Losartan instructions for administration

Losartan Instructions for Administration
Adult Hypertensive Patients Pediatric Hypertensive Patients ≥ 6 years of age Preparation of Suspension (for 200 mL of a 2.5 mg/mL suspension) Hypertensive Patients with Left Ventricular Hypertrophy Nephropathy in Type 2 Diabetic Patients ---

Adult Hypertensive Patients
Cozaar may be administered with other antihypertensive agents, and with or without food.

Dosing must be individualized. The usual starting dose of Cozaar is 50 mg once daily, with 25 mg used in patients with possible depletion of intravascular volume (e.g., patients treated with diuretics) and patients with a history of hepatic impairment. Cozaar can be administered once or twice daily with total daily doses ranging from 25 mg to 100 mg.

If the antihypertensive effect measured at trough using once-a-day dosing is inadequate, a twice-a-day regimen at the same total daily dose or an increase in dose may give a more satisfactory response. The effect of losartan is substantially present within one week but in some studies the maximal effect occurred in 3-6 weeks.

If blood pressure is not controlled by Cozaar alone, a low dose of a diuretic may be added. Hydrochlorothiazide has been shown to have an additive effect.

No initial dosage adjustment is necessary for elderly patients or for patients with renal impairment, including patients on dialysis.

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Pediatric Hypertensive Patients ≥ 6 years of age
The usual recommended starting dose is 0.7 mg/kg once daily (up to 50 mg total) administered as a tablet or a suspension (see Preparation of Suspension). Dosage should be adjusted according to blood pressure response. Doses above 1.4 mg/kg (or in excess of 100 mg) daily have not been studied in pediatric patients.

Cozaar is not recommended in pediatric patients <6 years of age or in pediatric patients with glomerular filtration rate <30 mL/min/1.73 m2

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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 Cozaar 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™ and Ora-Sweet SF™ Add 190 mL of the 50/50 Ora-Plus™/Ora-Sweet SF™ (Trademarks of Paddock Laboratories, Inc.) 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 2-8°C (36-46°F) and can be stored for up to 4 weeks. Shake the suspension prior to each use and return promptly to the refrigerator.

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Hypertensive Patients with Left Ventricular Hypertrophy
The usual starting dose is 50 mg of Cozaar once daily. Hydrochlorothiazide 12.5 mg daily should be added and/or the dose of Cozaar should be increased to 100 mg once daily followed by an increase in hydrochlorothiazide to 25 mg once daily based on blood pressure response.

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Nephropathy in Type 2 Diabetic Patients
The usual starting dose is 50 mg once daily. The dose should be increased to 100 mg once daily based on blood pressure response. Cozaar may be administered with insulin and other commonly used hypoglycemic agents (e.g., sulfonylureas, glitazones and glucosidase inhibitors).

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