Olmesartan hctz 40-25

What is Olmesartan / HCTZ?

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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  • Aliskiren
  • Dofetilide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

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Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Aminolevulinic Acid
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  • Oxyphenbutazone
  • Parecoxib
  • Phenylbutazone
  • Piketoprofen
  • Piroxicam
  • Proglumetacin
  • Propionic Acid
  • Propyphenazone
  • Proquazone
  • Rofecoxib
  • Salicylic Acid
  • Salsalate
  • Sodium Salicylate
  • Sulindac
  • Tenoxicam
  • Tiaprofenic Acid
  • Tolfenamic Acid
  • Tolmetin
  • Topiramate
  • Valdecoxib

Evaluation of antihypertensive therapy with the combination of olmesartan medoxomil and hydrochlorothiazide*:

Abstract

Background:

Most patients with hypertension require more than one agent to control blood pressure (BP). The purpose of this study was to assess the efficacy and safety of the angiotensin II receptor blocker olmesartan medoxomil in combination with hydrochlorothiazide (HCTZ).

Methods:

This was a randomized, double-blind, factorial design study. After a placebo run-in period, eligible patients (n = 502) with a baseline mean seated diastolic blood pressure (SeDBP) of 100 to 115 mm Hg were randomized to one of 12 groups: placebo, olmesartan medoxomil monotherapy (10, 20, or 40 mg/day, HCTZ monotherapy (12.5 or 25 mg/day), or one of six groups of olmesartan medoxomil/HCTZ combination therapy. The primary endpoint was the change in mean trough SeDBP from baseline at week 8. Statistical analyses were conducted to determine whether at least one combination produced a larger reduction in SeDBP at week 8 than the individual corresponding component doses, but did not compare BP reductions with different combination doses.

Results:

Olmesartan medoxomil plus HCTZ produced greater reductions in both SeDBP and seated systolic blood pressure (SeSBP) at week 8 than did monotherapy with either component. All olmesartan medoxomil/HCTZ combinations significantly reduced SeDBP and SeSBP compared with placebo in a dose-dependent manner. Reductions from baseline in mean trough SeSBP/SeDBP were 3.3/8.2 mm Hg, 20.1/16.4 mm Hg, and 26.8/21.9 mm Hg with placebo, olmesartan medoxomil/HCTZ 20/12.5 mg, and olmesartan medoxomil/HCTZ 40/25 mg, respectively. All treatments were well tolerated.

Conclusions:

Olmesartan medoxomil/HCTZ combination therapy produced BP reductions of up to 26.8/21.9 mm Hg and was well tolerated.

With only up to 34% of Americans with hypertension achieving a goal blood pressure (BP) of <140/90 mm Hg, more aggressive and multifaceted modes of therapy are required.1–3 Major studies have shown that most patients with hypertension need two or more antihypertensive drugs to achieve BP control.4–7 Substantial evidence supports the efficacy of angiotensin II blockade using angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs) to lower BP and to protect the heart and kidneys.8–16 Based on these data, the American Diabetes Association recommends the use of ACE inhibitors as first-line therapy for hypertensive patients with type 1 diabetic renal disease, and ARB for those with type 2 diabetes and renal disease.17

Placebo-controlled clinical trials have shown that the BP-lowering efficacy of olmesartan medoxomil monotherapy, a long-acting, once-daily ARB, at its starting dosage (20 mg/day) and maximal dosage (40 mg/day) compares favorably with that of other antihypertensive agents such as atenolol, captopril, felodipine, and amlodipine besylate, as well as other ARBs, in clinical efficacy trials.18–22

Hydrochlorothiazide (HCTZ) is a thiazide diuretic that is commonly used in combination with other antihypertensive agents, including ARBs.23,24 Hydrochlorothiazide is known to activate the renin-angiotensin-aldosterone system (RAAS), providing a strong rationale for the combination of an ARB with HCTZ.25–29 The objective of this factorial design study was to assess the efficacy and safety of olmesartan medoxomil in combination with HCTZ at various dosages compared with monotherapy with each drug and with placebo.

