TRADENAME

WARNING: FETAL TOXICITY

BOXED WARNING SECTION

When pregnancy is detected, discontinue Arbli as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) ] .

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

Arbli (losartan potassium) oral suspension, 10 mg/mL, is a white, translucent suspension with a peppermint odor.

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

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

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

7 DRUG INTERACTIONS

DRUG INTERACTIONS SECTION

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

10 OVERDOSAGE

OVERDOSAGE SECTION

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.

11 DESCRIPTION

DESCRIPTION SECTION

Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p -( o -1 H -tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C 22 H 22 ClKN 6 O, and its structural formula is: Losartan potassium is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Arbli is available as a white, translucent oral suspension with a peppermint odor. Each mL contains 10 mg losartan potassium (equivalent to 9.2 mg losartan), inactive ingredients are: hypromellose, methyl paraben, natural peppermint flavor, polyethylene glycol, povidone, propyl paraben, propylene glycol, purified water, simethicone, sodium phosphates, sucralose, and xanthan gum.

12 CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

13 NONCLINICAL TOXICOLOGY

NONCLINICAL TOXICOLOGY SECTION

14 CLINICAL STUDIES

CLINICAL STUDIES SECTION

16 HOW SUPPLIED

HOW SUPPLIED SECTION

Arbli (losartan potassium)is a white, translucent oral suspension. Each mL contains 10 mg losartan potassium (equivalent to 9.2 mg losartan). It is supplied as 165 mL in a high-density polyethylene (HDPE) bottle with a child-resistant cap and tamper-evident seal. Shake for 20 seconds prior to each use. NDC 83245-053-06 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.

17 PATIENT COUNSELING INFORMATION

INFORMATION FOR PATIENTS SECTION

Administration Information Instruct patients or caregivers to use oral dosing syringe(s) or an oral dosing cup to correctly measure the prescribed amount of medication. Inform patients that oral dosing syringe(s) or an oral dosing cup may be obtained from their pharmacy. Pregnancy Advise pregnant women and females of reproductive potential of the potential risk to the fetus and to inform their healthcare providers of a known, suspected, or planned pregnancy during treatment with losartan [see Warning and Precautions (5.3) and Use in Specific Population (8.1) ]. Lactation Advise women not to breastfeed during treatment with Arbli and for 2 days after the last dose [see Use in Specific Populations (8.2) ] . Potassium Supplements Advise patients receiving losartan not to use potassium supplements or salt substitutes containing potassium without consulting their healthcare provider [see Drug Interactions (7.1) ] . Manufactured for: Scienture LLC Commack, NY 11725 Distributed by: Scienture LLC Commack, NY 11725 10/25-R1 PPM-0085

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL