Irbesartan
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Questions & Answers
Side Effects & Adverse Reactions
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 as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimesters of pregnancy. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus.
In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment. If oligohydramnios is observed, discontinue irbesartan, unless it is considered life saving for the mother. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of in utero exposure to irbesartan for hypotension, oliguria, and hyperkalemia (see PRECAUTIONS: Pediatric Use).
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 doses ≥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 doses ≥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.
Radioactivity was present in the rat and rabbit fetus during late gestation and in rat milk following oral doses of radiolabeled irbesartan.
Excessive reduction of blood pressure was rarely seen (<0.1%) in patients with uncomplicated hypertension. Initiation of antihypertensive therapy may cause symptomatic hypotension in patients with intravascular volume- or sodium-depletion, e.g., in patients treated vigorously with diuretics or in patients on dialysis. Such volume depletion should be corrected prior to administration of irbesartan, or a low starting dose should be used (see DOSAGE AND ADMINISTRATION).
If hypotension occurs, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Hypertension
Irbesartan tablet USP is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
Nephropathy in Type 2 Diabetic Patients
Irbesartan tablet USP is indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (>300 mg/day) in patients with type 2 diabetes and hypertension. In this population, irbesartan tablet USP 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 PHARMACOLOGY: Clinical Studies).
History
There is currently no drug history available for this drug.
Other Information
Irbesartan USP is an angiotensin II receptor (AT1 subtype) antagonist.
Irbesartan USP is a non-peptide compound, chemically described as a 2-butyl-3-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one.
Its empirical formula is C25H28N6O, and the structural formula:
Irbesartan USP 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.
Irbesartan is available for oral administration in unscored tablets containing 75 mg, 150 mg, or 300 mg of Irbesartan USP. Inactive ingredients include: calcium stearate, carboxy methyl cellulose calcium, colloidal silicon dioxide, microcrystalline cellulose and povidone.
Sources
Irbesartan Manufacturers
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American Health Packaging
![Irbesartan Tablet [American Health Packaging]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Irbesartan | American Health Packaging
Irbesartan tablet USP may be administered with other antihypertensive agents and with or without food.
Hypertension
The recommended initial dose of irbesartan tablet USP is 150 mg once daily. Patients requiring further reduction in blood pressure should be titrated to 300 mg once daily.
A low dose of a diuretic may be added, if blood pressure is not controlled by irbesartan alone. Hydrochlorothiazide has been shown to have an additive effect (see CLINICAL PHARMACOLOGY: Clinical Studies). Patients not adequately treated by the maximum dose of 300 mg once daily are unlikely to derive additional benefit from a higher dose or twice-daily dosing.
No dosage adjustment is necessary in elderly patients, or in patients with hepatic impairment or mild to severe renal impairment.
Nephropathy in Type 2 Diabetic Patients
The recommended target maintenance dose is 300 mg once daily. There are no data on the clinical effects of lower doses of irbesartan on diabetic nephropathy (see CLINICAL PHARMACOLOGY: Clinical Studies).
Volume- and Salt-Depleted Patients
A lower initial dose of Irbesartan tablet USP (75 mg) is recommended in patients with depletion of intravascular volume or salt (eg, patients treated vigorously with diuretics or on hemodialysis) (see WARNINGS: Hypotension in Volume- or Salt-Depleted Patients).
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Mylan Pharmaceuticals Inc.
Irbesartan | Mylan Pharmaceuticals Inc.
Irbesartan tablets may be administered with other antihypertensive agents and with or without food.
HypertensionThe recommended initial dose of irbesartan tablets is 150 mg once daily. Patients requiring further reduction in blood pressure should be titrated to 300 mg once daily.
A low dose of a diuretic may be added, if blood pressure is not controlled by irbesartan tablets alone. Hydrochlorothiazide has been shown to have an additive effect (see CLINICAL PHARMACOLOGY: Clinical Studies). Patients not adequately treated by the maximum dose of 300 mg once daily are unlikely to derive additional benefit from a higher dose or twice daily dosing.
No dosage adjustment is necessary in elderly patients or in patients with hepatic impairment or mild to severe renal impairment.
