Medroxy­ progesterone

FDA label

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Renal Undefined

Hepatic Contraindicated in known liver impairment or disease; no dose adjustment is given.

All three indications are pulsed courses, not continuous daily therapy — dose duration and the cycle day on which the course starts are part of the dose.

Instructions

• Use the lowest effective dose for the shortest duration consistent with treatment goals and the individual woman's risks.
• Progestin withdrawal bleeding usually occurs 3–7 days after discontinuing therapy.
• Re-evaluate periodically as clinically appropriate (for example at 3–6 month intervals) to determine whether treatment is still necessary.
• A woman without a uterus does not need a progestin with estrogen.
• In women with a uterus, undertake adequate diagnostic measures such as endometrial sampling to rule out malignancy for undiagnosed persistent or recurring abnormal vaginal bleeding.
• Patients with recurrent abnormal uterine bleeding may benefit from planned menstrual cycling.

Contraindications

• Undiagnosed abnormal genital bleeding
• Known, suspected, or history of breast cancer
• Known or suspected estrogen- or progesterone-dependent neoplasia
• Active DVT or pulmonary embolism, or a history of these
• Active arterial thromboembolic disease (e.g., stroke, MI), or a history of these
• Known liver impairment or disease
• Known or suspected pregnancy

Cautions

• WHI estrogen plus progestin substudy: increased DVT, PE, stroke and MI in postmenopausal women 50–79 yr on CE 0.625 mg + MPA 2.5 mg over 5.6 years.
• WHIMS ancillary study: increased risk of probable dementia in postmenopausal women ≥65 yr over 4 years on CE + MPA.
• Increased risk of invasive breast cancer with estrogen plus progestin.
• Do not use estrogen plus progestin for prevention of cardiovascular disease or dementia.
• In the absence of comparable data these risks should be assumed similar for other doses and other estrogen/progestin combinations and dosage forms.
• Prescribe progestins with estrogens at the lowest effective dose for the shortest duration consistent with treatment goals.

Adverse reactions

• Genitourinary: abnormal uterine bleeding (irregular, increased or decreased), change in menstrual flow, breakthrough bleeding, spotting, amenorrhea, changes in cervical erosion and secretions.
• Breast: tenderness, mastodynia, galactorrhea.
• Cardiovascular: thromboembolic disorders including thrombophlebitis and pulmonary embolism.
• GI: nausea, cholestatic jaundice.
• Skin: urticaria, pruritus, edema, generalized rash; acne, alopecia, hirsutism.
• Eyes: neuro-ocular lesions such as retinal thrombosis and optic neuritis.
• CNS: mental depression, insomnia, somnolence, dizziness, headache, nervousness.
• Other: hypersensitivity reactions including anaphylaxis/anaphylactoid reactions and angioedema; weight change; pyrexia; edema/fluid retention; fatigue; decreased glucose tolerance.

Pregnancy Contraindicated — should not be used during pregnancy; possible increased risk of hypospadias, clitoral enlargement and labial fusion with first-trimester exposure, though a clear association is not established.

Lactation Undefined