Irbesartan And Hydrochlorothiazide

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Uses

Irbesartan and hydrochlorothiazide tablets USP are indicated for the treatment of hypertension.

Irbesartan and hydrochlorothiazide tablets USP may be used in patients whose blood pressure is not adequately controlled on monotherapy.

Irbesartan and hydrochlorothiazide tablets USP may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.

The choice of irbesartan and hydrochlorothiazide tablets USP as initial therapy for hypertension should be based on an assessment of potential benefits and risks.

Patients with stage 2 (moderate or severe) hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and may be shaped by considerations such as the baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with monotherapy.

Data from Studies V and VI [see Clinical Studies (14.2)] provide estimates of the probability of reaching a blood pressure goal with irbesartan and hydrochlorothiazide tablets USP compared to irbesartan or HCTZ monotherapy. The relationship between baseline blood pressure and achievement of a SeSBP < 140 or < 130 mmHg or SeDBP < 90 or < 80 mmHg in patients treated with irbesartan and hydrochlorothiazide tablets USP compared to patients treated with irbesartan or HCTZ monotherapy are shown in Figures 1a through 2b.

Figure 1a: Probability of Achieving SBP < 140 mmHg in Patients From Initial Therapy Studies V (Week 8) and VI (Week 7)*

Figure 1b: Probability of Achieving SBP < 130 mmHg in Patients From Initial Therapy Studies V (Week 8) and VI (Week 7)*

Figure 2a: Probability of Achieving DBP < 90 mmHg in Patients From Initial Therapy Studies V (Week 8) and VI (Week 7)*

Figure 2b: Probability of Achieving DBP < 80 mmHg in Patients From Initial Therapy Studies V (Week 8) and VI (Week 7)*

* For all probability curves, patients without blood pressure measurements at Week 7 (Study VI) and Week 8 (Study V) were counted as not reaching goal (intent-to-treat analysis).

The above graphs provide a rough approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 sitting systolic blood pressure ≤ 140 mmHg) for the treatment groups. The curve of each treatment group in each study was estimated by logistic regression modeling from all available data of that treatment group. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures.

For example, a patient with a blood pressure of 180/105 mmHg has about a 25% likelihood of achieving a goal of < 140 mmHg (systolic) and 50% likelihood of achieving < 90 mmHg (diastolic) on irbesartan alone (and lower still likelihoods on HCTZ alone).

The likelihood of achieving these goals on irbesartan and hydrochlorothiazide tablets USP rises to about 40% (systolic) or 70% (diastolic).

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Other Information

Irbesartan and hydrochlorothiazide tablets USP are a combination of an angiotensin II receptor antagonist (AT1 subtype), irbesartan, and a thiazide diuretic, hydrochlorothiazide (HCTZ).

Irbesartan is a non-peptide compound, chemically described as a 2-Butyl-3-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one. Its structural formula is:

C25H28N6O M.W. 428.5

Irbesartan is a white to off-white crystalline powder. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan is slightly soluble in alcohol and methylene chloride and practically insoluble in water.

Hydrochlorothiazide is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its structural formula is:

C7H8ClN3O4S2 M.W. 297.7

Hydrochlorothiazide is a white, or practically white, practically odorless, crystalline powder. Hydrochlorothiazide is very slightly soluble in water and freely soluble in sodium hydroxide solution.

Irbesartan and hydrochlorothiazide is available for oral administration in tablets containing 150 mg or 300 mg of irbesartan combined with 12.5 mg of hydrochlorothiazide. Inactive ingredients include: colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, ferric oxide yellow, magnesium stearate, microcrystalline cellulose, poloxamer, povidone and pregelatinized starch.

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Irbesartan And Hydrochlorothiazide Manufacturers

Legacy Pharmaceutical Packaging

Irbesartan And Hydrochlorothiazide | Legacy Pharmaceutical Packaging

2.1 General Considerations
The side effects of irbesartan are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter [see Adverse Reactions (6)].

Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.

Irbesartan and hydrochlorothiazide tablets USP may be administered with or without food.

Irbesartan and hydrochlorothiazide tablets USP may be administered with other antihypertensive agents.

Renal impairment. The usual regimens of therapy with irbesartan and hydrochlorothiazide tablets USP may be followed as long as the patient’s creatinine clearance is > 30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so irbesartan and hydrochlorothiazide tablets USP are not recommended.

Hepatic impairment. No dosage adjustment is necessary in patients with hepatic impairment.
2.2 Add-On Therapy
In patients not controlled on monotherapy with irbesartan or hydrochlorothiazide, the recommended doses of irbesartan and hydrochlorothiazide tablets USP, in order of increasing mean effect, are (irbesartan-hydrochlorothiazide) 150/12.5 mg, 300/12.5 mg, and 300/25 mg. The largest incremental effect will likely be in the transition from monotherapy to 150/12.5 mg [see Clinical Studies (14.2)].
2.3 Replacement Therapy
Irbesartan and hydrochlorothiazide tablets USP may be substituted for the titrated components.
2.4 Initial Therapy
The usual starting dose is irbesartan and hydrochlorothiazide tablets USP 150/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 300/25 mg tablet once daily as needed to control blood pressure [see Clinical Studies (14.2)]. Irbesartan and hydrochlorothiazide tablets USP are not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.2)].

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Watson Laboratories, Inc.

Irbesartan And Hydrochlorothiazide | Watson Laboratories, Inc.

2.1 General Considerations
The side effects of irbesartan are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter. [See Adverse Reactions (6).]

Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.

Irbesartan and hydrochlorothiazide tablets may be administered with or without food.

Irbesartan and hydrochlorothiazide tablets may be administered with other antihypertensive agents.

Renal impairment. The usual regimens of therapy with irbesartan and hydrochlorothiazide tablets may be followed as long as the patient's creatinine clearance is >30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so irbesartan and hydrochlorothiazide tablets are not recommended.

Hepatic impairment. No dosage adjustment is necessary in patients with hepatic impairment.
2.2 Add-On Therapy
In patients not controlled on monotherapy with irbesartan or hydrochlorothiazide, the recommended doses of irbesartan and hydrochlorothiazide tablets, in order of increasing mean effect, are (irbesartan-hydrochlorothiazide) 150 mg/12.5 mg, 300 mg/12.5 mg, and 300 mg/25 mg. The largest incremental effect will likely be in the transition from monotherapy to 150 mg/12.5 mg. [See Clinical Studies (14.2).]
2.3 Replacement Therapy
Irbesartan and hydrochlorothiazide tablets may be substituted for the titrated components.
2.4 Initial Therapy
The usual starting dose is irbesartan and hydrochlorothiazide tablet 150 mg/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of 300 mg/25 mg once daily as needed to control blood pressure [see Clinical Studies (14.2)]. Irbesartan and hydrochlorothiazide tablets are not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.2)].

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Qualitest Pharmaceuticals

Irbesartan And Hydrochlorothiazide | Qualitest Pharmaceuticals

2.1 General Considerations
The side effects of irbesartan are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter [see Adverse Reactions (6)].
Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.
Irbesartan and Hydrochlorothiazide Tablets may be administered with or without food.
Irbesartan and Hydrochlorothiazide Tablets may be administered with other antihypertensive agents.
Renal impairment: The usual regimens of therapy with Irbesartan and Hydrochlorothiazide Tablets may be followed as long as the patient's creatinine clearance is >30mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so Irbesartan and Hydrochlorothiazide Tablets is not recommended.
Hepatic impairment: No dosage adjustment is necessary in patients with hepatic impairment.
2.2 Add-On Therapy
In patients not controlled on monotherapy with irbesartan or hydrochlorothiazide, the recommended doses of Irbesartan and Hydrochlorothiazide Tablets, in order of increasing mean effect, are (irbesartan-hydrochlorothiazide) 150 mg/12.5 mg, 300 mg/12.5 mg, and 300 mg/25 mg. The largest incremental effect will likely be in the transition from monotherapy to 150 mg/12.5 mg [see Clinical Studies (14.2)].
2.3 Replacement Therapy
Irbesartan and Hydrochlorothiazide Tablets may be substituted for the titrated components.
2.4 Initial Therapy
The usual starting dose is Irbesartan and Hydrochlorothiazide Tablets 150 mg/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 300 mg/25 mg tablet once daily as needed to control blood pressure [see Clinical Studies (14.2)]. Irbesartan and Hydrochlorothiazide Tablets are not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.2)].

