Dosage & Administration
The recommended starting dose of BENICAR HCT is 40/12.5 mg once daily in patients whose blood pressure is not adequately controlled with olmesartan monotherapy. Dose can be titrated up to 40 /25 mg if necessary.
The recommended starting dose of BENICAR HCT is 20/12.5 mg once daily in patients whose blood pressure is not adequately controlled with HCT monotherapy or who experience dose-limiting adverse reactions with hydrochlorothiazide. Dose can be titrated up to 40 /25 mg if necessary.
Patients titrated to the individual components (olmesartan and hydrochlorothiazide) may instead receive the corresponding dose of BENICAR HCT.
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Benicar HCT Prescribing Information
- When pregnancy is detected, discontinue BENICAR HCT as soon as possible[see5.1FetalToxicity
Pregnancy Category D
Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue BENICAR HCT as soon as possible
[seeUse in Specific Populations (8.1)].Thiazides cross the placental barrier and appear in cord blood. Adverse reactions include fetal or neonatal jaundice and thrombocytopenia
[seeUse in Specific Populations (8.1)].]. - Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus[see5.1FetalToxicity
Pregnancy Category D
Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue BENICAR HCT as soon as possible
[seeUse in Specific Populations (8.1)].Thiazides cross the placental barrier and appear in cord blood. Adverse reactions include fetal or neonatal jaundice and thrombocytopenia
[seeUse in Specific Populations (8.1)].].
BENICAR HCT (olmesartan medoxomil and hydrochlorothiazide) is indicated for the treatment of hypertension, to lower blood pressure. BENICAR HCT is not indicated for the initial therapy of hypertension
The recommended starting dose of BENICAR HCT is 40/12.5 mg once daily in patients whose blood pressure is not adequately controlled with olmesartan monotherapy. Dose can be titrated up to 40 /25 mg if necessary.
The recommended starting dose of BENICAR HCT is 20/12.5 mg once daily in patients whose blood pressure is not adequately controlled with HCT monotherapy or who experience dose-limiting adverse reactions with hydrochlorothiazide. Dose can be titrated up to 40 /25 mg if necessary.
Patients titrated to the individual components (olmesartan and hydrochlorothiazide) may instead receive the corresponding dose of BENICAR HCT.
- Recommended starting dose in patients not adequately controlled with olmesartan monotherapy, 40/12.5 mg
- Recommended starting dose in patients not adequately controlled with hydrochlorothiazide monotherapy, 20/12.5 mg
- Adjust dose after 2 to 4 weeks, as needed, to a maximum of 40 mg / 25 mg olmesartan / hydrochlorothiazide
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with BENICAR HCT.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
BENICAR HCT may be used alone, or in combination with other antihypertensive drugs.
The recommended starting dose of BENICAR HCT is 40/12.5 mg once daily in patients whose blood pressure is not adequately controlled with olmesartan monotherapy. Dose can be titrated up to 40 /25 mg if necessary.
The recommended starting dose of BENICAR HCT is 20/12.5 mg once daily in patients whose blood pressure is not adequately controlled with HCT monotherapy or who experience dose-limiting adverse reactions with hydrochlorothiazide. Dose can be titrated up to 40 /25 mg if necessary.
Patients titrated to the individual components (olmesartan and hydrochlorothiazide) may instead receive the corresponding dose of BENICAR HCT.
BENICAR HCT (olmesartan / hydrochlorothiazide) is supplied as film-coated, non-scored tablets:
- 20 mg/12.5 mg reddish-yellow, circular, debossed with Sankyo on one side and C22 on the other side
- 40 mg/12.5 mg reddish-yellow, oval, debossed with Sankyo on one side and C23 on the other side
- 40 mg/25 mg pink, oval, debossed with Sankyo on one side and C25 on the other side
- Nursing mothers: Avoid use while nursing; discontinue either nursing or the drug ().8.3Nursing Mothers
It is not known whether olmesartan is excreted in human milk, but olmesartan is secreted at low concentration in the milk of lactating rats. Thiazides appear in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue BENICAR HCT, taking into account the importance of the drug to the mother.
BENICAR HCT is contraindicated:
- In patients with hypersensitivity to any component of BENICAR HCT[see Adverse Reactions (6.1Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Olmesartan medoxomilandhydrochlorothiazideThe concomitant use of olmesartan medoxomil and hydrochlorothiazide was evaluated for safety in 1243 hypertensive patients. Treatment with olmesartan medoxomil and hydrochlorothiazide was well tolerated, with an incidence of adverse events similar to that of placebo. Adverse reactions were generally mild, transient and not dependent on the dose of olmesartan medoxomil and hydrochlorothiazide.
