Information on Tablets A-Z
Generic name: Estradiol and Norethindrone acetate
Why is this drug 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 this drug: Hormone replacement therapy employing estrogen alone has been linked to a dramatic increase in the risk of endometrial cancer (cancer in the lining of the uterus). However, addition of a progestin to the treatment, as in CombiPatch, reverses this increase. While critics of hormone replacement therapy are concerned about its cancer-causing potential, proponents point out that, in addition to relieving menopausal symptoms, hormone replacement appears to have a protective effect against heart disease and brittle bones (osteoporosis).
How should you take this medication: 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. Use the same site no more than once a 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. More common side effects may include: Abdominal pain, abnormal PAP smear results, acne, back pain, breast enlargement or pain, bronchitis, constipation, depression, diarrhea, dizziness, gas, flu symptoms, headache, indigestion, infection, insomnia, joint pain, menstrual problems, nausea, nervousness, pain, painful or increased menstruation, rash, respiratory problems, runny nose, sinus inflammation, skin reaction, sore throat, swelling, tooth disorders, vaginal bleeding or discharge, vaginal inflammation, weakness
Why should this drug 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 Phlebitis, stroke, or any other clotting disorder Known or suspected breast cancer Any type of tumor stimulated by estrogen An allergy to any component of the patch
Special warnings about this medication: Some experts suspect that high doses of estrogen, or prolonged use, may slightly increase the risk of breast cancer. Most studies, however, have failed to show any link. Estrogen at high doses (5 milligrams a day) does have the potential of causing clot-related disorders, including heart attack, 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 surfaces anyway, 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. 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. If you have a condition that could be aggravated by excess fluid such as asthma, epilepsy, migraine headaches, heart disease, or kidney problems use CombiPatch with caution. 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. 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. Although women who take oral estrogen after menopause face a 2- to 4-fold increase in the odds of gallbladder disease, no such increase has been reported with the patch.
Possible food and drug interactions when taking this medication: The manufacturer has not reported interactions.
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: 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 such as the product brand-named Vivelle. 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.