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Avkare, Inc.

Irbesartan And Hydrochlorothiazide | Avkare, Inc.

2.1 General Considerations
The side effects of irbesartan are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter [see Adverse Reactions (6)].

Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.

Irbesartan and hydrochlorothiazide tablets USP may be administered with or without food.

Irbesartan and hydrochlorothiazide tablets USP may be administered with other antihypertensive agents.

Renal impairment. The usual regimens of therapy with irbesartan and hydrochlorothiazide tablets USP may be followed as long as the patient’s creatinine clearance is > 30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so irbesartan and hydrochlorothiazide tablets USP are not recommended.

Hepatic impairment. No dosage adjustment is necessary in patients with hepatic impairment.
2.2 Add-On Therapy
In patients not controlled on monotherapy with irbesartan or hydrochlorothiazide, the recommended doses of irbesartan and hydrochlorothiazide tablets USP, in order of increasing mean effect, are (irbesartan-hydrochlorothiazide) 150/12.5 mg, 300/12.5 mg, and 300/25 mg. The largest incremental effect will likely be in the transition from monotherapy to 150/12.5 mg [see Clinical Studies (14.2)].
2.3 Replacement Therapy
Irbesartan and hydrochlorothiazide tablets USP may be substituted for the titrated components.
2.4 Initial Therapy
The usual starting dose is irbesartan and hydrochlorothiazide tablets USP 150/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 300/25 mg tablet once daily as needed to control blood pressure [see Clinical Studies (14.2)]. Irbesartan and hydrochlorothiazide tablets USP are not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.2)].

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Solco Healthcare Us, Llc

Irbesartan And Hydrochlorothiazide | Procter & Gamble Manufacturing Company

apply liberally 15 minutes before sun exposure reapply at least every 2 hours use water resistant sunscreen if swimming or sweating Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses children under 6 months: ask a doctor

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Mylan Pharmaceuticals Inc.

Irbesartan And Hydrochlorothiazide | Mylan Pharmaceuticals Inc.

2.1 General Considerations
The side effects of irbesartan are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose dependent (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter. [See Adverse Reactions (6).]

Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.

Irbesartan and hydrochlorothiazide tablets may be administered with or without food.

Irbesartan and hydrochlorothiazide tablets may be administered with other antihypertensive agents.
Renal Impairment
The usual regimens of therapy with irbesartan and hydrochlorothiazide tablets may be followed as long as the patient's creatinine clearance is > 30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so irbesartan and hydrochlorothiazide tablets are not recommended.
Hepatic Impairment
No dosage adjustment is necessary in patients with hepatic impairment.
2.2 Add-On Therapy
In patients not controlled on monotherapy with irbesartan or hydrochlorothiazide, the recommended doses of irbesartan and hydrochlorothiazide tablets, in order of increasing mean effect, are (irbesartan-hydrochlorothiazide) 150 mg/12.5 mg, 300 mg/12.5 mg, and 300 mg/25 mg. The largest incremental effect will likely be in the transition from monotherapy to 150 mg/12.5 mg. [See Clinical Studies (14.2).]
2.3 Replacement Therapy
Irbesartan and hydrochlorothiazide tablets may be substituted for the titrated components.
2.4 Initial Therapy
The usual starting dose is irbesartan and hydrochlorothiazide tablets 150 mg/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of 300 mg/25 mg once daily as needed to control blood pressure [see Clinical Studies (14.2)]. Irbesartan and hydrochlorothiazide tablets are not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.2)].

