Avapro

Name: Avapro

How supplied

Dosage Forms And Strengths

AVAPRO 75 mg is a white to off-white biconvex oval tablet debossed with a heart on one side and “2871” on the other.

AVAPRO 150 mg is a white to off-white biconvex oval tablet debossed with a heart on one side and “2872” on the other.

AVAPRO 300 mg is a white to off-white biconvex oval tablet debossed with a heart on one side and “2873” on the other.

Storage And Handling

AVAPRO (irbesartan) is available as white to off-white biconvex oval 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 tablets as follows:

  75 mg 150 mg 300 mg
Debossing 2871 2872 2873
Bottle of 30 0024-5850-30 0024-5851-30 0024-5852-30
Bottle of 90 0024-5850-90 0024-5851-90 0024-5852-90

Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].

sanofi-aventis U.S. LLC, Bridgewater, NJ 08807, A SANOFI COMPANY. Revised: July 2016

Inform MD

Before receiving Avapro, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

  • have congestive heart failure
  • have kidney disease
  • are on dialysis
  • are pregnant or breastfeeding

Tell your doctor if you are allergic to Avapro, the active ingredient in Avapro, or any other medication.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Avapro Overdose

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Avapro FDA Warning

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.

What is irbesartan?

Irbesartan is an angiotensin II receptor antagonist. Irbesartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.

Irbesartan is used to treat high blood pressure (hypertension). It is sometimes given together with other blood pressure medications.

Irbesartan is also used to treat kidney problems caused by type 2 diabetes.

Irbesartan may also be used for purposes not listed in this medication guide.

Commonly used brand name(s)

In the U.S.

  • Avapro

Available Dosage Forms:

  • Tablet

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Angiotensin II Receptor Antagonist

Precautions While Using Avapro

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert. If you feel dizzy, lie down so you do not faint. Then sit for a few moments before standing to prevent the dizziness from returning.

Check with your doctor right away if you become sick while taking this medicine, especially with severe or continuing nausea and vomiting or diarrhea. These conditions may cause you to lose too much water and may lead to low blood pressure. You can also loose water by sweating, so drink plenty of water during exercise or in hot weather.

Ask your doctor before you use medicines, supplements, or salt substitutes that contain potassium.

Do not take other medicines unless they have been discussed with your doctor. This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.

Avapro Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Chills
  • cold sweats
  • confusion
  • dizziness, faintness, or lightheadedness when getting up from lying or sitting position
Less common
  • Bladder pain
  • bloody or cloudy urine
  • chest pain
  • difficult, burning, or painful urination
  • fast, pounding, or irregular heartbeat or pulse
  • frequent urge to urinate
  • lower back or side pain
Rare
  • Chest discomfort
  • decreased urine output
  • dilated neck veins
  • extreme fatigue
  • feeling of warmth
  • fever
  • irregular breathing
  • irregular heartbeat
  • nausea
  • pain or discomfort in the arms, jaw, back, or neck
  • redness of the face, neck, arms, and occasionally, upper chest
  • shortness of breath
  • sweating
  • swelling of the face, fingers, feet, or lower legs
  • tightness in the chest
  • troubled breathing
  • vomiting
  • weight gain
Incidence not known
  • Abdominal or stomach pain
  • black, tarry stools
  • bleeding gums
  • clay-colored stools
  • dark urine
  • decreased frequency of urine
  • headache
  • increased thirst
  • itching
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of appetite
  • muscle cramps or spasms
  • muscle pain or stiffness
  • nervousness
  • numbness or tingling in the hands, feet, or lips
  • pinpoint red spots on the skin
  • rash
  • unpleasant breath odor
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting of blood
  • weakness or heaviness of the legs
  • weight gain
  • yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Acid or sour stomach
  • belching
  • body aches or pain
  • bone pain
  • congestion
  • cough
  • diarrhea
  • dryness or soreness of the throat
  • feeling of indigestion
  • general feeling of discomfort or illness
  • heartburn
  • hoarseness
  • joint pain
  • pain in the chest below the breastbone
  • runny nose
  • shivering
  • sneezing
  • stomach discomfort or upset
  • stuffy nose
  • sweating
  • tender, swollen glands in the neck
  • trouble sleeping
  • trouble with swallowing
  • voice changes
Rare
  • Blistering, crusting, irritation, itching, or reddening of the skin
  • bloated or full feeling
  • blurred or loss of vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • change in hearing
  • cracked, dry, scaly skin
  • decreased interest in sexual intercourse
  • depression
  • difficulty having a bowel movement (stool)
  • disturbed color perception
  • double vision
  • ear drainage
  • earache or pain in the ear
  • excess air or gas in the stomach or intestines
  • halos around lights
  • hives or welts
  • inability to have or keep an erection
  • large, flat, blue or purplish patches in the skin
  • loss in sexual ability, desire, drive, or performance
  • night blindness
  • overbright appearance of lights
  • pain, swelling, or redness in the joints
  • passing gas
  • sleepiness or unusual drowsiness
  • tunnel vision
Incidence not known
  • Feeling of constant movement of self or surroundings
  • sensation of spinning

