DOSAGE AND ADMINISTRATION
PREVACID I.V. 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 drug that is available for administration. Read the following instructions carefully.
There are two methods for preparing PREVACID I.V. 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. for Injection.
STEP ONE - Reconstitution in Vial
- -First Prevacid I.V. 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 25°C (77°F) 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 25°C (77°F) and should be administered within the designated time period as listed in the Table below. No refrigeration is required.
| 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. 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 25°C (77°F) and should be administered within the designated time period as listed in the Table below. No refrigeration is required.
| 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
IN-LINE FILTER THAT IS PROVIDED MUST BE USED when administering PREVACID I.V. for Injection via an administration set.
As lansoprazole may be incompatible with other drugs and/or diluents, follow these steps:
- Flush the PREVACID I.V. for Injection administration port before administration of PREVACID I.V. for Injection with either:
- 0.9% Sodium Chloride Injection, USP,
- Lactated Ringer’s Injection, USP, or
- 5% Dextrose Injection, USP.
Attach the filter and administration set.
Administer the drug over 30 minutes.
Remove and discard the administration set, including the filter, used for PREVACID I.V. for Injection.
Flush the administration port.
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, whenever solution and container permit.
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. 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.
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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 µm pore size). |
Store PREVACID I.V. 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.
U.S. Patent No. 4,628,098.
Distributed by
TAP Pharmaceuticals Inc.
Lake Forest, IL 60045, U.S.A.
MINI-BAG is a trademark of Baxter International Inc.
(List 3954)
1020002
R3, Rev. June 2006
© 2004 - 2006 TAP Pharmaceutical Products Inc.
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