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Winthrop U.s.

Irbesartan And Hydrochlorothiazide | Winthrop U.s.

2.1 General Considerations
The side effects of irbesartan are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter. [See Adverse Reactions (6).]

Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.

Irbesartan and hydrochlorothiazide tablets may be administered with or without food.

Irbesartan and hydrochlorothiazide tablets may be administered with other antihypertensive agents.

Renal impairment. The usual regimens of therapy with irbesartan and hydrochlorothiazide tablets may be followed as long as the patient's creatinine clearance is >30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so irbesartan and hydrochlorothiazide tablets are not recommended.

Hepatic impairment. No dosage adjustment is necessary in patients with hepatic impairment.
2.2 Add-On Therapy
In patients not controlled on monotherapy with irbesartan or hydrochlorothiazide, the recommended doses of irbesartan and hydrochlorothiazide tablets, in order of increasing mean effect, are (irbesartan-hydrochlorothiazide) 150/12.5 mg, 300/12.5 mg, and 300/25 mg. The largest incremental effect will likely be in the transition from monotherapy to 150/12.5 mg. [See Clinical Studies (14.2).]
2.3 Replacement Therapy
Irbesartan and hydrochlorothiazide tablets may be substituted for the titrated components.
2.4 Initial Therapy
The usual starting dose is irbesartan and hydrochlorothiazide 150/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of 300/25 mg once daily as needed to control blood pressure [see Clinical Studies (14.2)]. Irbesartan and hydrochlorothiazide tablets are not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.2)].

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Aurobindo Pharma Limited

Irbesartan And Hydrochlorothiazide | Aurobindo Pharma Limited

2.1 General Considerations
The side effects of irbesartan are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter [see Adverse Reactions (6)].

Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.

Irbesartan and hydrochlorothiazide tablets may be administered with or without food.

Irbesartan and hydrochlorothiazide tablets may be administered with other antihypertensive agents.

Renal impairment. The usual regimens of therapy with irbesartan and hydrochlorothiazide tablets may be followed as long as the patient’s creatinine clearance is >30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so irbesartan and hydrochlorothiazide tablets are not recommended.

Hepatic impairment. No dosage adjustment is necessary in patients with hepatic impairment.
2.2 Add-On Therapy
In patients not controlled on monotherapy with irbesartan or hydrochlorothiazide, the recommended doses of irbesartan and hydrochlorothiazide tablets, in order of increasing mean effect, are (irbesartan-hydrochlorothiazide) 150 mg/12.5 mg, 300 mg/12.5 mg, and 300 mg/25 mg. The largest incremental effect will likely be in the transition from monotherapy to 150 mg/12.5 mg [see Clinical Studies (14.2)].
2.3 Replacement Therapy
Irbesartan and hydrochlorothiazide tablets may be substituted for the titrated components.
2.4 Initial Therapy
The usual starting dose is irbesartan and hydrochlorothiazide tablet 150 mg/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of 300 mg/25 mg once daily as needed to control blood pressure [see Clinical Studies (14.2)]. Irbesartan and hydrochlorothiazide tablets are not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.2)].

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Macleods Pharmaceuticals Limited

Irbesartan And Hydrochlorothiazide | Macleods Pharmaceuticals Limited

2.1 General Considerations
The side effects of irbesartan are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent (primarily hypokalemia) and dose-independent phenomena (eg, pancreatitis), the former much more common than the latter. [See Adverse Reactions (6).]

Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.

Irbesartan and hydrochlorothiazide tablets may be administered with or without food.

Irbesartan and hydrochlorothiazide tablets may be administered with other antihypertensive agents.