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Indications and Usage for Avapro

Hypertension

Avapro® is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug.

Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

Avapro may be used alone or in combination with other antihypertensive agents.

Nephropathy in Type 2 Diabetic Patients

Avapro is indicated for the treatment of diabetic nephropathy in patients with type 2 diabetes and hypertension, an elevated serum creatinine, and proteinuria (>300 mg/day). In this population, Avapro reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end-stage renal disease (need for dialysis or renal transplantation) [see Clinical Studies (14.2)].

Dosage Forms and Strengths

Avapro 75 mg is a white to off-white biconvex oval tablet debossed with a heart on one side and "2871" on the other.

Avapro 150 mg is a white to off-white biconvex oval tablet debossed with a heart on one side and "2872" on the other.

Avapro 300 mg is a white to off-white biconvex oval tablet debossed with a heart on one side and "2873" on the other.

Adverse Reactions

The following important adverse reactions are described elsewhere in the labeling:

  • Hypotension in Volume- or Salt-depleted Patients [see Warnings and Precautions (5.2)]
  • Impaired Renal Function [see Warnings and Precautions (5.3)]

Clinical 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.

Hypertension

Avapro has been evaluated for safety in more than 4300 patients with hypertension and about 5000 subjects overall. This experience includes 1303 patients treated for over 6 months and 407 patients for 1 year or more.

In placebo-controlled clinical trials, the following adverse reactions were reported in at least 1% of patients treated with Avapro (n=1965) and at a higher incidence versus placebo (n=641), excluding those too general to be informative and those not reasonably associated with the use of drug because they were associated with the condition being treated or are very common in the treated population, include: diarrhea (3% vs 2%), dyspepsia/heartburn (2% vs 1%), and fatigue (4% vs 3%).

Irbesartan use was not associated with an increased incidence of dry cough, as is typically associated with ACE inhibitor use. In placebo-controlled studies, the incidence of cough in irbesartan-treated patients was 2.8% versus 2.7% in patients receiving placebo.

Nephropathy in Type 2 Diabetic Patients

Hyperkalemia: In the Irbesartan Diabetic Nephropathy Trial (IDNT) (proteinuria ≥900 mg/day, and serum creatinine ranging from 1.0–3.0 mg/dL), the percent of patients with potassium >6 mEq/L was 18.6% in the Avapro group versus 6.0% in the placebo group. Discontinuations due to hyperkalemia in the Avapro group were 2.1% versus 0.4% in the placebo group.

In IDNT, the adverse reactions were similar to those seen in patients with hypertension with the exception of an increased incidence of orthostatic symptoms which occurred more frequently in the Avapro versus placebo group: dizziness (10.2% vs 6.0%), orthostatic dizziness (5.4% vs 2.7%) and orthostatic hypotension (5.4% vs 3.2%).

Post-Marketing Experience

The following adverse reactions have been identified during post-approval 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.

Urticaria; angioedema (involving swelling of the face, lips, pharynx, and/or tongue); increased liver function tests; jaundice; hepatitis; hyperkalemia; thrombocytopenia; increased CPK; tinnitus.

