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Progesterone

Generic Name
Progesterone
Brand Names
Bijuva, Crinone, Endometrin, Prochieve, Prometrium
Drug Type
Small Molecule
Chemical Formula
C21H30O2
CAS Number
57-83-0
Unique Ingredient Identifier
4G7DS2Q64Y

Overview

Progesterone is a hormone that occurs naturally in females, and is essential for endometrial receptivity, embryo implantation, and the successful establishment of pregnancy. A low progesterone concentration or an insufficient response to progesterone can cause infertility and pregnancy loss . Progesterone is used in various contraceptive preparations to prevent ovulation and fertilization , as well as in other formulations to promote and support pregnancy. Please see Medroxyprogesterone acetate, Megestrol acetate, Dydrogesterone and Hydroxyprogesterone entries for information on various other forms of progesterone. Pharmaceutical progesterone is made from a plant source as a starting material and is chemically identical to progesterone of human ovarian origin . Progesterone is available in gelatinized capsule form, vaginal gel form, tablet form, vaginal insert form, and injection form, all used for various purposes .

Background

Progesterone is a hormone that occurs naturally in females, and is essential for endometrial receptivity, embryo implantation, and the successful establishment of pregnancy. A low progesterone concentration or an insufficient response to progesterone can cause infertility and pregnancy loss . Progesterone is used in various contraceptive preparations to prevent ovulation and fertilization , as well as in other formulations to promote and support pregnancy. Please see Medroxyprogesterone acetate, Megestrol acetate, Dydrogesterone and Hydroxyprogesterone entries for information on various other forms of progesterone. Pharmaceutical progesterone is made from a plant source as a starting material and is chemically identical to progesterone of human ovarian origin . Progesterone is available in gelatinized capsule form, vaginal gel form, tablet form, vaginal insert form, and injection form, all used for various purposes .

Indication

Gelatinized capsules The gelatinized capsules are indicated for use in the prevention of endometrial hyperplasia in non-hysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea . Vaginal gel Progesterone gel (8%) is indicated as progesterone supplementation or replacement as part of an Assisted Reproductive Technology (“ART”) treatment for infertile women with progesterone deficiency. The lower concentration progesterone gel (4%) is used in the treatment of secondary amenorrhea, with the use of the 8% concentration if there is no therapeutic response to the 4% gel . Vaginal insert This form is indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women . Injection (intramuscular) This drug is indicated in amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer . Tablets, contraceptive The tablet form of progesterone in contraceptive formulations is indicated for the prevention of pregnancy .

Associated Conditions

  • Abnormal Uterine Bleeding
  • Amenorrhea
  • Endometrial hyperplasia caused by conjugated estrogen
  • Moderate to Severe Vasomotor Symptoms
  • Pregnancy
  • Secondary Amenorrhea
  • Recurrent spontaneous preterm birth

FDA Approved Products

Progesterone
Manufacturer:Preferred Pharmaceuticals Inc.
Route:ORAL
Strength:200 mg in 1 1
Approved: 2023/09/12
NDC:68788-8295
FLUOCINOLONE ACETONIDE 0.01% / MINOXIDIL 7% / PROGESTERONE 0.1%
Manufacturer:Sincerus florida, LLC
Route:TOPICAL
Strength:0.1 g in 100 g
Approved: 2019/05/08
NDC:72934-4080
Prochieve
Manufacturer:Columbia Laboratories
Route:VAGINAL
Strength:90 mg in 1.125 g
Approved: 2009/11/19
NDC:55056-1601
Prochieve
Manufacturer:Columbia Laboratories
Route:VAGINAL
Strength:45 mg in 1.125 g
Approved: 2009/11/19
NDC:55056-0406
PROGESTERONE
Manufacturer:Banner Life Sciences LLC.
Route:ORAL
Strength:200 mg in 1 1
Approved: 2015/09/30
NDC:69387-102

Singapore Approved Products

No Singapore products found for this drug

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