Renal impairment. The usual regimens of therapy with irbesartan and hydrochlorothiazide tablets may be followed as long as the patient's creatinine clearance is >30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so irbesartan and hydrochlorothiazide tablets are not recommended.

Hepatic impairment. No dosage adjustment is necessary in patients with hepatic impairment.
2.2 Add-On Therapy
In patients not controlled on monotherapy with irbesartan or hydrochlorothiazide, the recommended doses of irbesartan and hydrochlorothiazide tablets, in order of increasing mean effect, are (irbesartan and hydrochlorothiazide) 150/12.5 mg, 300/12.5 mg, and 300/25 mg. The largest incremental effect will likely be in the transition from monotherapy to 150/12.5 mg. [See Clinical Studies (14.2).]
2.3 Replacement Therapy
Irbesartan and hydrochlorothiazide tablets may be substituted for the titrated components.
2.4 Initial Therapy
The usual starting dose is irbesartan and hydrochlorothiazide tablets 150/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 300/25 mg tablet once daily as needed to control blood pressure [see Clinical Studies (14.2)].Irbesartan and hydrochlorothiazide tablets are not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.2)].

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Teva Pharmaceuticals Usa Inc

Irbesartan And Hydrochlorothiazide | Mylan Pharmaceuticals Inc.

2.1 Dosage in Adult Patients
The dose of moxifloxacin hydrochloride tablets is 400 mg (orally) once every 24 hours. The duration of therapy depends on the type of infection as described in Table 1.
Table 1. Dosage and Duration of Therapy in Adult Patients * Due to the designated pathogens [see Indications and Usage (1)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
Type of Infection*

Dose

Every 24

hours

Duration†

(days)

Acute Bacterial Sinusitis (1.1)

400 mg

10

Acute Bacterial Exacerbation of Chronic Bronchitis (1.2)

400 mg

5

Community Acquired Pneumonia (1.3)

400 mg

7 to 14

Uncomplicated Skin and Skin Structure Infections (SSSI ) (1.4)

400 mg

7

Complicated SSSI (1.5)

400 mg

7 to 21

Complicated Intra-Abdominal Infections (1.6)

400 mg

5 to 14

Plague (1.7)‡

400 mg

10 to 14
Conversion of Intravenous to Oral Dosing in Adults
Intravenous formulation is indicated when it offers a route of administration advantageous to the patient (for example, patient cannot tolerate an oral dosage form). When switching from intravenous to oral formulation, no dosage adjustment is necessary. Patients whose therapy is started with moxifloxacin hydrochloride injection may be switched to moxifloxacin hydrochloride tablets when clinically indicated at the discretion of the physician.
2.2 Important Administration Instructions Moxifloxacin Hydrochloride Tablets With Multivalent Cations
Administer moxifloxacin hydrochloride tablets at least 4 hours before or 8 hours after products containing magnesium, aluminum, iron or zinc, including antacids, sucralfate, multivitamins and didanosine buffered tablets for oral suspension or the pediatric powder for oral solution [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].
With Food
Moxifloxacin hydrochloride tablets can be taken with or without food, drink fluids liberally.

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Lupin Pharmaceuticals, Inc.

Irbesartan And Hydrochlorothiazide | Lupin Pharmaceuticals, Inc.

2.1 General Considerations
The side effects of irbesartan are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter. [See ADVERSE REACTIONS (6).]

Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.

Irbesartan and hydrochlorothiazide tablets may be administered with or without food.

Irbesartan and hydrochlorothiazide tablets may be administered with other antihypertensive agents.

Renal Impairment The usual regimens of therapy with irbesartan and hydrochlorothiazide tablets may be followed as long as the patient's creatinine clearance is >30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so irbesartan-hydrochlorothiazide is not recommended.