Avapro - Clinical Pharmacology

Mechanism of Action

Angiotensin II is a potent vasoconstrictor formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the primary vasoactive hormone of the renin-angiotensin system, and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Irbesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively binding to the AT1 angiotensin II receptor found in many tissues (e.g., vascular smooth muscle, adrenal gland). There is also an AT2 receptor in many tissues, but it is not involved in cardiovascular homeostasis.

Irbesartan is a specific competitive antagonist of AT1 receptors with a much greater affinity (more than 8500-fold) for the AT1 receptor than for the AT2 receptor and no agonist activity.

Blockade of the AT1 receptor removes the negative feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and circulating angiotensin II do not overcome the effects of irbesartan on blood pressure.

Irbesartan does not inhibit ACE or renin or affect other hormone receptors or ion channels known to be involved in the cardiovascular regulation of blood pressure and sodium homeostasis.

Pharmacodynamics

In healthy subjects, single oral irbesartan doses of up to 300 mg produced dose-dependent inhibition of the pressor effect of angiotensin II infusions. Inhibition was complete (100%) 4 hours following oral doses of 150 mg or 300 mg and partial inhibition was sustained for 24 hours (60% and 40% at 300 mg and 150 mg, respectively).

In hypertensive patients, angiotensin II receptor inhibition following chronic administration of irbesartan causes a 1.5- to 2-fold rise in angiotensin II plasma concentration and a 2- to 3-fold increase in plasma renin levels. Aldosterone plasma concentrations generally decline following irbesartan administration, but serum potassium levels are not significantly affected at recommended doses.

In hypertensive patients, chronic oral doses of irbesartan (up to 300 mg) had no effect on glomerular filtration rate, renal plasma flow, or filtration fraction. In multiple dose studies in hypertensive patients, there were no clinically important effects on fasting triglycerides, total cholesterol, HDL-cholesterol, or fasting glucose concentrations. There was no effect on serum uric acid during chronic oral administration, and no uricosuric effect.

Pharmacokinetics

Absorption

The oral absorption of irbesartan is rapid and complete with an average absolute bioavailability of 60% to 80%. Following oral administration of Avapro, peak plasma concentrations of irbesartan are attained at 1.5 to 2 hours after dosing. Food does not affect the bioavailability of irbesartan.

Irbesartan exhibits linear pharmacokinetics over the therapeutic dose range.

Distribution

Irbesartan is 90% bound to serum proteins (primarily albumin and α1-acid glycoprotein) with negligible binding to cellular components of blood. The average volume of distribution is 53 to 93 liters.

Studies in animals indicate that radiolabeled irbesartan weakly crosses the blood-brain barrier and placenta. Irbesartan is excreted in the milk of lactating rats.

Elimination

Total plasma and renal clearances are in the range of 157 to 176 mL/min and 3.0 to 3.5 mL/min, respectively. The terminal elimination half-life of irbesartan averages 11 to 15 hours. Steady-state concentrations are achieved within 3 days. Limited accumulation of irbesartan (<20%) is observed in plasma upon repeated once-daily dosing and is not clinically relevant.

Metabolism

Irbesartan is an orally active agent that does not require biotransformation into an active form. Irbesartan is metabolized via glucuronide conjugation and oxidation. Following oral or intravenous administration of 14C-labeled irbesartan, more than 80% of the circulating plasma radioactivity is attributable to unchanged irbesartan. The primary circulating metabolite is the inactive irbesartan glucuronide conjugate (approximately 6%). The remaining oxidative metabolites do not add appreciably to irbesartan's pharmacologic activity.

In vitro studies indicate irbesartan is oxidized primarily by CYP2C9; metabolism by CYP3A4 is negligible.

Excretion

Irbesartan and its metabolites are excreted by both biliary and renal routes. Following either oral or intravenous administration of 14C-labeled irbesartan, about 20% of radioactivity is recovered in the urine and the remainder in the feces, as irbesartan or irbesartan glucuronide.

