Zantac Injection Dosage

Parenteral Administration

In some hospitalized patients with pathological hypersecretory conditions or intractable duodenal ulcers, or in patients who are unable to take oral medication, ZANTAC Injection may be administered parenterally according to the following recommendations:

Intramuscular Injection: 50 mg (2 mL) every 6 to 8 hours. (No dilution necessary.)

Intermittent Intravenous Injection:

a. Intermittent Bolus: 50 mg (2 mL) every 6 to 8 hours. Dilute ZANTAC Injection, 50 mg, in 0.9% sodium chloride injection or other compatible IV solution (see Stability) to a concentration no greater than 2.5 mg/mL (20 mL). Inject at a rate no greater than 4 mL/min (5 minutes).

b. Intermittent Infusion: 50 mg (2 mL) every 6 to 8 hours. Dilute ZANTAC Injection, 50 mg, in 5% dextrose injection or other compatible IV solution (see Stability) to a concentration no greater than 0.5 mg/mL (100 mL). Infuse at a rate no greater than 5 to 7 mL/min (15 to 20 minutes).

In some patients it may be necessary to increase dosage. When this is necessary, the increases should be made by more frequent administration of the dose, but generally should not exceed 400 mg/day.

Continuous Intravenous Infusion: Add ZANTAC Injection to 5% dextrose injection or other compatible IV solution (see Stability). Deliver at a rate of 6.25 mg/hour (e.g., 150 mg [6 mL] of ZANTAC Injection in 250 mL of 5% dextrose injection at 10.7 mL/hour).

For Zollinger-Ellison patients, dilute ZANTAC Injection in 5% dextrose injection or other compatible IV solution (see Stability) to a concentration no greater than 2.5 mg/mL. Start the infusion at a rate of 1.0 mg/kg/hour. If after 4 hours either a measured gastric acid output is >10 mEq/hour or the patient becomes symptomatic, the dose should be adjusted upward in 0.5-mg/kg/hour increments, and the acid output should be remeasured. Dosages up to 2.5 mg/kg/hour and infusion rates as high as 220 mg/hour have been used.

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.

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

Directions for Dispensing

Pharmacy Bulk Package—Not for Direct Infusion: The pharmacy bulk package is for use in a pharmacy admixture service only under a laminar flow hood. The closure should be penetrated only once with a sterile transfer set or other sterile dispensing device, which allows measured distribution of the contents, and the contents dispensed in aliquots using aseptic technique. CONTENTS SHOULD BE USED AS SOON AS POSSIBLE FOLLOWING INITIAL CLOSURE PUNCTURE. DISCARD ANY UNUSED PORTION WITHIN 24 HOURS OF FIRST ENTRY. Following closure puncture, container should be maintained below 30°C (86°F) under a laminar flow hood until contents are dispensed.