Generic Name
Losartan
Brand Names
ARBLI, Losortan, Hyzaar, Cozaar
FDA approval date: April 06, 2010
Classification: Angiotensin 2 Receptor Blocker
Form: Tablet, Suspension
What is ARBLI (Losartan)?
Hypertension Losartan potassium and hydrochlorothiazide tablets USP are indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy of hypertension, except when the hypertension is severe enough that the value of achieving prompt blood pressure control exceeds the risk of initiating combination therapy in these patients. Hypertensive Patients With Left Ventricular Hypertrophy Losartan potassium and hydrochlorothiazide tablets USP are 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.
Approved To Treat
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Brand Information
ARBLI (losartan potassium)
WARNING:FETAL TOXICITY
When pregnancy is detected, discontinue
1DOSAGE FORMS AND STRENGTHS
- Arbli (losartan potassium) oral suspension, 10 mg/mL, is a white, translucent suspension with a peppermint odor.
2CONTRAINDICATIONS
Arbli is contraindicated:
- In patients who are hypersensitive to any component of this product.
- For co-administration with aliskiren in patients with diabetes.
3OVERDOSAGE
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
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.
4DESCRIPTION
Losartan potassium is an angiotensin II receptor blocker acting on the AT
Its empirical formula is C
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.
5HOW SUPPLIED
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.
6PATIENT COUNSELING INFORMATION
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
Lactation
Advise women not to breastfeed during treatment with Arbli and for 2 days after the last dose
Potassium Supplements
Advise patients receiving losartan not to use potassium supplements or salt substitutes containing potassium without consulting their healthcare provider
Manufactured for:
Scienture LLC
Commack, NY 11725
Distributed by:
Scienture LLC
Commack, NY 11725
10/25-R1
PPM-0085
7PRINCIPAL DISPLAY PANEL
