Prempro is a hormone replacement therapy for menopausal and postmenopausal women.
Tablets are taken once daily.
Women should take Prempro tablets at the same time every day.
Prempro is a brand-name hormonal replacement therapy for women. It helps relieve the symptoms of menopause and prevent osteoporosis in postmenopausal women. The drug contains two active ingredients: conjugated estrogens and progestin. Tablets are taken daily. Because there are some risks associated with hormone replacement, healthcare providers use the lowest possible dose and will require regular check-ups to re-assess the treatment. For most women the benefits of therapy outweigh the risks, but there are some women who should not be placed on hormone replacement therapy.
Prempro is sold only in one dosage form:
Tablets:
0.3 mg conjugated estrogens/1.5 mg medroxyprogesterone
0.45 mg/1.5 mg
0.625 mg/2.5 mg
0.625 mg/5 mg
Healthcare providers prescribe Prempro to relieve moderate to severe vasomotor symptoms (hot flashes) as well as the vaginal and urinary tract changes that can cause bothersome symptoms (dryness, frequent urination) during menopause. While hormone replacement therapy (HRT) is no longer recommended as the first-line medication to prevent osteoporosis (bone loss) in postmenopausal women, the FDA has approved the drug for those who cannot take non-estrogen medications.
Prempro is not safe for some women to take. It is important to know that women who have a history of breast or uterine cancer should not take hormone replacement therapy. For a full list of conditions that prohibit the use of HRT, see the FAQ “Who should not take Prempro” below. It is also not appropriate for women who have had a hysterectomy because the progestin component of the medication is not necessary.
Prempro dosage chart |
|||
|---|---|---|---|
| Indication | Starting dosage | Standard dosage | Maximum dosage |
| Vasomotor or genitourinary symptoms of menopause | 1 tablet once per day | 1 tablet at the lowest effective dose taken once daily | 0.625 mg/5 mg daily |
| Osteoporosis prophylaxis in postmenopausal women | 1 tablet once per day | 1 tablet at the lowest effective dose taken once daily | 0.625 mg/5 mg daily |
Vasomotor symptoms of menopause include hot flashes, flushing, and night sweats. Between 50% and 75% of women going through menopause experience these problems, which can last for seven years or more. Hormone replacement therapies such as Prempro are very effective at treating menopausal vasomotor symptoms. They can reduce the frequency of vasomotor symptoms by 75% on average.
The lack of estrogen associated with menopause also causes changes in the genital and urinary tract tissues, a condition called genitourinary syndrome of menopause. 50% of menopausal women experience genital and urinary tract symptoms of menopause. These include vaginal atrophy (thinning) and dryness that can cause vaginal discomfort and pain during sex. Changes in the urinary tissues can cause burning and increased frequency of urination, and increase the risk for urinary tract infections.
All of these problems are caused by the reduction of estrogen during menopause, and replacing estrogen is an effective way to treat these problems. Like many hormone replacement drugs that treat menopause, Prempro contains both an estrogen (estrone sulfate and sodium equilin sulfate) and a progestogen (medroxyprogesterone acetate). The added progesterone helps to prevent uterine cancer or the thickening of the uterine lining (endometrial hyperplasia), both of which can be caused by estrogen-only hormone replacement. Women who don’t have an intact uterus can take estrogen-alone therapy such as Premarin. However, women taking unopposed estrogen like Premarin will need regular mammograms.
Hormone replacement is associated with risks that, for many women, are outweighed by the benefits. Women taking estrogens have an increased risk of breast cancer, blood clots, and stroke. Many women with certain health conditions cannot safely take hormone-replacement drugs.
Because of the risk, doctors try to use the lowest possible dose. Women who only need hormone replacement for urogenital problems may be prescribed a topical treatment instead of a pill to minimize the risk of side effects.
When healthcare professionals prescribe Prempro, they will need to examine the patient every three to six months. In that exam, the prescriber will re-evaluate treatment, adjust the dose if necessary, or discontinue the treatment.