Nephropathy in Type 2 Diabetic PatientsThe recommended target maintenance dose is 300 mg once daily. There are no data on the clinical effects of lower doses of irbesartan tablets on diabetic nephropathy (see CLINICAL PHARMACOLOGY: Clinical Studies).
Volume- and Salt-Depleted PatientsA lower initial dose of irbesartan tablets (75 mg) is recommended in patients with depletion of intravascular volume or salt (e.g., patients treated vigorously with diuretics or on hemodialysis) (see WARNINGS: Hypotension in Volume- or Salt-Depleted Patients).
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Camber Pharmaceuticals, Inc.
Irbesartan | Camber Pharmaceuticals, Inc.
Irbesartan tablet USP may be administered with other antihypertensive agents and with or without food.
Hypertension
The recommended initial dose of irbesartan tablet USP is 150 mg once daily. Patients requiring further reduction in blood pressure should be titrated to 300 mg once daily.
A low dose of a diuretic may be added, if blood pressure is not controlled by irbesartan alone. Hydrochlorothiazide has been shown to have an additive effect (see CLINICAL PHARMACOLOGY: Clinical Studies). Patients not adequately treated by the maximum dose of 300 mg once daily are unlikely to derive additional benefit from a higher dose or twice-daily dosing.
No dosage adjustment is necessary in elderly patients, or in patients with hepatic impairment or mild to severe renal impairment.
Nephropathy in Type 2 Diabetic Patients
The recommended target maintenance dose is 300 mg once daily. There are no data on the clinical effects of lower doses of irbesartan on diabetic nephropathy (see CLINICAL PHARMACOLOGY: Clinical Studies).
Volume- and Salt-Depleted Patients
A lower initial dose of Irbesartan tablet USP (75 mg) is recommended in patients with depletion of intravascular volume or salt (eg, patients treated vigorously with diuretics or on hemodialysis) (see WARNINGS: Hypotension in Volume- or Salt-Depleted Patients).
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Legacy Pharmaceutical Packaging
Irbesartan | Great Lakes Wholesale, Marketing, & Sales, Inc.
do not take more than the recommended dose
(see overdose warning) adults and children 12 years and older: take 2 caplets with water repeat every 6 hours, as needed do not exceed 6 caplets per day children under 12 years: ask a doctor -
Watson Laboratories, Inc.
Irbesartan | Watson Laboratories, Inc.
Irbesartan tablets may be administered with other antihypertensive agents and with or without food.
HypertensionThe recommended initial dose of irbesartan tablets is 150 mg once daily. Patients requiring further reduction in blood pressure should be titrated to 300 mg once daily.
A low dose of a diuretic may be added, if blood pressure is not controlled by irbesartan tablets alone. Hydrochlorothiazide has been shown to have an additive effect (see CLINICAL PHARMACOLOGY: Clinical Studies). Patients not adequately treated by the maximum dose of 300 mg once daily are unlikely to derive additional benefit from a higher dose or twice-daily dosing.
No dosage adjustment is necessary in elderly patients, or in patients with hepatic impairment or mild to severe renal impairment.
Nephropathy in Type 2 Diabetic PatientsThe recommended target maintenance dose is 300 mg once daily. There are no data on the clinical effects of lower doses of irbesartan tablets on diabetic nephropathy (see CLINICAL PHARMACOLOGY: Clinical Studies).
Volume- and Salt-Depleted PatientsA lower initial dose of irbesartan tablets (75 mg) is recommended in patients with depletion of intravascular volume or salt (e.g., patients treated vigorously with diuretics or on hemodialysis) (see WARNINGS: Hypotension in Volume- or Salt-Depleted Patients).
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Teva Pharmaceuticals Usa Inc
Irbesartan | Teva Pharmaceuticals Usa Inc
Irbesartan tablets USP may be administered with other antihypertensive agents and with or without food.
HypertensionThe recommended initial dose of irbesartan tablets USP is 150 mg once daily. Patients requiring further reduction in blood pressure should be titrated to 300 mg once daily.
