IRBESARTAN 300 mg/1
IRBESARTAN · TABLET · Alembic Pharmaceuticals Limited
IRBESARTAN is a tablet containing irbesartan at 300 mg/1, taken oral. Manufactured by Alembic Pharmaceuticals Limited.
Key Facts
- Brand Name
- IRBESARTAN
- Generic Name
- IRBESARTAN
- NDC Code (Product)
46708-441- Manufacturer
- Alembic Pharmaceuticals Limited
- Strength
- 300 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA091236
- Drug Class
- Angiotensin 2 Receptor Blocker [EPC]
- Marketing Start
- 07/01/2016
Recall History
Prinston Pharmaceutical Inc
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Aurobindo Pharma Limited (Unit I)
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Prinston Pharmaceutical Inc
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Lupin Pharmaceuticals Inc.
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Sciegen Pharmaceuticals Inc
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Lupin Pharmaceuticals Inc.
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Golden State Medical Supply Inc.
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product.
Sciegen Pharmaceuticals Inc
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Sciegen Pharmaceuticals Inc
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Irbesartan tablets are an angiotensin II receptor blocker (ARB) 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. ( 1.1 ) Treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. ( 1.2 ) 1.1 Hypertension Irbesartan tablets are 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 guidel…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Indication Dose Hypertension ( 2.2 ) 150 to 300 mg once daily Diabetic Nephropathy ( 2.3 ) 300 mg once daily 2.1 General Considerations Irbesartan tablets may be administered with other antihypertensive agents and with or without food. 2.2 Hypertension The recommended initial dose of irbesartan tablets is 150 mg once daily. The dosage can be increased to a maximum dose of 300 mg once daily as needed to control blood pressure [see Clinical Studies (14.1) ]. 2.3 Nephropathy in Type 2 Diabetic Patients The recommended dose is 300 mg once daily [see Clinical Studies (14.2) ]. 2.4 Dose Adjustment in Volume and Salt-Depleted Patients The recommended initial dose is 75 mg once daily in patients with depletion of intravascular volume or salt (e.g., patients treated vigorously with diuretics or on hemodialysis) [see Warnings and Precautions (5.2) ].
Contraindications
4 CONTRAINDICATIONS Irbesartan tablets are contraindicated in patients who are hypersensitive to any component of this product. Do not coadministrate aliskiren with irbesartan tablets in patients with diabetes. Hypersensitivity to any component of this product. ( 4 ) Coadministration with aliskiren in patients with diabetes. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Lithium: Risk of lithium toxicity. ( 7 ) Nonsteroidal Anti-inflammatory Drugs (NSAIDs) and COX-2 inhibitors: Increased risk of renal impairment. Reduced antihypertensive effects. ( 7 ) Dual blockade of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia. ( 7 ) 7.1 Agents Increasing Serum Potassium Coadministration of irbesartan tablets with other drugs that raise serum potassium levels may result in hyperkalemia, sometimes severe. Monitor serum potassium in such patients. 7.2 Lithium Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of irbesartan and lithium. Monitor lithium levels in patients receiving irbesartan and lithium. 7.3 Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists (including irbesartan) may result in deterioration of renal function, including possible acute renal fai…
Adverse Reactions
6 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) ] Nephropathy in type 2 diabetic patients: The most common adverse reactions which were more frequent than placebo were hyperkalemia dizziness, orthostatic dizziness, and orthostatic hypotension. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Solco Healthecare US LLC. at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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 Irbesartan tablets have been evaluated for safety in more than 4300 patients with hypertension and about 5000 s…
Frequently Asked Questions
What is IRBESARTAN used for?
IRBESARTAN contains IRBESARTAN. It is a tablet taken oral. Consult your doctor for specific uses.
Is IRBESARTAN a controlled substance?
IRBESARTAN is not classified as a controlled substance by the DEA.
What is the generic name for IRBESARTAN?
The generic name for IRBESARTAN is IRBESARTAN. There are 10 other brand versions of IRBESARTAN.
What is the NDC code for IRBESARTAN 300 mg/1?
The NDC (National Drug Code) for IRBESARTAN 300 mg/1 is 46708-441, listed by Alembic Pharmaceuticals Limited.
Other IRBESARTAN Dosages
Other Irbesartan Brands
See all →- Irbesartan and Hydrochlorothiazide12.5 mg/10093-8232
- Irbesartan150 mg/131722-730
- Irbesartan150 mg/150090-1284
- Irbesartan75 mg/150228-160
- Irbesartan and Hydrochlorothiazide25 mg/162332-053
- Irbesartan and Hydrochlorothiazide12.5 mg/163187-653
- Irbesartan300 mg/163629-5241
- Irbesartan150 mg/165162-285
- Irbesartan300 mg/170518-1543
- Irbesartan75 mg/170518-2685
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)