| EXP: 48 hours (RT).
||48 hours at room temperature when added to or diluted with most commonly used IV solutions.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Do not freeze. 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.
||Undiluted, ranitidine injection tends to exhibit a yellow color that may intensify over time without adversely affecting potency.
Dosing: 50 mg q6-8h (max 400mg/day) IM or IV.
Continuous infusion: initally, 50 mg ivpb x 1, followed by 6.25 mg/hr titrated to gastric pH >4.0 for prophylaxis or >7 for treatment. Note: Continuous infusion is preferred in patients who are actively bleeding.
DOSAGE AND 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:
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/h (e.g., 150 mg [6 mL] of ZANTAC Injection in 250 mL of 5% dextrose injection at 10.7 mL/h).
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 per hour. If after 4 hours either a measured gastric acid output is >10 mEq/h or the patient becomes symptomatic, the dose should be adjusted upward in 0.5-mg/kg per hour increments, and the acid output should be remeasured. Dosages up to 2.5 mg/kg per hour and infusion rates as high as 220 mg/h have been used.
While limited data exist on the administration of IV ranitidine to children, the recommended dose in pediatric patients is for a total daily dose of 2 to 4 mg/kg, to be divided and administered every 6 to 8 hours, up to a maximum of 50 mg given every 6 to 8 hours. This recommendation is derived from adult clinical studies and pharmacokinetic data in pediatric patients. Limited data in neonatal patients (less than one month of age) receiving ECMO have shown that a dose of 2 mg/kg is usually sufficient to increase gastric pH to >4 for at least 15 hours. Therefore, doses of 2 mg/kg given every 12 to 24 hours or as a continuous infusion should be considered.
Dosage Adjustment for Patients With Impaired Renal Function
The administration of ranitidine as a continuous infusion has not been evaluated 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.
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.
ZANTAC Injection, 25 mg/mL, containing phenol 0.5% as preservative, in a 40-mL pharmacy bulk package (NDC 0173-0363-00). Also: 2ml vial.
Store between 4° and 25°C (39° and 77°F); excursions permitted to 30°C (86°F). Protect from light. Store vial in carton until time of use.
Research Triangle Park, NC 27709
ZANTAC is a registered trademark of Warner-Lambert Company, used under license.
All rights reserved.
July 2006 RL-2313
Source: [package insert]