A low dose of a diuretic may be added, if blood pressure is not controlled by irbesartan tablets USP alone. Hydrochlorothiazide has been shown to have an additive effect (see CLINICAL PHARMACOLOGY, Clinical Studies). Patients not adequately treated by the maximum dose of 300 mg once daily are unlikely to derive additional benefit from a higher dose or twice-daily dosing.
No dosage adjustment is necessary in elderly patients, or in patients with hepatic impairment or mild to severe renal impairment.
Nephropathy in Type 2 Diabetic PatientsThe recommended target maintenance dose is 300 mg once daily. There are no data on the clinical effects of lower doses of irbesartan tablets USP on diabetic nephropathy (see CLINICAL PHARMACOLOGY, Clinical Studies).
Volume- and Salt-Depleted PatientsA lower initial dose of irbesartan tablets USP (75 mg) is recommended in patients with depletion of intravascular volume or salt (e.g., patients treated vigorously with diuretics or on hemodialysis) (see WARNINGS, Hypotension in Volume- or Salt-Depleted Patients).
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Qualitest Pharmaceuticals
Irbesartan | Qualitest Pharmaceuticals
Irbesartan Tablets may be administered with other antihypertensive agents and with or without food.
Hypertension
The recommended initial dose of Irbesartan Tablet is 150 mg once daily. Patients requiring further reduction in blood pressure should be titrated to 300 mg once daily.
A low dose of a diuretic may be added, if blood pressure is not controlled by Irbesartan Tablets alone. Hydrochlorothiazide has been shown to have an additive effect (see CLINICAL PHARMACOLOGY: Clinical Studies). Patients not adequately treated by the maximum dose of 300 mg once daily are unlikely to derive additional benefit from a higher dose or twice-daily dosing.
No dosage adjustment is necessary in elderly patients, or in patients with hepatic impairment or mild to severe renal impairment.
Nephropathy in Type 2 Diabetic Patients
The recommended target maintenance dose is 300 mg once daily. There are no data on the clinical effects of lower doses of Irbesartan Tablets on diabetic nephropathy (see CLINICAL PHARMACOLOGY: Clinical Studies).
Volume- and Salt-Depleted Patients
A lower initial dose of Irbesartan Tablet (75 mg) is recommended in patients with depletion of intravascular volume or salt (eg, patients treated vigorously with diuretics or on hemodialysis) (see WARNINGS: Hypotension in Volume- or Salt- Depleted Patients). -
American Health Packaging
Irbesartan | American Health Packaging
Irbesartan tablets may be administered with other antihypertensive agents and with or without food.
Hypertension
The recommended initial dose of irbesartan tablets is 150 mg once daily. Patients requiring further reduction in blood pressure should be titrated to 300 mg once daily.
A low dose of a diuretic may be added, if blood pressure is not controlled by irbesartan tablets alone. Hydrochlorothiazide has been shown to have an additive effect (see CLINICAL PHARMACOLOGY: Clinical Studies). Patients not adequately treated by the maximum dose of 300 mg once daily are unlikely to derive additional benefit from a higher dose or twice-daily dosing.
No dosage adjustment is necessary in elderly patients, or in patients with hepatic impairment or mild to severe renal impairment.
Nephropathy in Type 2 Diabetic Patients
The recommended target maintenance dose is 300 mg once daily. There are no data on the clinical effects of lower doses of irbesartan tablets on diabetic nephropathy (see CLINICAL PHARMACOLOGY: Clinical Studies).
Volume- and Salt-Depleted Patients
A lower initial dose of irbesartan tablets (75 mg) is recommended in patients with depletion of intravascular volume or salt (e.g., patients treated vigorously with diuretics or on hemodialysis) (see WARNINGS: Hypotension in Volume- or Salt-Depleted Patients). -
Solco Healthcare U.s., Llc
Irbesartan | Solco Healthcare U.s., Llc
Irbesartan may be administered with other antihypertensive agents and with or without food.
HypertensionThe recommended initial dose of Irbesartan is 150 mg once daily. Patients requiring further reduction in blood pressure should be titrated to 300 mg once daily.
A low dose of a diuretic may be added, if blood pressure is not controlled by Irbesartan alone. Hydrochlorothiazide has been shown to have an additive effect (see CLINICAL PHARMACOLOGY: Clinical Studies). Patients not adequately treated by the maximum dose of 300 mg once daily are unlikely to derive additional benefit from a higher dose or twice-daily dosing.
