Progestedin Special Precautions

Progesterone capsules are not a treatment for premature labor. Prescription of progesterone beyond the first trimester of pregnancy may reveal gravidic cholestasis. Progesterone capsules are not suitable for use as a contraceptive. If unexplained, sudden or gradual, partial or complete loss of vision, proptosis or diplopia, papilloedema, retinal vascular lesions or migraine occur during therapy, the drug should be discontinued and appropriate diagnostic and therapeutic measures instituted. Progesterone capsules are intended to be co-prescribed with an estrogen product as hormone replacement therapy (HRT). Epidemiological evidence suggests that the use of HRT is associated with an increased risk of developing deep vein thrombosis (DVT) or pulmonary embolism. The prescribing information for the co-prescribed estrogen product should be referred to for information about the risks of venous thromboembolism.
There is suggestive evidence of a small increased risk of breast cancer with estrogen replacement therapy. It is not known whether concurrent progesterone influences the risk of cancer in postmenopausal women taking hormone replacement therapy. The prescribing information for the co-prescribed estrogen product should be referred to for information about the risks of breast cancer.
Progesterone should only be used in pregnancy during the first trimester and only by the vaginal route. Progesterone is not a treatment of threatening premature labor. The use of micronized progesterone during the second and third trimesters of pregnancy can lead to the development of cholestatic jaundice of pregnancy or hepato-cellular liver disease.
Precautions: Prior to taking hormone replacement therapy (and at regular intervals thereafter) each woman should be assessed. A personal and family medical history should be taken and physical examination should be guided by this and by the contraindications and warnings for this product. Progesterone capsules should not be taken with food and should be taken at bedtime. Concomitant food ingestion increases the bioavailability of progesterone capsules.
Progesterone capsules should be used cautiously in patients with conditions that might be aggravated by fluid retention (e.g. hypertension, cardiac disease, renal disease, epilepsy, migraine, asthma); in patients with a history of depression, diabetes, mild to moderate hepatic dysfunction, migraine or photosensitivity and in breastfeeding mothers.
Clinical examination of the breasts and pelvic examination should be performed where clinically indicated rather than as a routine procedure. Women should be encouraged to participate in the national breast cancer screening programme (mammography) and the national cervical cancer screening programme (cervical cytology) as appropriate for their age. Breast awareness should also be encouraged and women are advised to report any changes in their breasts to their doctor or nurse.
Effects on ability to drive and use machines: Progesterone capsules may cause drowsiness and/or dizziness in a minority of patients; therefore caution is advised in drivers and users of machines. Taking the capsules at bedtime should reduce these effects during the day.