Methods

Study population

This was a randomized, double-blind, factorial design study conducted at 48 investigational sites in the United States. Eligibility criteria for randomization included the following: average SeDBP ≥100 and ≤115 mm Hg at both week 3 and week 4 placebo run-in visits, with at least 4 days between the two visits; a difference of ≤7 mm Hg between the two SeDBP measurements; and at least 80% compliance with the study drug regimen during the placebo run-in period. Patients with serious medical disorders, and those with a body weight ≥50% of ideal body weight for height and frame size (calculated according to the 1983 Metropolitan Life Insurance table), were excluded. The protocol and one amendment were reviewed and approved by either a central or local institutional review board at each of the investigational sites. The study was conducted in accordance with institutional review board committee and informed consent regulations of 21 Code of Federal Regulations parts 50 and 56, and principles of the Declaration of Helsinki and its amendments. Written informed consent was obtained from each study participant at the screening visit.

Study design

After an initial single-blind, 4-week, placebo run-in period, eligible patients (n = 502) were randomized to one of 12 treatment groups for 8 weeks of double-blind treatment with placebo, olmesartan medoxomil monotherapy (at doses of 10, 20, or 40 mg/day), HCTZ monotherapy (at doses of 12.5 or 25 mg/day), or olmesartan medoxomil/HCTZ combination therapy (including all possible combinations of doses used in the monotherapy groups). The factorial design was used to assess the efficacy and safety of olmesartan medoxomil in combination with HCTZ across a range of doses for each therapy. Patients were evaluated for therapeutic efficacy and safety on day 1 and at weeks 1, 4, and 8. Patients were instructed to take their study medication once daily in the morning with breakfast. On the day of a scheduled visit, they were instructed not to take their dose of study medication until after BP measurements were recorded and all tests were performed.

Body weight was measured at screening and at day 1. Blood pressure and heart rate were measured before the daily dose of study medication was taken on day 1 and at weeks 1, 4, and 8 (all BP measurements were to be obtained before 12 noon on the day of the scheduled study visit, and within 20 to 28 h after the previous dose of study medication). Duplicate readings were taken of seated and standing cuff BP at trough; the average of the two seated BP and the two standing BP measurements were used as the seated and standing readings, respectively, for the visit.

Safety was monitored by assessing the occurrence of adverse events (AEs) at every visit and by performing clinical laboratory tests (ie, hematology, blood chemistry, and urinalysis). All patients who were randomly assigned to study drug treatment and received at least one dose of randomized study drug were included in the safety analysis.

Efficacy variables

The primary efficacy variable was the change from baseline in mean trough SeDBP at week 8, using the last observation carried forward (LOCF) for patients who did not complete the protocol. Secondary efficacy variables included the change from baseline in mean seated systolic blood pressure (SeSBP) at week 8 and in mean standing diastolic blood pressure (StDBP) and systolic blood pressure (StSBP) at week 8, and responder rates, defined as an SeDBP <90 mm Hg or a ≥10 mm Hg reduction in SeDBP at week 8.

Statistical analysis

The sample size was calculated for a two-sided significance level of .05, based on the primary efficacy variable (change from baseline in mean SeDBP at week 8), to achieve 90% power for the AVE procedure proposed by Hung and colleagues.30

Baseline and demographic characteristics were presented for each treatment group. Categorical demographic variables were summarized as percentages and compared between treatments using a χ2 test. Continuous variables including baseline vital signs, age, height, weight, and duration of hypertension history were compared using one-way analysis of variance with treatment as a factor.

Criteria for antihypertensive efficacy included the following: 1) determination of whether at least one combination dose produced a larger reduction in SeDBP at week 8 than the individual corresponding component doses; 2) evaluation of which combinations were more effective in reducing BP compared with the respective placebo treatments; and 3) determination of the responder rate, defined as SeDBP <90 mm Hg or a decrease in SeDBP from baseline of ≥10 mm Hg. Changes in BP and heart rate from baseline to week 8 were compared within each dose combination group by paired t test.