No dosage adjustment is necessary in elderly patients, or in patients with hepatic impairment or mild to severe renal impairment.
Nephropathy in Type 2 Diabetic PatientsThe recommended target maintenance dose is 300 mg once daily. There are no data on the clinical effects of lower doses of Irbesartan on diabetic nephropathy (see CLINICAL PHARMACOLOGY: Clinical Studies).
Volume- and Salt-Depleted PatientsA lower initial dose of Irbesartan (75 mg) is recommended in patients with depletion of intravascular volume or salt (eg, patients treated vigorously with diuretics or on hemodialysis) (see WARNINGS: Hypotension in Volume- or Salt-Depleted Patients).
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American Health Packaging
Irbesartan | American Health Packaging
Irbesartan tablets may be administered with other antihypertensive agents and with or without food.
Hypertension
The recommended initial dose of irbesartan tablets is 150 mg once daily. Patients requiring further reduction in blood pressure should be titrated to 300 mg once daily.
A low dose of a diuretic may be added, if blood pressure is not controlled by irbesartan tablets alone. Hydrochlorothiazide has been shown to have an additive effect (see CLINICAL PHARMACOLOGY: Clinical Studies). Patients not adequately treated by the maximum dose of 300 mg once daily are unlikely to derive additional benefit from a higher dose or twice-daily dosing.
No dosage adjustment is necessary in elderly patients, or in patients with hepatic impairment or mild to severe renal impairment.
Nephropathy in Type 2 Diabetic Patients
The recommended target maintenance dose is 300 mg once daily. There are no data on the clinical effects of lower doses of irbesartan tablets on diabetic nephropathy (see CLINICAL PHARMACOLOGY: Clinical Studies).
Volume- and Salt-Depleted Patients
A lower initial dose of irbesartan tablets (75 mg) is recommended in patients with depletion of intravascular volume or salt (e.g., patients treated vigorously with diuretics or on hemodialysis) (see WARNINGS: Hypotension in Volume- or Salt-Depleted Patients). -
Bryant Ranch Prepack
Irbesartan | Bryant Ranch Prepack
Irbesartan tablets may be administered with other antihypertensive agents and with or without food.
Hypertension
The recommended initial dose of irbesartan is 150 mg once daily. Patients requiring further reduction in blood pressure should be titrated to 300 mg once daily.
A low dose of a diuretic may be added, if blood pressure is not controlled by irbesartan tablets alone. Hydrochlorothiazide has been shown to have an additive effect (see CLINICAL PHARMACOLOGY: Clinical Studies). Patients not adequately treated by the maximum dose of 300 mg once daily are unlikely to derive additional benefit from a higher dose or twice-daily dosing.
No dosage adjustment is necessary in elderly patients, or in patients with hepatic impairment or mild to severe renal impairment.
Nephropathy in Type 2 Diabetic Patients
The recommended target maintenance dose is 300 mg once daily. There are no data on the clinical effects of lower doses of irbesartan tablets on diabetic nephropathy (see CLINICAL PHARMACOLOGY: Clinical Studies).
Volume- and Salt-Depleted Patients
A lower initial dose of irbesartan tablets (75 mg) is recommended in patients with depletion of intravascular volume or salt (eg, patients treated vigorously with diuretics or on hemodialysis) (see WARNINGS: Hypotension in Volume- or Salt-Depleted Patients).
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Winthrop U.s.
Irbesartan | Apotex Corp.
Monitoring of blood levels has increased the efficacy and safety of anticonvulsants (see PRECAUTIONS, Laboratory Tests). Dosage should be adjusted to the needs of the individual patient. A low initial daily dosage with a gradual increase is advised. As soon as adequate control is achieved, the dosage may be reduced very gradually to the minimum effective level. Medication should be taken with meals.
