Lupron
INDICATIONS
LUPRON INJECTION (leuprolide acetate) is indicated in the palliative treatment of advanced prostatic cancer.
DOSAGE AND ADMINISTRATION
The recommended dose is 1 mg (0.2 mL or 20 unit mark) administered as a single daily subcutaneous injection. As with other drugs administered chronically by subcutaneous injection, the injection site should be varied periodically. Each 0.2 mL contains 1 mg of leuprolide acetate, sodium chloride for tonicity adjustment, 1.8 mg of benzyl alcohol as preservative and water for injection. The pH may have been adjusted with sodium hydroxide and/or acetic acid.
Follow the pictorial directions on the reverse side of this package insert for administration.
NOTE: As with all parenteral products, inspect the solution for discoloration and particulate matter before each use.
HOW SUPPLIED
LUPRON INJECTION (leuprolide acetate) is a sterile solution supplied in a 2.8 mL multiple-dose vial. The vial is packaged as follows: 14 Day Patient Administration Kit with 14 disposable syringes and 28 alcohol swabs, NDC 0300-3612-28 and six-vial carton, NDC 0300-3612-24.
Store below 77°F (25°C). Do not freeze. Protect from light; store vial in carton until use.
Manufactured for
TAP Pharmaceuticals Inc.
Lake Forest, IL 60045, U.S.A.
By Abbott Laboratories
North Chicago, IL 60064, U.S.A.
Rev. October, 2005
© 1993 — 2005 TAP Pharmaceutical Products Inc.
FDA rev date: 09/15/05
Generic Name: Leuprolide Acetate Injection
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Lupron
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