The hypothesis to be tested was that none of the dose combinations were more effective than the associated component doses. The first step of the efficacy evaluation was the AVE test,30 a test procedure based on the average of the maximum differences in response (change from baseline in SeDBP at week 8) of each combination and their corresponding components. This test was used to determine whether at least one combination existed that was more efficacious than its corresponding components. Once this was confirmed, a quadratic dose-response model was fitted to calculate the predicted dose response. A 95% CI was calculated for the treatment effect of each of the 12 groups to identify which combination was better than its individual components. Based on the fitted model, a response surface graph was generated to facilitate visual inspection of the treatment effects. Statistical analyses comparing the BP reductions obtained with different combination doses were not performed.

Safety and tolerability were assessed through the recording of clinical AEs and evaluation of clinical laboratory parameters. Summary statistics, patient listings, or both were provided for each treatment group for all safety parameters. Reasons for early withdrawal from the study were tabulated for each treatment group.

Results

A total of 863 patients were screened; of these, 750 were found eligible for enrollment, 502 were randomized, and 451 completed the study. Of the 502 patients who were randomly assigned to one of 12 treatment groups (35 to 47 patients per group), 55.6% were male and 74.1% were of white ethnicity. Mean age was 53 years, and mean baseline SeDBP and SeSBP in the 12 treatment groups ranged from 102.6 to 104.4 mm Hg and from 151.9 to 156.6 mm Hg, respectively. There were no statistically significant differences in baseline characteristics among the 12 treatment groups (Tables 1 and 2).

Table 1

Baseline patient demographics (all randomized)

HCTZ = hydrochlorothiazide

Table 1

Baseline patient demographics (all randomized)

HCTZ = hydrochlorothiazide

Table 2

Mean SeSBP and SeDBP at baseline and at week 8 LOCF (intent-to-treat population)

HCTZ = hydrochlorothiazide; LOCF = last observation carried forward; SeDBP = seated diastolic blood pressure; SeSBP = seated systolic blood pressure.

Table 2

Mean SeSBP and SeDBP at baseline and at week 8 LOCF (intent-to-treat population)

HCTZ = hydrochlorothiazide; LOCF = last observation carried forward; SeDBP = seated diastolic blood pressure; SeSBP = seated systolic blood pressure.

Changes in trough seated and standing blood pressure

The raw mean SeSBP and SeDBP reductions from baseline for olmesartan medoxomil combined with HCTZ ranged from −20.5/−16.0 mm Hg to −28.3/−22.3 mm Hg. The AVE test was used to confirm the existence of at least one combination that was superior to its components. The P value corresponding to the AVE test for the week 8 SeDBP (P < .01) was smaller than the .05 critical value. Thus, at least one dose combination was more effective than its components in lowering SeDBP from baseline to week 8. Dose-related reductions in SeDBP at week 8, fitted by the quadratic model, were observed with increasing doses of olmesartan medoxomil monotherapy, HCTZ monotherapy, and olmesartan medoxomil/HCTZ combination therapy. All six olmesartan medoxomil/HCTZ combinations significantly reduced SeDBP compared with placebo (there was no overlap in the 95% CI computed from the quadratic model for each of the olmesartan medoxomil/HCTZ combination therapies and the 95% CI for placebo, ie, 0 mg olmesartan medoxomil/0 mg HCTZ; Fig. 1 and Table 2). The greatest reduction in SeDBP (∼22 mm Hg) occurred with the combination of olmesartan medoxomil/HCTZ 40/25 mg/day. Evidence of efficacy for all active treatments was observed as early as week 1 and increased throughout the course of the study.

Fig 1. Fig 1.