Epilepsy (see INDICATIONS AND USAGE)
Adults and children over 12 years of age-Initial: 200 mg b.i.d. for tablets (400 mg/day). Increase at weekly intervals by adding up to 200 mg/day using a t.i.d. or q.i.d. regimen of carbamazepine tablets until the optimal response is obtained. Dosage generally should not exceed 1,000 mg daily in children 12 to 15 years of age, and 1200 mg daily in patients above 15 years of age. Doses up to 1600 mg daily have been used in adults in rare instances. Maintenance: Adjust dosage to the minimum effective level, usually 800 to 1200 mg daily.
Children 6 to 12 years of age-Initial: 100 mg b.i.d. for tablets (200 mg/day). Increase at weekly intervals by adding up to 100 mg/day using a t.i.d. or q.i.d. regimen of carbamazepine tablets until the optimal response is obtained. Dosage generally should not exceed 1,000 mg daily. Maintenance: Adjust dosage to the minimum effective level, usually 400 to 800 mg daily.
Children under 6 years of age-Initial: 10 to 20 mg/kg/day b.i.d. or t.i.d. for tablets. Increase weekly to achieve optimal clinical response administered t.i.d. or q.i.d. Maintenance: Ordinarily, optimal clinical response is achieved at daily doses below 35 mg/kg. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the therapeutic range. No recommendation regarding the safety of carbamazepine for use at doses above 35 mg/kg/24 hours can be made.
Combination Therapy: Carbamazepine may be used alone or with other anticonvulsants. When added to existing anticonvulsant therapy, the drug should be added gradually while the other anticonvulsants are maintained or gradually decreased, except phenytoin, which may have to be increased (see PRECAUTIONS, Drug Interactions, and Pregnancy Category D).
Trigeminal Neuralgia (see INDICATIONS AND USAGE)
Initial: On the first day, 100 mg b.i.d. for tablets for a total daily dose of 200 mg. This daily dose may be increased by up to 200 mg/day using increments of 100 mg every 12 hours for tablets, only as needed to achieve freedom from pain. Do not exceed 1200 mg daily.
Maintenance: Control of pain can be maintained in most patients with 400 to 800 mg daily. However, some patients may be maintained on as little as 200 mg daily, while others may require as much as 1200 mg daily. At least once every 3 months throughout the treatment period, attempts should be made to reduce the dose to the minimum effective level or even to discontinue the drug.
Dosage Information for Tablets Indication Initial Dose Subsequent Dose Maximum Daily Dose EpilepsyUnder 6 yr
10 to 20 mg/kg/dayb.i.d. or t.i.d.
Increase weekly toachieve optimal clinical
response, t.i.d. or q.i.d.
35 mg/kg/24 hr (seeDosage and Administration
section above)
6 to 12 yr 100 mg b.i.d. (200mg/day)
Add up to 100 mg/dayat weekly intervals,
t.i.d. or q.i.d.
1000 mg/24 hr Over 12 yr 200 mg b.i.d. (400mg/day)
Add up to 200 mg/dayat weekly intervals,
t.i.d. or q.i.d.
1000 mg/24 hr (12 to 15 yr)1200 mg/24 hr (>15 yr)
1600 mg /24 hr (adults, in
rare instances)
TrigeminalNeuralgia
100 mg b.i.d. (200mg/day)
Add up to 200 mg/dayin increments of 100
mg every 12 hr
1200 mg/24 hr -
Aurobindo Pharma Limited
Irbesartan | Aurobindo Pharma Limited
Irbesartan tablets may be administered with other antihypertensive agents and with or without food.
Hypertension
The recommended initial dose of irbesartan tablets is 150 mg once daily. Patients requiring further reduction in blood pressure should be titrated to 300 mg once daily.
A low dose of a diuretic may be added, if blood pressure is not controlled by irbesartan tablets alone. Hydrochlorothiazide has been shown to have an additive effect (see CLINICAL PHARMACOLOGY: Clinical Studies). Patients not adequately treated by the maximum dose of 300 mg once daily are unlikely to derive additional benefit from a higher dose or twice-daily dosing.
No dosage adjustment is necessary in elderly patients, or in patients with hepatic impairment or mild to severe renal impairment.
Nephropathy in Type 2 Diabetic Patients
The recommended target maintenance dose is 300 mg once daily. There are no data on the clinical effects of lower doses of irbesartan tablets on diabetic nephropathy (see CLINICAL PHARMACOLOGY: Clinical Studies).
