hydroxyprogesterone caproate


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hydroxyprogesterone caproate

(hye-drox-ee-pro-jess-te-rone kap-roe-ate) ,

Makena

(trade name)

Classification

Therapeutic: hormones
Pharmacologic: progestins
Pregnancy Category: B

Indications

To ↓ the risk of preterm birth in women with a singleton pregnancy who have a history of previous singleton preterm birth.

Action

A synthetic analog of progesterone. Produces secretory changes in the endometrium. ↑s basal temperature. Produces changes in the vaginal epithelium. Relaxes uterine smooth muscle. Stimulates mammary alveolar growth. Inhibits pituitary function.
Action in reducing risk of recurrent preterm birth is unknown.

Therapeutic effects

↓ risk of preterm birth in women at risk.

Pharmacokinetics

Absorption: Slowly absorbed following IM administration.
Distribution: Unknown.
Protein Binding: Extensively bound to plasma proteins.
Metabolism and Excretion: Extensively metabolized by the liver.
Half-life: 7.8 days.

Time/action profile (blood levels)

ROUTEONSETPEAKDURATION
IMunknown4.6 days7 days

Contraindications/Precautions

Contraindicated in: Hypersensitivity to hydroxyprogesterone or castor oil;History of or known thrombosis/thromboembolic disorder;History of or known/suspected breast cancer or other hormone-sensitive cancer;Unexplained abnormal vaginal bleeding unrelated to pregnancy;Cholestatic jaundice of pregnancy;Benign/malignant liver tumors or active liver disease;Uncontrolled hypertension.
Use Cautiously in: Risk factors for thromboembolic disorders (may ↑ risk);Diabetes mellitus or risk factors for diabetes mellitus (may impair glucose tolerance);History of preeclampsia, epilepsy, cardiac or renal impairment (may be adversely affected by fluid retention);History of depression (may worsen);Safe and effective use in children <16 yr has not been established.

Adverse Reactions/Side Effects

Central nervous system

  • depression

Cardiovascular

  • hypertension

Gastrointestinal

  • diarrhea
  • jaundice
  • nausea

Dermatologic

  • urticaria (most frequent)
  • pruritus

Fluid and Electrolyte

  • fluid retention

Hematologic

  • thromboembolism (life-threatening)

Local

  • injections site reactions (most frequent)

Miscellaneous

  • allergic reactions including angioedema

Interactions

Drug-Drug interaction

May ↑ metabolism and ↓ blood levels and effectiveness of drugs metabolized by the CYP1A2, CYP2A6 and CYP2B6 enzyme systems.

Route/Dosage

Intramuscular (Adults) 250 mg once weekly starting between 16 wks, 0 days and 20 wks, 6 days continuing until wk 37 of gestation or delivery, whichever occurs first.

Availability

Solution for IM injection (contains castor oil): 1250 mg/5 mL vial (250 mg/mL)

Nursing implications

Nursing assessment

  • Monitor for signs and symptoms of thromboembolic disorders throughout therapy.
  • Monitor vital signs during therapy. If hypertension occurs, consider discontinuation of therapy.
  • Assess for signs and symptoms of allergic reactions (urticaria, pruritus, angioedema) during therapy. Consider discontinuation if allergic reactions occur.
  • Monitor for fluid retention during therapy, especially in patients at ↑ risk for complications (preeclampsia, epilepsy, migraine, asthma, cardiac or renal dysfunction).
  • Assess mental status and mood changes, especially in women with a history of depression. Discontinue hydroxyprogesterone if depression recurs or worsens.
  • Lab Test Considerations: May ↓ glucose tolerance. Monitor serum glucose in prediabetic and diabetic women during therapy.

Potential Nursing Diagnoses

Deficient knowledge, related to disease process and medication regimen (Patient/Family Teaching)

Implementation

  • Intramuscular: Draw up 1 mL of solution into a 3 mL syringe with an 18 gauge needle. Solution is clear, yellow, viscous and oily. Do not administer solutions that are cloudy or contain particles. Change needle to 21 gauge 1 1/2 inch needle. Inject into upper outer quadrant of gluteus maximus slowly, over 1 min or longer. Apply pressure to injection site to minimize bruising and swelling. Store hydroxyprogesterone in original box, at room temperature, protected from light. Discard unused product after 5 wks from first use.

Patient/Family Teaching

  • Instruct patient to continue to receive injection weekly from health care professional. If a dose is missed, consult health care professional for instructions regarding returning to schedule.
  • Advise patient to notify health care professional if signs and symptoms of blood clots (leg swelling, redness in your leg, a spot on your leg that is warm to touch, leg pain that worsens when you bend your foot), allergic reactions (hives, itching, swelling of the face), depression, or yellowing of skin and whites of the eyes occur.
  • Inform patient that injection site reactions (pain, swelling, itching, bruising, nodule formation) may occur. If ↑ pain over time, oozing of blood or fluid, or swelling occur, notify health care professional.

Evaluation/Desired Outcomes

  • ↓ risk of preterm birth in women at risk.
References in periodicals archive ?
The effect of 17 alpha hydroxyprogesterone caproate on pregnancy outcome in an active-duty military population.
Inefficacy of 17 I+- hydroxyprogesterone caproate in the prevention of prematurity in twin pregnancy.
Among the products recalled by NECC is hydroxyprogesterone caproate, or I7P, which is a compounded version of Makena.
An uprising over this price gouging forced the FDA to back down and state it "does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate.
She had had two abortions during the last two years and was receiving hydroxyprogesterone caproate treatment.
Hydroxyprogesterone caproate in oil is commercially available in the United States in 125 mg/mL and 250 mg/mL strengths.
Food and Drug Administration (FDA) and K-V Pharmaceutical citing information and an analysis provided to the FDA by K-V Pharmaceutical in October 2011 regarding samples of bulk hydroxyprogesterone caproate (17P) active pharmaceutical ingredients (APIs) and compounded hydroxyprogesterone products.
Tenders are invited for Inj Hydroxyprogesterone Caproate 250 Mg 1 Ml
No major safety problems were identified in the Food and Drug Administration's review of compounded formulations of hydroxyprogesterone caproate, but the agency continues to emphasize that the approved version of the product, known as Makena, used to reduce the risk of preterm birth in certain patients, is more reliable.
Hydroxyprogesterone caproate was initially approved in 1956 for treatment and prevention of recurrent miscarriage, among other indications, but was withdrawn in 2000 because of manufacturing problems.
Though the initial study by Meis and colleagues was reported in 2003,17-alpha hydroxyprogesterone caproate (17P) for the prevention of recurrent PTB was not commercially approved by the FDA until February 2011.
17 Hydroxyprogesterone caproate reverses induced vasoconstriction of fetoplacental arteries by thromboxane mimetic U46619.

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