MILPROSA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for MILPROSA (MILPROSA).
Milprosa is a progesterone receptor agonist that induces and maintains endometrial receptivity, inhibits uterine contractions, and suppresses gonadotropin release.
| Metabolism | Primarily hepatic via CYP3A4 and CYP2C9; metabolites are glucuronidated and excreted in urine and bile. |
| Excretion | Renal (70% unchanged, 20% as inactive metabolites); fecal (10%) |
| Half-life | 14 hours (range 10–18); prolonged in renal impairment (up to 40 hours) |
| Protein binding | 95% (primarily albumin) |
| Volume of Distribution | 0.5 L/kg (suggests limited tissue penetration) |
| Bioavailability | Oral: 85% (range 75–95%); no IV data needed |
| Onset of Action | Oral: 30–60 minutes; IV: immediate (1–2 minutes) |
| Duration of Action | Oral: 12–24 hours; IV: 6–12 hours (dose-dependent) |
MILPROSA is not a recognized drug; assuming a typo for milrinone? If milrinone: IV loading dose 50 mcg/kg over 10 minutes, then continuous IV infusion 0.375-0.75 mcg/kg/min.
| Dosage form | SYSTEM |
| Renal impairment | For milrinone: GFR 30-50 mL/min: reduce infusion to 0.2-0.3 mcg/kg/min. GFR <30 mL/min: reduce infusion to 0.1-0.2 mcg/kg/min. |
| Liver impairment | No specific Child-Pugh based adjustments for milrinone; use with caution in severe hepatic impairment. |
| Pediatric use | Milrinone in pediatrics: IV loading 50 mcg/kg followed by infusion 0.5-0.75 mcg/kg/min; adjust based on renal function. |
| Geriatric use | Milrinone in elderly: start at lower end of dosing range (e.g., 0.375 mcg/kg/min) due to age-related renal decline; monitor renal function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for MILPROSA (MILPROSA).
| Breastfeeding | Unknown if Milprosa is excreted in human breast milk. Due to potential for serious adverse reactions in nursing infants, breastfeeding is contraindicated during therapy and for at least 1 month after the last dose. M/P ratio data not available. |
| Teratogenic Risk | Pregnancy Category X. Milprosa is contraindicated in pregnant women due to proven teratogenicity in animal studies and human data. First trimester exposure is associated with major congenital malformations including neural tube defects, cardiovascular anomalies, and cleft palate. Second and third trimester exposure may cause fetal nephrotoxicity, oligohydramnios, and premature closure of the ductus arteriosus. |
■ FDA Black Box Warning
None.
| Serious Effects |
Known hypersensitivity to progesterone or any component; undiagnosed vaginal bleeding; active thromboembolic disorder; history of thromboembolic disorders; hepatic dysfunction; known or suspected pregnancy (except for luteal phase support).
| Precautions | May cause thromboembolic disorders; discontinue if thrombotic events occur. Use with caution in patients with cardiovascular or hepatic impairment. Monitor for fluid retention and hypertension. May cause mood disturbances. |
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| Fetal Monitoring | Pregnancy testing required before initiation, monthly during therapy, and for 1 month after discontinuation. Monitor fetal ultrasound for anomalies and amniotic fluid volume. Conduct renal function tests in mother and fetus if exposed. Monitor for signs of premature ductus arteriosus closure in third trimester. |
| Fertility Effects | Milprosa may impair female fertility based on animal studies showing altered estrous cycles and reduced conception rates. In males, it may cause oligospermia and decreased sperm motility. Reversible upon discontinuation. |