Volume- and Salt-Depleted Patients
A lower initial dose of irbesartan tablets (75 mg) is recommended in patients with depletion of intravascular volume or salt (e.g., patients treated vigorously with diuretics or on hemodialysis) (see WARNINGS: Hypotension in Volume- or Salt-Depleted Patients). -
Macleods Pharmaceuticals Limited
Irbesartan | Macleods Pharmaceuticals Limited
Irbesartan tablets may be administered with other antihypertensive agents and with or without food.
Hypertension
The recommended initial dose of irbesartan is 150 mg once daily. Patients requiring further reduction in blood pressure should be titrated to 300 mg once daily.
A low dose of a diuretic may be added, if blood pressure is not controlled by irbesartan tablets alone. Hydrochlorothiazide has been shown to have an additive effect (see CLINICAL PHARMACOLOGY: Clinical Studies). Patients not adequately treated by the maximum dose of 300 mg once daily are unlikely to derive additional benefit from a higher dose or twice-daily dosing.
No dosage adjustment is necessary in elderly patients, or in patients with hepatic impairment or mild to severe renal impairment.
Nephropathy in Type 2 Diabetic Patients
The recommended target maintenance dose is 300 mg once daily. There are no data on the clinical effects of lower doses of irbesartan tablets on diabetic nephropathy (see CLINICAL PHARMACOLOGY: Clinical Studies).
Volume- and Salt-Depleted Patients
A lower initial dose of irbesartan tablets (75 mg) is recommended in patients with depletion of intravascular volume or salt (eg, patients treated vigorously with diuretics or on hemodialysis) (see WARNINGS: Hypotension in Volume- or Salt-Depleted Patients). -
Teva Pharmaceuticals Usa Inc
Irbesartan | Cantrell Drug Company
FOR SLOW INTRAVENOUS USE. PRESERVATIVE FREE INJECTION SOLUTION.
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Apotex Corp.
Irbesartan | Apotex Corp.
Irbesartan tablets may be administered with other antihypertensive agents and with or without food.
HypertensionThe recommended initial dose of irbesartan is 150 mg once daily. Patients requiring further reduction in blood pressure should be titrated to 300 mg once daily.
A low dose of a diuretic may be added, if blood pressure is not controlled by irbesartan alone. Hydrochlorothiazide has been shown to have an additive effect (see CLINICAL PHARMACOLOGY, Clinical Studies). Patients not adequately treated by the maximum dose of 300 mg once daily are unlikely to derive additional benefit from a higher dose or twice-daily dosing.
No dosage adjustment is necessary in elderly patients, or in patients with hepatic impairment or mild to severe renal impairment.
Nephropathy in Type 2 Diabetic PatientsThe recommended target maintenance dose is 300 mg once daily. There are no data on the clinical effects of lower doses of irbesartan on diabetic nephropathy (see CLINICAL PHARMACOLOGY, Clinical Studies).
Volume- and Salt-Depleted PatientsA lower initial dose of irbesartan (75 mg) is recommended in patients with depletion of intravascular volume or salt (eg, patients treated vigorously with diuretics or on hemodialysis) (see WARNINGS, Hypotension in Volume- or Salt-Depleted Patients).
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Lupin Pharmaceuticals, Inc.
Irbesartan | Lupin Pharmaceuticals, Inc.
Irbesartan Tablets USP may be administered with other antihypertensive agents and with or without food.
HypertensionThe recommended initial dose of irbesartan is 150 mg once daily. Patients requiring further reduction in blood pressure should be titrated to 300 mg once daily.
A low dose of a diuretic may be added, if blood pressure is not controlled by irbesartan tablets USP alone. Hydrochlorothiazide has been shown to have an additive effect (see CLINICAL PHARMACOLOGY: Clinical Studies). Patients not adequately treated by the maximum dose of 300 mg once daily are unlikely to derive additional benefit from a higher dose or twice-daily dosing.
No dosage adjustment is necessary in elderly patients, or in patients with hepatic impairment or mild to severe renal impairment.
