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Drugs reference index «Estradiol/norethindrone acetate transdermal system»

Estradiol/norethindrone acetate transdermal system

Brand names: CombiPatch

Why is Estradiol/norethindrone acetate transdermal system prescribed?

A remedy for the symptoms of menopause, CombiPatch combines the hormones estrogen (estradiol) and progestin (norethindrone acetate) in a slow-release patch that's applied to the skin. The product eases such symptoms of menopause as feelings of warmth in the face, neck, and chest, and the sudden intense episodes of heat and sweating known as "hot flashes." It is also prescribed to relieve external vaginal irritation and internal vaginal dryness.

CombiPatch can also be used as an estrogen supplement by women unable to produce sufficient amounts of estrogen on their own. Problems prompting the need for supplementation include ovarian failure, hypogonadism (impaired hormone production), and surgical removal of the ovaries.

Most important fact about Estradiol/norethindrone acetate transdermal system

Using estrogen may increase your chances of getting heart attacks, strokes, blood clots, dementia, breast cancer, and endometrial cancer (cancer in the lining of the uterus). Because estrogen replacement therapy is not advisable if you are in any danger of developing cancer or blood clots, your doctor should take a complete medical and family history, and perform a complete physical exam, before prescribing CombiPatch. It is important to have regular check-ups (at least once a year) and to report any unusual vaginal bleeding to your doctor immediately.

Hormone replacement therapy using estrogens, with or without progestin, should not be used to prevent heart disease or dementia. Recent studies have confirmed an increased rate of heart attack, stroke, dangerous blood clots, and dementia among women taking estrogen or estrogen combinations. Blood clots can lead to phlebitis, stroke, heart attack, a loss of blood supply to the lungs, a blockage in the blood vessels serving the eye, and other serious disorders. Because of these risks hormone replacement therapy should be given at the lowest effective dose for the shortest time. Your doctor will determine the dosage that is best for you.

How should you take Estradiol/norethindrone acetate transdermal system?

Apply the patch to a smooth, clean, dry area of the skin on your lower abdomen. Do not apply it on or near your breasts, at your waistline, or to oily, damaged, or irritated areas. Rotate sites; the same area should not be used again for at least one week. Wear only one patch at a time.

Do not expose the patch to the sun for prolonged periods of time. If it falls off during bathing or other activities, reapply it to a different part of the lower abdomen. If necessary, use a new patch.

Remove the patch carefully to avoid skin irritation. If any adhesive remains, wait 15 minutes then gently rub the area with a cream or lotion to remove the residue.

  • If you miss a dose...If you forget to apply a new patch when you are supposed to, do it as soon as you remember. If it is almost time to change patches anyway, skip the one you missed and go back to your regular schedule. Do not apply more than one patch at a time unless directed by your doctor.
  • Storage instructions...Store the sealed foil patches at room temperature, away from extreme heat and cold, for up to 3 months.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking CombiPatch.

  • Side effects may include:Abdominal pain, back pain, breakthrough bleeding, breast pain, dizziness, flu symptoms, headaches (including migraines), menstrual problems, nausea, nervousness, painful menstruation, respiratory problems, skin reaction, sore throat, vaginal inflammation, vomiting, weakness

Why should Estradiol/norethindrone acetate transdermal system not be prescribed?

The hormones in CombiPatch should not be used during pregnancy. You should also avoid this product if you have:

  • Unexplained vaginal bleeding
  • Liver disease
  • Known or suspected breast cancer
  • Any type of tumor stimulated by estrogen
  • Phlebitis, stroke, or any other blood clotting disorder
  • An allergy to any component of the patch

Special warnings about Estradiol/norethindrone acetate transdermal system

Estrogen, with or without progestins, has the potential of causing clot-related disorders, including heart attack and stroke, pulmonary embolism (a clot in the lungs), and thrombophlebitis (a clot in the veins). If you have a history of deep-vein thrombosis (a clot in the legs), or of thrombosis in your family, be sure to tell your doctor. The chance of developing a clot-related problem can be reduced by using the lowest dose of estrogen that still proves effective. If a problem develops, you'll have to stop using the patch. Likewise, you should discontinue the patch and call your doctor immediately if you suffer a loss of vision, any other eye problems, or a migraine headache.