Hepatic Impairment No dosage adjustment is necessary in patients with hepatic impairment.
2.2 Add-On Therapy
In patients not controlled on monotherapy with irbesartan or hydrochlorothiazide, the recommended doses of irbesartan and hydrochlorothiazide tablets, in order of increasing mean effect, are (irbesartan-hydrochlorothiazide) 150/12.5 mg, 300/12.5 mg, and 300/25 mg. The largest incremental effect will likely be in the transition from monotherapy to 150/12.5 mg. [See CLINICAL STUDIES (14.2).]
2.3 Replacement Therapy
Irbesartan and hydrochlorothiazide tablets may be substituted for the titrated components.
2.4 Initial Therapy
The usual starting dose is irbesartan and hydrochlorothiazide tablets, 150/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 300/25 mg tablet once daily as needed to control blood pressure [see CLINICAL STUDIES (14.2)]. Irbesartan and hydrochlorothiazide tablet is not recommended as initial therapy in patients with intravascular volume depletion [see WARNINGS AND PRECAUTIONS (5.2)].

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Apotex Corp.

Irbesartan And Hydrochlorothiazide | Apotex Corp.

2.1 General Considerations
The side effects of irbesartan are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter [see Adverse Reactions (6)].

Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.

Irbesartan and hydrochlorothiazide tablets may be administered with or without food.

Irbesartan and hydrochlorothiazide tablets may be administered with other antihypertensive agents.

Renal impairment

The usual regimens of therapy with irbesartan and hydrochlorothiazide tablets may be followed as long as the patient's creatinine clearance is >30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so irbesartan and hydrochlorothiazide tablets are not recommended.

Hepatic impairment

No dosage adjustment is necessary in patients with hepatic impairment.
2.2 Add-On Therapy
In patients not controlled on monotherapy with irbesartan or hydrochlorothiazide, the recommended doses of irbesartan and hydrochlorothiazide tablets, in order of increasing mean effect, are (irbesartan-hydrochlorothiazide) 150/12.5 mg, 300/12.5 mg, and 300/25 mg. The largest incremental effect will likely be in the transition from monotherapy to 150/12.5 mg [see Clinical Studies (14.2)].
2.3 Replacement Therapy
Irbesartan and hydrochlorothiazide tablets may be substituted for the titrated components.
2.4 Initial Therapy
The usual starting dose is irbesartan and hydrochlorothiazide tablet 150/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 300/25 mg tablet once daily as needed to control blood pressure [see Clinical Studies (14.2)]. Irbesartan and hydrochlorothiazide tablets are not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.2)].

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Roxane Laboratories, Inc.

Irbesartan And Hydrochlorothiazide | Roxane Laboratories, Inc.

2.1 General Considerations
The side effects of irbesartan are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter [see Adverse Reactions (6)].

Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.

Irbesartan and hydrochlorothiazide tablets may be administered with or without food.

Irbesartan and hydrochlorothiazide tablets may be administered with other antihypertensive agents.

Renal Impairment: The usual regimens of therapy with irbesartan and hydrochlorothiazide tablets may be followed as long as the patient's creatinine clearance is >30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so irbesartan and hydrochlorothiazide tablets are not recommended.

Hepatic Impairment: No dosage adjustment is necessary in patients with hepatic impairment.
2.2 Add-On Therapy
In patients not controlled on monotherapy with irbesartan or hydrochlorothiazide, the recommended doses of irbesartan and hydrochlorothiazide tablets, in order of increasing mean effect, are (irbesartan and hydrochlorothiazide) 150/12.5 mg, 300/12.5 mg, and 300/25 mg. The largest incremental effect will likely be in the transition from monotherapy to 150/12.5 mg [see Clinical Studies (14.2)].
2.3 Replacement Therapy
Irbesartan and hydrochlorothiazide tablets may be substituted for the titrated components.
2.4 Initial Therapy
The usual starting dose is irbesartan and hydrochlorothiazide tablets 150/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of 300/25 mg tablet once daily as needed to control blood pressure [see Clinical Studies (14.2)]. Irbesartan and hydrochlorothiazide tablets are not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.2)].

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