Commercial Estradiol and Progesterone for treatment of perimenopause/menopausal symptoms

Patient Drug Information
Commercial Estradiol and Progesterone for treatment of 
Perimenopause/Menopausal symptoms

FPG-MENOPAUSE-PIB-OHAZ01
 

Written information about this prescription has been provided for you. Please read this information before you take this medication. If you have questions concerning this prescription, a pharmacist is available during normal business hours to answer these questions. You can call the pharmacy using the number listed on the prescription label. 

Your treatment plan is personalized for you and may include a combination of commercially available medications and custom compounded medications.  PLEASE CAREFULLY REVIEW YOUR MEDICATION LABELS TO DETERMINE WHICH OF THE FOLLOWING INGREDIENTS IN THIS GUIDE ARE CONTAINED IN YOUR MEDICATIONS. 

Important Information about your prescription: 

This medication should only be taken by the patient whose name appears on the prescription label.

Medication information and side effects 

• Estradiol is a naturally occurring female sex hormone. Estradiol can be used to treat vasomotor symptoms, such as hot flashes and night sweats, in perimenopause and menopause. It can also help prevent postmenopausal osteoporosis.
  • Estradiol’s most common side effects when taken by mouth are stomach pain, headache,  breast tenderness or pain, and fatigue.
  • Estradiol’s most common side effects when used topically are depression, swelling due to fluid retention, application site irritation such as itching and pain, headache, stomach pain, nausea, bloating, breakthrough bleeding, breast tenderness or pain, sinus infection, upper respiratory infection, joint and back pain.
  • Estradiol’s most common side effects when used intravaginally are vaginal itching and discomfort, yeast infection, headache, abdominal pain, diarrhea, and upper respiratory tract infections.

• Progesterone  is a naturally occurring steroid hormone. Progesterone is used in combination with estradiol or estrogen to help prevent endometrial hyperplasia (a condition where the lining of the uterus becomes abnormally thick).
  • Progesterone’s most common side effects are depression, headache, dizziness, stomach pain, bloating, nausea, vomiting, diarrhea, changes to the urinary tract, breast tenderness or pain, and muscle or joint pain. 

Direction for use: 

• Refer to your prescription label for your prescriber’s directions and recommended dose and frequency.
• Estradiol and Progesterone are considered hazardous medications that should be handled with care, as it can be absorbed through the skin and may affect hormone levels. Always store it safely and wash your hands immediately after handling.
• Estradiol Tablets:
  • Take one tablet by mouth once daily with or without food. Take with food if it causes an upset stomach.
  • Take this medication at the same time each day.
• Estradiol Patch:
  • Apply one patch once weekly or as directed by your provider.

1. Wash and completely dry the lower abdomen or upper portion of the buttock where you will apply the patch. Apply to clean, dry, healthy skin that is free of oil, powder, or lotion.
2. Avoid the waistline or other areas where tight clothing may rub the patch off. Do not apply to breasts.
3. Tear open the pouch at the indentation and carefully remove the patch. Do not use scissors as this may cut the patch.
4. Remove and discard the protective liner that covers the sticky side of the patch. Do not touch the sticky side. Immediately apply the patch to the application site.
5. After application, hold patch in place using palm of hand for 10 seconds. Leave the patch on your skin for seven days. If the patch begins to lift, press it firmly around the edges to reattach.
6. If a patch falls off before it has been worn for a full seven days, apply a new patch for the remainder of the dosing interval. Then, remove the replacement patch  even if you’ve worn it for only a day or two. When replacing a patch, reapply to a new site to begin the next seven-day dosing interval. 
7. Rotate application sites on your lower abdomen or upper buttock to avoid skin irritation. Allow a seven-day interval between applications at a particular site.
8. Remove patch slowly after use to avoid skin irritation.
9. If any adhesive remains on the skin after removal, first allow skin to dry for 15 minutes, then gently rub area with an oil-based cream or lotion
10. Please refer to the package insert within the medication box for detailed application instructions.

• Estradiol Vaginal Cream:
  • Apply intravaginally once daily or as directed by your provider.

1. Remove the cap from the tube. There may not be a seal on the tube.
2. Grab the applicator included in the box. Do not separate plunger from the applicator.
3. Screw the threaded end of the applicator onto the open tube until secure.
4. Position upright in order to see the calibrated gram amounts marked on the applicator.
5. Gently squeeze the tube from the bottom to expel the prescribed amount of cream into the applicator. As the cream is squeezed into the applicator, the plunger will rise to indicate the amount of grams.
6. Once the prescribed amount of medication is in the applicator, unscrew the applicator from the tube and place the cap back on the tube.
7. To deliver the medication, gently insert the applicator deeply into the vagina and depress the plunger to its original position.
8. Clean the applicator after each use. Pull the plunger to remove it from the barrel and wash both with warm water and mild soap. Do not boil or use hot water.
9. Please refer to the package insert within the medication box for detailed application instructions.

• Progesterone Capsules:
  • Take one capsule by mouth at bedtime with a full glass of water. 

Storage 

• Estradiol Tablets: Store at room temperature between 68°F to 77°F (20°C to 25°C). Protect from light.
• Estradiol Patch: Store at room temperature between 68°F to 77°F (20°C to 25°C). Store in the provided protective pouch.
• Estradiol Vaginal Cream: Store at room temperature in the original container between 68°F to 77°F (20°C to 25°C). Protect from heat.
• Progesterone Capsules: Store at room temperature between 68°F to 77°F (20°C to 25°C). Protect from excessive moisture.
• Keep all medications in a safe and secure place. Keep out of reach of children and pets. 