Estrogen replacement therapy increases the risk of developing cancer of the lining of the uterus (endometrial cancer). The risk increases with longer use and higher doses. Combining estrogen and progestin reduces the risk of endometrial cancer caused by estrogen alone. However, this combination is not recommended for women who have had a hysterectomy (removal of the uterus), since they are not at risk for endometrial cancer.

Using estrogen may also increase your chances of breast cancer, ovarian cancer, and gallbladder disease.

Use estrogen with caution if you have severely low blood levels of calcium (hypocalcemia).

Tell your doctor if you've ever had liver problems, thyroid problems, or visions problems. Using estrogen could make these conditions worse. Other conditions that could worsen during estrogen therapy include asthma, diabetes, epilepsy, migraine, or the genetic disorder porphyria. Be sure your doctor is aware of any medical problems you have.

Hormone therapy occasionally causes a rise in blood pressure. If you have a blood pressure problem, use CombiPatch with caution and have your pressure checked regularly.

Hormones also tend to cause fluid retention. Use CombiPatch with caution if you have a condition that could be aggravated by excess fluid such as asthma, epilepsy, migraine headaches, heart disease, or kidney problems.

If you suffer from endometriosis, a condition where the endometrium (the lining of the uterus) doesn't shed properly and attaches to the outside of the uterus or other areas such as the ovaries or bowels, hormone therapy may cause a worsening of this condition.

Because estrogen can increase triglyceride levels, you'll need to be closely monitored if your triglycerides tend to be high. If you have diabetes, CombiPatch may also affect your blood sugar levels.

The use of CombiPatch may increase your chance of a stroke. If you feel you are at risk, talk with your doctor about your options.

In general, estrogens have been known to increase the likeliness of lupus, red rashes, and liver lesions.

Estrogen therapy occasionally causes abnormal uterine bleeding or breast pain. In view of concerns about cancer, you should have these symptoms checked by your doctor. In general, you should not take estrogen for more than 1 year without a follow-up physical exam. Ideally, you should have a checkup every 3 to 6 months.

In elderly patients, the combination of estrogen and progesterone was shown to increase the risk of developing dementia.

Let your doctor know if you're going to have surgery or will be on bed rest; you may need to stop taking estrogens.

Possible food and drug interactions when taking Estradiol/norethindrone acetate transdermal system

Tell the doctor about all prescription, over-the-counter, and herbal medications you are taking. The manufacturer does not list specific drug interactions for CombiPatch. However, it's possible that if estrogen is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before using estrogen with the following:

Antibiotics such as clarithromycin and erythromycinAntifungal drugs such as itraconazole and ketoconazoleAnti-HIV drugs such as ritonavirGrapefruit juiceSeizure medications such as carbamazepine and phenobarbitalRifampinSt. John's wort

Special information if you are pregnant or breastfeeding

Estrogens such as the one in CombiPatch should not be used during pregnancy. They pose a danger of birth defects, particularly in the reproductive tract.

The hormones in CombiPatch do appear in breast milk and may affect its quantity and quality. You should avoid taking them while breastfeeding unless it's absolutely necessary.

Recommended dosage for Estradiol/norethindrone acetate transdermal system

ADULTS

Your doctor will determine the dosage that is right for you. Typically hormone replacement therapy should be for the shortest duration to relieve your symptoms. You should be evaluated every three to six months.

The recommended starting dose is one patch containing 0.05 milligrams estradiol and 0.14 milligrams norethindrone acetate applied twice a week (every 3 to 4 days). Your doctor may increase your dose to a patch containing 0.05 milligrams estradiol and 0.25 milligrams norethindrone acetate if needed.

CombiPatch can also be used in conjunction with a 0.05 milligram estradiol-only patch. The estradiol-only patch is applied twice a week for the first 14 days of a 28-day cycle, and CombiPatch is applied twice weekly for the remaining 14 days.

If you are currently taking another form of hormone replacement therapy, you should complete the current cycle before switching to CombiPatch.

Irregular bleeding may occur, particularly in the first 6 months of therapy, but generally decreases with time and often stops completely.

Overdosage

Even a large overdose of the hormones in CombiPatch would pose little danger; and the patch form of delivery renders such a dose highly unlikely. Nevertheless, if you think there's a chance, seek medical attention immediately. Symptoms would include nausea and withdrawal bleeding.

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