Arbli From Scienture

The FDA has approved a ready-to-use oral liquid suspension formulation of losartan potassium (Arbli; Scienture LLC). The medication is approved to treat hypertension in adults and children 6 years or older, to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, and to treat diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension.¹ Before the approval, losartan products were available only as solid dosage forms that required compounding to a liquid formulation.²

Image credit: grinny | stock.adobe.com

PHARMACOLOGY AND PHARMACOKINETICS

Losartan is an angiotensin II receptor blocker. It reaches mean peak concentration 1 hour after oral administration and displays an elimination half-life of approximately 2 hours.¹

DOSAGE AND ADMINISTRATION

The dose for the treatment of hypertension in adults is 50 mg orally once daily, which may be increased to 100 mg daily if needed. The pediatric dose for hypertension is 0.7 mg/kg orally once daily with a maximum of 50 mg. The dose for the treatment of hypertension with left ventricular hypertrophy is 50 mg orally once daily. If additional blood pressure control is required, hydrochlorothiazide 12.5 mg may be added and/or losartan may be increased to 100 mg orally once daily, followed by an increase to hydrochlorothiazide 25 mg. The dose for the treatment of nephropathy in patients with type 2 diabetes is 50 mg orally once daily, which may be increased to 100 mg orally once daily if needed for blood pressure control. Patients with mild-to-moderate hepatic impairment should begin treatment with 25 mg once daily.¹

CLINICAL TRIALS

Losartan was studied in 4 placebo-controlled, 6- to 12-week trials of adults with hypertension. Doses of 50 mg, 100 mg, and 150 mg once daily demonstrated statistically significant systolic and diastolic mean decreases in blood pressure compared with placebo. Losartan was also evaluated in combination with hydrochlorothiazide in 3 additional trials, resulting in placebo-adjusted blood pressure reductions. When evaluated in pediatric patients, losartan displayed a dose-dependent reduction in systolic and diastolic blood pressure.

The phase 3 LIFE study (NCT00338260) compared losartan and atenolol in patients with hypertension and left ventricular hypertrophy and found that treatment with losartan resulted in a 13% reduction in risk of the first occurrence of cardiovascular death, nonfatal stroke, or nonfatal myocardial infarction as compared with the atenolol group. The phase 3 RENAAL study (NCT00308347) compared losartan 50 mg daily with placebo in patients with type 2 diabetes with nephropathy and found that treatment with losartan resulted in a 16% risk reduction in the primary end point, which was the time to the first occurrence of doubling of serum creatinine, end-stage renal disease, or death.¹

CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS

Because it can cause fetal harm when administered during pregnancy, losartan carries a boxed warning stating that the medication should be discontinued immediately if pregnancy is detected. Treatment with losartan is contraindicated in patients with hypersensitivity to any component of the medication and when coadministered with aliskiren in patients with diabetes.

Volume or salt depletion should be corrected before beginning treatment with losartan. Renal function and serum potassium should be monitored periodically. Concomitant use with agents that increase serum potassium can increase the risk of hyperkalemia. Concomitant use with lithium can increase the risk of lithium toxicity. Use with nonsteroidal anti-inflammatory drugs can increase the risk of renal impairment and reduce the antihypertensive, diuretic, and natriuretic effects of losartan. Dual inhibition of the renin-angiotensin system can increase the risk of hyperkalemia, hypotension, renal impairment, and syncope.

Patients should not breastfeed during treatment with losartan and for 2 days after the last dose. It should not be used by patients younger than 2 years or pediatric patients with a glomerular filtration rate less than 30 mL/min/1.73 m². The most common adverse reactions are back pain, dizziness, nasal congestion, and upper respiratory infection.

REFERENCES

1. Arbli. Prescribing information. Scienture LLC; 2025. Accessed March 26, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218772s000lbl.pdf

2. Scienture announces the US FDA approval of its NDA for SCN-102, to be launched as Arbli (losartan potassium) oral suspension, 10 mg/mL. News release. Scienture Holdings, Inc. March 18, 2025. Accessed March 26, 2025. https://scienture.com/news/scienture-announces-the-u-s-fda-approval-of-its-nda-for-scn-102-to-be-launched-as-arblitm-losartan-potassium-oral-suspension-10mg-ml-the-global-market-for-losartan-potassium-was-approximately/