The AVE test confirmed that at least one combination treatment produced significantly larger reductions in SeSBP than either component from baseline to week 8 (P < .01). All six olmesartan medoxomil/HCTZ combinations resulted in statistically significant reductions in SeSBP, compared with placebo, with a dose-response related to both drug components (Fig. 2 and Table 2). Model fitted mean reductions in StDBP and StSBP followed patterns similar to those observed for seated BP (Table 3).

Table 3

Change from baseline (model fitted) in mean trough StSBP/StDBP (mm Hg) at week 8 LOCF

Abbreviations as in Table 2.

Table 3

Change from baseline (model fitted) in mean trough StSBP/StDBP (mm Hg) at week 8 LOCF

Abbreviations as in Table 2.

Fig 2. Fig 2.

Responder and control rates

The proportion of patients with BP response (trough SeDBP <90 mm Hg, or a reduction from baseline ≥10 mm Hg) for each of the 12 treatment groups at week 8 LOCF is shown in Table 4. The highest responder rate was observed in the group assigned to olmesartan medoxomil/HCTZ 40/25 mg/day. The proportion of patients with diastolic control (trough SeDBP <90 mm Hg) and systolic control (trough SeSBP <140 mm Hg) at week 8 LOCF is also shown in Table 4. Although statistical analyses comparing the responder and control rates of different combinations were not performed, the highest rates were observed in the olmesartan medoxomil/HCTZ 40/25 mg/day group.

Table 4

Responder and control† rates for 12 groups at Week 8 LOCF

*

Trough seated diastolic blood pressure <90 mm Hg, or a reduction from baseline ≥10 mm Hg.

Diastolic control = trough seated diastolic blood pressure <90 mm Hg; systolic control = trough seated systolic blood pressure <140 mm Hg.

Abbreviations as in Table 2.

Table 4

Responder and control† rates for 12 groups at Week 8 LOCF

*

Trough seated diastolic blood pressure <90 mm Hg, or a reduction from baseline ≥10 mm Hg.

Diastolic control = trough seated diastolic blood pressure <90 mm Hg; systolic control = trough seated systolic blood pressure <140 mm Hg.

Abbreviations as in Table 2.

Safety

All dosages of olmesartan medoxomil monotherapy and combination therapy with HCTZ were safe and well tolerated, with no significant or clinically relevant differences in the incidence of treatment-emergent AEs noted by dosage. The percentage of patients who experienced at least one treatment-emergent AE was 57.1% in the placebo group, 51.1% in the HCTZ monotherapy groups, 49.6% in the olmesartan medoxomil monotherapy groups, and 57.1% in the olmesartan medoxomil/HCTZ groups. Most AEs were judged to be remotely or definitely not drug related, and mild or moderate in intensity. Only one patient, who received placebo, experienced a serious AE (unstable angina).

The overall discontinuation rate due to AEs of patients who received one or both of the active study drugs was low (2.0%), and there was no apparent association between discontinuation due to an AE and dosage of any study medication, used alone or in combination. Of the three most common AEs, the incidence of dizziness tended to increase with increasing dosage of HCTZ and olmesartan medoxomil/HCTZ combination. None of the episodes of dizziness were judged by the investigator to be severe. Although upper respiratory tract infection was among the most frequently reported AE, it was not dose related and did not result in any discontinuations of therapy.

Although mean values for renal function tests (blood urea nitrogen and serum creatinine) remained stable from baseline to the end of treatment, minor increases occurred more frequently in olmesartan medoxomil/HCTZ combination–treated patients than in those who received placebo or olmesartan medoxomil monotherapy. Because of the small number of patients in each treatment group, however, it is difficult to determine whether the increases in BUN or creatinine were due to study treatment. Increased BUN occurred in four subjects (two patients in each of the two highest olmesartan medoxomil dose groups in combination with HCTZ). Of these events, study investigators judged one to be possibly related to the study drug, one to be remotely related, and two as definitely not related. Only one patient (40 mg olmesartan medoxomil/25 mg HCTZ group) had a marked BUN abnormality (57 mg/dL), but this event was resolved with increased water intake and was judged by the investigator to be not clinically significant and definitely not related to the study drug. A similar pattern was observed for serum creatinine. Markedly abnormal creatinine levels occurred in two patients. One subject in the 20 mg olmesartan medoxomil/25 HCTZ group had a serum creatinine level of 2.1 mg/dL, which was considered clinically significant by the investigator. The other subject, in the 40 mg olmesartan medoxomil/25 mg HCTZ group, had a serum creatinine level of 2.2 mg/dL, which was judged to be not clinically significant. Uric acid levels increased in both the HCTZ 12.5 and 25 mg groups from baseline to week 8, but mean values remained below the upper level of normal (7.5 mg/dL).

