hydroxyprogesterone

hydroxyprogesterone

 [hi-drok″se-pro-jes´ter-ōn]
1. 17α-hydroxyprogesterone; an intermediate formed in the conversion of cholesterol to cortisol, androgens, and estrogens.
2. a synthetic preparation of the caproate ester, used in treatment of dysfunctional uterine bleeding and menstrual cycle abnormalities, and in the diagnosis of endogenous estrogen production; administered orally.

hydroxyprogesterone

(hye-drox-ee-pro-jess-te-rone) ,

Hy/Gesterone

(trade name),

Hylutin

(trade name),

Pro-Depo

(trade name),

Prodrox

(trade name),

Pro-Span

(trade name)

Classification

Therapeutic: hormones
Pharmacologic: progestins
Pregnancy Category: D

Indications

Treatment of amenorrhea and functional uterine bleeding associated with hormonal imbalance.Production of secretory endometrium.Diagnostic agent for endogenous estrogen production.

Action

A synthetic analog of progesterone.
Produces secretory changes in the endometrium.
Increases basal temperature.
Produces changes in the vaginal epithelium.
Relaxes uterine smooth muscle.
Stimulates mammary alveolar growth.
Inhibits pituitary function.
Produces withdrawal bleeding (requires estrogen).

Therapeutic effects

Restoration of normal hormonal balance.

Pharmacokinetics

Absorption: Systemic absorption follows IM administration.
Distribution: Unknown.
Metabolism and Excretion: Metabolized by the liver with renal excretion of metabolites.
Half-life: Unknown, but levels are measurable for up to 4 weeks with IM administration.

Time/action profile (hormonal effects)

ROUTEONSETPEAKDURATION
IMunknownunknown9–17 days

Contraindications/Precautions

Contraindicated in: Hypersensitivity; Hypersensitivity to castor oil, sesame oil, or benzyl alcohol; Thromboembolic disorders; Severe liver disease; Breast carcinoma; Undiagnosed vaginal bleeding; Missed abortion; Pregnancy, lactation, or children.
Use Cautiously in: Cardiac disease; Renal dysfunction; Asthma; Seizures; Migraine headaches; Diabetes mellitus.

Adverse Reactions/Side Effects

Central nervous system

  • cerebral thrombosis (life-threatening)
  • depression

Respiratory

  • coughing
  • dyspnea

Cardiovascular

  • pulmonary embolism (life-threatening)
  • edema
  • thrombophlebitis

Gastrointestinal

  • cholestatic jaundice

Genitourinary

  • breakthrough bleeding (most frequent)
  • amenorrhea
  • cervical changes

Dermatologic

  • increased pigmentation
  • rashes

Miscellaneous

  • allergic reactions
  • weight changes

Interactions

Drug-Drug interaction

Interferes with the effects of bromocriptine (causes amenorrhea or galactorrhea).

Route/Dosage

Amenorrhea, Dysfunctional Uterine Bleeding, Metrorrhagia
Intramuscular (Adults) 375 mg.
Production of Secretory Endometrium
Intramuscular (Adults) 125–250 mg given on the 10th day of the cycle, repeated q 7 days until suppression is no longer required.

Availability (generic available)

Injection: 125 mg/mL, 250 mg/mL

Nursing implications

Nursing assessment

  • BP should be monitored periodically throughout therapy.
  • Monitor fluid intake and output ratios and weekly weight. Report significant discrepancies or steady weight gain to physician or other health care professional.
  • Monitor pattern and amount of vaginal bleeding (pad count).
  • Lab Test Considerations: Monitor hepatic function before and periodically throughout therapy. May cause increased serum glucose and alkaline phosphatase levels. May decrease pregnanediol excretion concentrations.
    • May cause increased LDL and decreased HDL and amino acid concentrations.

Potential Nursing Diagnoses

Sexual dysfunction (Indications)

Implementation

  • Intramuscular: Administer deep IM. Use dry needle and syringe to prevent clouding of solution.

Patient/Family Teaching

  • Advise patient to report signs and symptoms of fluid retention (swelling of ankles and feet, weight gain), thromboembolic disorders (pain, swelling, tenderness in extremities, headache, chest pain, blurred vision), depression, or hepatic dysfunction (yellowed skin or eyes, pruritus, dark urine, light-colored stools) to health care professional.
    • Instruct patient to notify health care professional if change in vaginal bleeding pattern or spotting occurs.
    • Instruct patient to stop taking medication and notify health care professional if pregnancy is suspected.
    • Caution patient to use sunscreen and protective clothing to prevent increased pigmentation.
    • Instruct patient to practice good oral hygiene, have teeth cleaned regularly, and notify dentist if tenderness, swelling, or bleeding gums occur.
    • Advise patients with diabetes to monitor serum glucose carefully and report any abnormalities to health care professional; may decrease glucose tolerance.
    • Advise patient to notify health care professional of medication regimen before treatment or surgery.
    • Emphasize the importance of routine follow-up physical exams, including BP; ophthalmic, breast, abdominal, and pelvic examinations; and PAP smears.
  • Amenorrhea or Functional Uterine Bleeding: Explain 28-day cyclic dosage schedule. Cyclic therapy begins after 4 days of desquamation from initial dose or 21 days after injection if bleeding did not occur. Explain that several months of estrogen therapy may be required before menstruation occurs.

Evaluation/Desired Outcomes

  • Development of normal cyclic menses.
  • Control of the spread of advanced metastatic uterine cancer..
References in periodicals archive ?
LPCN 1107 is potentially the first oral hydroxyprogesterone caproate product candidate indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA.
M2 PHARMA-March 27, 2019-Slayback Pharma wins US FDA approval of Hydroxyprogesterone Caproate Injection, USP 250 mg/ 1 m in single-dose vial
M2 EQUITYBITES-March 27, 2019-Slayback Pharma wins US FDA approval of Hydroxyprogesterone Caproate Injection, USP 250 mg/ 1 m in single-dose vial
Global Banking News-March 27, 2019-Slayback Pharma wins US FDA approval of Hydroxyprogesterone Caproate Injection, USP 250 mg/ 1 m in single-dose vial
DOH is also announcing that seven partners have agreed to administer 17-alpha hydroxyprogesterone (17P) through funding that the Department has secured from the CDC, as part of the Preventative Health Services Block Grant.
Seventeen hydroxyprogesterone, dehydroepiandrosterone sulfate (DHEAS), and testosterone were normal.
Serum concentrations of pregnenolone, 17a hydroxyprogesterone, corticosterone, DHEA, and androstenedione were measured by LC-MS method using an Agilent 1200 Series HPLC system for HPLC (Agilent Technologies Inc., California, USA) and an AB Sciex API5000 tandem mass spectrometer (AB Sciex Pte.
After publication of the results of the Meis Trial (1) in 2003 demonstrating the benefits of weekly administration of intramuscular 17P (17-alpha hydroxyprogesterone caproate, or hydroxyprogesterone caproate, or OHPC, referred to as 17P for brevity) when administered between 16 and 36 6/7 weeks of reducing the risk of recurrent preterm birth (PTB), the only available form of the medication for this indication was from compounding pharmacies.
The effect of 17 alpha hydroxyprogesterone caproate on pregnancy outcome in an active-duty military population.
Lumara Health's flagship product, Makena (hydroxyprogesterone caproate injection), is the only Food and Drug Administration-approved product to reduce the risk of recurrent pre-term birth in certain at-risk women.
Inefficacy of 17 I+- hydroxyprogesterone caproate in the prevention of prematurity in twin pregnancy.

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