Specific Populations

Sex

No sex-related differences in pharmacokinetics are observed in healthy elderly (age 65–80 years) or in healthy young (age 18–40 years) subjects. In studies of hypertensive patients, there is no sex difference in half-life or accumulation, but somewhat higher plasma concentrations of irbesartan are observed in females (11%–44%). No sex-related dosage adjustment is necessary.

Geriatrics

In elderly subjects (age 65–80 years), irbesartan elimination half-life is not significantly altered, but AUC and Cmax values are about 20% to 50% greater than those of young subjects (age 18–40 years). No dosage adjustment is necessary in the elderly.

Race/Ethnicity

In healthy black subjects, irbesartan AUC values are approximately 25% greater than whites; there is no difference in Cmax values.

Renal Impairment

The pharmacokinetics of irbesartan are not altered in patients with renal impairment or in patients on hemodialysis. Irbesartan is not removed by hemodialysis. No dosage adjustment is necessary in patients with mild to severe renal impairment unless a patient with renal impairment is also volume depleted [see Warnings and Precautions (5.2) and Dosage and Administration (2.4)].

Hepatic Insufficiency

The pharmacokinetics of irbesartan following repeated oral administration are not significantly affected in patients with mild to moderate cirrhosis of the liver. No dosage adjustment is necessary in patients with hepatic insufficiency.

Drug-Drug Interactions

In vitro studies show significant inhibition of the formation of oxidized irbesartan metabolites with the known cytochrome CYP2C9 substrates/inhibitors sulphenazole, tolbutamide and nifedipine. However, in clinical studies the consequences of concomitant irbesartan on the pharmacodynamics of warfarin were negligible. Based on in vitro data, no interaction would be expected with drugs whose metabolism is dependent upon cytochrome P450 isoenzymes 1A1, 1A2, 2A6, 2B6, 2D6, 2E1, or 3A4.

In separate studies of patients receiving maintenance doses of warfarin, hydrochlorothiazide, or digoxin, irbesartan administration for 7 days has no effect on the pharmacodynamics of warfarin (prothrombin time) or pharmacokinetics of digoxin. The pharmacokinetics of irbesartan are not affected by coadministration of nifedipine or hydrochlorothiazide.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

No evidence of carcinogenicity was observed when irbesartan was administered at dosages of up to 500/1000 mg/kg/day (males/females, respectively) in rats and 1000 mg/kg/day in mice for up to 2 years. For male and female rats, 500 mg/kg/day provided an average systemic exposure to irbesartan (AUC0–24 hour, bound plus unbound) about 3 and 11 times, respectively, the average systemic exposure in humans receiving the maximum recommended dose (MRD) of 300 mg irbesartan/day, whereas 1000 mg/kg/day (administered to females only) provided an average systemic exposure about 21 times that reported for humans at the MRD. For male and female mice, 1000 mg/kg/day provided an exposure to irbesartan about 3 and 5 times, respectively, the human exposure at 300 mg/day.

Irbesartan was not mutagenic in a battery of in vitro tests (Ames microbial test, rat hepatocyte DNA repair test, V79 mammalian-cell forward gene-mutation assay). Irbesartan was negative in several tests for induction of chromosomal aberrations (in vitrohuman lymphocyte assay; in vivomouse micronucleus study).

Irbesartan had no adverse effects on fertility or mating of male or female rats at oral dosages ≤650 mg/kg/day, the highest dose providing a systemic exposure to irbesartan (AUC0–24 hour, bound plus unbound) about 5 times that found in humans receiving the MRD of 300 mg/day.

Animal Toxicology and/or Pharmacology

When pregnant rats were treated with irbesartan from Day 0 to Day 20 of gestation (oral doses of 50 mg/kg/day, 180 mg/kg/day, and 650 mg/kg/day), increased incidences of renal pelvic cavitation, hydroureter and/or absence of renal papilla were observed in fetuses at dosages ≥50 mg/kg/day (approximately equivalent to the maximum recommended human dose [MRHD], 300 mg/day, on a body surface area basis). Subcutaneous edema was observed in fetuses at dosages ≥180 mg/kg/day (about 4 times the MRHD on a body surface area basis). As these anomalies were not observed in rats in which irbesartan exposure (oral doses of 50, 150, and 450 mg/kg/day) was limited to gestation days 6 to 15, they appear to reflect late gestational effects of the drug. In pregnant rabbits, oral doses of 30 mg irbesartan/kg/day were associated with maternal mortality and abortion. Surviving females receiving this dose (about 1.5 times the MRHD on a body surface area basis) had a slight increase in early resorptions and a corresponding decrease in live fetuses. Irbesartan was found to cross the placental barrier in rats and rabbits.

