Source: FDA, National Drug Code (US) Revision Year: 2025
Arbli is indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and nonfatal 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 losartan.
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.
Arbli may be administered with other antihypertensive agents.
Arbli is indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Arbli is indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio ≥300 mg/g) in patients with type 2 diabetes and a history of hypertension. In this population, Arbli 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 (14.3)].
Instruct patients or caregivers to use oral dosing syringe(s) or an oral dosing cup to measure the prescribed amount of medication. Inform patients that oral dosing syringe(s) or an oral dosing cup may be obtained from their pharmacy.
The usual starting dose of Arbli is 50 mg orally once daily. The dosage can be increased to a maximum dose of 100 mg orally once daily as needed to control blood pressure [see Clinical Studies (14.1)]. A starting dose of 25 mg once daily is recommended for patients with possible intravascular depletion (e.g., on diuretic therapy).
The usual recommended starting dose is 0.7 mg per kg orally once daily (up to 50 mg total) administered as a suspension. Dosage should be adjusted according to blood pressure response. Doses above 1.4 mg per kg (or in excess of 100 mg) daily have not been studied in pediatric patients [see Clinical Pharmacology (12.3), Clinical Studies (14.1), and Warnings and Precautions (5.2)].
Arbli is not recommended in pediatric patients less than 2 years of age or in pediatric patients with estimated glomerular filtration rate less than 30 mL/min/1.73 m² [see Use in Specific Populations (8.4), Clinical Pharmacology (12.3), and Clinical Studies (14)].
The usual starting dose is 50 mg of Arbli orally once daily. Hydrochlorothiazide 12.5 mg daily should be added and/or the dose of Arbli should be increased to 100 mg orally once daily followed by an increase in hydrochlorothiazide to 25 mg once daily based on blood pressure response [see Clinical Studies (14.2)].
The usual starting dose is 50 mg orally once daily. The dose should be increased to 100 mg orally once daily based on blood pressure response [see Clinical Studies (14.3)].
In patients with mild-to-moderate hepatic impairment the recommended starting dose of Arbli is 25 mg orally once daily. Arbli has not been studied in patients with severe hepatic impairment [see Use in Specific Populations (8.8) and Clinical Pharmacology (12.3)].
Significant lethality was observed in mice and rats after oral administration of 1,000 mg/kg and 2,000 mg/kg, respectively, about 44 and 170 times the maximum recommended human dose on a mg/m² basis.
Limited data are available in regard to overdosage in humans. The most likely manifestation of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted.
Neither losartan nor its active metabolite can be removed by hemodialysis.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light.
Store and dispense in original container. Once the bottle is opened, use it within 60 days.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.