Precautions and contraindications

Estradiol: 

• Do not take this medication if you are allergic to estrogen, estradiol or any of its components.
• Do not take this medication if you are pregnant or may be pregnant.
• Notify your provider if you are breastfeeding or planning to breastfeed.
• Do not take this medication if you have a history of or currently have breast cancer, ovarian cancer, endometrial cancer, or a hormone-sensitive tumor.
• Do not take this medication if you have or have a history of heart attack, stroke, blood clots or clotting disorders. Signs and symptoms of a blood clot may include chest, arm, back, neck, or jaw pain or pressure; numbness or weakness on one side of your body; trouble speaking or thinking; change in balance or eyesight; shortness of breath; or swelling, warmth, or pain in the arm or leg.
• Do not use this medication if you currently have or have a history of liver disease or impairment. Notify your provider immediately if you experience signs of a liver problem such as dark urine, light-colored stools, or yellow skin or eyes.
• Seek immediate medical care if you experience signs or symptoms of gallbladder or pancreas problems such as pain in the upper right belly area or very bad stomach pain with or without vomiting.
• Talk with your doctor if you will need to be still for long periods of time like long trips, bedrest after surgery, or illness. Not moving for long periods may raise your chance of blood clots.
• Notify all your healthcare providers about starting this medication.
• Notify your doctor if you are taking medications for your thyroid.
• Retinal vascular thrombosis has been reported in women receiving estrogens. Stop taking this medication if you experience a sudden partial or complete loss of vision, double vision, bulging eyes, a change in how contact lenses feel, or you experience severe migraine. Seek emergent medical attention and notify your doctor right away.
• Be sure to have regular breast exams and gynecology check-ups. You will also need to do breast self-exams on a regular basis.
• Notify your provider if you notice a lump in the breast, abnormal pain in the breast, or any nipple discharge.
• Notify your provider right away if you have unexplained vaginal bleeding or pain when passing urine.
• This medication may elevate your triglyceride levels. Notify your provider if you have hypertriglyceridemia or a high triglyceride level.
• This medication may cause dark patches of skin on your face. Use sunscreen; avoid prolonged sun exposure, sunlamps, or tanning beds; and wear protective clothing and eyewear to reduce your risk.
• Limit or avoid drinking alcohol while on this medication.
• Avoid smoking while on this medication.
• Monitor your blood sugars and blood pressure regularly. This medication may raise both.
• If you are allergic to tartrazine (FD&C Yellow No. 5), talk with your doctor. Some products have tartrazine.

Progesterone:

• Do not take this medication if you are allergic to progesterone, peanuts, peanut oil or any components of this medication.

• Do not use this medication if you have abnormal genital bleeding.
• Do not take this medication if you have or have a history of heart attack, stroke, blood clots or clotting disorders. Signs and symptoms of a blood clot may include chest, arm, back, neck, or jaw pain or pressure; numbness or weakness on one side of your body; trouble speaking or thinking; change in balance or eyesight; shortness of breath; or swelling, warmth, or pain in the arm or leg.
• Do not use this medication if you currently have or have a history of liver disease or impairment. Notify your provider immediately if you experience signs of a liver problem such as dark urine, light-colored stools, or yellow skin or eyes.
• Do not take this medication if you are pregnant or may be pregnant.
• Notify your provider if you are breastfeeding or planning to breastfeed.
• Talk with your doctor if you will need to be still for long periods of time like long trips, bedrest after surgery, or illness. Not moving for long periods of time may raise your chance of blood clots.
• Do not take this medication if you have or have a history of breast cancer, endometrial cancer, or a hormone-sensitive tumor.
• Notify your provider right away If you have unexplained vaginal bleeding, pain when passing urine, or urinating more often.
• Be sure to have regular breast exams and gynecology check-ups. You will also need to do breast self-exams on a regular basis.
• Notify your provider if you notice a lump in the breast, abnormal pain in breast, or any nipple discharge.
• This medication is not a method of birth control and will not prevent pregnancy. Contact your doctor or pharmacist for more information.
• Retinal vascular thrombosis has been reported in women receiving estrogens. Stop taking this medication if you experience a sudden partial or complete loss of vision, double vision, bulging eyes, a change in how contact lenses feel, or you experience severe migraine. Seek emergent medical attention and notify your doctor right away. 

Missed Dose

• Estradiol Tablets: If you miss a dose of the medication, take it as soon as you remember. If it is close to the time for your next dose, skip the missed dose and go back to your normal time. Do not take extra doses or 2 doses at the same time.
• Estradiol Patch: If you forget to apply a new patch after removing the old patch, apply the new patch as soon as you remember. Do not apply multiple patches unless otherwise directed by your provider.
• Estradiol vaginal Cream: If you miss an application of the medication, apply it as soon as you remember. If it is close to the time for your next dose, skip the missed dose and go back to your normal time. Do not take extra doses or 2 doses at the same time.
• Progesterone Capsules: If you miss a dose of the medication, take it as soon as you remember. If it is close to the time for your next dose, skip the missed dose and go back to your normal time. Do not take extra doses or 2 doses at the same time.

Disposal of Medications

• Estradiol and progesterone are considered hazardous medications. Do not flush unused medication down the toilet or pour in the sink or drain. Dispose according to local regulations.
• Estradiol Patch: Discard used patches by folding the sticky side of the patch together and placing in household trash in a manner that prevents accidental application or ingestion by others.

Additional Information 

If you have questions about your medication, please contact the pharmacy using the number on the label of your prescription product.

Questions

This written information may not cover all possible information. If you have any questions, contact your pharmacist or medical provider.

A local or a toll-free telephone service is available, staffed by registered pharmacists, to answer questions about your medication. You can find the number for the pharmacy on the label of your prescription product.

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