No adverse trends in liver enzyme levels were noted for any olmesartan medoxomil/HCTZ combination group, and no patient in an olmesartan medoxomil/HCTZ combination group discontinued the study because of elevation in aspartate aminotransferase or alanine aminotransferase. Electrolyte (sodium, potassium, bicarbonate, chloride, calcium, and phosphorus) mean values generally did not change during the study, although there was a slight decrease in the mean values of potassium in the olmesartan medoxomil/HCTZ combination groups. No cases of marked hypokalemia were observed, although a markedly elevated serum potassium of 5.9 mEq/L occurred in one patient in the 40 mg olmesartan medoxomil/25 mg HCTZ group, which was considered not to be clinically significant by the investigator.

Discussion

This study demonstrates that combination therapy with olmesartan medoxomil and HCTZ provides clinically meaningful antihypertensive effects. The greater antihypertensive efficacy of the olmesartan medoxomil/HCTZ combinations compared with that of the individual drugs was evident in a dose-dependent manner. All doses of olmesartan medoxomil/HCTZ combination therapy significantly decreased SeDBP and SeSBP compared with placebo. Evidence of efficacy for all active treatments was observed after 1 week of treatment, with further increases in efficacy reported throughout the course of the study. After 8 weeks of therapy, the proportion of patients with a BP response increased in a dose-dependent manner with olmesartan medoxomil alone, with HCTZ alone, and with combination therapy.

Olmesartan medoxomil, both alone and in combination with HCTZ, was safe and well tolerated. The incidences of AEs, serious AEs, and discontinuations related to AEs were comparable among treatment groups and similar to the rates observed with placebo. The safety profile for olmesartan medoxomil/HCTZ was qualitatively similar to that reported for other ARB/HCTZ combinations.29,31 As with the safety and tolerability profile of olmesartan medoxomil monotherapy, there was no dose-response relationship between the overall rates of AEs, serious AEs, and discontinuations because of AEs and increasing doses of olmesartan medoxomil/HCTZ combination therapy. The progressively declining incidence of headache observed with increasing dosages of combination therapy in this analysis is consistent with previous reports, which note that headache may be a feature of uncontrolled hypertension, and that safe and well tolerated antihypertensive therapies may result in a reduced incidence of headache.32 Changes in laboratory values (BUN, creatinine, and uric acid) were not of clinical significance and were similar to the changes noted with other ARB/HCTZ combinations.29,31

Olmesartan medoxomil/HCTZ combination therapy is especially promising for patients in need of multiple agents to achieve their BP goal. Most hypertensive patients require combination therapy to attain the recommended goal BPs of <140/90 mm Hg for the general hypertensive population and <130/80 mm Hg for high-risk hypertensive patients such as those with diabetes or renal disease.3–7,33 Furthermore, the current view of effective management of hypertension relies on combining drugs with different but complementary mechanisms of action to obtain greater BP reductions.3,34,35 The antihypertensive response to ARBs is potentiated in the presence of a negative salt balance.36 By promoting salt elimination and stimulating the RAAS via intrarenal mechanisms, thiazide diuretics make BP more dependent on angiotensin II, thereby enhancing the antihypertensive efficacy of ARBs.36,37

In this study, the combination of the RAAS blocker olmesartan medoxomil with the diuretic HCTZ resulted in BP reductions of up to 26.8/21.9 mm Hg. Combinations of drugs with complementary mechanisms have the added benefit of allowing the use of lower doses of component drugs, thereby minimizing the risk of AEs and potentially enhancing patient compliance.25–28,34,35,38

In conclusion, the combination of olmesartan medoxomil/HCTZ is a safe, well tolerated, and effective option for antihypertensive therapy, demonstrating greater BP reduction than monotherapy with either of its components. Antihypertensive efficacy of the combination of olmesartan medoxomil and HCTZ improved with increasing doses.

