hypokalemia). Some dose-independent phenomena (e.g., pancreatitis) do occur with hydrochlorothiazide. Therapy with any combination of olmesartan medoxomil and hydrochlorothiazide will be associated with both sets of dose-independent side effects.
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.
Replacement TherapyBENICAR HCT® (olmesartan medoxomil-hydrochlorothiazide) may be substituted for its titrated components.
Dose Titration by Clinical EffectBENICAR HCT® is available in strengths of 20 mg/12.5 mg, 40 mg/12.5 mg and 40 mg/25 mg. A patient whose blood pressure is inadequately controlled by BENICAR® or hydrochlorothiazide alone may be switched to once daily BENICAR HCT® (olmesartan medoxomil-hydrochlorothiazide).
Dosing should be individualized. Depending on the blood pressure response, the dose may be titrated at intervals of 2-4 weeks.
If blood pressure is not controlled by BENICAR® alone, hydrochlorothiazide may be added starting with a dose of 12.5 mg and later titrated to 25 mg once daily.
If a patient is taking hydrochlorothiazide, BENICAR® may be added starting with a dose of 20 mg once daily and titrated to 40 mg, for inadequate blood pressure control. If large doses of hydrochlorothiazide have been used as monotherapy and volume depletion or hyponatremia is present, caution should be used when adding BENICAR® or switching to BENICAR HCT® as marked decreases in blood pressure may occur (see WARNINGS, Hypotension in Volume- or Salt-Depleted Patients). Consideration should be given to reducing the dose of hydrochlorothiazide to 12.5 mg before adding BENICAR®. The antihypertensive effect of BENICAR HCT® is related to the dose of both components over the range of 10 mg/12.5 mg to 40 mg/25 mg (see CLINICAL PHARMACOLOGY, Clinical Trials). The dose of BENICAR HCT® is one tablet once daily. More than one tablet daily is not recommended.
BENICAR HCT® may be administered with other antihypertensive agents.
Patients with Renal ImpairmentThe usual regimens of therapy with BENICAR HCT® may be followed provided the patient’s creatinine clearance is >30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so BENICAR HCT® is not recommended.
Patients with Hepatic ImpairmentNo dosage adjustment is necessary with hepatic impairment (see CLINICAL PHARMACOLOGY, Special Populations).
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Cardinal Health
Benicar Hct | Cardinal Health
The usual recommended starting dose of BENICAR® (olmesartan medoxomil) is 20 mg once daily when used as monotherapy in patients who are not volume-contracted. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose may be increased to 40 mg. Doses above 40 mg do not appear to have greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily. No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40mL/min) or with moderate to marked hepatic dysfunction (see CLINICAL PHARMACOLOGY, Special Populations). For patients with possible depletion of intravascular volume (e.g., patients treated with diuretics, particularly those with impaired renal function), BENICAR® should be initiated under close medical supervision and consideration should be given to use of a lower starting dose (see WARNINGS, Hypotension in Volume- or Salt-Depleted Patients).
Hydrochlorothiazide is effective in doses between 12.5 mg and 50 mg once daily.
The side effects (see WARNINGS) of BENICAR® are generally rare and independent of dose; those of hydrochlorothiazide are most typically dose-dependent (primarily hypokalemia). Some dose-independent phenomena (e.g., pancreatitis) do occur with hydrochlorothiazide. Therapy with any combination of olmesartan medoxomil and hydrochlorothiazide will be associated with both sets of dose-independent side effects.
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.
Replacement TherapyBENICAR HCT® (olmesartan medoxomil-hydrochlorothiazide) may be substituted for its titrated components.
Dose Titration by Clinical EffectBENICAR HCT® is available in strengths of 20 mg/12.5 mg, 40 mg/12.5 mg and 40 mg/25 mg. A patient whose blood pressure is inadequately controlled by BENICAR® or hydrochlorothiazide alone may be switched to once daily BENICAR HCT® (olmesartan medoxomil-hydrochlorothiazide).
Dosing should be individualized. Depending on the blood pressure response, the dose may be titrated at intervals of 2-4 weeks.
If blood pressure is not controlled by BENICAR® alone, hydrochlorothiazide may be added starting with a dose of 12.5 mg and later titrated to 25 mg once daily.
