Premphase

1 What is Premphase?

Brand: Premphase, Prempro, Prempro Low Dose

Generic: Conjugated Estrogens and Medroxyprogesterone Acetate

Premphase is hormone combinations used for the treatment of moderate to severe hot flashes, dryness in and around the vagina, osteoporosis and other symptoms of menopause. This drug requires a prescription.

2 What to Know Before Using

Before using Premphase, you must know all about the risks and complications associated with it. Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals.

Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications. Studies in children on the correlation of age to the effects of this drug combination have not been performed while safety and efficacy have not been established.

Studies in the elderly have not reported any geriatric-specific problems. Caution is required in giving this drug to elderly patients as they are more likely to have breast cancer, stroke, or dementia.

Fetal abnormalities have been found out in studies of animals and pregnant women.

This drug is not recommended for use in women who are or may become pregnant because the risk clearly outweighs any possible benefit. This drug may alter milk production or composition.

Monitor your infant for side effects and adequate milk intake if an alternative to this medication is not prescribed. Discuss with your healthcare professional about the risks and benefits of this drug before breastfeeding.

Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects.

Inform your healthcare professional if you are taking any other drugs such as Bupropion, Dasabuvir, Donepezil, Clarithromycin, Etoricoxib, Ginseng, Ketoconazole, Levothyroxine, Licorice, St John's Wort, or Tipranavir.

Inform your healthcare professional if you are taking any other prescription or non-prescription drugs. Intake of specific food or using alcohol or tobacco with this drug is associated with an increased risk of certain side effects.

Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco.

Inform your healthcare provider for any other medical problems such as:

3 Proper Usage

Proper usage of Premphase requires strict adherence to your doctor’s orders. To prevent any side effects, take this drug exactly as directed on the label or as prescribed by your healthcare professional.

The dose of this drug will be variable for different patients. The directions on the label or the prescription by your healthcare professional should be followed.

The dosage of this drug you take depends on the medical problem for which you are using this drug.

Adults with menopause symptoms and prevention of osteoporosis are given one tablet once a day for 28 days, the cycle is repeated afterwards.

The maroon colored tablet is taken on days 1 to 14, and the light blue tablet is taken on days 15 to 28. Use in children is not recommended.

A missed dose should be taken as soon as possible. However, skip the missed dose and go back to your regular dosing schedule if it is almost time for your next dose.

Store the drug in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children.

Dispose any outdated or expired drugs and ask your healthcare professional for the proper disposal of the drugs.

4 Precautions to Take

Before using Premphase, there are some precautions you must take. Your health care provider should closely monitor the effectiveness of this drug as well as check for unwanted effects. Unwanted effects can be detected using pelvic exam, breast exam, and mammogram.

Pregnancy is very unlikely in postmenopausal women but it is important to note that this drug has teratogenic effects. Increased risk for having blood clots, strokes, or heart attacks have been associated with this drug.

This risk may continue even after you stop using the drug and this risk is amplified if you have hypertension, high cholesterol in your blood, diabetes, or if you are overweight or smoke cigarettes.

Contact emergency medical services immediately if you experience confusion, difficulty speaking, double vision, headaches, an inability to move arms, legs or facial muscle, or an inability to speak.

Risks of breast cancer, endometrial cancer, or uterine cancer are increased with prolonged use of this drug.

Consult with your healthcare professional about the risk and benefits of this drug and if you should also use a progestin drug if you still have your uterus. Inform your healthcare professional immediately if you have unusual vaginal bleeding.

Women 65 years of age and older taking this drug may have increased risks of dementia.

Before any kind of surgery or emergency treatment, inform the medical doctor or dentist in charge that you are using this drug. This drug may also affect the results of certain medical tests.

Consult with your healthcare professional immediately if you experience a severe headache or sudden loss of vision or any other change in vision occurs while you are taking this drug. You may be referred to an ophthalmologist to have your eyes checked.

Consult with your healthcare professional before drinking grapefruit juice, or take any other prescription or nonprescription drugs, and herbal or vitamin supplements.

5 Potential Side Effects

As with many medications, there are several potential side effects associated with Premphase. Side effects may vary for each individual and prompt medical attention should be given if they occur.

 Consult with your healthcare professional immediately if you experience symptoms of:

  • acid or sour stomach
  • anxiety
  • backache
  • belching
  • change in vaginal discharge
  • chest pain or discomfort
  • clear or bloody discharge from the nipple
  • confusion
  • cough
  • the difficulty with speaking
  • the difficulty with swallowing
  • dimpling of the breast skin
  • dizziness or lightheadedness
  • double vision
  • fainting
  • fast heartbeat
  • full or bloated feeling or pressure in the stomach
  • headache
  • heartburn
  • hives
  • itching or rash
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • indigestion
  • inverted nipple
  • loss of appetite
  • lump in the breast or under the arm
  • nausea
  • pain or discomfort in the arms, jaw, back, or neck pain or feeling of pressure in the pelvis pain
  • redness or swelling in the arm or leg
  • persistent crusting or scaling of the nipple
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • redness or swelling of the breast
  • slow speech
  • sore on the skin of the breast that does not heal
  • stomach discomfort
  • upset or pain
  • sudden shortness of breath or troubled to breathe
  • sweating
  • swelling of the abdominal or stomach area
  • tightness in the chest
  • unusual tiredness or weakness
  • vaginal bleeding
  • vomiting

Some side effects may occur that usually do not need medical attention. As your body adjusts to the medicine, the side effects will slowly disappear. Ask your healthcare professional about ways to prevent or reduce some of these side effects.

If any of the following side effects persists or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional. Report any side effects to the FDA hotline at 1-800-FDA-1088.

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