Dosage Adjustment for Patients With Impaired Renal Function
The administration of ranitidine as a continuous infusion has not been eva luated in patients with impaired renal function. On the basis of experience with a group of subjects with severely impaired renal function treated with ZANTAC, the recommended dosage in patients with a creatinine clearance <50 mL/min is 50 mg every 18 to 24 hours. Should the patient's condition require, the frequency of dosing may be increased to every 12 hours or even further with caution. Hemodialysis reduces the level of circulating ranitidine. Ideally, the dosing schedule should be adjusted so that the timing of a scheduled dose coincides with the end of hemodialysis.

Elderly patients are more likely to have decreased renal function, therefore caution should be exercised in dose selection, and it may be useful to monitor renal function (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Geriatric Use and PRECAUTIONS: Geriatric Use).

Stability
Undiluted, ZANTAC Injection tends to exhibit a yellow color that may intensify over time without adversely affecting potency. ZANTAC Injection is stable for 48 hours at room temperature when added to or diluted with most commonly used IV solutions, e.g., 0.9% sodium chloride injection, 5% dextrose injection, 10% dextrose injection, lactated ringer's injection, or 5% sodium bicarbonate injection.

ZANTAC Injection Premixed in flexible plastic containers is sterile through the expiration date on the label when stored under recommended conditions.

Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

HOW SUPPLIED
ZANTAC Injection, 25 mg/mL, containing phenol 0.5% as preservative, is available as follows:

NDC 0173-0362-38, 2-mL single-dose vials (Tray of 10)

NDC 0173-0363-01, 6-mL multidose vials (Singles)

Store between 4° and 25°C (39° and 77°F); excursions permitted to 30°C (86°F). Protect from light.

ZANTAC Injection Premixed, 50 mg/50 mL, in 0.45% sodium chloride, is available as a sterile, premixed solution for IV administration in single-dose, flexible plastic containers (NDC 0173-0441-00) (case of 24). It contains no preservatives.

Store between 2° and 25°C (36° and 77°F). Protect from light.

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat; however, brief exposure up to 40°C does not adversely affect the product. Protect from freezing.

GlaxoSmithKline

Research Triangle Park, NC 27709

ZANTAC® Injection:

GlaxoSmithKline

Research Triangle Park, NC 27709

ZANTAC® Injection Premixed:

Manufactured for GlaxoSmithKline

Research Triangle Park, NC 27709

by Hospira, Inc., Lake Forest, IL 60045

ZANTAC is a registered trademark of Warner-Lambert Company, used under license.

MULTISTIK is a registered trademark of Bayer Healthcare LLC.

©2009, GlaxoSmithKline. All rights reserved.

April 2009

ZNJ:5PI

Principal Display Panel

NDC 0173-0362-38

Zantac®

(ranitidine hydrochloride)

Injection

50 mg

2mL

25 mg/mL*

For IV or IM injection , or IV infusion.

Rx only

Sterile

2 Trays of 5 x 2-