ENDOMETRIN VAGINAL TABLET 100mg FOR VAGINAL USE

Product Information

Registration Status: Active

ENDOMETRIN VAGINAL TABLET 100mg is approved to be sold in Singapore with effective from 2016-05-12. It is marketed by FERRING PHARMACEUTICALS PTE LTD, with the registration number of SIN15005P.

This product contains Progesterone 100mg in the form of TABLET, EFFERVESCENT. It is approved for VAGINAL use.

This product is manufactured by QPharma AB in SWEDEN.

It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.

Description

The major progestational steroid that is secreted primarily by the corpus luteum and the placenta. Progesterone acts on the uterus, the mammary glands, and the brain. It is required in embryo implantation, pregnancy maintenance, and the development of mammary tissue for milk production. Progesterone, converted from pregnenolone, also serves as an intermediate in the biosynthesis of gonadal steroid hormones and adrenal corticosteroids.

Indication

For progesterone supplementation or replacement as part of an Assisted Reproductive Technology (ART) treatment for infertile women with progesterone deficiency and for the treatment of secondary amenorrhea. Also used for the reduction of the incidence of endometrial hyperplasia and the attendant risk of endometrial carcinoma in postmenopausal women receiving estrogen replacement therapy, as well as treatment of abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology such as fibroids or uterine cancer.

Mechanism of Action

Progesterone shares the pharmacological actions of the progestins. Progesterone binds to the progesterone and estrogen receptors. Target cells include the female reproductive tract, the mammary gland, the hypothalamus, and the pituitary. Once bound to the receptor, progestins like Progesterone will slow the frequency of release of gonadotropin releasing hormone (GnRH) from the hypothalamus and blunt the pre-ovulatory LH (luteinizing hormone) surge. In women who have adequate endogenous estrogen, progesterone transforms a proliferative endometrium into a secretory one. Progesterone is essential for the development of decidual tissue and is necessary to increase endometrial receptivity for implantation of an embryo. Once an embryo has been implanted, progesterone acts to maintain the pregnancy. Progesterone also stimulates the growth of mammary alveolar tissue and relaxes uterine smooth muscle. It has little estrogenic and androgenic activity.

Pharmacokinetics

Absorption: Progesterone absorption is prolonged with an absorption half-life of approximately 25-50 hours.
Distribution
Metabolism: Progesterone is metabolized primarily by the liver largely to pregnanediols and pregnanolones.
Elimination

Clearance

* 2510 +/- 135 L/day [cycling women]

Active Ingredient/Synonyms

Source of information: Drugbank (External Link). Last updated on: 3^rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.