DOSAGE AND ADMINISTRATION
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 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:
- 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).
- 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).
ZANTAC Injection Premixed solution, 50 mg, in 0.45% sodium chloride, 50 mL, requires no dilution and should be infused over 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. Pediatric Use: 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. ZANTAC Injection Premixed in Flexible Plastic Containers: Instructions for Use: To Open: Tear outer wrap at notch and remove solution container. Check for minute leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be impaired. Preparation for Administration: Use aseptic technique.
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Close flow control clamp of administration set.
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Remove cover from outlet port at bottom of container.
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Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated. NOTE: See full directions on administration set carton.
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Suspend container from hanger.
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Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of ZANTAC Injection Premixed.
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Open flow control clamp to expel air from set. Close clamp.
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Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture.
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Perform venipuncture.
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Regulate rate of administration with flow control clamp.
Caution: ZANTAC Injection Premixed in flexible plastic containers is to be administered by slow IV drip infusion only. Additives should not be introduced into this solution. If used with a primary IV fluid system, the primary solution should be discontinued during ZANTAC Injection Premixed infusion.
Do not administer unless solution is clear and container is undamaged. Warning: Do not use flexible plastic container in series connections. 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 (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. 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.
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