Irbesartan And Hydrochlorothiazide Tablet
NDC 72162-2317

The NDC code 72162-2317 is assigned by the FDA to the product Irbesartan And Hydrochlorothiazide. This pharmaceutical product is labeled by Bryant Ranch Prepack and is currently categorized as listed product. The medication is a tablet administered via oral route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 72162-2317-3, 72162-2317-9. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

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 (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 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) *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 rise to about 40% (systolic) or 70% (diastolic).

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

• HYDROCHLOROTHIAZIDE 12.5 mg/1 - A thiazide diuretic often considered the prototypical member of this class. It reduces the reabsorption of electrolytes from the renal tubules. This results in increased excretion of water and electrolytes, including sodium, potassium, chloride, and magnesium. It is used in the treatment of several disorders including edema, hypertension, diabetes insipidus, and hypoparathyroidism.
• IRBESARTAN 150 mg/1 - A spiro compound, biphenyl and tetrazole derivative that acts as an angiotensin II type 1 receptor antagonist. It is used in the management of HYPERTENSION, and in the treatment of kidney disease.

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

• RxCUI: 310792 - irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet
• RxCUI: 310792 - hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral Tablet
• RxCUI: 310792 - HCTZ 12.5 MG / irbesartan 150 MG Oral Tablet

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

• Angiotensin 2 Receptor Antagonists - [MoA] (Mechanism of Action)
• Angiotensin 2 Receptor Blocker - [EPC] (Established Pharmacologic Class)
• Increased Diuresis - [PE] (Physiologic Effect)
• Thiazide Diuretic - [EPC] (Established Pharmacologic Class)
• Thiazides - [CS]