arbli

Hypertension Usual adult dose: 50 mg orally once daily. ( 2.2 ) Usual pediatric starting dose: 0.7 mg per kg orally once daily (up to 50 mg). ( 2.2 ) Hypertensive Patients with Left Ventricular Hypertrophy Usual starting dose: 50 mg orally once daily. ( 2.3 ) Add hydrochlorothiazide 12.5 mg and/or increase Arbli to 100 mg orally followed by an increase to hydrochlorothiazide 25 mg if further blood pressure response is needed. ( 2.3 , 14.2 ) Nephropathy in Type 2 Diabetic Patients Usual dose: 50 mg orally once daily. ( 2.4 ) Increase dose to 100 mg orally once daily if further blood pressure response is needed. ( 2.4 ) 2.1 Important Administration Information 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. 2.2 Hypertension Adult Hypertension 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). Pediatric Hypertension The usual recommended starting dose is 0.7 mg per kg orally once daily (up to 50 mg total) administered…

Most common adverse reactions (incidence ≥2% and greater than placebo) are: dizziness, upper respiratory infection, nasal congestion, and back pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Scienture LLC at 1-833-754-4917 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. Hypertension Arbli has been evaluated for safety in more than 3,300 adult patients treated for essential hypertension and 4058 patients/subjects overall. Over 1,200 patients were treated for over 6 months and more than 800 for over one year. Treatment with Arbli was well-tolerated with an overall incidence of adverse events similar to that of placebo. In controlled clinical trials, discontinuation of therapy for adverse events occurred in 2.3% of patients treated with Arbli and 3.7% of patients given placebo. In 4 clinical trials involving over 1,000 patients on various doses (10 mg to 150 mg) of losartan potassium and over 300 patients given placebo, the adverse events that occurred in ≥2% of patients treated with Arbli and more commonly than placebo were: dizziness (3% vs. 2%), upper respiratory infection…

Arbli is contraindicated: In patients who are hypersensitive to any component of this product. For co-administration with aliskiren in patients with diabetes. Hypersensitivity to any component. ( 4 ) Co-administration with aliskiren in patients with diabetes. ( 4 )

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/m 2 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.

U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.

Agents Increasing Serum Potassium: Risk of hyperkalemia. ( 7.1 ) Lithium: Risk of lithium toxicity. ( 7.2 ) NSAIDs: Increased risk of renal impairment and reduced diuretic, natriuretic, and antihypertensive effects. ( 7.3 ) Dual Inhibition of the Renin-Angiotensin System: Increased risk of renal impairment, hypotension, syncope, and hyperkalemia. ( 7.4 ) 7.1 Agents Increasing Serum Potassium Co-administration of losartan with other drugs that raise serum potassium levels may result in hyperkalemia. Monitor serum potassium in such patients. 7.2 Lithium Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists. Monitor serum lithium levels during concomitant use. 7.3 Non-Steroidal 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, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists (including losartan) may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving losartan and NSAID therapy. The antihypertensive effect of angiotensin II receptor antagonists, including losartan, may be attenuated by NSAIDs, including selective COX-2 inhibitors. 7.4 Dual Blockade of the Renin-Angiotensin System (RAS) Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, syncope, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. The Veterans Affairs Nephropathy in Diabetes (VA NEPHRON-D) trial enrolled 1,448 patients with type 2 diabetes, elevated urinary-albumin-to-creatinine ratio, and decreased estimated glomerular filtration rate (GFR 30 to 89.9 mL/min), randomized them to lisinopril or placebo on a background of losartan therapy and followed them for a median of 2.2 years. Patients receiving the combination of losartan and lisinopril did not obtain any additional benefit compared to monotherapy for the combined endpoint of decline in GFR, end stage renal disease, or death, but experienced an increased incidence of hyperkalemia and acute kidney injury compared with the monotherapy group. In most patients no benefit has been associated with using two RAS inhibitors concomitantly. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function, and electrolytes in patients on losartan and other agents that affect the RAS. Do not co-administer aliskiren with losartan in patients with diabetes. Avoid use of aliskiren with losartan in patients with renal impairment (GFR <60 mL/min).