What is this medication?
Progesterone (Oral), Prometrium
Officially indicated for the prevention of endometrial hyperplasia, treatment of secondary amenorrhea or abnormal uterine bleeding, and for postmenopausal women who are receiving conjugated estrogens.
“ALERT: US Boxed Warning
Cardiovascular disorders (capsule):
Estrogens plus progestin therapy should not be used for the prevention of cardiovascular disorders. The Women’s Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of myocardial infarction (MI), stroke, pulmonary embolism (PE), and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens 0.625 mg combined with medroxyprogesterone 2.5 mg relative to placebo.
Probable dementia (capsule):
Estrogens plus progestin therapy should not be used for the prevention of dementia. The Women’s Health Initiative Memory Study (WHIMS) estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years and older during 4 years of treatment with daily conjugated estrogens 0.625 mg combined with medroxyprogesterone 2.5 mg, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.
Breast cancer (capsule):
The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer.
Risks versus benefits (capsule):
In the absence of comparable data, assume these risks to be similar for other doses of conjugated estrogens and medroxyprogesterone and other combinations and dosage forms of estrogens and progestins. Prescribe progestins with estrogens at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.”
How does this medication work?
Progesterone is a steroid hormone that plays a regulatory role in the female reproductive system by allowing the endometrium to transition from a proliferative to the secretory stage, facilitates blastocyst nesting and is essential to the maintenance of pregnancy. Progesterone also plays an important role in several tissues not belonging to the reproductive system, such as the mammary gland in preparation for breastfeeding, the cardiovascular system, central nervous system, and bones.
How should I take this medication?
Oral: Take 400mg once daily at bedtime for 10 days.
Endometrial hyperplasia, prevention
Oral: Take 200mg once daily at bedtime for 12 days sequentially per 28-day cycle.
How To Take: You can take with food to increase oral absorption of Prometrium/Progesterone. Take the medication exactly as prescribed by your doctor at the same time each day.
What should I watch for while using this medication?
Use with caution in postmenopausal women using conjugated estrogens in combination with medroxyprogesterone acetate
Use with caution in patients who perform tasks that require mental alertness
Use with caution in patients who may have asthma, cardiac impairment, epilepsy, migraines, and diabetes due to a higher risk of fluid retention
Use with caution in patients who may have depression
Do not use in cases of hepatic and/or renal impairment
Do not use during pregnancy
Contact Your Doctor if You Ever Experience: If you experience a sudden, intense, severe headache or chest pain; sudden loss of coordination; sudden loss of vision or speech disturbances; chest or calf pain; weakness in the extremities; sudden shortness of breath of pain with breathing (may indicate thromboembolic disorder); persistent or recurrent vaginal bleeding (may indicate endometrial cancer); edema; abdominal pain or jaundice (may indicate hepatitis or gallbladder disease).
What if I miss a dose?
If you miss a dose, make sure to take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
How should I store this medication?
Keep out of the reach of children at all times. Store at room temperature, 59 to 86° F (15 to 30° C). Protect from light. Keep the container tightly closed. Properly dispose of any unused medication after the expiration date.
What are the possible side effects of using this medication?
Central Nervous System: Headache (16% to 31%), dizziness (15% to 24%), depression (19%)
Endocrine and Metabolic: Breast tenderness (27%), mastalgia (6% to 16%)
Gastrointestinal: Abdominal pain (20%), bloating (12%)
Genitourinary: Urinary tract abnormality (11%)
Infection: Viral infection (12%)
Neuromuscular and Skeletal: Musculoskeletal pain (12%)
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