Generic Name
Irbesartan
Brand Names
Avapro, Avalide
FDA approval date: September 27, 2012
Classification: Angiotensin 2 Receptor Blocker
Form: Tablet
What is Avapro (Irbesartan)?
Irbesartan USP is an angiotensin II receptor blocker indicated for: Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
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Brand Information
Avapro (irbesartan)
WARNING: FETAL TOXICITY
- When pregnancy is detected, discontinue AVAPRO as soon as possible
- Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus
1DOSAGE FORMS AND STRENGTHS
AVAPRO 75 mg is a white to off-white, biconvex oval, film-coated tablet debossed with a heart on one side and "2871" on the other.
AVAPRO 150 mg is a white to off-white, biconvex oval, film-coated tablet debossed with a heart on one side and "2872" on the other.
AVAPRO 300 mg is a white to off-white, biconvex oval, film-coated tablet debossed with a heart on one side and "2873" on the other.
2CONTRAINDICATIONS
AVAPRO is contraindicated in patients who are hypersensitive to any component of this product.
Do not coadminister aliskiren with AVAPRO in patients with diabetes.
3ADVERSE REACTIONS
The following important adverse reactions are described elsewhere in the labeling:
- Hypotension in Volume or Salt-Depleted Patients
- Impaired Renal Function
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
3.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of AVAPRO. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or to establish a causal relationship to drug exposure.
Blood and lymphatic system: Anemia, Thrombocytopenia
Ear and labyrinth: Tinnitus
Gastrointestinal: Intestinal angioedema
Hepatobiliary: Hepatitis, Jaundice
Immune system: Anaphylactic reaction including anaphylactic shock
Investigations: Increased liver function tests, Increased CPK (Creatine Phosphokinase)
Metabolism and nutrition: Hyperkalemia, Hypoglycemia in diabetic patients
Skin and subcutaneous tissue: Urticaria, Angioedema (involving swelling of the face, lips, pharynx, and/or tongue)
4OVERDOSAGE
No data are available in regard to overdosage in humans. However, daily doses of 900 mg for 8 weeks were well-tolerated. The most likely manifestations of overdosage are expected to be hypotension and tachycardia; bradycardia might also occur from overdose. Irbesartan is not removed by hemodialysis.
Acute oral toxicity studies with irbesartan in mice and rats indicated acute lethal doses were in excess of 2000 mg/kg, about 25-fold and 50-fold the MRHD (300 mg) based on body surface area, respectively.
5DESCRIPTION
AVAPRO (irbesartan) is an angiotensin II receptor (AT
Irbesartan is a non-peptide compound, chemically described as a 2-butyl-3-[
Its empirical formula is C
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.
AVAPRO is available for oral administration in unscored, film-coated tablets containing 75 mg, 150 mg, or 300 mg of irbesartan. Inactive ingredients include: carnauba wax, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, and titanium dioxide.
6HOW SUPPLIED/STORAGE AND HANDLING
AVAPRO (irbesartan) is available as white to off-white, biconvex oval, film-coated tablets, debossed with a heart shape on one side and a code on the other (see Table below). Unit-of-use bottles contain 30 or 90 film-coated tablets as follows:
7PRINCIPAL DISPLAY PANEL - 150 mg Tablet Bottle Label
30 Tablets
NDC 0024-5851-30
Avapro
Rx only
sanofi
8PRINCIPAL DISPLAY PANEL - 300 mg Tablet Bottle Label
30 Tablets
NDC 0024-5852-30
Avapro
Rx only
sanofi