Nephropathy in Type 2 Diabetic PatientsThe recommended target maintenance dose is 300 mg once daily. There are no data on the clinical effects of lower doses of irbesartan tablets USP on diabetic nephropathy (see CLINICAL PHARMACOLOGY: Clinical Studies).
Volume- and Salt-Depleted PatientsA lower initial dose of irbesartan tablets USP (75 mg) is recommended in patients with depletion of intravascular volume or salt (eg, patients treated vigorously with diuretics or on hemodialysis) (see WARNINGS: Hypotension in Volume- or Salt-Depleted Patients).
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Carilion Materials Management
Irbesartan | Carilion Materials Management
Irbesartan tablets USP may be administered with other antihypertensive agents and with or without food.
HypertensionThe recommended initial dose of irbesartan tablets USP is 150 mg once daily. Patients requiring further reduction in blood pressure should be titrated to 300 mg once daily.
A low dose of a diuretic may be added, if blood pressure is not controlled by irbesartan tablets USP alone. Hydrochlorothiazide has been shown to have an additive effect (see , ). Patients not adequately treated by the maximum dose of 300 mg once daily are unlikely to derive additional benefit from a higher dose or twice-daily dosing. CLINICAL PHARMACOLOGYClinical Studies
No dosage adjustment is necessary in elderly patients, or in patients with hepatic impairment or mild to severe renal impairment.
Nephropathy in Type 2 Diabetic PatientsThe recommended target maintenance dose is 300 mg once daily. There are no data on the clinical effects of lower doses of irbesartan tablets USP on diabetic nephropathy (see , ). CLINICAL PHARMACOLOGYClinical Studies
Volume- and Salt-Depleted PatientsA lower initial dose of irbesartan tablets USP (75 mg) is recommended in patients with depletion of intravascular volume or salt (e.g., patients treated vigorously with diuretics or on hemodialysis) (see , ). WARNINGSHypotension in Volume- or Salt-Depleted Patients
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Bryant Ranch Prepack
Irbesartan | Bryant Ranch Prepack
Irbesartan tablets USP may be administered with other antihypertensive agents and with or without food.
HypertensionThe recommended initial dose of irbesartan tablets USP is 150 mg once daily. Patients requiring further reduction in blood pressure should be titrated to 300 mg once daily.
A low dose of a diuretic may be added, if blood pressure is not controlled by irbesartan tablets USP alone. Hydrochlorothiazide has been shown to have an additive effect (see CLINICAL PHARMACOLOGY, Clinical Studies). Patients not adequately treated by the maximum dose of 300 mg once daily are unlikely to derive additional benefit from a higher dose or twice-daily dosing.
No dosage adjustment is necessary in elderly patients, or in patients with hepatic impairment or mild to severe renal impairment.
Nephropathy in Type 2 Diabetic PatientsThe recommended target maintenance dose is 300 mg once daily. There are no data on the clinical effects of lower doses of irbesartan tablets USP on diabetic nephropathy (see CLINICAL PHARMACOLOGY, Clinical Studies).
Volume- and Salt-Depleted PatientsA lower initial dose of irbesartan tablets USP (75 mg) is recommended in patients with depletion of intravascular volume or salt (e.g., patients treated vigorously with diuretics or on hemodialysis) (see WARNINGS, Hypotension in Volume- or Salt-Depleted Patients).
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Roxane Laboratories, Inc.
Irbesartan | Roxane Laboratories, Inc.
Irbesartan tablets may be administered with other antihypertensive agents and with or without food.
HypertensionThe recommended initial dose of irbesartan tablets is 150 mg once daily. Patients requiring further reduction in blood pressure should be titrated to 300 mg once daily.
A low dose of a diuretic may be added, if blood pressure is not controlled by irbesartan tablets alone. Hydrochlorothiazide has been shown to have an additive effect (see CLINICAL PHARMACOLOGY: Clinical Studies). Patients not adequately treated by the maximum dose of 300 mg once daily are unlikely to derive additional benefit from a higher dose or twice-daily dosing.
No dosage adjustment is necessary in elderly patients, or in patients with hepatic impairment or mild to severe renal impairment.
