Product Information
Registration Status: ActiveSIN14879P
PROLUTON DEPOT INJECTION 250MG/ML is approved to be sold in Singapore with effective from 2015-10-27. It is marketed by BAYER (SOUTH EAST ASIA) PTE LTD, with the registration number of SIN14879P.
This product contains Hydroxyprogesterone Caproate 0.250g/ml in the form of INJECTION. It is approved for INTRAVENOUS use.
This product is manufactured by Bayer Pharma AG in GERMANY.
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.
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}Description
Hydroxyprogesterone caproate is a synthetic steroid hormone that is similar to medroxyprogesterone acetate and megestrol acetate. It is an ester derivative of 17α-hydroxyprogesterone formed from caproic acid (hexanoic acid). Hydroxyprogesterone caproate was previously marketed under the trade name Delalutin by Squibb, which was approved by the U.S. Food and Drug Administration (FDA) in 1956 and withdrawn from marketing in 1999. The U.S. FDA approved Makena from KV Pharmaceutical (previously named as Gestiva) on February 4, 2011 for prevention of preterm delivery in women with a history of preterm delivery, sparking a pricing controversy.
Indication
Hydroxyprogesterone caproate is indicated for the prevention of spontaneous preterm births in singleton pregnancies in women who have previously had a spontaneous preterm birth. (1)
Mechanism of Action
The mechanism by which progesterone prevents preterm birth is not well understood, but many pathways are likely involved. (1) 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. (2) 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. (2)
Pharmacokinetics
- Absorption
- Absorption of 17-hydroxyprogesteron caproate is slow, occurring over a long period of time. (3)
- Distribution
- Hydroxyprogesterone caproate has a high volume of distribution. (3)
- Metabolism
- The main enzymes involved in metabolism of hydroxyprogesterone caproate are cytochrome P450 (CYP) 3A4 and to a lesser extent CYP3A5. (3)
- Elimination
Clearance
Clearance is highly variable from patient to patient. (3)
Toxicity
Injection site pain is the most common adverse effect associated with hydroxyprogesterone caproate. Other commonly reported adverse effects include: injection site swelling, urticaria, pruritus, injection site pruritus, nausea, injection site nodule, and diarrhea. (4)
Active Ingredient/Synonyms
17alpha-Caproyloxypregn-4-ene-3,20-dione | Delalutin | Hydroxyprogesterone | Oxiprogesterone Caproate | Primolut depot | Hydroxyprogesterone caproate |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.