PROLUTON DEPOT 250MG INJ (1ML AMP)

국가: 말레이시아

언어: 영어

출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

유효 성분:

HYDROXYPROGESTERONE HEXANOATE/CAPROATE

제공처:

BAYER CO. (MALAYSIA) SDN. BHD.

INN (국제 이름):

HYDROXYPROGESTERONE HEXANOATE/CAPROATE

패키지 단위:

1mL x 1 unit Ampoules

Manufactured by:

BAYER AG

환자 정보 전단

Not Applicable

제품 특성 요약

last updated: 20 Oct 2017
Proluton Depot
Composition
1 ml Proluton Depot contains 250 mg hydroxyprogesterone caproate in oily solution.
Pharmacodynamic properties
Pharmacotherapeutic group: Progestogens
(ATC): G03D
Proluton Depot contains the progestogen hydroxyprogesterone capr oate in oily solution.
Hydroxyprogesterone caproate is an ester of the natural hydroxyprogesterone and exerts typical
progestogenic effects in women, comparable to progesterone such as antigonadotrophic effects, secretory
transformation of the endometrium and thickening of the cervical mucus. In opposite to the short -lasting
progesterone, hydroxyprogesterone caproate has a progestogenic depot effect. Following intramuscular
administration, m aximum concentrations in the plasma are reached within 2 -5 days. Th e thermogenic effect
of the preparation is weak.
The administration of 250 mg hydroxyprogesterone caproate leads to secretory transformation of the
endometrium; the effect lasts about 10 days if an estrogen is administered at the same time.
Proluton Depot does not inhibit the production of progesterone during the luteal phase and has no
estrogenic, corticoid or androgenic effect. Moreover, it has no inhibitory effect on the placental production
of hormones.
Pharmacokinetic properties
Absorption
Within 3 0 days after intramuscular administration, hydroxyprogesterone caproate was gradually and
completely released from the depot. The parent compound reached maximum concentrations in serum of 17
± 6 ng/ml within 2 -5 days after administration. Thereafter, the serum levels of hydroxyprogesterone
caproate decreased slowly, and the compound was eliminated from the serum within 23 - 28 days post
dose.
Distribution There is no formation of secondary depots or deep compartments (e.g. fat) in the body.
Metabolism
Hydroxyprogesterone caproate is predominately metabolized as the complete steroid ester. Only small
amounts of estradiol and its metabolites could be detected. The parent compound was practically not
detectable in urine and feces ind