If a patient is taking hydrochlorothiazide, BENICAR® may be added starting with a dose of 20 mg once daily and titrated to 40 mg, for inadequate blood pressure control. If large doses of hydrochlorothiazide have been used as monotherapy and volume depletion or hyponatremia is present, caution should be used when adding BENICAR® or switching to BENICAR HCT® as marked decreases in blood pressure may occur (see WARNINGS, Hypotension in Volume- or Salt-Depleted Patients). Consideration should be given to reducing the dose of hydrochlorothiazide to 12.5 mg before adding BENICAR®. The antihypertensive effect of BENICAR HCT® is related to the dose of both components over the range of 10 mg/12.5 mg to 40 mg/25 mg (see CLINICAL PHARMACOLOGY, Clinical Trials). The dose of BENICAR HCT® is one tablet once daily. More than one tablet daily is not recommended.
BENICAR HCT® may be administered with other antihypertensive agents.
Patients with Renal ImpairmentThe usual regimens of therapy with BENICAR HCT® may be followed provided the patient’s creatinine clearance is >30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so BENICAR HCT® is not recommended.
Patients with Hepatic ImpairmentNo dosage adjustment is necessary with hepatic impairment (see CLINICAL PHARMACOLOGY, Special Populations).
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Cardinal Health
Benicar Hct | Cardinal Health
The usual recommended starting dose of BENICAR® (olmesartan medoxomil) is 20 mg once daily when used as monotherapy in patients who are not volume-contracted. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose may be increased to 40 mg. Doses above 40 mg do not appear to have greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily. No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40mL/min) or with moderate to marked hepatic dysfunction (see CLINICAL PHARMACOLOGY, Special Populations). For patients with possible depletion of intravascular volume (e.g., patients treated with diuretics, particularly those with impaired renal function), BENICAR® should be initiated under close medical supervision and consideration should be given to use of a lower starting dose (see WARNINGS, Hypotension in Volume- or Salt-Depleted Patients).
Hydrochlorothiazide is effective in doses between 12.5 mg and 50 mg once daily.
The side effects (see WARNINGS) of BENICAR® are generally rare and independent of dose; those of hydrochlorothiazide are most typically dose-dependent (primarily hypokalemia). Some dose-independent phenomena (e.g., pancreatitis) do occur with hydrochlorothiazide. Therapy with any combination of olmesartan medoxomil and hydrochlorothiazide will be associated with both sets of dose-independent side effects.
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.
Replacement TherapyBENICAR HCT® (olmesartan medoxomil-hydrochlorothiazide) may be substituted for its titrated components.
Dose Titration by Clinical EffectBENICAR HCT® is available in strengths of 20 mg/12.5 mg, 40 mg/12.5 mg and 40 mg/25 mg. A patient whose blood pressure is inadequately controlled by BENICAR® or hydrochlorothiazide alone may be switched to once daily BENICAR HCT® (olmesartan medoxomil-hydrochlorothiazide).
Dosing should be individualized. Depending on the blood pressure response, the dose may be titrated at intervals of 2-4 weeks.
If blood pressure is not controlled by BENICAR® alone, hydrochlorothiazide may be added starting with a dose of 12.5 mg and later titrated to 25 mg once daily.
If a patient is taking hydrochlorothiazide, BENICAR® may be added starting with a dose of 20 mg once daily and titrated to 40 mg, for inadequate blood pressure control. If large doses of hydrochlorothiazide have been used as monotherapy and volume depletion or hyponatremia is present, caution should be used when adding BENICAR® or switching to BENICAR HCT® as marked decreases in blood pressure may occur (see WARNINGS, Hypotension in Volume- or Salt-Depleted Patients). Consideration should be given to reducing the dose of hydrochlorothiazide to 12.5 mg before adding BENICAR®. The antihypertensive effect of BENICAR HCT® is related to the dose of both components over the range of 10 mg/12.5 mg to 40 mg/25 mg (see CLINICAL PHARMACOLOGY, Clinical Trials). The dose of BENICAR HCT® is one tablet once daily. More than one tablet daily is not recommended.
BENICAR HCT® may be administered with other antihypertensive agents.
Patients with Renal ImpairmentThe usual regimens of therapy with BENICAR HCT® may be followed provided the patient’s creatinine clearance is >30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so BENICAR HCT® is not recommended.
Patients with Hepatic ImpairmentNo dosage adjustment is necessary with hepatic impairment (see CLINICAL PHARMACOLOGY, Special Populations).
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Daiichi Sankyo, Inc.
