Prempro

The active ingredients in Prempro are conjugated estrogens and medroxyprogesterone acetate. Estrogen is a naturally occurring hormone that is created in your ovaries. Conjugated estrogens are a mixture of estrogens that are used to replace those you may have lost through menopause. It helps relieve menopausal symptoms such as hot flashes and vaginal dryness. It will also help strengthen your bones and can help prevent osteoporosis.

Medroxyprogesterone acetate, the second active ingredient in Prempro, is a progestin that stops the damage in your uterus and helps to prevent uterine cancer.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Prempro. However, the following is a synopsis of the general guidelines for the use of Prempro:

• You take Prempro once daily at the same time each day.
• If you happen to miss a dose, take the missed dose immediately. Do this unless it is closer to the time of your next dose, in which case, skip this dose and take your next dose at the normal time.

The most common side effects of Prempro seen in clinical trials as compared to placebo include:

• Abdominal pain
• Back pain
• Weakness
• Bloating
• Nausea
• Vaginal discharge
• Headache
• Itching
• Depression
• Breast pain
• Menstrual cramps

Some individuals may experience serious side effects while using Prempro. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• An allergic reaction
• Stroke (sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance)
• Heart attack (chest pain or pressure)
• Increased risk of endometrial cancer (unusual or heavy vaginal bleeding and severe pelvic pain)
• Increased risk of breast cancer (breast lumps or pain)
• Increased risk of blood clots (sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs)
• Gallbladder disease (stomach pain, fever, nausea or vomiting that won’t go away, or a yellowing of your skin and eyes)

These are not all of the possible adverse reactions of Prempro. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Prempro, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Unusual vaginal bleeding
• Liver disease
• Endometriosis
• Hereditary angioedema
• Uterus problems, such as fibroids
• Porphyria
• A family or personal history of obesity
• A thyroid disorder
• Had a hysterectomy
• A history of stroke, heart attack, or blood clot
• High blood pressure or cholesterol
• High levels of calcium
• A pregnancy, plan to become pregnant or are breastfeeding
• Prempro passes into your breast milk.

Boxed Warning

There is a chance of developing breast cancer, cardiovascular disorders, dementia, and endometrial cancer.

You should not take estrogen with progestin therapy as it can lead to cardiovascular disease or dementia. There is also a risk of stroke, deep vein thrombosis (DVT), myocardial infarction (MI), invasive breast cancer, and pulmonary embolism (PE).

If you take estrogen-alone therapy, there is an increased risk of endometrial cancer (if you are a woman with a uterus who takes unopposed estrogens). It should not be used for the prevention of cardiovascular disease (heart disease), dementia, increased risk of DVT, stroke, and probable dementia (in postmenopausal women 65 years of age or older).

The Women’s Health Initiative (WHI) reported the majority of these findings.

• Undiagnosed abnormal genital bleeding
• Known or suspected pregnancy
• Known, suspected, or history of breast cancer
• Known or suspected estrogen-dependent neoplasia
• Active DVT, PE, or a history of these conditions
• Active arterial thromboembolic disease (ex. stroke and MI) or a history of these conditions
• Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders
• Known liver dysfunction or disease
• Known anaphylactic reaction or angioedema to Prempro

Prempro typically begins to relieve menopausal symptoms such as hot flashes within a few days to a couple of weeks. Improvements in bone density or prevention of osteoporosis may take several months of consistent use. The time frame can vary, so it's important to take Prempro as prescribed and consult your healthcare provider about your progress.

When Prempro is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Inducers or inhibitors of CYP3A4, including grapefruit juice
• Aminoglutethimide

A Prempro tablet contains both conjugated estrogens (CE), such as estradiol, and medroxyprogesterone acetate (MPA) in the following strengths:

• 0.3 mg CE and 1.5 mg MPA (commonly known as Prempro 0.3/1.5)
• 0.45 mg CE and 1.5 mg MPA
• 0.625 mg CE and 2.5 mg MPA
• 0.625 mg CE and 5 mg MPA

Prempro is one tablet and Premphase consists of two tablets.

Store Prempro at room temperature between 68°F to 77°F (20°C to 25°C). You can also store it between 59°F to 86°F (15°C to 30°C) for short periods of time if needed.

It is manufactured by Pfizer, inc.

Currently, there is no generic available for Prempro in the United States.

To stop taking Prempro, consult your healthcare provider to determine the safest way to discontinue the medication based on your health needs. Your doctor may recommend tapering the dose gradually to reduce the risk of withdrawal symptoms or a return of menopausal symptoms.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you. Prempro should not be used during pregnancy, as it may harm the developing fetus.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you. Prempro is not recommended while breastfeeding, as its hormones can pass into breast milk and may affect the nursing infant.