How does this medication work? What will it do for me?
Estrogen and progesterone are female hormones that are produced by the ovaries. When used together, they are often referred to as hormone replacement therapy (HRT). During menopause, the ovaries produce less estrogen and progesterone and symptoms can occur. This medication is used to manage menopausal symptoms such as abnormal uterine bleeding, hot flashes, sweating, and chills.
This combination of HRT may also help prevent osteoporosis caused by estrogen deficiency when combined with diet, calcium, and exercise. It is used to prevent osteoporosis only in women who are at serious risk and cannot take other medications normally given to prevent osteoporosis.
This medication is designed for use by women who have not had their uterus removed. The progesterone ingredient of the medication is present to reduce the risk of endometrial (uterine) cancer posed by estrogen and would not be required by women who have had a hysterectomy (i.e., they have had their uterus removed).
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
0.625 mg/2.5 mg
Each oval, maroon tablet, branded "0.625" on one side in white ink, contains conjugated estrogens CSD 0.625 mg. Each oval, white MPA tablet, scored on one side, debossed with 2 opposing "C"on the other side, contains medroxyprogesterone acetate 2.5 mg. Nonmedicinal ingredients: maroon Premarin tablet: calcium sulfate, carnauba wax, edible ink, erythrosine Aluminum Lake, FD&C Blue No. 2, FD&C Yellow No. 6, glyceryl monooleate, lactose, magnesium stearate, methylcellulose, microcrystalline cellulose, pharmaceutical glaze, polyethylene glycol, povidone, sodium benzoate, stearic acid, sucrose, and titanium dioxide; white MPA tablet: lactose, magnesium stearate, methylcellulose, and microcrystalline cellulose.
0.625 mg/5 mg
Each oval, maroon tablet, branded "0.625" on one side in white ink, contains conjugated estrogens CSD 0.625 mg. Each oval, purple MPA tablet, scored on one side, debossed with 2 opposing "C" on the other side, contains medroxyprogesterone acetate 5 mg. Nonmedicinal ingredients: maroon Premarin tablet: calcium sulfate, carnauba wax, edible ink, erythrosine aluminum lake, FD&C Blue No. 2, FD&C Yellow No. 6, glyceryl monooleate, lactose, magnesium stearate, methylcellulose, microcrystalline cellulose, pharmaceutical glaze, polyethylene glycol, povidone, sodium benzoate, stearic acid, sucrose, and titanium dioxide; purple MPA tablet: D&C Blue No. 1 Aluminum Lake, D&C Red No. 30 Aluminum Lake, lactose, magnesium stearate, methylcellulose, and microcrystalline cellulose.
How should I use this medication?
Each package of medication contains one 28-day treatment cycle. The starting dose is 1 maroon tablet (conjugated estrogen) plus 1 white tablet (medroxyprogesterone), taken once daily for 28 days. Once the package of tablets is finished, a fresh package is started the following day.
The use of HRT should be limited to the shortest time possible to achieve the goals of each individual woman. It is important to have regular checkups with your doctor to decide if this medication is still necessary.
Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important that this medication be taken exactly as prescribed by your doctor.
If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Conjugated estrogens - medroxyprogesterone should not be taken by anyone who:
- is allergic to conjugated estrogens - medroxyprogesterone or to any of the ingredients of the medication
- is or may be pregnant
- has abnormal liver test results caused by liver disease or liver problems
- has diseases of circulation or clotting (thrombophlebitis, thrombosis, or other thromboembolic disorders such as stroke) or has a history of these conditions associated with estrogen use
- has endometrial hyperplasia
- has had partial or complete loss of vision due to blood vessel-related eye disease
- has or has had blood clots in the heart
- has or has had known or suspected breast or endometrial (lining of the uterus) cancer
- has undiagnosed abnormal vaginal bleeding
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- breast changes (lumps, swelling, or discharge)
- changes in vaginal bleeding (spotting, breakthrough bleeding, prolonged or heavier bleeding, or complete stoppage of bleeding)
- first migraine headache
- rapid weight gain
- signs of liver problems (yellowing of the skin or eye whites)
Stop taking the medication and seek immediate medical attention if any of the following occur:
- symptoms of a heart attack (e.g., sudden pain or discomfort in the chest, neck, jaw, shoulder, arms, or back; shortness of breath; nausea or vomiting; cool, clammy skin; and anxiety or denial)
- symptoms of a stroke (e.g., sudden weakness or numbness in the face, arm, or leg - even if the weakness is temporary; sudden trouble speaking; sudden confusion; sudden vision changes; sudden severe and unusual headache; or sudden dizziness or loss of balance)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Note the following important information about estrogen replacement therapy: The Women's Health Initiative (WHI) study results indicated an increased risk of heart attack, stroke, breast cancer, blood clots in the lungs, and blood clots in the leg veins in postmenopausal women during 5 years of treatment with 0.625 mg conjugated equine estrogens and 2.5 mg medroxyprogesterone compared to women receiving sugar tablets. Other combinations of estrogen and progestins were not studied. However, until additional data are available, the risks should be assumed to be similar for other hormone replacement products. Therefore,
- estrogen with or without progestins should be used at the lowest dose that relieves your menopausal symptoms for the shortest time period possible, as directed by your doctor; and
- estrogen with or without progestins should not be used to prevent heart disease, heart attacks, or strokes.
