Irbesartan And Hydrochlorothiazide Recall
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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).
There is currently no drug history available for this drug.
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.
Irbesartan And Hydrochlorothiazide Manufacturers
- Legacy Pharmaceutical Packaging
- Watson Laboratories, Inc.
- Qualitest Pharmaceuticals
- Avkare, Inc.
- Solco Healthcare Us, Llc
- Mylan Pharmaceuticals Inc.
- Winthrop U.s.
- Aurobindo Pharma Limited
- Macleods Pharmaceuticals Limited
- Teva Pharmaceuticals Usa Inc
- Lupin Pharmaceuticals, Inc.
- Apotex Corp.
- Roxane Laboratories, Inc.
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