Irbesartan and Hydrochlorothiazide

IRBESARTAN AND HYDROCHLOROTHIAZIDE — irbesartan and hydrochlorothiazide tablet, film coated
Aurobindo Pharma Limited

WARNING: FETAL TOXICITY

1 INDICATIONS AND USAGE

Irbesartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension.
Irbesartan and hydrochlorothiazide tablets may be used in patients whose blood pressure is not adequately controlled on monotherapy.
Irbesartan and hydrochlorothiazide tablets 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 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 compared to irbesartan or hydrochlorothiazide 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 compared to patients treated with irbesartan or hydrochlorothiazide 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)*
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Figure 1b: Probability of Achieving SBP <130 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week 7)*
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Figure 2a: Probability of Achieving DBP <90 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week 7)*
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Figure 2b: Probability of Achieving DBP <80 mmHg in patients from Initial Therapy Studies V (Week 8) and VI (Week7)*
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*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 hydrochlorothiazide alone).The likelihood of achieving these goals on irbesartan and hydrochlorothiazide tablets rises to about 40% (systolic) or 70% (diastolic).

2 DOSAGE AND ADMINISTRATION

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 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) ].

3 DOSAGE FORMS AND STRENGTHS

Irbesartan and hydrochlorothiazide tablets USP, 150 mg/12.5 mg are peach colored, film-coated biconvex oval shaped tablets, debossed with “H 35” on one side and plain on the other side.

Irbesartan and hydrochlorothiazide tablets USP, 300 mg/12.5 mg are peach colored, film-coated biconvex oval shaped tablets, debossed with “H 36” on one side and plain on the other side.

Irbesartan and hydrochlorothiazide tablets USP, 300 mg/25 mg are pink colored, film-coated biconvex oval shaped tablets, debossed with “H 37” on one side and plain on the other side.

4 CONTRAINDICATIONS

  • Irbesartan and hydrochlorothiazide tablets are contraindicated in patients who are hypersensitive to any component of this product.
  • Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.
  • Do not coadminister aliskiren with irbesartan and hydrochlorothiazide tablets in patients with diabetes [see Drug Interactions (7)].

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