Blood pressure: Increased or decreased blood pressure may occur for women using this medication. Blood pressure should be monitored with estrogen use.
Blood problems: Women taking estrogen alone or in combination with progesterone have been reported to have an increased risk of conditions associated with blood clotting. Although the risk is small, it's important to be aware of this possibility during estrogen replacement therapy and to report any unusual symptoms to your doctor. Women with severe varicose veins or severe obesity, and those needing to stay in bed for 3 weeks or more, are generally considered to be at increased risk of blood clots.
Breast cancer: Some studies have found an association between a modest increase in the risk of developing breast cancer and the use of hormone replacement therapy after menopause. Women who have history of breast cancer should not use estrogens. If you have a family history of breast cancer, breast nodules, fibrocystic disease of the breast, or abnormal mammograms, you should be closely monitored by your doctor if you use estrogens. Women using estrogens should have regular breast examinations and should be taught how to do a breast self-examination. Your doctor may also recommend regular mammograms, depending on your age, risk factors, and previous mammogram results. Discuss the benefits and risks with your doctor so that you can make an informed choice about using this medication.
Cholesterol: When taken by mouth, estrogen can increase triglycerides in the blood. Your doctor may check your cholesterol levels while you are taking estrogen.
Dementia: Women over age 65 receiving combined estrogen and progestin replacement therapy may be at increased risk of developing dementia (loss of memory and intellectual function). If you are over 65 years of age, your doctor should closely monitor you for loss of memory and intellectual function.
Diabetes: Estrogens may affect blood sugar control. Anyone with diabetes should carefully monitor their blood glucose levels while taking any medication containing estrogen.
Endometrial cancer: There is evidence from several studies that estrogens, taken without progesterones, increase the risk of uterine cancer. Taking a progesterone (such as medroxyprogesterone) appropriately along with the estrogen reduces this risk to the same level as that of a woman who does not take estrogen. For this reason, all women who have not had their uterus removed should also take progesterone if they use estrogens.
Fibroids: This medication may worsen fibroids, causing sudden enlargement, pain, or tenderness. If you notice these effects, contact your doctor.
Fluid retention: Estrogen may cause fluid retention. Women with heart or kidney problems, epilepsy, or asthma should be monitored carefully when taking it.
Gallbladder: An increased risk of gallbladder disease has been reported in postmenopausal women taking oral estrogens.
Heart disease and stroke: Studies indicate an increased risk of heart disease and stroke with estrogen (with or without progestins) for postmenopausal women. If you experience symptoms of a heart attack (chest pain, tightness or pressure, sweating, nausea, feeling of impending doom) or stroke (sudden dizziness, headache, loss of speech, changes in vision, weakness or numbness in the arms and legs) while taking this medication, get immediate medical attention.
Kidney disease: People with kidney disease should be monitored by their doctor while using estrogen.
Liver disease: If you have or have had liver problems, you may require special monitoring by your doctor while you use this medication. Make sure to tell your doctor if you have ever had liver problems.
Pregnancy: This medication should not be taken by pregnant women. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: Estrogen should not be used during breast-feeding. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children.
What other drugs could interact with this medication?
There may be an interaction between conjugated estrogens - medroxyprogesterone and any of the following:
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
All material copyright MediResource Inc. 1996 – 2019. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Premplus