Hucedil-500
HYCEDIL-500 (Hydroxyprogesterone caproate)is a synthetic progestin used for the prevention of spontaneous preterm births in singleton pregnancies in women who have previously had a spontaneous preterm birth.
HYCEDIL-500 (Hydroxyprogesterone caproate) was previously indicated in the US for the prevention of spontaneous preterm births in singleton pregnancies in women with a history of spontaneous preterm birth. This indication was revoked by the FDA in April 2023.
HYCEDIL-500 (Hydroxyprogesterone caproate) remains indicated in other jurisdictions for the management of primary and secondary amenorrhea, corpus luteum insufficiency, and for the prevention of preterm birth.
Pharmacodynamics
No specific pharmacodynamic studies have been performed to assess hydroxyprogesterone caproate(HYCEDIL-500) injections. However, the mechanism of action is likely related to increased interaction between progesterone and progesterone receptors.
Mechanism of action HYCEDIL-500 ( HYDROXYPROGESTRONE CAPROATE 500MG)
The mechanism by which progesterone prevents preterm birth is not well understood, but many pathways are likely involved. Progesterone plays a vital role in regulation of the female reproductive system and is important for successful implantation of the embryo and maintenance of pregnancy. It acts by binding to progesterone receptors in the uterus, ovaries, breasts and in the central nervous system. These receptors exist in 2 isoforms, PR-A and PR-B. Progesterone binding to these receptors ultimately leads to regulation of gene transcription. This results in an anti-inflammatory effect which blunts the proinflammatory state that occurs with initiation of labor, and maintains uterine queiscence by stabilizing progesterone acting on the myometrium.
Absorption:
Absorption of 17-hydroxyprogesteron caproate is slow, occurring over a long period of time.
Volume of distribution:
Hydroxyprogesterone caproate (Hycedil-500) has a high volume of distribution.
Protein binding:
Hydroxyprogesterone caproate (Hycedil-500) is extensively protein bound in the plasma.
Metabolism:
The main enzymes involved in metabolism of hydroxyprogesterone caproate (Hycedil-500) are cytochrome P450 (CYP) 3A4 and to a lesser extent CYP3A5.
Route of elimination:
Following intramuscular injection, approximately 50% of hydroxyprogesterone caproate (Hycedil-500) metabolites are eliminated in the feces, while approximately 30% of metabolites are eliminated in the urine.
Half-life:
Half-life = 16 days (±6 days).
Clearance
Clearance is highly variable from patient to patient.
