pro-JESS-te-rone
REMS
Contraindicated in:
Thromboembolic disease (e.g., deep vein thrombosis [DVT], pulmonary embolism [PE], MI, stroke)
;Protein C, protein S, or antithrombin deficiency or other thrombophilic disorder
;Use Cautiously in:
Long-term use (more than 4–5 yr); may ↑ risk of MI, stroke, invasive breast cancer, DVT, PE, and dementia in postmenopausal women
;Breast cancer
;Cardiovascular disease
;CV: DVT, edema, MI, thrombophlebitis
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
Neuro:
dementia
, depression, headache, STROKEResp: PE
Misc: gingival bleeding, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA), MALIGNANCY (BREAST, ENDOMETRIAL, OVARIAN)
Drug-drug:
Secondary Amenorrhea
Abnormal Uterine Bleeding
Prevention of Endometrial Hyperplasia
Assisted Reproductive Technology
Absorption: Micronization ↑ oral and vaginal absorption.
Distribution: Unknown.
Protein Binding: ≥90%.
Half-Life: Several min.
(plasma concentrations)
| ROUTE | ONSET | PEAK | DURATION |
|---|---|---|---|
| PO | unknown | 2–4 hr | unknown |
| Vaginal | unknown | 34.8–55 hr | unknown |
| IM | unknown | 19.6–28 hr | unknown |
Inform postmenopausal women that long-term use may ↑ risk of MI, stroke, invasive breast cancer, PE, DVT, and dementia.
Emphasize the importance of routine follow-up physical exams, including BP; breast, abdomen, and pelvic examinations; and Pap smears.
Advise patient to promptly report signs and symptoms of changes in vision or speech; sudden new, severe headaches; severe pains in chest or legs, with or without shortness of breath; weakness; or fatigue promptly to health care provider immediately.
NDC Code