Appendix

List of principal investigators

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Hansson L , Zanchetti A , Carruthers SG , Dahlöf B , Elmfeldt D , Julius S , Menard J , Rahn KH , Wedel H , Westerling S , for the HOT Study Group: Effects of intensive blood-pressure lowering and low-dose aspirin in patients with hypertension: principal results of the Hypertension Optimal Treatment (HOT) randomised trial. Lancet 1998;351:1755–1762. 6. Kusek JW , Lee JY , Smith DE , Milligan S , Faulkner M , Cornell CE , Kopple JD , Greene PG : Effect of blood pressure control and antihypertensive drug regimen on quality of life: the African American Study of Kidney Disease and Hypertension (AASK) Pilot Study. Control Clin Trials 1996;17(Suppl 4):40S–46S. 7. ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group: Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). 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N Engl J Med 2001;345:1667–1675. 16. Dahlöf B , Devereux RB , Kjeldsen SE , Julius S , Beevers G , Faire U , Fyhrquist F , Ibsen H , Kristiansson K , Lederballe-Pedersen O , Lindholm LH , Nieminen MS , Omvik P , Oparil S , Wedel H , for the LIFE Study Group Cardiovascular morbidity and mortality in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): a randomised trial against atenolol. Lancet 2002;359:995–1003. 17. American Diabetes Association: Diabetic nephropathy. Diabetes Care 2002;25(Suppl 1):S85–S89. 18. Neutel JM : Clinical studies of CS-866, the newest angiotensin II receptor antagonist. Am J Cardiol 2001;87(Suppl):37C–43C. 19. Stumpe KO , Ludwig M : Antihypertensive efficacy of olmesartan compared with other antihypertensive drugs. J Hum Hypertens 2002;16(Suppl 2):S24–S28. 20. Van Mieghem W : A multi-centre, double-blind, efficacy, tolerability and safety study of the oral angiotensin II-antagonist olmesartan medoxomil versus atenolol in patients with mild to moderate essential hypertension (Abstract). J Hypertens 2001;19(Suppl 2):S152–S153. 21. Chrysant SG , Marbury T , Robinson TS : Antihypertensive efficacy and safety of olmesartan medoxomil compared with amlodipine for mild-to-moderate hypertension. J Hum Hypertens 2003;17:425–432. 22. Oparil S , Williams D , Chrysant SG , Marbury TC , Neutel J : Comparative efficacy of olmesartan, losartan, valsartan, and irbesartan in the control of essential hypertension. J Clin Hypertens 2001;3:283–291, 318. 23. Schrijver G , Weinberger MH : Hydrochlorothiazide and spironolactone in hypertension. Clin Pharmacol Ther 1979;25:33–42. 24. Pickkers P , Hughes AD , Russel FG , Thien T , Smits P : Thiazide-induced vasodilation in humans is mediated by potassium channel activation. Hypertension 1998;32:1071–1076. 25. Chrysant SG , for the Lisinopril-Hydrochlorothiazide Group: Antihypertensive effectiveness of low-dose lisinopril-hydrochlorothiazide combination: a large multicenter study. Arch Intern Med 1994;154:737–743. 26. Chrysant SG , Fagan T , Glazer R , Kriegman A : Effects of benazepril and hydrochlorothiazide, given alone and in low- and high-dose combinations, on blood pressure in patients with hypertension. Arch Fam Med 1996;5:17–24. 27. Chrysant SG , Fox AA , Stimpel M : Comparison of moexipril, a new ACE inhibitor, to verapamil-SR as add-on therapy to low dose hydrochlorothiazide in hypertensive patients. Am J Hypertens 1995;8:418–421. 28. Chrysant SG : Perindopril/hydrochlorothiazide dose combinations for the treatment of hypertension: a multicenter study. J Clin Pharmacol 1997;37:47–52. 29. Chrysant SG : Fixed low-dose drug combination for the treatment of hypertension. Arch Fam Med 1998;7:370–376. 30. Hung HM , Chi GY , Lipicky RJ : Testing for the existence of a desirable dose combination. Biometrics 1993;49:85–94. 31. Kochar M , Guthrie R , Triscari J , Kassler-Taub K , Reeves RA : Matrix study of irbesartan with hydrochlorothiazide in mild-to-moderate hypertension. Am J Hypertens 1999;12:797–805. 32. Hansson L , Smith DH , Reeves R , Lapuerta P : Headache in mild-to-moderate hypertension and its reduction by irbesartan therapy. Arch Intern Med 2000;160:1654–1658. 33. Estacio RO , Schrier RW : Antihypertensive therapy in type 2 diabetes: implications of the Appropriate Blood pressure Control in Diabetes (ABCD) trial. Am J Cardiol 1998;82(Suppl 9B):9R–14R. 34. Neutel JM , Smith DH , Weber MA : Low-dose combination therapy: an important first-line treatment in the management of hypertension. Am J Hypertens 2001;14:286–292. 35. Chrysant SG , Womboldt DG , Feliciano N , Zheng H : Long-term efficacy, safety, and tolerability of valsartan and hydrochlorothiazide in patients with essential hypertension. Curr Ther Res 1998;59:762–772. 36. Corvol P , Plouin PF : Angiotensin II receptor blockers: current status and future prospects. Drugs 2002;62:53–64. 37. Burnier M : Angiotensin II type 1 receptor blockers. Circulation 2001;103:904–912. 38. Moser M , Black HR : The role of combination therapy in the treatment of hypertension. Am J Hypertens 1998;11:73S–78S.