Nephropathy in Type 2 Diabetic PatientsThe recommended target maintenance dose is 300 mg once daily. There are no data on the clinical effects of lower doses of irbesartan tablets on diabetic nephropathy (see CLINICAL PHARMACOLOGY:Clinical Studies).
Volume- and Salt-Depleted PatientsA lower initial dose of irbesartan tablets (75 mg) are recommended in patients with depletion of intravascular volume or salt (e.g., patients treated vigorously with diuretics or on hemodialysis) (see WARNINGS: Hypotension in Volume- or Salt-depleted Patients).
-
Avpak
Irbesartan | Avpak
Irbesartan tablet USP may be administered with other antihypertensive agents and with or without food.
Hypertension
The recommended initial dose of irbesartan tablet USP is 150 mg once daily. Patients requiring further reduction in blood pressure should be titrated to 300 mg once daily.
A low dose of a diuretic may be added, if blood pressure is not controlled by irbesartan alone. Hydrochlorothiazide has been shown to have an additive effect (see CLINICAL PHARMACOLOGY: Clinical Studies). Patients not adequately treated by the maximum dose of 300 mg once daily are unlikely to derive additional benefit from a higher dose or twice-daily dosing.
No dosage adjustment is necessary in elderly patients, or in patients with hepatic impairment or mild to severe renal impairment.
Nephropathy in Type 2 Diabetic Patients
The recommended target maintenance dose is 300 mg once daily. There are no data on the clinical effects of lower doses of irbesartan on diabetic nephropathy (see CLINICAL PHARMACOLOGY: Clinical Studies).
Volume- and Salt-Depleted Patients
A lower initial dose of Irbesartan tablet USP (75 mg) is recommended in patients with depletion of intravascular volume or salt (eg, patients treated vigorously with diuretics or on hemodialysis) (see WARNINGS: Hypotension in Volume- or Salt-Depleted Patients).
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![Irbesartan Tablet [American Health Packaging]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=18a75b2b-b511-4a9a-968e-b95ee7790fbf&name=fb7c569a-d41d-429d-8e05-e73c1ae4b380-05.jpg)
![Irbesartan Tablet [Solco Healthcare U.s., Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0f96b0f6-c1c9-4191-916c-507b384d2136&name=eff37327-ff5c-4b80-9ffe-3ab00635bd3f-04.jpg)
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![Irbesartan (Irbesartan ) Tablet [Bryant Ranch Prepack]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=44b72da1-4434-461f-8e3c-264ad46f85df&name=52411.jpg)
![Irbesartan Tablet, Film Coated [Winthrop U.s.]](https://www.recallguide.org/wp-content/themes/bootstrap/assets/img/drug-image-placeholder.jpg)
![Irbesartan Tablet [Aurobindo Pharma Limited]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=2113a901-2612-4557-b86d-3afc006fb8bb&name=irbesartan-fig4.jpg)
![Irbesartan (Irbesartan ) Tablet Irbesartan Tablet [Macleods Pharmaceuticals Limited]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e8635a1c-ae06-4e23-99f7-e704f91d6f43&name=irbe150mg30tab.jpg)
![Irbesartan Tablet [Teva Pharmaceuticals Usa Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=053a62b8-92c2-47e8-bbdd-ff2ec4d75dc7&name=52533-002-10.jpg)
![Irbesartan Tablet, Film Coated [Apotex Corp.]](http://recallguide.cwdevelopsp.com/wp-content/themes/recallguide/assets/img/drug-image-placeholder.jpg)
![Irbesartan Tablet [Lupin Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a7c093c2-3eef-4956-8a14-c36aada0304f&name=irbesartantabletsusp-figure-02.jpg)
![Irbesartan Tablet [Carilion Materials Management]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1c887cd1-564b-4db7-9b18-4e240bb97209&name=68151-3569.jpg)
![Irbesartan Tablet [Bryant Ranch Prepack]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6e857cf4-3a3a-4cdb-9e50-71c87ad69ac9&name=54311.jpg)
![Irbesartan Tablet [Roxane Laboratories, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6deb32db-7924-47cb-af4c-d46f59999b76&name=0054-0250-13.jpg)
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