Combipatch (Estradiol / Norethindrone Acetate)

Description

CombiPatch is a transdermal patch that's made up of hormones to treat menopausal symptoms, vaginal atropy due to menopause, and low estrogen levels caused by hypogonadism, castration, or primary ovarian failure in women with a uterus.

The hormones in CombiPatch are estradiol and norethindrone acetate.

CombiPatch is supplied in the following strengths:

• 0.05 mg estradiol with 0.14 mg norethindrone acetate
• 0.05 mg estradiol with 0.25 mg norethindrone acetate

Directions

The instructions that come with your CombiPatch prescription should be carefully read and followed. Use CombiPatch as prescribed by your doctor. Talk to your doctor or pharmacist about any questions or concerns you may have.

Application

Apply CombiPatch to smooth, clean, dry, and undamaged skin of the lower abdomen. Avoid placing the patch on or near the breasts or at the waistline where clothing could rub it off. It's recommended that you rotate the application sites, allowing at least one week between applications to the same site. Only one patch at a time should be worn during the 3- or 4-day dosing interval. Do not expose the patch to the sun for long periods of time.

Removal

Remove the patch slowly. If there is adhesive still stuck to the skin, allow your skin to dry for 15 minutes, then gently rub the area with an oily cream or lotion to remove it.

Storage
Store CombiPatch systems in their sealed foil pouches in the refrigerator between 36°F and 46°F. Keep CombiPatch out of reach of children and pets.

Ingredients

Each CombiPatch transdermal system contains estradiol and norethindrone acetate.

Contraindications

Avoid using CombiPatch if you have any of the following:

• Abnormal, undiagnosed vaginal bleeding 
• Current, suspected, or a history of breast cancer
• Current or suspected estrogen-dependent cancer
• Current or a history of blood clots in the legs or lungs
• Active stroke or heart attack
• Previous allergic reaction or swelling associated with CombiPatch
• Liver disorders
• Blood clotting disorders, including protein C, protein S, or antithrombin deficiency
• Pregnant

Cautions

CombiPatch has a FDA Boxed Warning against the use of estrogens and progestins for preventing cardiovascular disease or dementia. The FDA Boxed Warning also warns that estrogen plus progestin therapy can increase the risk of blood clots in the legs or lungs, stroke, and heart attack in postmenopausal women. Further, the FDA Boxed Warning warns that estrogen plus progestin therapy can increase the risk of dementia and breast cancer in women. Estrogen alone has been shown to increase the risk of endometrial cancer in women with a uterus. Estrogen alone has also been shown to increase the risk of stroke, blood clots, and dementia in postmenopausal women. Estrogens with or without progestins should be used at the lowest dose possible and for the shortest duration of time while meeting treatment goals.

• Before you use CombiPatch, tell your doctor about:
• All the medications you take
• Your allergies
• Your health history and medical problems
• Your pregnancy or breastfeeding status
• Postmenopausal women who take estrogens may be at increased risk of gallbladder disease that requires surgery.
• Women who take estrogens and have breast or bone cancer may be at risk for high calcium levels.
• Estrogens can cause blood clots in the retina of the eyes.
• CombiPatch may cause swelling of the eyes, face, tongue, legs, ankles, or fingers. Seek medical care right away if you experience any of these effects.
• CombiPatch may cause severe allergic reactions that include hives, itching, or swelling. Seek medical care immediately if you experience any of these effects.
• Blood pressure may increase with estrogen use.
• Triglyceride levels in the blood that can lead to pancreatitis may increase with the use of estrogens.
• A dose increase in hormone replacement therapy may be required in women who are also taking estrogens.
• Estrogens can cause fluid retention.
• Conditions such as asthma, diabetes, seizures, migraines, lupus, and benign liver tumors may worsen with estrogen use. Women with any of these conditions should use CombiPatch with caution.

Side Effects

Stomach pain, diarrhea, depression, sore throat, application site reactions, breast pain, and vaginal inflammation are some of CombiPatch's side effects. However, these are not the only side effects that may develop.

Call your doctor immediately if you have bothersome or persistent side effects.

Reference:

1. CombiPatch (estradiol/norethindrone acetate transdermal system). Miami, FL: Noven Pharmaceuticals, Inc.; 2021.

About Dr. Savannah Muncy (Page Author)

Dr. Muncy (PharmD) studied science and education as an undergraduate before attending the Appalachian College of Pharmacy where she completed her PharmD in three years. She is currently using her pharmacy and healthcare expertise to write medical content for clients all around the world. She is focused on delivering the most current, accurate, and engaging information to healthcare professionals and patients. Read More....