Standard adult dosage for menopausal symptoms: One tablet at the lowest effective dose taken once daily
Maximum adult dosage for menopausal symptoms: 0.625 mg/5 mg daily
Another consequence of low estrogen levels during and after menopause is osteoporosis. 1 out of 3 women get osteoporosis when they get older (as compared to 1 out of 5 men). Estrogen helps to preserve bone density. When its levels drop, the body breaks down more bone tissue than it creates. The weakened bones are vulnerable to fractures.
While HRT can be used for the prevention of osteoporosis in women who have gone through menopause, it is associated with increased risk of heart attacks, blood clots, stroke and cancer in older women. For this reason, many medical associations have recommended against the use of HRT for the prevention or treatment of osteoporosis unless there is a reason non-estrogen treatments cannot be taken. If HRT is used, doctors follow the same dosage guidelines: use the lowest possible dose. They will require regular check-ups to monitor and re-evaluate the treatment.
Standard adult dosage for osteoporosis prevention in postmenopausal women: one tablet at the lowest effective dose taken once daily
Maximum adult dosage for osteoporosis prevention in postmenopausal women: 0.625 mg/5 mg daily
Prempro is not FDA approved for use in children.
Dosage reductions are not necessary for kidney disease, age, or any other medical condition. Prempro is never prescribed to women with liver impairment or liver disease.
Prempro is taken in 28-day cycles, just like birth control pills. The tablets come in a blister pack with seven tablets arranged in rows of four. Each row is numbered by week from one to four.
Take this medicine exactly as instructed.
Please read the Patient Information sheet that comes with the medicine.
Take the tablets in order across each row.
Do not remove tablets from the blister pack until you’re ready to take the tablet.
Take only one tablet daily.
Take the tablet at the same time every day.
Swallow the tablet with a drink of water.
Store the tablets in their blister pack and original carton at room temperature.
Prempro is a long-term treatment for menopausal symptoms and, in some carefully selected cases, the prevention of osteoporosis. In clinical studies, women taking Prempro experienced significant reductions in the frequency of vasomotor symptoms after 12 weeks of daily doses as compared to a placebo. Genitourinary symptoms significantly improved in women taking Prempro after 13 weeks.
The half-life (how long it takes the amount of the drug in the bloodstream to be reduced by half) of the estrogens in Prempro is approximately four to 18 hours. The half-life of the progestogen (medroxyprogesterone) is about 38 to 48 hours. It should take the body about eight to 10 days to completely clear a dose of Prempro from the system.
Take a dose as soon as it’s remembered. If it’s almost time for the next dose, skip the missed dose and take the next dose as scheduled.
Ask the pharmacist or healthcare provider if you should leave a skipped dose in the blister pack or throw it out. Prempro is prescribed on a 28-day cycle, so it’s important to take pills for four weeks.
Prempro can be taken for months or years as long as it works and doesn’t cause significant side effects. The generally accepted time to take Prempro is five years, but this can be extended on an individual basis. Women taking Prempro will need regular check-ups every three to six months to re-assess treatment.
Prempro can be stopped at any time, but symptoms of menopause may start recurring or worsen. Talk to the healthcare provider first.
The standard treatment for menopausal symptoms is estrogen (combined with a progestogen for women with an intact uterus). Women who cannot take hormone replacement treatments may be put on other non-hormone drugs such as gabapentin, fezolinetant, and antidepressants. Different types of antidepressants include SSRIs (paroxetine, citalopram, or escitalopram) and SNRIs (venlafaxine, duloxetine, or desvenlafaxine).
Alternative treatments for osteoporosis prevention or treatment include bisphosphonates, vitamin D supplements, calcium supplements, and weight-bearing exercise. If osteoporosis is more advanced and severe, treatments include estradiol receptor modulators, a monoclonal antibody treatment called Xgeva (denosumab), and parathyroid hormone peptides.