Benicar Hct | Daiichi Sankyo, Inc.
The usual recommended starting dose of BENICAR® (olmesartan medoxomil) is 20 mg once daily when used as monotherapy in patients who are not volume-contracted. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose may be increased to 40 mg. Doses above 40 mg do not appear to have greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily. No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40mL/min) or with moderate to marked hepatic dysfunction (see CLINICAL PHARMACOLOGY, Special Populations). For patients with possible depletion of intravascular volume (e.g., patients treated with diuretics, particularly those with impaired renal function), BENICAR® should be initiated under close medical supervision and consideration should be given to use of a lower starting dose (see WARNINGS, Hypotension in Volume- or Salt-Depleted Patients).
Hydrochlorothiazide is effective in doses between 12.5 mg and 50 mg once daily.
The side effects (see WARNINGS) of BENICAR® are generally rare and independent of dose; those of hydrochlorothiazide are most typically dose-dependent (primarily hypokalemia). Some dose-independent phenomena (e.g., pancreatitis) do occur with hydrochlorothiazide. Therapy with any combination of olmesartan medoxomil and hydrochlorothiazide will be associated with both sets of dose-independent side effects.
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.
Replacement TherapyBENICAR HCT® (olmesartan medoxomil-hydrochlorothiazide) may be substituted for its titrated components.
Dose Titration by Clinical EffectBENICAR HCT® is available in strengths of 20 mg/12.5 mg, 40 mg/12.5 mg and 40 mg/25 mg. A patient whose blood pressure is inadequately controlled by BENICAR® or hydrochlorothiazide alone may be switched to once daily BENICAR HCT® (olmesartan medoxomil-hydrochlorothiazide).
Dosing should be individualized. Depending on the blood pressure response, the dose may be titrated at intervals of 2-4 weeks.
If blood pressure is not controlled by BENICAR® alone, hydrochlorothiazide may be added starting with a dose of 12.5 mg and later titrated to 25 mg once daily.
If a patient is taking hydrochlorothiazide, BENICAR® may be added starting with a dose of 20 mg once daily and titrated to 40 mg, for inadequate blood pressure control. If large doses of hydrochlorothiazide have been used as monotherapy and volume depletion or hyponatremia is present, caution should be used when adding BENICAR® or switching to BENICAR HCT® as marked decreases in blood pressure may occur (see WARNINGS, Hypotension in Volume- or Salt-Depleted Patients). Consideration should be given to reducing the dose of hydrochlorothiazide to 12.5 mg before adding BENICAR®. The antihypertensive effect of BENICAR HCT® is related to the dose of both components over the range of 10 mg/12.5 mg to 40 mg/25 mg (see CLINICAL PHARMACOLOGY, Clinical Trials). The dose of BENICAR HCT® is one tablet once daily. More than one tablet daily is not recommended.
BENICAR HCT® may be administered with other antihypertensive agents.
Patients with Renal ImpairmentThe usual regimens of therapy with BENICAR HCT® may be followed provided the patient’s creatinine clearance is >30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so BENICAR HCT® is not recommended.
Patients with Hepatic ImpairmentNo dosage adjustment is necessary with hepatic impairment (see CLINICAL PHARMACOLOGY, Special Populations).
![Benicar Hct (Olmesartan Medoxomil And Hydrochlorothiazide) Tablet, Film Coated [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d3e52a81-5c91-4d3d-9aa3-b7e078c24257&name=Benicar4025Daiichi.jpg)
![Benicar Hct (Olmesartan Medoxomil-hydrochlorothiazide) Tablet, Film Coated [Pd-rx Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=91d45442-4232-4111-9dd8-0d787085af6d&name=55289443.jpg)
![Benicar Hct (Olmesartan Medoxomil And Hydrochlorothiazide) Tablet, Film Coated [Cardinal Health]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9b91af80-14ff-4ece-8647-4265b7fa6240&name=image-01.jpg)
![Benicar Hct (Olmesartan Medoxomil And Hydrochlorothiazide) Tablet, Film Coated [Cardinal Health]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=14c650fb-7244-4f94-9dbc-a878120732b4&name=image-01.jpg)
![Benicar Hct (Olmesartan Medoxomil-hydrochlorothiazide) Tablet, Film Coated [Daiichi Sankyo, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6bbc032a-3cc4-4b1d-8124-1784214a2821&name=benicarhcttablets-figure-3.jpg)
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