Proton Pump Inhibitor Lansoprazole Lyophilized Powder for Injection
30mg/5ml I.V. infusion only Gastrointestinal Drugs
lansoprazole injection, powder, for solution
for Injection 30 mg/vial
For I.V. infusion only. Must be further diluted before I.V. use.
Contains 1 single dose vial and 1 required in-line filter (1.2 µm
The vial contains 30 mg of the active ingredient lansoprazole, 60
10 mg meglumine and 3.45 mg sodium hydroxide.
After reconstitution with 5 mL of Sterile Water for
Injection, USP, the resulting solution will contain
lansoprazole 6 mg/mL (30 mg/5 mL).
Protect from light.
Open with caution, vial located at this end of carton.
The active ingredient in (lansoprazole) for Injection is a
sulfinyl] benzimidazole, a compound that inhibits gastric acid
secretion. Its empirical formula is C16H14F3N3O2S with a molecular
weight of 369.37. lansoprazole has the following structure:
Lansoprazole is a white to brownish-white odorless crystalline
powder which melts with decomposition at approximately 166°C.
Lansoprazole is freely soluble in dimethylformamide; soluble in
methanol; sparingly soluble in ethanol; slightly soluble in ethyl
acetate, dichloromethane and acetonitrile; very slightly soluble in
ether; and practically insoluble in hexane and water.
Lansoprazole is stable when exposed to light for up to two months.
The rate of degradation of the compound in aqueous solution
increases with decreasing pH.
Lansoprazole I.V. for Injection contains 30 mg of the active
ingredient lansoprazole, 60 mg mannitol, 10 mg meglumine, and 3.45
mg sodium hydroxide and is supplied as a sterile, lyophilized
powder for I.V. (intravenous) use. The solution of Lansoprazole
I.V. for Injection has a pH of approximately 11 following the first
reconstitution with Sterile Water for Injection, USP, and
approximately 10.2, 10.0, or 9.5 after further dilution with either
0.9% Sodium Chloride Injection, USP, Lactated Ringer's Injection,
USP, or 5% Dextrose Injection, USP, respectively.
INDICATIONS AND USAGE
When patients are unable to take the oral formulations,
Lansoprazole I.V. 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 Lansoprazole I.V.
for Injection as an initial treatment of erosive esophagitis have
not been demonstrated. Refer to full prescribing information for
the oral formulations of Lansoprazole.
Lansoprazole I.V. for Injection is contraindicated in patients with
known severe hypersensitivity to any component of the formulation.
Single intravenous doses of Lansoprazole at 218 mg/kg in mice
(approximately 30 times the recommended human dose based on BSA)
and 167 mg/kg in rats (approximately 46 times the recommended human
dose based on BSA) were lethal. The symptoms of acute toxicity were
decreased locomotor response, ataxia, ptosis and tonic convulsions.
Lansoprazole is not removed from the circulation by hemodialysis.
DOSAGE AND ADMINISTRATION
Lansoprazole 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 lansoprazole that is
available for administration. Read the following instructions
There are two methods for preparing Lansoprazole I.V. for
Reconstitution in Vial and Preparation of Admixture.
Direct reconstitution with Baxter's MINI-BAG Plus Container.
Do not administer with other drugs or diluents as this may cause
IN-LINE FILTER THAT IS PROVIDED MUST BE USED when administering
PREVACID I.V. for Injection via an administration set.
Follow these steps:
- Flush the PREVACID I.V. for Injection administration port before
administration of PREVACID I.V. for Injection with at least 5 cc of
- 0.9% Sodium Chloride Injection, USP,
- Lactated Ringer’s Injection, USP, or
- 5% Dextrose Injection, USP.
- Attach the filter and administration set.
- Administer PREVACID I.V. for Injection over 30 minutes.
- Remove and discard the administration set, including the filter,
used for PREVACID I.V. for Injection.
- Flush the administration port with at least 5 cc of above mentioned
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
Parenteral drug products should be inspected visually for
particulate matter and discoloration prior to administration.
|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|
Store in a cool, dry place. Protect from light.
Keep out of reach of children.