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If you are a patient and have questions about Prochieve 4%, please contact your healthcare provider.
Important Safety Information
Prochieve 4% is indicated for the treatment of secondary amenorrhea. In clinical studies, the most commonly reported adverse events for Prochieve 4% when used with estrogen therapy were cramps, bloating, fatigue, headache, depression, emotional lability, and sleep disorder.
Prochieve 4% is contraindicated for use in individuals with known sensitivity to Prochieve 4% (progesterone or any of the other ingredients); undiagnosed vaginal bleeding; liver dysfunction or disease; known or suspected malignancy of the breast or genital organs; missed abortion; active thrombophlebitis or thromboembolic disorders, or a history of hormone-associated thrombophlebitis or thromboembolic disorders. If thrombotic disorders occur or are suspected, Prochieve 4% should be discontinued immediately.
Please see full Prescribing Information.
REFERENCES: 1. PROCHIEVE® 4% [package insert]. Livingston, NJ: Columbia Laboratories, Inc; 2004. 2. Shantha S, Brooks-Gunn J, Locke RJ, Warren MP. Natural vaginal progesterone is associated with minimal psychological side effects: a preliminary study. J Womens Health Gend Based Med. 2001;10:991-997. 3. Warren MP, Shantha S. Uses of progesterone in clinical practice. Int J Fertil. 1999;44:96-103. 4. Fanchin R, de Ziegler D, Bergeron C, Righini C, Torrisi C, Frydman R. Transvaginal administration of progesterone. Obstet Gynecol. 1997;90:396-401.
Prochieve 4% is marketed by ASCEND Therapeutics, Inc. and manufactured by Fleet Laboratories Ltd.
©2008 ASCEND Therapeutics, Inc. All Rights Reserved.
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