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Progesterone Capsules

Overview of Progesterone Capsules

Dosage Strength

  • Compounded Immediate Release: 10 mg, 25 mg, 50 mg, 75 mg, 125 mg, 150 mg, 250 mg, 300 mg
  • Compounded Slow Release: 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, 125 mg, 150 mg, 175 mg, 200 mg, 250 mg, 300 mg
  • Commercial (Generic): 100 mg, 200 mg
  • Commercial (Prometrium®): 100 mg, 200 mg

General Information

Progesterone is a progestin that occurs naturally. It is produced in the body by the ovaries, testes, placenta, and adrenal cortex. Progesterone is generally used to treat amenorrhea and irregular uterine bleeding, as well as as a contraceptive. Progesterone is also used to avoid early pregnancy failure in women with corpus luteum insufficiency, including those who utilize assisted reproductive technology (ART). Furthermore, the use of progesterone for preterm delivery prevention is being researched. Preliminary studies suggest that progesterone may be useful in preventing preterm birth in high-risk women, particularly those with a history of preterm birth;1 however, the ideal dosage and route have yet to be discovered. If progesterone is to be used to prevent preterm birth, the American College of Obstetricians and Gynecologists (ACOG) Committee recommends that it be used only in women who have a history of spontaneous birth at 37 weeks gestation, until more data supporting its use in other high-risk women becomes available. 2 A study has been published that supports the use of vaginal progesterone in women with a short cervix. 3 Progesterone is commercially available as an intramuscular injection, intravaginal gel, intravaginal insert, oral capsules, or powder for use in impromptu formulations (e.g., vaginal suppositories). A yearly progesterone-releasing IUD (Progestasert®) insertion has been discontinued. The FDA authorized progesterone in 1939. Micronized progesterone capsules for oral administration were approved for secondary amenorrhea in May 1998, and for the prevention of endometrial hyperplasia in postmenopausal women with an intact uterus receiving estrogen replacement treatment in December 1998. A progesterone vaginal gel (Crinone®) was licensed in May 1997 for progesterone supplementation or replacement as part of an ART regimen for infertile women; a second intravaginal gel, ProchieveTM, was released to the US market in 2002. Endometrin®, a vaginal insert for progesterone supplementation as part of an ART therapy in infertile women, was approved in June 2007.

References

1.Meis PJ, Klebanoff M, Thom E, et al. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. N Eng J Med 2003;348:2379-85.
2.ACOG Committee on Obstetric Practice. Committee Opinion: use of progesterone to reduce preterm birth. Obstet Gynecol 2003;102:1115-6.
3.Fonseca EB, Celik E, Parra M, et al. Progesterone and the risk of preterm birth among women with a short cervix. N Engl J Med 2007;357:462-8.
4.Grady D, Rubin SM, Petitti DB, et al. Hormone therapy to prevent disease and prolong life in postmenopausal women. Ann Intern Med 1992;117:1016-37.
5.Endometrin (progesterone) vaginal insert package insert. Hunt Valley, MD: Pharmaceutics International, Inc.; 2014 Jun.
6.Crinone (progesterone vaginal gel) package insert. Parsippany, NJ: Watson Pharma, Inc.; 2011 Dec.
7.American Academy of Pediatrics (AAP) Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics 2001;108:776-89.
8.Prometrium® (progesterone) package insert. Marietta, GA: Solvay Pharmaceuticals Inc.; 1998 Dec.
9.Shumaker SA, Legault C, Rapp SR, et al. Estrogen plus progestin and the incidence of dementia and mild cognitive impairment in postmenopausal women. The Women’s Health Initiative Memory Study: A randomized controlled trial (WHIMS). JAMA 2003;289:2651-62.
10.Endometrin® (progesterone) package insert. Hunt Valley, MD: Pharmaceutics International, Inc.; 2007 Jun.
11.Prochieve® (progesterone) package insert. Livingston, NJ: Columbia Laboratories, Inc.; 2004 Oct.
12.Dilantin® Kapseals® (extended phenyotin sodium capsules, USP) package insert. Morris Plains, NJ: Parke Davis; 1999 Aug.
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20.Lewis DP, VanDyke DC, Stumbo PJ, et al. Drug and environmental factors associated with adverse pregnancy outcomes Part 1: Antiepileptic drugs, contraceptives, smoking and folate. Ann Pharmacother 1998;32:802—17.
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23.Elestrin™ (estradiol) package insert. San Antonio,TX: DPT Laboratories, Ltd.; 2006 Dec.
24.Archer JSM, Archer DF. Oral contraceptive efficacy and antibiotic interaction: A myth debunked. J Am Acad Dermatol 2002;46:917—23.
25.Dickinson BD, Altman RD, Nielsen NH, Sterling ML, for the Council on Scientific Affairs, American Medical Association (AMA). Drug interactions between oral contraceptives and antibiotics. Obstet Gynecol 2001;98:853—60. Review.
26.Uniphyl® (theophylline, anhydrous) tablets package insert. Stamford, CT: Purdue Pharmaceutical Products LP; 2004 Mar.
27.Biaxin® (clarithromycin) package insert. North Chicago, IL: Abbott Laboratories; 2007 March.
28.Cardizem® CD (diltiazem) package insert. Kansas City, MO: Aventis Pharmaceuticals, Inc.; 2007 Sep.
29.VFEND® (voriconazole) package insert. New York,NY: Pfizer Inc; 2008 Mar.
30.Emend® capsules (aprepitant) package insert. Whitehouse Station, NJ: Merck & Co., Inc.; 2007 Nov.
31.Parlodel (bromocriptine) package insert. East Hanover, NJ: Novartis Pharmaceutical Corporation, Inc.; 2003 Mar.
32.Christen RD, McClay EF, Plaxe SC, et al. Phase I/pharmacokinetic study of high-dose progesterone and doxorubicin. J Clin Oncol 1993;11:2417—26.
33.Targretin® (bexarotene capsules) package insert. San Diego CA: Ligand Pharmaceuticals Inc.; 2003 April.
34.Tracleer® (bosentan) package insert. South San Francisco, CA: Actelion Pharmaceuticals US, Inc.; 2007 Feb.
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36.Progesterone capsule package insert. High Point, NC: Banner Pharmacaps Inc; 2013 Nov.
37.Prochieve (progesterone) vaginal gel package insert. Livingston, NJ: Columbia Laboratories, Inc.; 2009 Nov.
38.Jick H, Jick SS, Gurewich V, et al. Risk of idiopathic cardiovascular death and nonfatal venous thromboembolism in women using oral contraceptives with differing progestagen components. Lancet 1995;346:1589-93.
39.World Health Organization. Effect of different progestagens in low oestrogen oral contraceptives on venous thromboembolic disease. Lancet 1995;346:1582-8.
40.Bloemenkamp KWM, Rosendaal FR, Helmerhorst FM, et al. Enhancement by factor V Leiden mutation of risk of deep-vein thrombosis associated with oral contraceptives containing a third-generation progestagen. Lancet 1995;346:1593-6.

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