Estradiol and levonorgestrel transdermal

Estradiol is a form of estrogen, a female sex hormone that regulates many processes in the body. Levonorgestrel is a form of progesterone, a female hormone important for regulating ovulation and menstruation.

Estradiol and levonorgestrel is a combination medicine used to treat menopause symptoms such as hot flashes, and to prevent osteoporosis (bone loss) in menopausal women.

Estradiol and levonorgestrel may also be used for purposes other than those listed here.

Do not use if you are pregnant.

You should not use this medicine if you have had a hysterectomy, or if you have any of the following conditions: liver disease, a bleeding disorder, unusual vaginal bleeding, a history of breast or uterine cancer, or if you have ever had a heart attack, stroke, or a blood clot.

Estradiol and levonorgestrel should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions. Long-term use may also increase your risk of breast cancer or blood clot.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Apply the skin patch to clean, dry skin on your lower stomach. The patch should be worn around-the-clock for one week. Choose a different place on your lower stomach each time you apply a new patch. Avoid skin that is oily, irritated, or damaged.

Do not apply a skin patch to your breasts. Do not apply a patch where it might be rubbed off by tight clothing, such as under an elastic waistband.

If a patch falls off, try putting it back on to a different skin area, pressing the patch into place for 10 seconds. If the patch will not stick you may apply a new one.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using estradiol and levonorgestrel.

Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis, and have regular mammograms while taking estradiol and levonorgestrel.

Store at room temperature away from moisture and heat. Keep this medicine in the foil pouch until ready to use.

Apply a skin patch as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra patches to make up the missed dose.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

• signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;

• signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs;

• vomiting, jaundice (yellowing of the skin or eyes);

• unusual vaginal bleeding;

• a lump in your breast;

• fluid retention (swelling, rapid weight gain); or

• high levels of calcium in your blood--nausea, vomiting, stomach pain, loss of appetite, constipation, increased thirst or urination, muscle pain or weakness, joint pain, confusion, and feeling tired or restless.

Common side effects may include:

• nausea, vomiting, bloating, stomach cramps;

• headache;

• breast pain;

• hair loss; or

• vaginal itching or discharge, breakthrough bleeding.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Estradiol and levonorgestrel combination skin patch is used treat moderate to severe hot flashes and other symptoms of menopause or low amounts of estrogen. It is also used in women to prevent osteoporosis after menopause.

Estradiol is an estrogen hormone. Levonorgestrel is a progesterone. The hormones from the patch are absorbed through your skin into your body. It works by preventing symptoms, such as feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating (hot flashes) in women during menopause.

estradiol and levonorgestrel is available only with your doctor's prescription.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For estradiol and levonorgestrel, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to estradiol and levonorgestrel or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Use of estradiol and levonorgestrel combination skin patch is not indicated in the pediatric population. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of estradiol and levonorgestrel combination skin patch have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have breast cancer, stroke, or dementia, which may require caution in patients receiving estradiol and levonorgestrel combination skin patch.

Pregnancy

Breast Feeding

Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking estradiol and levonorgestrel, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using estradiol and levonorgestrel with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Tranexamic Acid

Using estradiol and levonorgestrel with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aprepitant
• Bosentan
• Bupropion
• Carbamazepine
• Ceritinib
• Conivaptan
• Dabrafenib
• Darunavir
• Dexamethasone
• Donepezil
• Efavirenz
• Eliglustat
• Enzalutamide
• Fosphenytoin
• Griseofulvin
• Idelalisib
• Isotretinoin
• Lesinurad
• Lixisenatide
• Lumacaftor
• Mitotane
• Modafinil
• Netupitant
• Oxcarbazepine
• Phenytoin
• Pitolisant
• Pixantrone
• Prednisone
• Rifabutin
• Rifampin
• St John's Wort
• Sugammadex
• Theophylline
• Tizanidine
• Topiramate
• Ulipristal
• Valproic Acid

Using estradiol and levonorgestrel with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acitretin
• Alprazolam
• Amprenavir
• Atazanavir
• Bacampicillin
• Betamethasone
• Bexarotene
• Clarithromycin
• Colesevelam
• Cyclosporine
• Delavirdine
• Efavirenz
• Eslicarbazepine Acetate
• Fosamprenavir
• Fosaprepitant
• Ginseng
• Ketoconazole
• Lamotrigine
• Levothyroxine
• Licorice
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nelfinavir
• Perampanel
• Prednisolone
• Rifapentine
• Ritonavir
• Rosuvastatin
• Rufinamide
• Selegiline
• Tacrine
• Telaprevir
• Tipranavir
• Troglitazone
• Troleandomycin
• Voriconazole
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using estradiol and levonorgestrel with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use estradiol and levonorgestrel, or give you special instructions about the use of food, alcohol, or tobacco.

• Caffeine

Other Medical Problems

The presence of other medical problems may affect the use of estradiol and levonorgestrel. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal or unusual vaginal bleeding or
• Blood clots (eg, deep vein thrombosis, pulmonary embolism), active or history of or
• Breast cancer, known or suspected, or history of or
• Heart attack, active or history of or
• Liver disease or
• Protein C or protein S deficiency, or other known blood clotting disorders or
• Stroke, active or history of or
• Surgery with a long period of inactivity or
• Tumors (estrogen-dependent), known or suspected—Should not be used in patients with these conditions.

• Angioedema or anaphylaxis—Should not be used in patients who have experienced these conditions with prior use of estradiol and levonorgestrel combination skin patch.

• Asthma or
• Cancer, history of or
• Diabetes or
• Edema (fluid retention or body swelling) or
• Endometriosis or
• Epilepsy (seizures) or
• Gallbladder disease or
• Heart disease or
• Hereditary angioedema (swelling of the face, lips, tongue, or throat) or
• Hypercalcemia (high calcium in the blood) or
• Hypertension (high blood pressure) or
• Hypertriglyceridemia (high triglycerides or fats in the blood) or
• Hypocalcemia (low calcium in the blood), severe or
• Hypothyroidism (an underactive thyroid) or
• Jaundice during pregnancy or from using hormonal therapy in the past or
• Liver tumors or
• Migraine headache or
• Porphyria (an enzyme problem) or
• Systemic lupus erythematosus (SLE)—Use with caution. May make these conditions worse.

• Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Data not available