Crinone, Prometrium, and Oil for Injection:

• Secondary amenorrhea.

Oil for injection:

• Abnormal uterine bleeding.

Prometrium:

• Prevention of endometrial hyperplasia in postmenopausal women who have not had a hysterectomy (with estrogen).

Crinone and Endometrin:

• Part of assisted reproductive technology in the management of infertility.

Contraindicated in:

• Hypersensitivity
• Hypersensitivity to parabens or sesame oil/seeds (IM suspension only)
• Hypersensitivity to peanuts (Prometrium only)
• Undiagnosed vaginal bleeding
• Thromboembolic disease
• Cerebrovascular disease
• Severe hepatic impairment
• Breast or genital cancer
• Missed abortion
• OB: Pregnancy.

Use Cautiously in:

• History of hepatic impairment
• Cardiovascular disease
• Depression
• Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant.

CV: DEEP VEIN THROMBOSIS, edema, MI, thrombophlebitis.

Derm: chloasma, melasma, rash.

EENT: retinal thrombosis.

Endo: amenorrhea, breakthrough bleeding, breast tenderness, changes in menstrual flow, galactorrhea, spotting.

GI: ↓ weight, constipation, hepatitis, nausea.

GU: cervical erosions, pelvic pain, vaginal discharge.

Local: irritation or pain at IM injection site.

Metab: ↑ weight.

Neuro: depression, headache, STROKE.

Resp: PULMONARY EMBOLISM.
Misc: gingival bleeding, (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA)HYPERSENSITIVITY REACTIONS .

Drug-Drug:

• May ↓ effectiveness of bromocriptine when used concurrently for galactorrhea and amenorrhea.

(Generic available)

• Capsules (Prometrium): 100 mg; 200 mg;
• Oil for injection: 50 mg/mL;
• Vaginal gel (Crinone): 4%; 8%;
• Vaginal insert (Endometrin): 100 mg;
• In combination with: estradiol (Bijuva). See Appendix [not included in this PDA edition].

Secondary Amenorrhea

• PO (Adults): 400 mg once daily in the evening for 10 days.
• Vag (Adults): 45 mg (1 applicatorful of 4% gel) once every other day for up to 6 doses; may be ↑ to 90 mg (1 applicatorful of 8% gel) once every other day for up to 6 doses.
• IM (Adults): 100–150 mg (single dose) or 5–10 mg once daily for 6–8 days given 8–10 days before expected menstrual period.

Abnormal Uterine Bleeding

• IM (Adults): 5–10 mg once daily for 6 days.

Prevention of Endometrial Hyperplasia

• PO (Adults): 200 mg once daily at bedtime for 12 days sequentially per 28-day cycle.

Assisted Reproductive Technology

• Vag (Adults): Patients who require progesterone supplementation: 90 mg (1 applicatorful of 8% gel) once daily; if pregnancy occurs, may continue for up to 10–12 wk or 100 mg insert 2 or 3 times daily starting the day after oocyte retrieval and continuing for up to 10 wk total duration; Patients with partial or complete ovarian failure who require progesterone replacement (intravaginal gel): 90 mg (1 applicatorful of 8% gel) twice daily; if pregnancy occurs, may continue for up to 10–12 wk.

Crinone, Endometrin, Prometrium

• Produces:
  • Secretory changes in the endometrium,
  • Increase in basal body temperature,
  • Histologic changes in vaginal epithelium,
  • Relaxation of uterine smooth muscle,
  • Mammary alveolar tissue growth,
  • Pituitary inhibition,
  • Withdrawal bleeding in the presence of estrogen.

• Restoration of hormonal balance with control of uterine bleeding.
• Successful outcome in assisted reproduction.

Therapeutic Classification: hormones

Pharmacologic Classification: progestins

Absorption: Micronization increases oral and vaginal absorption.

Distribution: Unknown.

Protein Binding: ≥90%.

Metabolism/Excretion: Metabolized by the liver; 50–60% eliminated by kidneys; 10% eliminated in feces.

Half-life: Several min.

(plasma concentrations)

• Explain purpose of progesterone to patient.
• 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), mental depression, or hepatic impairment (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.
• Caution patient to use sunscreen and protective clothing to prevent photosensitivity reactions.
• Advise patient to notify health care professional of medication regimen before treatment or surgery.
• Advise females of reproductive potential to notify health care professional immediately if pregnancy is planned or suspected, or if breastfeeding.
• Emphasize the importance of routine follow-up physical exams, including BP; breast, abdomen, and pelvic examinations; and Pap smears.
• Vag: Instruct patient not to use vaginal gel concurrently with other vaginal agents. If these agents must be used concurrently, administer at least 6 hr before or after vaginal gel. Small, white globules may appear as a vaginal discharge possibly due to gel accumulation, even several days after use.

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