Author notes

* This study was supported by a grant from Sankyo Pharma Inc., Parsippany, NJ. © 2004 by the American Journal of Hypertension, Ltd. American Journal of Hypertension, Ltd.

Olmesartan / HCTZ Side Effects

Check your blood pressure regularly while you are taking this medicine. Ask your doctor or health care professional what your blood pressure should be and when you should contact him or her. When you check your blood pressure, write down the measurements to show your doctor or health care professional. If you are taking this medicine for a long time, you must visit your health care professional for regular checks on your progress. Make sure you schedule appointments on a regular basis.

You must not get dehydrated. Ask your doctor or health care professional how much fluid you need to drink a day. Check with him or her if you get an attack of severe diarrhea, nausea and vomiting, or if you sweat a lot. The loss of too much body fluid can make it dangerous for you to take this medicine.

Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child, particularly in the second or third trimester. Talk to your health care professional or pharmacist for more information.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this drug affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol can make you more drowsy and dizzy. Avoid alcoholic drinks.

This medicine may affect your blood sugar level. If you have diabetes, check with your doctor or health care professional before changing the dose of your diabetic medicine.

Avoid salt substitutes unless you are told otherwise by your doctor or health care professional.

Do not treat yourself for coughs, colds, or pain while you are taking this medicine without asking your doctor or health care professional for advice. Some ingredients may increase your blood pressure.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

Olmesartan and Hydrochlorothiazide

Generic Name: Olmesartan and Hydrochlorothiazide (ole me SAR tan & hye droe klor oh THYE a zide)
Brand Name: Benicar HCT

Medically reviewed by Drugs.com. Last updated on Sep 25, 2019.

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Interactions
  • More

Warning

  • Do not take if you are pregnant. Use during pregnancy may cause birth defects or loss of the unborn baby. If you get pregnant or plan on getting pregnant while taking olmesartan and hydrochlorothiazide, call your doctor right away.