The rate of withdrawals for adverse events in all trials of hypertensive patients was 2.0% (25/1243) on olmesartan medoxomil plus hydrochlorothiazide and 2.0% (7/342) on placebo.
In a placebo-controlled, factorial clinical trial of olmesartan medoxomil (2.5 mg to 40 mg) and hydrochlorothiazide (12.5 mg to 25 mg), the following adverse reactions reported in Table 1 occurred in >2% of patients, and more often on the olmesartan medoxomil and hydrochlorothiazide combination than on placebo.
Table 1: Adverse Reactions in a Factorial Trial of Patients with Hypertension Olmesartan/HCTZ
(N=247)
(%)Olmesartan
(N=125)
(%)HCTZ
(N=88)
(%)Placebo
(N=42)
(%)Nausea 3 2 1 0 Hyperuricemia 4 0 2 2 Dizziness 9 1 8 2 Upper Respiratory Infection 7 6 7 0 Other adverse reactions that have been reported with an incidence of greater than 1.0%, whether or not attributed to treatment, in the more than 1200 hypertensive patients treated with olmesartan medoxomil and hydrochlorothiazide in controlled or open-label trials are listed below.
Body as a Whole:chest pain, back pain, peripheral edemaCentral and Peripheral Nervous System:vertigoGastrointestinal:abdominal pain, dyspepsia, gastroenteritis, diarrheaLiver and Biliary System:SGOT increased, GGT increased, ALT increasedMetabolic and Nutritional:creatine phosphokinase increasedMusculoskeletal:arthritis, arthralgia, myalgiaRespiratory System:coughingSkin and Appendages Disorders:rashUrinary System:hematuriaFacial edema was reported in 2/1243 patients receiving olmesartan medoxomil and hydrochlorothiazide. Angioedema has been reported with angiotensin II receptor antagonists, including BENICAR HCT.
HydrochlorothiazideOther adverse reactions that have been reported with hydrochlorothiazide are listed below:
Body as a Whole:weaknessDigestive:pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, cramping, gastric irritationHematologic:aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopeniaHypersensitivity:purpura, photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), fever, respiratory distress including pneumonitis and pulmonary edema, anaphylactic reactionsMetabolic:glycosuria, hyperuricemiaMusculoskeletal:muscle spasmNervous System/Psychiatric:restlessnessRenal:renal dysfunction, interstitial nephritisSkin:erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysisSpecial Senses:transient blurred vision, xanthopsiaClinical Laboratory Test FindingsCreatinine/bloodureanitrogen (BUN):Minor elevations in creatinine and BUN occurred in 1.7% and 2.5% respectively, of patients taking BENICAR HCT and 0% and 0% respectively, given placebo in controlled clinical trials.,6.2Post-marketing ExperienceThe following adverse reactions have been identified during post-approval use of BENICAR HCT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:
Body as a Whole:AstheniaGastrointestinal:VomitingMetabolic:HyperkalemiaMusculoskeletal:RhabdomyolysisSkin and Appendages:Alopecia, pruritusData from one controlled trial and an epidemiologic study have suggested that high-dose olmesartan may increase cardiovascular (CV) risk in diabetic patients, but the overall data are not conclusive. The randomized, placebo-controlled, double-blind ROADMAP trial (Randomized Olmesartan And Diabetes MicroAlbuminuria Prevention trial, n=4447) examined the use of olmesartan, 40 mg daily, vs. placebo in patients with type 2 diabetes mellitus, normoalbuminuria, and at least one additional risk factor for CV disease.
The trial met its primary endpoint, delayed onset of microalbuminuria, but olmesartan had no beneficial effect on decline in glomerular filtration rate (GFR). There was a finding of increased CV mortality (adjudicated sudden cardiac death, fatal myocardial infarction, fatal stroke, revascularization death) in the olmesartan group compared to the placebo group (15 olmesartan vs. 3 placebo, HR 4.9, 95% confidence interval [CI], 1.4, 17), but the risk of non-fatal myocardial infarction was lower with olmesartan (HR 0.64, 95% CI 0.35, 1.18).
The epidemiologic study included patients 65 years and older with overall exposure of > 300,000 patient-years. In the sub-group of diabetic patients receiving high-dose olmesartan (40 mg/d) for > 6 months, there appeared to be an increased risk of death (HR 2.0, 95% CI 1.1, 3.8) compared to similar patients taking other angiotensin receptor blockers. In contrast, high-dose olmesartan use in non-diabetic patients appeared to be associated with a decreased risk of death (HR 0.46, 95% CI 0.24, 0.86) compared to similar patients taking other angiotensin receptor blockers. No differences were observed between the groups receiving lower doses of olmesartan compared to other angiotensin blockers or those receiving therapy for < 6 months.
