Diabetic Nephropathy Treatments
Find Diabetic Nephropathy Treatments
Generic Name
Irbesartan
Brand Names
Avalide, Avapro
FDA approval date: September 27, 2012
Classification: Thiazide Diuretic
Form: Tablet
What is Avalide (Irbesartan)?
AVALIDE ® tablets are 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 hypertension are at relatively high risk for cardiovascular events , 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 (1.
Approved To Treat
Save this treatment for later
Not sure about your diagnosis?
Tired of the same old research?
Related Clinical Trials
Early Application of Budesonide Enteric-coated Capsules in the Treatment of Primary IgA Nephropathy.
Early Application of Budesonide Enteric-coated Capsules in the Treatment of Primary IgA Nephropathy.
Summary: This multicenter, open-label, prospective single-arm study will enroll adults (≥18 y) with primary IgA nephropathy confirmed by renal biopsy within 2 weeks, eGFR ≥20 ml/min/1.73 m² and 0.5-3.5 g/d proteinuria, to receive early (real-world) combination therapy with RASI (titrated irbesartan), SGLT2i (dapagliflozin 10 mg qd) and budesonide enteric-coated capsules (16 mg qd) for 9 months, followed by...
Potassium Correction for Renin-angiotensin-aldosterone System Optimization in Chronic Kidney Disease
Potassium Correction for Renin-angiotensin-aldosterone System Optimization in Chronic Kidney Disease
Summary: The goal of this placebo-controlled, double-blinded cross-over trial is to test whether patiromer, compared with placebo, better enables up-titration of RAAS-blocker treatment in patients with chronic kidney disease stage 3b/4. The main questions it aims to answer are: * Does patiromer allow uptitration of irbesartan, resulting in a significant reduction in albuminuria and blood pressure? * Does p...
Bariatric Surgery and Pharmacokinetics Irbesartan: BAR-MEDS Irbesartan
Summary: Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study th...
Related Latest Advances
Brand Information
Avalide (irbesartan and hydrochlorothiazide)
WARNING: FETAL TOXICITY
- When pregnancy is detected, discontinue AVALIDE as soon as possible
- Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus
1INDICATIONS AND USAGE
AVALIDE
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
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 AVALIDE rises to about 40% (systolic) or 70% (diastolic).
2DOSAGE FORMS AND STRENGTHS
AVALIDE
3CONTRAINDICATIONS
- AVALIDE is 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 AVALIDE in patients with diabetes
4DESCRIPTION
AVALIDE (irbesartan and hydrochlorothiazide) tablets are a combination of an angiotensin II receptor antagonist (AT
Irbesartan is a non-peptide compound, chemically described as a 2-butyl-3-[
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-2
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 film-coated tablets containing either 150 mg or 300 mg of irbesartan combined with 12.5 mg of hydrochlorothiazide. All dosage strengths contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, magnesium stearate, silicon dioxide, ferric oxide red, ferric oxide yellow, polyethylene glycol, titanium dioxide, and carnauba wax.
5PRINCIPAL DISPLAY PANEL - 150/12.5 mg Tablet Bottle Label
NDC 0024-5855-30
Avalide
30 Tablets
6PRINCIPAL DISPLAY PANEL - 300/12.5 mg Tablet Bottle Label
NDC 0024-5856-30
Avalide
30 Tablets
