IRBESARTAN AND HYDROCHLOROTHIAZIDE - irbesartan and hydrochlorothiazide tablet, film coated
Aurobindo Pharma Limited
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use irbesartan and hydrochlorothiazide safely and effectively. See full prescribing information for irbesartan and hydrochlorothiazide tablets, USP.
Irbesartan and Hydrochlorothiazide Tablets, USP Initial U.S. Approval: 1997 WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. RECENT MAJOR CHANGESINDICATIONS AND USAGEIrbesartan and hydrochlorothiazide tablets, USP are a combination of irbesartan, an angiotensin II receptor antagonist, and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension: DOSAGE AND ADMINISTRATIONDOSAGE FORMS AND STRENGTHSCONTRAINDICATIONSWARNINGS AND PRECAUTIONSADVERSE REACTIONSMost common adverse events (≥5% on irbesartan and hydrochlorothiazide and more often than on placebo) are dizziness, fatigue, and musculoskeletal pain. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2879 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
DRUG INTERACTIONS
Hydrochlorothiazide (7):
USE IN SPECIFIC POPULATIONS
See 17 for PATIENT COUNSELING INFORMATION. Revised: 3/2012 |
In patients not controlled on monotherapy with irbesartan or hydrochlorothiazide, the recommended doses of irbesartan and hydrochlorothiazide tablets, in order of increasing mean effect, are (irbesartan-hydrochlorothiazide) 150 mg/12.5 mg, 300 mg/12.5 mg, and 300 mg/25 mg. The largest incremental effect will likely be in the transition from monotherapy to 150 mg/12.5 mg [see Clinical Studies (14.2)].
Irbesartan and hydrochlorothiazide tablets may be substituted for the titrated components.
Pregnancy Category D
Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue irbesartan and hydrochlorothiazide as soon as possible [see Use in Specific Populations (8.1)].
Thiazides cross the placenta, and use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.
Irbesartan-Hydrochlorothiazide
In double-blind clinical trials of various doses of irbesartan and hydrochlorothiazide, the incidence of hypertensive patients who developed hypokalemia (serum potassium <3.5 mEq/L) was 7.5% versus 6% for placebo; the incidence of hyperkalemia (serum potassium >5.7 mEq/L) was <1% versus 1.7% for placebo. No patient discontinued due to increases or decreases in serum potassium. On average, the combination of irbesartan and hydrochlorothiazide had no effect on serum potassium. Higher doses of irbesartan ameliorated the hypokalemic response to hydrochlorothiazide.
Based on experience with the use of other drugs that affect the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium. Concurrent therapy with hydrochlorothiazide may reduce the frequency of this effect.
Hydrochlorothiazide
Hydrochlorothiazide can cause hypokalemia and hyponatremia. Hypomagnesemia can result in hypokalemia which appears difficult to treat despite potassium repletion. Drugs that inhibit the renin-angiotensin system can cause hyperkalemia. Monitor serum electrolytes periodically.
Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving thiazide therapy.
Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides.
Sulfonamide or sulfonamide derivative drugs, such as hydrochlorothiazide, can cause an idiosyncratic reaction, resulting in transient myopia and acute angle-closure glaucoma. Cases of acute angle-closure glaucoma have been reported with hydrochlorothiazide. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue drug intake as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.
Irbesartan/Hydrochlorothiazide (n=898) (%) | Placebo (n=236) (%) | Irbesartan (n=400) (%) | Hydrochlorothiazide (n=380) (%) |
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Body as a Whole
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Chest Pain | 2 | 1 | 2 | 2 |
Fatigue | 6 | 3 | 4 | 3 |
Influenza | 3 | 1 | 2 | 2 |
Cardiovascular
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Edema | 3 | 3 | 2 | 2 |
Tachycardia | 1 | 0 | 1 | 1 |
Gastrointestinal
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Abdominal Pain | 2 | 1 | 2 | 2 |
Dyspepsia/heartburn | 2 | 1 | 0 | 2 |
Nausea/vomiting | 3 | 0 | 2 | 2 |
Immunology
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Allergy | 1 | 0 | 1 | 1 |
Musculoskeletal
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Musculoskeletal Pain | 6 | 5 | 6 | 10 |
Nervous System
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Dizziness | 8 | 4 | 6 | 5 |
Dizziness Orthostatic | 1 | 0 | 1 | 1 |
Renal/Genitourinary
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Abnormality Urination | 2 | 1 | 1 | 2 |
Female patients of childbearing age should be told about the consequences of exposure to irbesartan and hydrochlorothiazide during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physician as soon as possible.
IRBESARTAN AND HYDROCHLOROTHIAZIDE
irbesartan and hydrochlorothiazide tablet, film coated |
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IRBESARTAN AND HYDROCHLOROTHIAZIDE
irbesartan and hydrochlorothiazide tablet, film coated |
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Labeler - Aurobindo Pharma Limited (650082092) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Aurobindo Pharma Limited | 650381903 | ANALYSIS(65862-629, 65862-630), MANUFACTURE(65862-629, 65862-630) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Aurobindo Pharma Limited | 918917647 | API MANUFACTURE(65862-629, 65862-630) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Aurobindo Pharma Limited | 918917662 | API MANUFACTURE(65862-629, 65862-630) |