me-DROX-ee-proe-JESS-te-rone
REMS
Contraindicated in:
Thromboembolic disease (e.g., deep vein thrombosis [DVT], pulmonary embolism [PE], MI, stroke)
;History of breast cancer
;Protein C, protein S, or antithrombin deficiency or other thrombophilic disorder
;Use Cautiously in:
Long-term use (>4–5 yr); may ↑ risk of MI, stroke, invasive breast cancer, DVT, PE, and dementia in postmenopausal women
;Cardiovascular disease
;CV: DVT, edema, MI, thrombophlebitis
EENT: retinal thrombosis
Endo: breast tenderness, galactorrhea, hyperglycemia
GI: drug-induced hepatitis, gingival bleeding
GU: amenorrhea, breakthrough bleeding, cervical erosions, changes in menstrual flow, dysmenorrhea
Local: injection site reactions
MS:
bone loss
Neuro:
dementia
, depression, STROKEResp: PE
Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS OR ANGIOEDEMA), MALIGNANCY (BREAST, ENDOMETRIAL, OVARIAN)
Drug-drug:
Drug-Natural Products:
Postmenopausal Women Receiving Concurrent Estrogen
Secondary Amenorrhea
Dysfunctional Uterine Bleeding/Induction of Menses
Renal or Endometrial Carcinoma
Endometriosis-Associated Pain
Prevention of Pregnancy
Therapeutic Classification: antineoplastics, contraceptive hormones
Pharmacologic Classification: hormones, progestins
Absorption: 0.6–10% absorbed after oral administration.
Distribution: Unknown.
Half-Life: 1st phase: 52 min; 2nd phase: 230 min; biological: 14.5 hr.
(IM = antineoplastic effects)
| ROUTE | ONSET | PEAK | DURATION |
|---|---|---|---|
| PO | unknown | unknown | unknown |
| IM | wk–mos | mo | unknown‡ |
| SC | unknown | 1 wk | 3 mo |
‡Contraceptive effect lasts 3 mo.
Inform postmenopausal women that long-term use may ↑ risk of MI, stroke, invasive breast cancer, PE, DVT, and dementia.
Advise patient to report signs and symptoms of thromboembolic disorders (pain, swelling, tenderness in extremities, headache, chest pain, blurred vision).
Emphasize the importance of routine follow-up physical exams, including BP check; breast, abdomen, and pelvic examinations; Papanicolaou smears every 6–12 mo; and mammogram every 12 mo or as directed. Health care provider will evaluate possibility of discontinuing medication every 3–6 mo. If on continuous (not cyclical) therapy or without concurrent estrogens, endometrial biopsy may be recommended, if uterus is intact.
NDC Code