Precautions and Contraindications
Progesterone shares the toxic potentials of progestins, and the usual precautions of progestin therapy should be observed. Prior to initiation of therapy with progesterone in women, a physical examination should be performed, including special attention to the breasts and pelvic organs and a Papanicolaou test (Pap smear). Women receiving progesterone should be given a copy of the patient labeling for the drug.
Progesterone should be used with caution, and only with careful monitoring, in patients with conditions that might be aggravated by fluid retention (e.g., asthma, seizure disorders, migraine, or cardiac or renal dysfunction). The drug should also be used with caution in patients with a history of mental depression; progesterone should be discontinued if depression recurs to a serious degree during therapy with the drug.
When breakthrough bleeding or irregular vaginal bleeding occurs during progesterone therapy, nonfunctional causes should be considered. Adequate diagnostic procedures should be performed in patients with undiagnosed vaginal bleeding.
Diabetic patients should be carefully monitored during progesterone therapy, since decreased glucose tolerance has been observed in women receiving estrogen-progestin combinations. Progesterone may mask the onset of climacteric in women.
The clinician and the patient using progesterone should be alert to the earliest signs and symptoms of myocardial infarction, cerebrovascular disorders, thromboembolism (e.g., venous thromboembolism, pulmonary embolism), thrombophlebitis, or retinal thrombosis. The drug should be discontinued immediately when any of these disorders occurs or is suspected.
If unexplained, sudden or gradual, partial or complete loss of vision; proptosis or diplopia; papilledema; retinal vascular lesions; or migraine occur during therapy with progesterone, the drug should be discontinued and appropriate diagnostic and therapeutic measures instituted.
Because dizziness has been reported during therapy with oral progesterone, patients receiving such therapy should be advised to use caution while driving or operating machinery.
Progesterone is contraindicated in patients with thrombophlebitis, thromboembolic disorders, cerebral apoplexy, or a history of these conditions. The drug is also contraindicated in patients with undiagnosed vaginal bleeding, missed abortion, known sensitivity to the drug or any ingredient in the formulation, markedly impaired liver function or liver disease, or carcinoma of the breast or for use as a pregnancy test.
Progesterone capsules are contraindicated in individuals with known hypersensitivity to peanuts because the capsules contain peanut oil.