Prochieve (Progesterone Vaginal Gel) - Indications and Dosage

INDICATIONS AND USAGE

ASSISTED REPRODUCTIVE TECHNOLOGY

Prochieve® 8% is indicated for progesterone supplementation or replacement as part of an Assisted Reproductive Technology ("ART") treatment for infertile women with progesterone deficiency.

SECONDARY AMENORRHEA

Prochieve® 4% is indicated for the treatment of secondary amenorrhea. Prochieve® 8% is indicated for use in women who have failed to respond to treatment with Prochieve® 4%.

DOSAGE AND ADMINISTRATION

ASSISTED REPRODUCTIVE TECHNOLOGY

Prochieve® 8% is administered vaginally at a dose of 90 mg once daily in women who require progesterone supplementation. Prochieve® 8% is administered vaginally at a dose of 90 mg twice daily in women with partial or complete ovarian failure who require progesterone replacement. If pregnancy occurs, treatment may be continued until placental autonomy is achieved, up to 10-12 weeks.

SECONDARY AMENORRHEA

Prochieve® 4% is administered vaginally every other day up to a total of six doses. For women who fail to respond, a trial of Prochieve® 8% every other day up to a total of six doses may be instituted.

It is important to note that a dosage increase from the 4% gel can only be accomplished by using the 8% gel. Increasing the volume of gel administered does not increase the amount of progesterone absorbed.

SEE Prochieve® PATIENT INFORMATION SHEET - HOW TO USE Prochieve®. Note: The PATIENT INFORMATION SHEET contains special instructions for using the applicator at altitudes above 2500 feet in order to avoid a partial release of Prochieve® before vaginal insertion.

HOW SUPPLIED

Prochieve® is available in the following strengths:

4% gel (45 mg) in a single use, one piece, disposable, white polyethylene vaginal applicator with a twist-off top. Each applicator contains 1.45 g of gel and delivers 1.125 g of gel.

NDC-55056-0406-1 - 6 Single-use prefilled applicators.

8% gel (90 mg) in a single use, one piece, disposable, white polyethylene vaginal applicator with a twist-off top. Each applicator contains 1.45 g of gel and delivers 1.125 g of gel.

NDC-55056-0806-1 - 6 Single-use prefilled applicators.

NDC-55056-0818-1 - 18 Single-use prefilled applicators

Each applicator is wrapped and sealed in a foil overwrap.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).

Rx only.

U.S. Patent Numbers 4,615,697 and 5,543,150.

Manufactured for:    Columbia Laboratories, Inc. Livingston, NJ 07039

Manufactured by:    Fleet Laboratories Ltd., Watford, United Kingdom

40905010002                                                      Revised February 2004