Avalide

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Uses

AVALIDE® (irbesartan-hydrochlorothiazide) Tablets is indicated for the treatment of hypertension.

AVALIDE may be used in patients whose blood pressure is not adequately controlled on monotherapy.

AVALIDE 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 AVALIDE 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 AVALIDE compared to irbesartan or HCTZ monotherapy. The relationship between baseline blood pressure and achievement of a SeSBP less than 140 or less than 130 mmHg or SeDBP less than 90 or less than 80 mmHg in patients treated with AVALIDE compared to patients treated with irbesartan or HCTZ monotherapy are shown in Figures 1a through 2b.


Figure 1a: Probability of Achieving SBP less than 140 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week 7)*	Figure 1b: Probability of Achieving SBP less than 130 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week 7)*

Figure 2a: Probability of Achieving DBP less than 90 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week 7)*	Figure 2b: Probability of Achieving DBP less than 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 (eg, Week 8 sitting systolic blood pressure less than or equal to 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 less than 140 mmHg (systolic) and 50% likelihood of achieving less than 90 mmHg (diastolic) on irbesartan alone (and lower still likelihoods on HCTZ alone).

The likelihood of achieving these goals on AVALIDE rises to about 40% (systolic) or 70% (diastolic).

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History

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Other Information

AVALIDE (irbesartan-hydrochlorothiazide) Tablets is 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 empirical formula is C25H28N6O, and its structural formula is:

Irbesartan is a white to off-white crystalline powder with a molecular weight of 428.5. 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 empirical formula is C7H8ClN3O4S2 and its structural formula is:

Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution.

AVALIDE is available for oral administration in tablets containing either 150 mg or 300 mg of irbesartan combined with 12.5 mg of hydrochlorothiazide or 300 mg of irbesartan combined with 25 mg hydrochlorothiazide. Inactive ingredients include: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, ferric oxide red, ferric oxide yellow, silicon dioxide, and magnesium stearate. In addition, the 300/25 mg pink film-coated tablet contains ferric oxide black, hypromellose-2910, PEG-3350, titanium dioxide, and carnauba wax.

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Avalide Manufacturers

Physicians Total Care, Inc.

Avalide | Physicians Total Care, Inc.

Enter section text here
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.
AVALIDE may be administered with or without food.
AVALIDE may be administered with other antihypertensive agents.
Renal impairment. The usual regimens of therapy with AVALIDE may be followed as long as the patient's creatinine clearance is greater than 30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so AVALIDE 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 AVALIDE, 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
AVALIDE may be substituted for the titrated components.
2.4 Initial Therapy
The usual starting dose is AVALIDE 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)]. AVALIDE is not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.2)].

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Cardinal Health

Avalide | Cardinal Health

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.
AVALIDE may be administered with or without food.
AVALIDE may be administered with other antihypertensive agents.
Renal impairment. The usual regimens of therapy with AVALIDE 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 AVALIDE 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 AVALIDE, 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
AVALIDE may be substituted for the titrated components.
2.4 Initial Therapy
The usual starting dose is AVALIDE 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)]. AVALIDE is not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.2)].

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Cardinal Health

Avalide | Cardinal Health

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.
AVALIDE may be administered with or without food.
AVALIDE may be administered with other antihypertensive agents.
Renal impairment. The usual regimens of therapy with AVALIDE 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 AVALIDE 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 AVALIDE, 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
AVALIDE may be substituted for the titrated components.
2.4 Initial Therapy
The usual starting dose is AVALIDE 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)]. AVALIDE is not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.2)].

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Bryant Ranch Prepack

Avalide | Bryant Ranch Prepack

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.
AVALIDE may be administered with or without food.
AVALIDE may be administered with other antihypertensive agents.
Renal impairment. The usual regimens of therapy with AVALIDE 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 AVALIDE 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 AVALIDE, 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
AVALIDE may be substituted for the titrated components.
2.4 Initial Therapy
The usual starting dose is AVALIDE 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)]. AVALIDE is not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.2)].

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Bristol-myers Squibb Company

Avalide | Bristol-myers Squibb Company

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.
AVALIDE may be administered with or without food.
AVALIDE may be administered with other antihypertensive agents.
Renal impairment. The usual regimens of therapy with AVALIDE 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 AVALIDE 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 AVALIDE, 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
AVALIDE may be substituted for the titrated components.
2.4 Initial Therapy
The usual starting dose is AVALIDE 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)]. AVALIDE is not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.2)].

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Sanofi-aventis U.s. Llc

Avalide | Sanofi-aventis U.s. Llc

AVAPRO may be administered with other antihypertensive agents and with or without food.
Hypertension
The recommended initial dose of AVAPRO (irbesartan) is 150 mg once daily. Patients requiring further reduction in blood pressure should be titrated to 300 mg once daily.
A low dose of a diuretic may be added, if blood pressure is not controlled by AVAPRO alone. Hydrochlorothiazide has been shown to have an additive effect (see CLINICAL PHARMACOLOGY: Clinical Studies). Patients not adequately treated by the maximum dose of 300 mg once daily are unlikely to derive additional benefit from a higher dose or twice-daily dosing.
No dosage adjustment is necessary in elderly patients, or in patients with hepatic impairment or mild to severe renal impairment.
Nephropathy in Type 2 Diabetic Patients
The recommended target maintenance dose is 300 mg once daily. There are no data on the clinical effects of lower doses of AVAPRO on diabetic nephropathy (see CLINICAL PHARMACOLOGY: Clinical Studies).
Volume- and Salt-Depleted Patients
A lower initial dose of AVAPRO (75 mg) is recommended in patients with depletion of intravascular volume or salt (eg, patients treated vigorously with diuretics or on hemodialysis) (see WARNINGS: Hypotension in Volume- or Salt-Depleted Patients).

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