Losartan

Renal Impairment Patients with renal insufficiency have elevated plasma concentrations of losartan and its active metabolite compared to subjects with normal renal function. No dose adjustment is necessary in patients with renal impairment unless a patient with renal impairment is also volume depleted [see Dosage and Administration, Warnings and Precautions and Clinical Pharmacology].

Dosage Modifications in Patients with Hepatic Impairment In patients with mild-to-moderate hepatic impairment the recommended starting dose of losartan potassium tablets is 25 mg once daily. Losartan potassium tablets has not been studied in patients with severe hepatic impairment [see Use in Special Populations and Clinical Pharmacology].

Preparation of Suspension (for 200 mL of a 2.5 mg/mL suspension) Add 10 mL of Purified Water USP to an 8 ounce (240 mL) amber polyethylene terephthalate (PET) bottle containing ten 50 mg losartan potassium tablets. Immediately shake for at least 2 minutes. Let the concentrate stand for 1 hour and then shake for 1 minute to disperse the tablet contents.

Separately prepare a 50/50 volumetric mixture of Ora-Plus TM and Ora-Sweet SF TM . Add 190 mL of the 50/50 Ora-Plus TM /Ora-Sweet SF TM mixture to the tablet and water slurry in the PET bottle and shake for 1 minute to disperse the ingredients. The suspension should be refrigerated at 2 to 8°C (36 to 46°F) and can be stored for up to 4 weeks.

Shake the suspension prior to each use and return promptly to the refrigerator.