Combipatch

The active ingredients in the Combipatch transdermal system are estradiol and norethindrone acetate. They help your body adjust to the hormonal changes that occur during menopause and with some illnesses that result in low estrogen levels.

Estradiol is used to bring your body's estrogen levels back to normal. This reduces vaginal dryness, vaginal discomfort, hot flashes, and night sweats—all signs of low estrogen.

Norethindrone is a type of progestin. It functions similarly to progesterone and aids in counteracting the impact of estrogen on uterine lining growth.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide, before using the Combi patch. However, the following is a synopsis of the general guidelines for the use of Combipatch:

• To reduce the chance of severe side effects, you should use Combipatch at the lowest effective dose for the shortest amount of time. Using Combipatch for long periods of time increases your risk of serious side effects. Discuss your symptoms and how the drug is affecting you with your doctor every few months.
• Twice a week, or every three to four days, apply CombiPatch (estradiol/norethindrone) to the skin of your lower abdomen. To help you remember, mark on your calendar when you need to change your patch.
• Before you put a fresh CombiPatch on, take off the old one. To reduce your chance of experiencing side effects like headaches, menstrual cramps, and breast soreness, avoid applying more than one patch to your skin at once.
• If you discontinue taking CombiPatch (estradiol/norethindrone) or neglect to put on a fresh patch every three to four days, you may have spotting and irregular vaginal bleeding. Menopause or low estrogen symptoms may also resurface.
• CombiPatch (estradiol/norethindrone) can be wet, but rubbing it could cause it to come off. After using a sauna, bath, shower, or swimming, be sure to check if your patch is still on your skin or if it has come off. If the patch comes off and you can’t reapply it, apply a new patch to a different area of skin.
• Avoid applying the patch to areas of the skin where it might be easily rubbed off (such as the waistline).
• Put CombiPatch (estradiol/norethindrone) on a dry, clean, and smooth area of your lower abdomen.
• When you're ready to apply a new patch onto your skin, peel open the pouch at the indented notch with your hand. Don't use scissors to open the pouch.
• Regular complete physical exams, which include lab and/or medical tests (such as blood pressure, breast exam/mammogram, pelvic exam, and Pap smear) should be done while you are using this medication.

The most common side effects of Combipatch include:

• Menstrual cramps.
• Breast pain.
• Weakness.
• Vaginitis (vaginal pain or itching).
• Unusual vaginal bleeding.
• Back pain.
• Application site reactions.
• Low thyroid hormone levels.
• Bloating.
• Weight gain.
• Shortness of breath.
• Buildup of fluids in your body (fluid retention).
• Increased triglyceride levels.

Some individuals may experience serious side effects while using Combipatch. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• An arm or leg blood clot may cause soreness, pain, or swelling; the skin may feel warm to the touch.
• Breathing difficulties and chest pain due to a blood clot in the lung.
• Heart attack symptoms include lightheadedness, cold sweats, shortness of breath, arm discomfort, and chest pain.
• Stroke symptoms include sudden weakness on one side of the body, facial drooping, altered speech or vision, disorientation, and a severe headache.
• Signs of liver problems like dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, throwing up, or yellowing of the skin or eyes (jaundice).
• Hives, itching, stomach pain, vomiting, difficulty breathing, and swelling of the face, lips, or tongue are signs of a severe allergic reaction.
• Increased risk of breast, ovarian, and uterine cancer.

These are not all of the possible side effects of Combipatch. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Combipatch, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including whether you have:

• A certain blood disorder (porphyria).
• A history of blood clots.
• High blood pressure.
• Breast cancer or cancer of the ovaries.
• Liver disease or liver tumor.
• Gallbladder disease.
• High cholesterol.
• Heart attack, stroke, or a tumor where estrogen makes it grow.
• Heart disease.
• Endometrial cancer or endometriosis.
• Had your uterus removed.
• Have unexplained vaginal bleeding.
• Family or personal history of a certain swelling disorder (angioedema).

Boxed Warning

• Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia.

• Abnormal vaginal bleeding that a healthcare professional hasn't diagnosed yet.
• Currently have or have had breast cancer.
• Currently have or have had an estrogen-dependent cancer or tumor.
• Currently have or have had a blood clot (e.g., DVT, PE).
• History of heart attack or stroke.
• Liver damage or liver problems.
• Blood-clotting conditions.
• Currently pregnant.

After a few weeks, noticeable changes usually start to show themselves, but it may take up to three months to see the full effects.

When Combipatch is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions.

Combipatch may interact with other drugs, especially those that impact hormone metabolism or specific enzymes. Anticonvulsants like phenytoin, some HIV drugs like ritonavir, and antibiotics like rifampin are a few examples of noteworthy interactions. Smoking and grapefruit juice can potentially reduce the effectiveness of Combipatch and raise the possibility of adverse effects.

A patch that releases 0.05 mg of estradiol and 0.14 mg of norethindrone daily will be your first dose.

Whether you're taking CombiPatch (estradiol/norethindrone) alone or in combination with an estradiol-only patch like Climara determines the maintenance dose.

If you are using CombiPatch (estradiol/norethindrone) alone, put one patch under your waist on your lower abdomen, and change it every three to four days.

Combining an estradiol-only patch with CombiPatch (estradiol/norethindrone):

Days 1 through 14: Put one patch on your skin that contains solely estradiol (0.05 mg per day), and change it every three to four days.

Days 15–28: Put one CombiPatch (estradiol/norethindrone) on your lower abdomen. Change it every three to four days.

Store your patches at room temperature and keep them out of reach of children.

Noven Therapeutics, LLC is the company that manufactures CombiPatch.

There are no lower-cost generics available for Combipatch.

Instead of stopping Combipatch (or any HRT) suddenly, it is usually advised to gradually lower the dosage over time. By doing this, the chance of experiencing rebound symptoms like sweats or hot flashes can be reduced.

Combipatch should not be used if you are pregnant. Notify your doctor if you are already pregnant or if you have any plans to become pregnant.

Estrogens plus progestins are found in your breast milk. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.