Uses of Olmesartan and Hydrochlorothiazide:

  • It is used to treat high blood pressure.
  • It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Olmesartan and Hydrochlorothiazide?

  • If you have an allergy to olmesartan, hydrochlorothiazide, or any other part of olmesartan and hydrochlorothiazide.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you are taking dofetilide.
  • If you are not able to pass urine.
  • If you are taking a drug that has aliskiren in it and you also have diabetes or kidney problems.
  • If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with olmesartan and hydrochlorothiazide.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take olmesartan and hydrochlorothiazide with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Olmesartan and Hydrochlorothiazide?

  • Tell all of your health care providers that you take olmesartan and hydrochlorothiazide. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how olmesartan and hydrochlorothiazide affects you.
  • To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
  • If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
  • Check your blood pressure as you have been told.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take olmesartan and hydrochlorothiazide.
  • If you are taking a salt substitute that has potassium in it, a potassium-sparing diuretic, or a potassium product, talk with your doctor.
  • If you are on a low-salt or salt-free diet, talk with your doctor.
  • Talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
  • Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
  • If you are taking lithium, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with olmesartan and hydrochlorothiazide.
  • If you also take colesevelam, take it at least 4 hours after you take olmesartan and hydrochlorothiazide.
  • If you take cholestyramine or colestipol, talk with your pharmacist about how to take them with olmesartan and hydrochlorothiazide.
  • Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
  • Tell your doctor if you have too much sweat, fluid loss, throwing up, or loose stools. This may lead to low blood pressure.
  • This medicine may make you sunburn more easily. Use care if you will be in the sun. Tell your doctor if you sunburn easily while taking this drug.
  • Watch for gout attacks.
  • If you have lupus, olmesartan and hydrochlorothiazide can make your lupus active or get worse. Tell your doctor right away if you get any new or worse signs.
  • This medicine may not work as well in black patients. Talk with the doctor.

How is this medicine (Olmesartan and Hydrochlorothiazide) best taken?

Use olmesartan and hydrochlorothiazide as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food.
  • To gain the most benefit, do not miss doses.
  • Keep taking olmesartan and hydrochlorothiazide as you have been told by your doctor or other health care provider, even if you feel well.
  • This medicine may cause you to pass urine more often. To keep from having sleep problems, try to take before 6 pm.
  • Take olmesartan and hydrochlorothiazide at the same time of day.
  • Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or very bad upset stomach or throwing up.
  • Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
  • Chest pain.
  • Swelling in the arms or legs.
  • Diarrhea that will not go away.
  • Severe diarrhea.
  • A big weight loss.
  • Dark urine or yellow skin or eyes.
  • Fever or chills.
  • Sore throat.
  • Feeling very tired or weak.
  • Any unexplained bruising or bleeding.
  • Restlessness.
  • Any skin change.
  • This medicine can cause certain eye problems. If left untreated, this can lead to lasting eyesight loss. If eye problems happen, signs like change in eyesight or eye pain most often happen within hours to weeks of starting olmesartan and hydrochlorothiazide. Call your doctor right away if you have these signs.

What are some other side effects of Olmesartan and Hydrochlorothiazide?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dizziness.
  • Nose and throat irritation.
  • Stuffy nose.
  • Runny nose.
  • Cough.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Olmesartan and Hydrochlorothiazide?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer information use

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about olmesartan and hydrochlorothiazide, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

More about hydrochlorothiazide / olmesartan

  • Side Effects
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  • 30 Reviews
  • Drug class: angiotensin II inhibitors with thiazides
  • FDA Alerts (4)

Consumer resources

  • Hydrochlorothiazide and olmesartan
  • Olmesartan and hydrochlorothiazide (Advanced Reading)

Other brands: Benicar HCT

Professional resources

  • Olmesartan and Hydrochlorothiazide (Wolters Kluwer)
  • … +1 more

Related treatment guides

  • High Blood Pressure

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