The maximum daily dose is the highest available dosage strength (0.625 mg conjugated estrogens/5 mg medroxyprogesterone).
Taking too much Prempro isn’t fatal but may cause adverse effects such as nausea, vomiting, abdominal pain, breast pain, fatigue, and drowsiness. If too much Prempro is taken, call a poison helpline or get medical help. The standard treatment for estrogen overdose is to stop taking the medicine.
Estrogens have several drug interactions, so give the prescriber a complete list of all the drugs and supplements being taken, particularly:
Macrolide antibiotics such as erythromycin and clarithromycin
Oral azole antifungals such as itraconazole or ketoconazole
Antiviral drugs called protease inhibitors
The COVID-19 treatment Paxlovid
The antiseizure drugs carbamazepine or phenobarbital
The herbal supplement St. John’s wort
Drinking alcohol is not prohibited when taking Prempro. However, even moderate alcohol intake may increase estrogens in the body, raising the risk of serious side effects.
Avoid grapefruit juice when taking Prempro. It may increase the risk of adverse effects.
Prempro should not be taken by pregnant women.
Prempro should not be taken by women who are breastfeeding, but it’s not prohibited. Estrogens affect lactation, decreasing the quality and amount of breast milk. The drug is detectable in breast milk, but its effects on nursing infants are not known.
Prempro is a potentially hazardous drug that can cause blood clots, stroke, heart attack, or breast cancer. For these reasons, it is never prescribed to women who are pregnant or have:
Abnormal vaginal bleeding that has not been checked by a doctor
Certain types of hormone-dependent cancers, such as breast, uterine or ovarian cancer
A history of blood clots such as deep vein thrombosis (DVT) or pulmonary embolism (PE)
A history of stroke
A history of heart attack
Liver disease or dysfunction
A bleeding disorder that increases the risk of blood clots (factor V Leiden, protein C, protein S, or antithrombin deficiency, )
To avoid possible complications or side effects, tell the prescriber about all medical conditions, particularly:
Unusual vaginal bleeding
Heart disease
Kidney problems
Thyroid problems
Parathyroid problems
High blood pressure
Epilepsy
Migraine headaches
High calcium
High cholesterol or a family history of high cholesterol
Porphyria
Endometriosis
The most common side effects of Prempro are muscle pain, depression, fluid retention, back pain, nausea, abdominal pain, bloating, breast tenderness, itchiness, and weight gain. Possible serious side effects include blood clots, cardiovascular problems, stroke, breast cancer, endometrial cancer, gallbladder disease, high or low calcium, retinal damage, high blood pressure, high cholesterol and fats, liver problems, underactive thyroid, and serious allergic reactions such as angioedema or anaphylaxis.
Alcohol, hormones, and postmenopausal women, Alcohol Health and Research World
Hormone replacement therapy, StatPearls
Premphase/Prempro conjugated estrogens and medroxyprogesterone acetate kit/tablet prescribing information, DailyMed (NIH National Library of Medicine)
Prempro drug summary, Prescriber’s Digital Reference (PDR)
Prevention and treatment of osteoporosis in women, Sage Choice
J. Elizabeth Allen, DO, FACEP, was born in Canada and moved to Pennsylvania as a teenager. She was the first in her family to go to college and become a physician. She earned her medical degree from the Philadelphia College of Osteopathic Medicine in 1996. She then went on to complete her residency in Emergency Medicine at the Albert Einstein Medical Center in Philadelphia and has maintained board certification from the American Board of Emergency Medicine. As an Assistant Professor of Emergency Medicine at the Penn State Milton S. Hershey Medical Center, Dr. Allen has been in practice for more than 20 years. She has taught innumerable residents and received eight “Teacher of the Year” awards. Dr. Allen has extensive experience in the areas of patient safety, quality, and peer review. She has been a contributing author to several books including Harwood-Nuss’ Clinical Practice of Emergency Medicine 7th Edition, Reichman's Emergency Medicine Procedures, and Prehospital Emergency Care Secrets.
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