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Zantac Injection

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Zantac Injection

Indications
Dosage
How Supplied

INDICATIONS

ZANTAC Injection (ranitidine hydrochloride injection) and ZANTAC Injection (ranitidine hydrochloride injection) Premixed are indicated in some hospitalized patients with pathological hypersecretory conditions or intractable duodenal ulcers, or as an alternative to the oral dosage form for short-term use in patients who are unable to take oral medication.

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
  1. Intermittent Bolus: 50 mg (2 mL) every 6 to 8 hours. Dilute ZANTAC Injection (ranitidine hydrochloride 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).
  2. Intermittent Infusion: 50 mg (2 mL) every 6 to 8 hours. Dilute ZANTAC Injection (ranitidine hydrochloride 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 (ranitidine hydrochloride 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 (ranitidine hydrochloride 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 (ranitidine hydrochloride injection) in 250 mL of 5% dextrose injection at 10.7 mL/hour).

For Zollinger-Ellison patients, dilute ZANTAC Injection (ranitidine hydrochloride 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.

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 1 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 (ranitidine hydrochloride 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.

  1. Close flow control clamp of administration set.
  2. Remove cover from outlet port at bottom of container.
  3. 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.
  4. Suspend container from hanger.
  5. Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of ZANTAC Injection (ranitidine hydrochloride injection) Premixed.
  6. Open flow control clamp to expel air from set. Close clamp.
  7. Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture.
  8. Perform venipuncture.
  9. Regulate rate of administration with flow control clamp.
Caution

ZANTAC Injection (ranitidine hydrochloride 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 infusion of ZANTAC Injection (ranitidine hydrochloride injection) Premixed.

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 (ranitidine hydrochloride 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 (ranitidine hydrochloride 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 (ranitidine hydrochloride 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 (ranitidine hydrochloride 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® (ranitidine hydrochloride injection) Injection: GlaxoSmithKline, Research Triangle Park, NC 27709. ZANTAC® (ranitidine hydrochloride injection) Injection Premixed: Manufactured for GlaxoSmithKline, Research Triangle Park, NC 27709 by Hospira, Inc., Lake Forest, IL 60045. February 2009.

Last reviewed on RxList: 3/31/2009
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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Additional Zantac Injection Information

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