Overall, these data raise a concern of a possible increased CV risk associated with the use of high-dose olmesartan in diabetic patients. There are, however, concerns with the credibility of the finding of increased CV risk, notably the observation in the large epidemiologic study for a survival benefit in non-diabetics of a magnitude similar to the adverse finding in diabetics.
Non-melanoma Skin CancerHydrochlorothiazide is associated with an increased risk of non-melanoma skin cancer. In a study conducted in the Sentinel System, increased risk was predominantly for squamous cell carcinoma (SCC) and in white patients taking large cumulative doses. The increased risk for SCC in the overall population was approximately 1 additional case per 16,000 patients per year, and for white patients taking a cumulative dose of ≥50,000mg the risk increase was approximately 1 additional SCC case for every 6,700 patients per year.
)] - In patients with anuria[see5.3ImpairedRenal Function
Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system and by diuretics. Patients whose renal function may depend in part on the activity of the renin-angiotensin system (
e.g., patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute renal failure on BENICAR HCT. Monitor renal function periodically in these patients. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on BENICAR HCT[seeDrug Interactions (7)].and6.1Clinical Trials ExperienceBecause clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Olmesartan medoxomilandhydrochlorothiazideThe concomitant use of olmesartan medoxomil and hydrochlorothiazide was evaluated for safety in 1243 hypertensive patients. Treatment with olmesartan medoxomil and hydrochlorothiazide was well tolerated, with an incidence of adverse events similar to that of placebo. Adverse reactions were generally mild, transient and not dependent on the dose of olmesartan medoxomil and hydrochlorothiazide.
The rate of withdrawals for adverse events in all trials of hypertensive patients was 2.0% (25/1243) on olmesartan medoxomil plus hydrochlorothiazide and 2.0% (7/342) on placebo.
In a placebo-controlled, factorial clinical trial of olmesartan medoxomil (2.5 mg to 40 mg) and hydrochlorothiazide (12.5 mg to 25 mg), the following adverse reactions reported in Table 1 occurred in >2% of patients, and more often on the olmesartan medoxomil and hydrochlorothiazide combination than on placebo.
Table 1: Adverse Reactions in a Factorial Trial of Patients with Hypertension Olmesartan/HCTZ
(N=247)
(%)Olmesartan
(N=125)
(%)HCTZ
(N=88)
(%)Placebo
(N=42)
(%)Nausea 3 2 1 0 Hyperuricemia 4 0 2 2 Dizziness 9 1 8 2 Upper Respiratory Infection 7 6 7 0 Other adverse reactions that have been reported with an incidence of greater than 1.0%, whether or not attributed to treatment, in the more than 1200 hypertensive patients treated with olmesartan medoxomil and hydrochlorothiazide in controlled or open-label trials are listed below.
Body as a Whole:chest pain, back pain, peripheral edemaCentral and Peripheral Nervous System:vertigoGastrointestinal:abdominal pain, dyspepsia, gastroenteritis, diarrheaLiver and Biliary System:SGOT increased, GGT increased, ALT increasedMetabolic and Nutritional:creatine phosphokinase increasedMusculoskeletal:arthritis, arthralgia, myalgiaRespiratory System:coughingSkin and Appendages Disorders:rashUrinary System:hematuriaFacial edema was reported in 2/1243 patients receiving olmesartan medoxomil and hydrochlorothiazide. Angioedema has been reported with angiotensin II receptor antagonists, including BENICAR HCT.
HydrochlorothiazideOther adverse reactions that have been reported with hydrochlorothiazide are listed below:
Body as a Whole:weaknessDigestive:pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, cramping, gastric irritationHematologic:aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopeniaHypersensitivity:purpura, photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), fever, respiratory distress including pneumonitis and pulmonary edema, anaphylactic reactionsMetabolic:glycosuria, hyperuricemiaMusculoskeletal:muscle spasmNervous System/Psychiatric:restlessnessRenal:renal dysfunction, interstitial nephritisSkin:erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysisSpecial Senses:transient blurred vision, xanthopsiaClinical Laboratory Test FindingsCreatinine/bloodureanitrogen (BUN):Minor elevations in creatinine and BUN occurred in 1.7% and 2.5% respectively, of patients taking BENICAR HCT and 0% and 0% respectively, given placebo in controlled clinical trials.] - For coadministration with aliskiren in patients with diabetes [see7.4Dual Blockade of the Renin Angiotensin System
Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on BENICAR HCT and other agents that affect the RAS.
Do not co-administer aliskiren with BENICAR HCT in patients with diabetes
[seeContraindications (4)].Avoid use of aliskiren with BENICAR HCT in patients with renal impairment (GFR <60 ml/min).].