Premphase

What is the most important information I should know about Premphase?

· Conjugated estrogens increase the risk of developing endometrial hyperplasia, a condition that may lead to cancer of the lining of the uterus. Taking a progestin, such as medroxyprogesterone, with conjugated estrogens lowers the risk of developing this condition. Visit your doctor regularly and report any unusual vaginal bleeding right away.

· The Women's Health Initiative (WHI) study found an increased risk of breast cancer, heart disease, nonfatal heart attacks, and blood clots in women taking estrogen and medroxyprogesterone combinations long-term. You should contact your doctor or healthcare provider to discuss your individual risks and benefits before taking a conjugated estrogen and medroxyprogesterone combination long-term. You should also talk to your doctor or healthcare provider on a regular basis (for example, every 3-6 months) about whether you should continue this treatment.

· Have yearly physical exams and examine your breasts for lumps on a monthly basis while taking Premphase.

· Do not take Premphase if you are pregnant or planning to become pregnant. It could affect the development of the baby.

 

What are Premphase?

· Conjugated estrogens are naturally occurring female sex hormones that are involved in the development and maintenance of the female reproductive system.

· Medroxyprogesterone is a female hormone, usually called "progesterone." It is important for the regulation of ovulation and menstruation.

· Together, conjugated estrogen and progesterone are used to treat the symptoms of menopause such as feelings of warmth in the face, neck and chest, or sudden intense spells of heat and sweating ("hot flashes" or "hot flushes"); to treat vulvar and vaginal changes caused by menopause (itching, burning, dryness in or around the vagina, difficulty or burning with urination); and to prevent thinning of the bones (osteoporosis).

· Premphase may also be used for purposes other than those listed in this medication guide.

 

What should I discuss with my healthcare provider before taking Premphase?

· Do not take Premphase without first talking to your doctor if you have     ·had an allergic reaction to another estrogen or progesterone product;     ·a circulation, bleeding, or blood-clotting disorder;     ·a history of blood clots in the leg or lung;     ·liver disease;     ·undiagnosed, abnormal vaginal bleeding; or     ·any type of breast, uterine, or hormone-dependent cancer.

· Taking Premphase may be dangerous in some cases if you have any of the conditions listed above.

· Before taking Premphase, tell your doctor if you have     ·high blood pressure, angina, or heart disease;     ·a history of heart attack or stroke;     ·high levels of cholesterol or triglycerides in the blood;     ·kidney disease;     ·thyroid problems;     ·asthma;     ·epilepsy;     ·migraines;     ·depression;     ·diabetes;     ·gallbladder disease;     ·uterine fibroids; or     ·had a hysterectomy (uterus removed).

· You may not be able to take Premphase, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

· The Women's Health Initiative (WHI) study found an increased risk of breast cancer, heart disease, nonfatal heart attacks, and blood clots in women taking estrogen and medroxyprogesterone combinations long-term. You should contact your doctor or healthcare provider to discuss your individual risks and benefits before taking a conjugated estrogen and medroxyprogesterone combination long-term. You should also talk to your doctor or healthcare provider on a regular basis (for example, every 3-6 months) about whether you should continue this treatment.

· Premphase are in the FDA pregnancy category X. This means that these medications are known cause birth defects in an unborn baby. Do not take Premphase if you are pregnant or if you could become pregnant during treatment.

· Premphase pass into breast milk, and the effects on a nursing infant are unknown. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

 

How should I take Premphase?

· Take Premphase exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

· Take each dose with a full glass of water.

· Take Premphase with food or milk to lessen stomach upset. Try to take doses at the same time each day. You may be taking the medication on a cycle, such as every day for 3 weeks with 1 week off each month to mimic the body's natural cycle. Follow the directions on the prescription label.

· Have yearly physical exams and examine your breasts for lumps on a monthly basis while taking a conjugated estrogen and medroxyprogesterone combination.

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· It is important to take Premphase regularly to get the most benefit.

· Your doctor may want you to have blood tests or other medical evaluations during treatment with a conjugated estrogen and medroxyprogesterone combination to monitor progress and side effects.

· Store Premphase at room temperature away from moisture and heat.

 

What happens if I miss a dose?

· Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and return to the regular dosing schedule. Do not take a double dose of this medication unless otherwise directed by your doctor.

 

What happens if I overdose?

· An overdose of a conjugated estrogen and medroxyprogesterone combination is unlikely to threaten life. Call an emergency room or poison control center for advice if an overdose is suspected.

· Symptoms of a conjugated estrogen and medroxyprogesterone combination overdose might include nausea, vomiting, and vaginal bleeding.

 

What should I avoid while taking Premphase?

· There are no restrictions on food, beverages, or activity while taking a conjugated estrogen and medroxyprogesterone combination unless your doctor directs otherwise.

 

What are the possible side effects of Premphase?

· Conjugated estrogens increase the risk of developing endometrial hyperplasia, a condition that may lead to cancer of the lining of the uterus. Taking a progestin, such as medroxyprogesterone, with conjugated estrogens lowers the risk of developing this condition. Visit your doctor regularly and report any unusual vaginal bleeding right away.

· The Women's Health Initiative (WHI) study found an increased risk of breast cancer, heart disease, nonfatal heart attacks, and blood clots in women taking estrogen and medroxyprogesterone combinations long-term. You should contact your doctor or healthcare provider to discuss your individual risks and benefits before taking a conjugated estrogen and medroxyprogesterone combination long-term. You should also talk to your doctor or healthcare provider on a regular basis (for example, every 3-6 months) about whether you should continue this treatment.

· Stop taking the conjugated estrogen and medroxyprogesterone combination and seek emergency medical attention or call your doctor immediately if you experience any of the following serious side effects:     ·an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);     ·a blood clot (pain, redness, and swelling in an arm or leg; shortness of breath; coughing blood; chest pain; headache; blurred vision; confusion; loss of speech, or dizziness);     ·unusual or abnormal vaginal bleeding;     ·gallbladder disease (pain, swelling, or tenderness in the abdomen);     ·liver damage (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, unusual bleeding or bruising, severe fatigue); or     ·a lump in a breast.

· Other, less serious side effects may be more likely to occur. Continue to take Premphase and talk to your doctor if you experience     ·changes in appetite or weight,     ·changes in blood sugar levels;     ·swelling of the hands or feet,     ·tiredness or weakness,     ·irregular bleeding or spotting,     ·depression,     ·an increase in body or facial hair or hair loss,     ·swollen or tender breasts,     ·nausea,     ·headache or insomnia,     ·changes in your voice, or     ·areas of darker skin.

· Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

 

What other drugs will affect Premphase?

· Before taking a conjugated estrogen and medroxyprogesterone combination, tell your doctor if you are taking any of the following medicines:     ·an anticoagulant (blood thinner) such as warfarin (Coumadin);     ·insulin or an oral diabetes medicine such as glipizide (Glucotrol), glyburide (Diabeta, Micronase), and others; or     ·tamoxifen (Nolvadex);

· A dosage adjustment or special monitoring may be required during treatment if you are taking any of the medicines listed above.

· Drugs other than those listed here may also interact with Premphase. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

 

Where can I get more information?

· Your pharmacist has additional information about Premphase written for health professionals that you may read.