Estradiol (estrogen) and norethindrone (progestin) skin patch is a hormone combination skin patch for the treatment of moderate to severe hot flashes and other symptoms of menopause such as changes in and around the vagina.
This drug can also be used in women with impaired or inadequate estrogen synthesis in their ovaries before menopause. The hormones from the patch are absorbed through your skin into your body.
This drug works by acting as hormone replacement to prevent symptoms of a feeling of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating in women during menopause.
Before taking this drug, the risks and benefits for your body should be discussed with your healthcare provider.
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.
Use of estradiol and norethindrone combination skin patch is contraindicated in the pediatric population while safety and efficacy have not been established.
No documentation of any geriatric-specific problems relating to the use of this drug combination skin patch.
Caution is required in elderly patients while taking this drug since they are more likely to have breast cancer, stroke, or dementia.
This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit since fetal abnormalities have been reported in pregnant animals or women.
This drug may alter milk production or composition and you should monitor the infant for side effects and adequate milk intake if an alternative to this drug is not prescribed.
Discuss with your healthcare professional the potential risks and benefits before taking this drug while 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:
This drug must be taken exactly as directed by your healthcare professional. To prevent any side effects, take this drug exactly as directed on the label or as prescribed by your healthcare professional.
Follow the instructions on the label or as directed by your healthcare professional. Inform your healthcare professional if you are currently using continuous estrogen or combination estrogen plus progestin therapy before starting CombiPatchВ® therapy.
Monthly bleeding or spotting at the completion of each cycle may happen. Apply this transdermal patch system on the skin of the lower abdomen two times a week, depending on your dosing regimen as advised by your healthcare professional.
Proper hand washing is recommended before and after using this patch. Carefully tear open the pouch and peel off the backing from the patch and apply the patch to a clean, dry, and hair-free area of the lower stomach.
This area must be free of powder, oil, or lotion for the patch to stick onto your skin. Press the patch firmly in place with your hand for about 10 seconds.
Applying the patch on the breast or over any skin folds, oily, broken, burned, or irritated skin, or areas with skin conditions, on the waistline or other places where tight clothing may rub it off is not recommended.
This patch must be worn at all times until the next patch. Exposure to the sun is not recommended. Apply the new patch to a different area of your lower abdomen when changing to a new patch.
Wait at least 1 week before applying a patch to the same area. Slowly peel it off from your skin when changing a patch.
If you have any patch adhesive left on your skin, allow it to dry for 15 minutes and gently rub the sticky area with oil or lotion to remove it.
It is best to change your patch on the same days of each week to help you remember. You may take a bath, shower, or swim while using this drug. Doing so will not affect the patch.
If a patch falls off, just put it back on a different area. If the patch does not stick completely, put on a new patch but continue to follow your original schedule for changing your patch.
To throw away a used patch: Fold the patch in half with the sticky side together and place it in a sturdy child-proof container. Throw this container in the trash away from children and pets.
Do not flush the patch down the toilet. 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 of hot flashes, atrophic vaginitis caused by menopause are prescribed with a continuous combined regimen by applying 1 CombiPatchВ® two times a week (every 3 to 4 days) for a 28-day cycle.
One CombiPatchВ® contains 0.05 milligrams of estradiol and 0.14 or 0.25 mg of norethindrone. Use in children is not recommended.
Adults under continuous sequential regimen should apply 0.05-milligram estradiol patch (Vivelle-DotВ®) two times a week (every 3 to 4 days) for the first 14 days of the 28-day cycle.
Then, apply one CombiPatchВ® two times a week (every 3 to 4 days) for the next 14 days of the 28-day cycle. One CombiPatchВ® contains 0.05 milligrams of estradiol and 0.14 or 0.25 mg of norethindrone.
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. Store the unopened pouches at room temperature for up to 6 months.
Do not store the patch outside of its pouch.
4 Precautions to 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.
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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