How Supplied/Storage and Handling

Avapro (irbesartan) is available as white to off-white biconvex oval 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 tablets as follows:

75 mg 150 mg 300 mg
Debossing 2871 2872 2873
Bottle of 30 0024-5850-30 0024-5851-30 0024-5852-30
Bottle of 90 0024-5850-90 0024-5851-90 0024-5852-90

Store at 25°C (77°F); excursions permitted to 15°C–30°C (59°F–86°F) [see USP Controlled Room Temperature].

PRINCIPAL DISPLAY PANEL - 75 mg Tablet Bottle Label

90 Tablets

NDC 0024-5850-90

Avapro®
(irbesartan)
Tablets
75 mg

Rx only

SANOFI

PRINCIPAL DISPLAY PANEL - 300 mg Tablet Bottle Label

90 Tablets

NDC 0024-5852-90

Avapro®
(irbesartan)
Tablets
300 mg

Rx only

SANOFI

Avapro 
irbesartan tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0024-5850
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
irbesartan (irbesartan) irbesartan 75 mg
Inactive Ingredients
Ingredient Name Strength
lactose monohydrate  
cellulose, microcrystalline  
croscarmellose sodium  
hypromelloses  
silicon dioxide  
magnesium stearate  
titanium dioxide  
polyethylene glycol 3000  
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape OVAL (biconvex) Size 10mm
Flavor Imprint Code 2871
Contains     
Packaging
# Item Code Package Description
1 NDC:0024-5850-30 30 TABLET in 1 BOTTLE
2 NDC:0024-5850-90 90 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020757 01/01/2013
Avapro 
irbesartan tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0024-5851
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
irbesartan (irbesartan) irbesartan 150 mg
Inactive Ingredients
Ingredient Name Strength
lactose monohydrate  
cellulose, microcrystalline  
croscarmellose sodium  
hypromelloses  
silicon dioxide  
magnesium stearate  
titanium dioxide  
polyethylene glycol 3000  
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape OVAL (biconvex) Size 13mm
Flavor Imprint Code 2872
Contains     
Packaging
# Item Code Package Description
1 NDC:0024-5851-30 30 TABLET in 1 BOTTLE
2 NDC:0024-5851-90 90 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020757 01/01/2013
Avapro 
irbesartan tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0024-5852
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
irbesartan (irbesartan) irbesartan 300 mg
Inactive Ingredients
Ingredient Name Strength
lactose monohydrate  
cellulose, microcrystalline  
croscarmellose sodium  
hypromelloses  
silicon dioxide  
magnesium stearate  
titanium dioxide  
polyethylene glycol 3000  
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape OVAL (biconvex) Size 16mm
Flavor Imprint Code 2873
Contains     
Packaging
# Item Code Package Description
1 NDC:0024-5852-30 30 TABLET in 1 BOTTLE
2 NDC:0024-5852-90 90 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020757 01/01/2013
Labeler - sanofi-aventis U.S. LLC (824676584)
Establishment
Name Address ID/FEI Operations
Sanofi Winthrop Industries 763683216 MANUFACTURE(0024-5850, 0024-5851, 0024-5852), ANALYSIS(0024-5850, 0024-5851, 0024-5852)
Establishment
Name Address ID/FEI Operations
sanofi-aventis U.S. LLC 011330557 LABEL(0024-5850, 0024-5851, 0024-5852), PACK(0024-5850, 0024-5851, 0024-5852)
Revised: 07/2016   sanofi-aventis U.S. LLC

What is irbesartan (avapro)?

Irbesartan is in a group of drugs called angiotensin II receptor antagonists. Irbesartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.

Irbesartan is used to treat high blood pressure (hypertension). It is sometimes given together with other blood pressure medications.

