U.S. Brand Names

Premphase®; Prempro™

Canadian Brand Names

Premphase®; Premplus®; Prempro™

Mexican Brand Names

Premelle

Pharmacologic Category

Estrogen and Progestin Combination

What key warnings should I know about before taking this medicine?

Estrogens, when used in females after menopause, may increase the risk of uterine cancer. Progestins may decrease this risk. A warning sign for cancer of the uterus is unusual vaginal bleeding. Report any unusual vaginal bleeding to healthcare provider.

Do not take estrogens to prevent heart disease or dementia. Using estrogens may increase your chances of having a heart attack, a stroke, breast cancer, or a blood clot.

Reasons not to take this medicine

• If you have an allergy to estrogens (conjugated/equine), medroxyprogesterone, or any other part of this medicine.

• Tell healthcare provider if you are allergic to any medicine. Make sure to tell about the allergy and how it affected you. This includes telling about rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other symptoms involved.

• If you have any of the following conditions: Blood clots, breast cancer, liver disease, stroke, tumor where estrogen makes it grow, or unexplained vaginal bleeding.

• If you have major surgery and need bedrest.

• If you are a heavy smoker (more than 15 cigarettes per day) and older than 35 years of age.

• If you turned yellow during pregnancy or with estrogen-based or hormone contraceptive use.

• If you do not have a uterus and are using this medicine to treat symptoms of menopause or to prevent osteoporosis.

What is this medicine used for?

• This medicine is used to prevent osteoporosis in postmenopausal females.

• This medicine is used to stop or reduce the symptoms of menopause.

• This medicine is used to treat vaginal irritation and dryness caused by menopause.

How does it work?

• When the body no longer produces estrogen, this medicine is used as an estrogen replacement.

• Medroxyprogesterone is a progesterone used to reduce endometrial cell changes and the risk of endometrial cancer.

How is it best taken?

• Take this medicine at a similar time of day.

• Take this medicine with food.

• This medicine works best when used with calcium/vitamin D supplements and weight-bearing exercises like walking or physical therapy.

• Follow diet plan and exercise program as recommended by healthcare provider.

What do I do if I miss a dose? (does not apply to patients in the hospital)

• Take a missed dose as soon as possible.

• If it is almost time for the next dose, skip the missed dose and return to your regular schedule.

• Do not take a double dose or extra doses.

What are the precautions when taking this medicine?

• There may be a higher risk of breast cancer.

• If you are taking a blood thinner, you will require more frequent monitoring.

• If you have any circulation problems, talk with healthcare provider.

• If you have gallbladder disease, talk with healthcare provider.

• If you have heart disease, talk with healthcare provider.

• If you have high blood pressure, talk with healthcare provider.

• If you have kidney disease, talk with healthcare provider.

• If you have migraines, talk with healthcare provider.

• If you have a weakened heart, talk with healthcare provider.

• Tell dentists, surgeons, and other healthcare providers that you use this medicine.

• Check medicines with healthcare provider. This medicine may not mix well with other medicines.

• Do not take St John's wort, dong quai, black cohosh, saw palmetto, red clover, or ginseng with this medicine.

• If you are taking this medicine and have high blood pressure, talk with healthcare provider before using over-the-counter products that may increase blood pressure. These include cough or cold remedies, diet pills, stimulants, ibuprofen or like products, and certain natural products or supplements.

• Limit alcohol intake (includes wine, beer, and liquor).

• Avoid cigarette smoking. Persons older than 35 years of age and/or smoking more than 15 cigarettes per day are at an increased risk for heart disease.

What are some possible side effects of this medicine?

• Headache.

• Belly pain.

• Nausea or vomiting. Small frequent meals, frequent mouth care, sucking hard, sugar-free candy, or chewing sugar-free gum may help.

• Breast enlargement.

• Change in sexual ability or desire. This is usually reversible.

What should I monitor?

• Change in condition being treated. Is it better, worse, or about the same?

• Check blood pressure regularly.

• If you are diabetic, you will need to monitor blood sugars closely.

• Check blood work (cholesterol panel). Talk with healthcare provider.

• Have a yearly eye exam.

• Bone density test.

• Periodic breast (monthly self-exam) and yearly gynecologic exams are important.

• Follow up with healthcare provider yearly.

Reasons to call healthcare provider immediately

• If you suspect an overdose, call your local poison control center or emergency department immediately.

• Signs of a life-threatening reaction. These include wheezing; chest tightness; fever; itching; bad cough; blue skin color; fits; or swelling of face, lips, tongue, or throat.

• Chest pain or pressure.

• Difficulty breathing.

• Change in strength on one side greater than the other, difficulty speaking or thinking, change in balance, or blurred vision.

• Swelling or pain of leg or arm.

• Severe headache.

• Severe nausea or vomiting.

• Not hungry.

• Dark urine or yellow skin or eyes.

• Change in contact lens tolerance.

• Sudden change in vision, eye pain or irritation.

• A lump in the breast or breast tenderness.

• Any rash.

• No improvement in condition or feeling worse.

How should I store this medicine?

• Store at room temperature.

• Protect from moisture. Do not store in a bathroom or kitchen.

General statements

• If you have a life-threatening allergy, wear allergy identification at all times.

• Do not share your medicine with others and do not take anyone else's medicine.

• Keep all medicine out of the reach of children and pets.

• Keep a list of all your medicines (prescription, natural products, supplements, vitamins, over-the-counter) with you. Give this list to healthcare provider (doctor, nurse, nurse practitioner, pharmacist, physician assistant).

• Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• Talk with healthcare provider before starting any new medicine, including over-the-counter, natural products, or vitamins.

Created: 2006-10-13 12:22:55.0

Modified: 2008-02-11 13:51:45.0

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