Indications  

Combipatch is a transdermal medication prescribed for women with a uterus to treat moderate to severe vasomotor symptoms (hot flashes and night sweats) and vulvar/vaginal atrophy (such as vaginal dryness) resulting from menopause.  

Combipatch is also used to treat hypoestrogenism (low estrogen level) caused by hypogonadism, castration, or primary ovarian failure. 

This transdermal patch contains two female hormones: estradiol, an estrogen, and norethindrone acetate (NETA), a progestational agent. Estradiol replenishes declining estrogen levels in the body, while NETA helps mitigate the risk of uterine cancer associated with estrogen use. 

Uses and Dosage 

Before using Combipatch and with every prescription refill, thoroughly review its medication guide and patient information leaflet. Please ask your doctor or pharmacist if you have any questions, or for clarifications. 

Combipatch therapy can be started anytime if not using continuous estrogen or combination estrogen plus progestin therapy.  

Those on therapy should complete their cycle before starting. The first day of the withdrawal bleeding is ideal to begin using Combipatch. 

Combipatch dosage is individualized based on medical condition and treatment response, with the aim of using the minimum effective dose. 

Typically, Combipatch is worn for the initial 14 days of a 28-day cycle and should be replaced every 3 to 4 days (twice weekly). 

To properly use this patch, follow these steps: 

1. Remove Combipatch from the pouch, tearing it open at the slit (do not use scissors). 
2. Peel off the adhesive liner, avoiding touching the sticky part with your fingers. 
3. Place the sticky side of the patch on the lower abdomen, below the panty line. 
4. Peel off the second side of the protective liner and firmly press the patch in place for about 10 seconds. Note: 
   • Avoid the waistline, as clothing and belts may rub off the patch. 
   • Do not apply the patch to or near the breasts. 
   • Apply only to clean, dry skin without any powder, oil, or lotion. 
   • Avoid applying it to injured, burned, irritated skin or areas with skin conditions or excessive hair. 
5. Press the patch firmly onto the skin and rub the edges with your fingers to ensure proper adhesion. Note: 
   • Bathing, swimming, or showering will not affect the patch. 
   • Avoid prolonged sun exposure on the patch. 
   • If the patch falls off, reapply it. If unable to reapply, use a new patch in a different area and continue the original placement schedule. 
   • If you stop using the patch or forget to apply a new one as scheduled, you may experience spotting, bleeding, and recurring symptoms. 
6. When changing the patch, remove the old one before applying a new patch. 
7. To dispose of the used patch, fold the sticky sides together, place it in a child-proof container, and discard it in the trash. Do not flush used patches down the toilet. 

For optimal results, use Combipatch consistently and adhere to a weekly patch replacement schedule. Consider marking your calendar as a reminder. 

Inform your doctor if your condition does not improve or worsens. 

Side Effects 

Listed below are the potential adverse effects that may arise from using Combipatch. Promptly notify your doctor if any of them persist or worsen. 

Common Side Effects 

• Redness, irritation, or rash on the skin where the patch is applied 
• Abdominal pain 
• Nausea 
• Vomiting 
• Bloating 
• Breast tenderness or enlargement 
• Weakness 
• Swelling of hands or feet 
• Spotty darkening of the skin, especially on the face 
• Difficulty wearing contact lenses 
• Vaginal irritation or discomfort 
• Alterations in menstrual cycle 
• Painful menstruation 
• Breakthrough bleeding 
• Headache 
• Weight changes 

Serious Side Effects 

• Changes in mental/mood (e.g., depression, memory loss) 
• Breast lumps 
• Increased or new vaginal itching, odor, or discharge 
• Severe stomach or abdominal pain 
• Persistent nausea or vomiting 
• Yellowing of eyes or skin 
• Dark urine 
• Swelling in hands, ankles, or feet 
• Increased thirst or urination 

Inform your doctor if you experience any of the severe side effects listed above. 

Allergic Reactions 

Severe allergic reactions to Combipatch are uncommon; however, seek immediate medical attention if you experience symptoms such as: 

• Rash 
• Itching or swelling, especially of the face, tongue, or throat 
• Severe dizziness 
• Trouble breathing. 

This list does not contain all the potential side effects of Combipatch. If you encounter any unlisted effects, notify your doctor right away. 

Cautions 

Before using Combipatch, inform your doctor and pharmacist if you have any known hypersensitivities, especially to estradiol, norethindrone, any other medications, or any of the ingredients present in this patch. 

For women using Combipatch specifically to address symptoms localized in the vagina, considering products applied directly inside the vagina is recommended before exploring medications taken orally, absorbed through the skin, or administered via injection. 

To ensure Combipatch is safe for you, disclose to your physician your medical background, specifically if you have a history of: 

• Vaginal bleeding of unknown cause 
• Certain cancers (breast cancer, uterine/ovarian cancer) 
• Blood clots 
• Stroke 
• Heart disease (heart attack) 
• Liver disease 
• Kidney disease 
• Family history of breast lumps, cancer, or blood clots 
• Family or personal history of angioedema (swelling disorder) 
• Blood clotting disorders (protein C or protein S deficiency) 
• High blood pressure 
• Diabetes 
• High blood cholesterol/triglyceride levels 
• Obesity 
• Lupus 
• Underactive thyroid (hypothyroidism) 
• Mineral imbalance (low or high calcium levels in the blood) 
• Hormone problem (hypoparathyroidism) 
• Uterus problems (fibroids, endometriosis) 
• Gallbladder disease 
• Asthma 
• Seizures 
• Migraine headaches 
• Blood disorder (porphyria) 
• Mental/mood disorders (dementia, depression) 

CombiPatch may interact with certain products, including: 

• Aromatase inhibitors (e.g., anastrozole, exemestane, letrozole) 
• Fulvestrant 
• Ospemifene 
• Raloxifene 
• Tamoxifen 
• Toremifene 
• Tranexamic acid 

To mitigate the risk of such drug interactions, inform your doctor and pharmacist about all your medicines, including prescription and over-the-counter drugs, other dietary supplements, and herbal products. 

Combipatch can potentially affect specific laboratory tests, such as the metyrapone test, leading to potential inaccuracies in test results. Inform laboratory personnel and your healthcare providers about your medication use. 

Inform your doctor about recent or upcoming surgeries and prolonged periods of immobility (e.g., extended plane flights), as these circumstances heighten the risk of blood clots, particularly when using estrogen-based products like Combipatch. It may be necessary to discontinue the medication or adopt specific precautions temporarily. 

Combipatch may induce melasma, resulting in patchy, dark facial and skin areas. Sunlight can exacerbate this condition. To mitigate the effect, restrict sun exposure, avoid tanning booths and sunlamps, apply sunscreen, and wear protective clothing when outdoors. 

Nearsighted or contact lens wearers may encounter vision issues or have difficulty wearing lenses. Consult an eye doctor if this happens. 

Inform the testing staff of your use of Combipatch before undergoing an MRI. Certain patches may contain metals that could result in severe burns during the procedure. Consult with your physician to determine if patch removal is necessary before the test and how to appropriately apply a new patch afterward. 

Combipatch is contraindicated during pregnancy. In the event of pregnancy or suspicion of pregnancy, inform your doctor promptly. 

Estrogens and progestins can be excreted in breast milk, potentially impacting the quantity and quality of milk produced. Consult with your doctor before breastfeeding while using this medication.