Irbesartan is also used to treat kidney problems caused by type 2 diabetes.

Irbesartan may also be used for purposes not listed in this medication guide.

What should I avoid?

Drinking alcohol can further lower your blood pressure and may increase certain side effects of Avapro.

Do not use potassium supplements or salt substitutes while you are taking Avapro, unless your doctor has told you to.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

In Summary

Common side effects of Avapro include: hyperkalemia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to irbesartan: oral tablet

Along with its needed effects, irbesartan (the active ingredient contained in Avapro) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking irbesartan:

More common
  • Chills
  • cold sweats
  • confusion
  • dizziness, faintness, or lightheadedness when getting up from lying or sitting position
Less common
  • Bladder pain
  • bloody or cloudy urine
  • chest pain
  • difficult, burning, or painful urination
  • fast, pounding, or irregular heartbeat or pulse
  • frequent urge to urinate
  • lower back or side pain
Rare
  • Chest discomfort
  • decreased urine output
  • dilated neck veins
  • extreme fatigue
  • feeling of warmth
  • fever
  • irregular breathing
  • irregular heartbeat
  • nausea
  • pain or discomfort in the arms, jaw, back, or neck
  • redness of the face, neck, arms, and occasionally, upper chest
  • shortness of breath
  • sweating
  • swelling of the face, fingers, feet, or lower legs
  • tightness in the chest
  • troubled breathing
  • vomiting
  • weight gain
Incidence not known
  • Abdominal or stomach pain
  • black, tarry stools
  • bleeding gums
  • clay-colored stools
  • dark urine
  • decreased frequency of urine
  • headache
  • increased thirst
  • itching
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of appetite
  • muscle cramps or spasms
  • muscle pain or stiffness
  • nervousness
  • numbness or tingling in the hands, feet, or lips
  • pinpoint red spots on the skin
  • rash
  • unpleasant breath odor
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting of blood
  • weakness or heaviness of the legs
  • weight gain
  • yellow eyes or skin

Some side effects of irbesartan may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Acid or sour stomach
  • belching
  • body aches or pain
  • bone pain
  • congestion
  • cough
  • diarrhea
  • dryness or soreness of the throat
  • feeling of indigestion
  • general feeling of discomfort or illness
  • heartburn
  • hoarseness
  • joint pain
  • pain in the chest below the breastbone
  • runny nose
  • shivering
  • sneezing
  • stomach discomfort or upset
  • stuffy nose
  • sweating
  • tender, swollen glands in the neck
  • trouble sleeping
  • trouble with swallowing
  • voice changes
Rare
  • Blistering, crusting, irritation, itching, or reddening of the skin
  • bloated or full feeling
  • blurred or loss of vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • change in hearing
  • cracked, dry, scaly skin
  • decreased interest in sexual intercourse
  • depression
  • difficulty having a bowel movement (stool)
  • disturbed color perception
  • double vision
  • ear drainage
  • earache or pain in the ear
  • excess air or gas in the stomach or intestines
  • halos around lights
  • hives or welts
  • inability to have or keep an erection
  • large, flat, blue or purplish patches in the skin
  • loss in sexual ability, desire, drive, or performance
  • night blindness
  • overbright appearance of lights
  • pain, swelling, or redness in the joints
  • passing gas
  • sleepiness or unusual drowsiness
  • tunnel vision
Incidence not known
  • Feeling of constant movement of self or surroundings
  • sensation of spinning

Irbesartan Pregnancy Warnings

AU: Use is contraindicated. UK: Use is not recommended during the first trimester of pregnancy and is contraindicated during the second and third trimesters. US: This drug should not be used during pregnancy unless there are no alternatives and the benefit outweighs the risk to the fetus. AU TGA pregnancy category: D US FDA pregnancy category: D Comments: Adequate methods of contraception should be encouraged.

Animal studies have revealed evidence of maternal mortality and abortion in addition to increased early resorptions and fetal toxicity. In humans, use of drugs that act on the renin angiotensin system (RAS) during the second and third trimesters increases fetal and neonatal morbidity and death. There are no controlled data in human pregnancy. AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details. US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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