Recommended Topic Related To:

Prevacid IV

"Dec. 20, 2010 -- New research suggests that one out of every 200 patients being treated with gastric acid-suppressive drugs for heartburn and other conditions may develop pneumonia.

Researchers led by Chun-Sick Eom, MD, MPH, from Seoul "...

Prevacid I.V.

Indications
Dosage
How Supplied

INDICATIONS

When patients are unable to take the oral formulations, PREVACID I.V. (lansoprazole for injection) for Injection is indicated as an alternative for the short-term treatment (up to 7 days) of all grades of erosive esophagitis. Once the patient is able to take medications orally, therapy can be switched to an oral formulation of PREVACID for a total of 6 to 8 weeks. The safety and efficacy of PREVACID I.V. (lansoprazole for injection) for Injection as an initial treatment of erosive esophagitis have not been demonstrated. Refer to full prescribing information for the oral formulations of PREVACID.

DOSAGE AND ADMINISTRATION

PREVACID I.V. (lansoprazole for injection) for Injection admixtures should be administered intravenously using the in-line filter provided. The filter must be used to remove precipitate that may form when the reconstituted drug product is mixed with I.V. solutions. Studies have shown that filtration does not alter the amount of lansoprazole that is available for administration. Read the following instructions carefully.

There are two methods for preparing PREVACID I.V. (lansoprazole for injection) for Injection:

1.   Reconstitution in Vial and Preparation of Admixture.

OR

2.   Direct reconstitution with Baxter's MINI-BAG Plus Container.

1. Reconstitution in Vial and Preparation of Admixture

There are two steps for preparing PREVACID I.V. (lansoprazole for injection) for Injection.

STEP ONE - Reconstitution in Vial

-     First PREVACID I.V. (lansoprazole for injection) MUST be reconstituted with Sterile Water for Injection, USP.

-     Inject 5 mL of ONLY Sterile Water for Injection, USP into a 30 mg vial of PREVACID I.V. for Injection. The resulting solution will contain lansoprazole 6 mg/mL (30 mg/5 mL).

-     Failure to reconstitute with Sterile Water may result in formation of precipitation/particulates.

-     Mix gently until the powder is dissolved.

The pH of this reconstituted solution is approximately 11. The reconstituted solution can be held for 1 hour when stored at 25C (77F) prior to further dilution.

STEP TWO - Preparation of Admixture

-     Dilute the reconstituted solution in either 50 mL of 0.9% Sodium Chloride Injection, USP, Lactated Ringer's Injection, USP, or 5% Dextrose Injection, USP.

- The admixture should be stored at 25C (77F) and should be administered within the designated time period as listed in Table 5. No refrigeration is required.

Table 5

Diluent pH Administer within:
0.9% Sodium Chloride Injection, USP Approximately 10.2 24 hours
Lactated Ringer's Injection, USP Approximately 10.0 24 hours
5% Dextrose Injection, USP Approximately 9.5 12 hours

-  Once the admixture is prepared, proceed to Instructions for Priming and Use of Filter.

2. Reconstitution with Baxter's MINI-BAG Plus Container

-     PREVACID I.V. (lansoprazole for injection) for Injection can be reconstituted directly into 50 mL of 0.9% Sodium Chloride for Injection, USP or 5% Dextrose Injection, USP utilizing Baxter's MINI-BAG Plus Container.

-     Refer to separate instructions that are provided with Baxter's MINI-BAG Plus Container.

-     Once the admixture is prepared, proceed to Instructions for Priming and Use of Filter.

The admixture should be stored at 25C (77F) and should be administered within the designated time period as listed in Table 6. No refrigeration is required.

Table 6

Diluent pH Administer within:
0.9% Sodium Chloride Injection, USP Approximately 10.2 24 hours
5% Dextrose Injection, USP Approximately 9.5 8 hours

Instructions for Priming and Use of Filter

TO PRIME FILTER

-     Prime administration set in usual manner and close administration set clamp.

-     Connect luer adapter of administration set to filter inlet using a twisting motion. Over-tightening should be avoided.

-     Hold filter below the level of solution container.

-     Open administration set clamp and slowly prime filter.

-     Close administration set clamp. Verify no air bubbles are present on patient side of filter.

-     If air bubbles are observed, open set clamp slightly to re-establish flow then gently tap filter housing. Observe that no air bubbles are present and close clamp.

-     Connect to patient and regulate flow. Filter may be primed using a syringe and saline.

-     The administration set can then be connected to inlet of filter.

PRECAUTIONS WITH USE OF FILTER

Follow instructions carefully:

-     Use Aseptic technique. For single use only. Do not resterilize or reuse. Do not use if package is damaged.

-     If repositioning of filter is required, loosen luer locking collar, reposition, then retighten locking collar firmly.

-     Maximum working pressure is 1500 mmHg (30 psi, 2 bar). When the working limits of the filter are exceeded, causes of the added resistance should be investigated and corrected.

-     The internal volume of the filter is approx. 0.7 mL.

-     The administration set clamp should be closed during solution container change.

-     Pumps should not be used downstream of filter.

Administration

Do not administer with other drugs or diluents as this may cause incompatibilities.

IN-LINE FILTER THAT IS PROVIDED MUST BE USED when administering PREVACID I.V. (lansoprazole for injection) for Injection via an administration set.

Follow these steps:

  1. Flush the PREVACID I.V. (lansoprazole for injection) for Injection administration port before administration of PREVACID I.V. (lansoprazole for injection) for Injection with at least 5 cc of either:
    • 0.9% Sodium Chloride Injection, USP,
    • Lactated Ringer's Injection, USP, or
    • 5% Dextrose Injection, USP.
  2. Attach the filter and administration set.
  3. Administer PREVACID I.V. (lansoprazole for injection) for Injection over 30 minutes.
  4. Remove and discard the administration set, including the filter, used for PREVACID I.V. (lansoprazole for injection) for Injection.
  5. Flush the administration port with at least 5 cc of above mentioned solutions.

If the administration port is not flushed and the administration set is not removed, lansoprazole degradation may occur with time, and black or brown particulate may be observed in the tubing or on the filter.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

Treatment of Erosive Esophagitis

The recommended adult dose (when patients are unable to take the oral therapy) is 30 mg of lansoprazole (1 vial of PREVACID I.V. (lansoprazole for injection) for Injection) per day administered by I.V. infusion over 30 minutes for up to 7 days. Once the patient is able to take medications orally, therapy can be switched to an oral PREVACID formulation for a total of 6 to 8 weeks. Refer to full prescribing information for the oral formulations of PREVACID.

No dosage adjustment is necessary in patients with renal insufficiency or the elderly. For patients with severe liver disease, dosage adjustment should be considered.

HOW SUPPLIED

PREVACID I.V. for Injection contains 30 mg of lansoprazole as white to pale yellow friable masses and powder in a vial and is available as follows:

NDC 0300-3954-25 Tray containing 10 single dose vial packs: Each pack containing one 30-mg single dose vial of PREVACID I.V. for Injection and 1 required in-line filter (1.2 m pore size).

 

Store PREVACID I.V. (lansoprazole for injection) for Injection at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Protect from light. Use carton to protect contents from light.

Distributed by: TAP Pharmaceuticals Inc.,Lake Forest, IL 60045, U.S.A.
MINI-BAG is a trademark of Baxter International Inc.
Rev. December 2006
FDA rev date: 5/16/2007

Last reviewed on RxList: 7/11/2007
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


GI Disorders

Get the latest treatment options.