Estrogel

The active ingredient in EstroGel is estradiol. Estradiol is one of the more potent estrogen hormones in the female body and plays an important role in women’s health. Total estrogen levels tend to decline during menopause which results in hot flashes, night sweats, and uncomfortable vaginal symptoms. Using estradiol during menopause helps replace the decline in the body’s natural estrogen produced by the ovaries.

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 EstroGel. However, the following is a synopsis of the general guidelines for the use of EstroGel:

• Use EstroGel exactly as prescribed by your healthcare provider. Do not exceed the recommended daily dose or duration of use.
• Before using EstroGel, the metered-dose pump must be primed if it is the first time you are using it. After priming, the pump is ready to be used.
• EstroGel is typically applied as a thin layer over your entire arm, inside and outside, from your wrist to your shoulder. Do not apply to the breast or in or around the vaginal area. Apply the directed number of pumps of product to clean, dry, unbroken skin once daily. Do not massage the product into the skin and let it fully dry.
• Do not let another person apply the product to your skin and wash hands immediately after use to avoid transferring the product.
• EstroGel contains alcohol and is flammable. Avoid any flames or smoking until the product has dried.
• Sunscreen can affect how much estradiol is absorbed. Generally, separation of application is recommended but consult your healthcare provider. They will know what is best to recommend for you.
• If you miss a dose of EstroGel, use it as soon as you remember. However, if more than 12 hours have passed, skip the missed dose and continue with your regular dosing schedule by using the next dose. Do not use a double dose of EstroGel to make up for a missed one.

The most common side effects of EstroGel include:

• Headache
• Breast tenderness
• Stomach cramps
• Bloating
• Nausea and vomiting
• Hair loss
• Fluid retention
• Yeast infection

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

• Unusual vaginal bleeding.
• Sudden and severe headaches.
• Signs of a stroke such as slurred speech, sudden numbness or weakness on one side of the body, facial drooping, or blurred vision.
• Signs of a heart attack such as chest pain that radiates to the jaw, neck, arms, shoulders, or back, shortness of breath, or lightheadedness.
• Signs of blood clots such as shortness of breath or swollen or painful legs.
• Signs of cancer such as unexplained weight loss, skin changes, blood or mucus in the stools, Lumps or swelling on breasts, or fatigue. EstroGel can increase the risk of ovarian cancer, uterine or endometrial cancer, or breast cancer.
• Signs of gallbladder disease such as severe pain in the upper right abdomen that may radiate to the back.
• High blood pressure.
• Signs of liver problems such as jaundice or yellowing of the skin or eyes, pain in the upper right abdomen, or dark urine.
• Angioedema (swelling of the lips, face, eyes, and tongue).

These are not all of the possible side effects of EstroGel. 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 EstroGel, 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 if you have:

• Unusual vaginal bleeding
• Asthma
• Epilepsy
• Diabetes
• Migraine
• Endometriosis
• Lupus
• Heart disease
• Porphyria
• Liver problems
• Thyroid problems
• Kidney problems
• High or low calcium levels in the blood
• High blood triglycerides

Boxed Warning

• If EstroGel is used on its own, there is an increased risk of endometrial hyperplasia or overgrowth of the uterus lining if the patient has not had a hysterectomy and still has their uterus. This overgrowth can be the start of uterine or endometrial cancer (cancer of the uterus).
• Using EstroGel alone can also cause an increased risk of stroke, deep vein thrombosis (DVT), and dementia in postmenopausal women 65 years of age or older. EstroGel should not be used alone to prevent cardiovascular disease or dementia.
• If EstroGel is used in combination with progestin therapy, there is an increased risk of pulmonary embolism, deep vein thrombosis (DVT), stroke, heart attack, and dementia. There is also an increased risk of breast cancer with this type of HRT or hormone therapy. EstroGel plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia.

Do not use EstroGel if you have:

• Unusual vaginal bleeding
• Breast cancer or a history of breast cancer
• Estrogen-dependent cancer
• Active DVT or PE or a history of venous thromboembolism
• History of stroke or MI
• Liver or hepatic impairment
• Deficiency of protein C or S, thrombophilia, or any other bleeding disorder
• Are currently pregnant

Studies looking at the efficacy of EstroGel on vasomotor symptoms saw improvement in hot flushes within 4 weeks. However, each person is different and some did not see benefit till after this period up to the 12-week mark.

When EstroGel is used 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, including:

• St. John’s Wort
• Phenobarbital
• Carbamazepine
• Rifampin
• Erythromycin
• Clarithromycin
• Ketoconazole
• Itraconazole
• Ritonavir

EstroGel is available as a metered-dose pump in the following strengths:

• 0.06% estradiol

EstroGel should be stored at room temperature away from heat and out of reach of children.

EstroGel is manufactured by the pharmaceutical company Ascend Therapeutics.

Yes, there is a generic version of the brand name EstroGel available.

Consult your doctor or pharmacist before starting, stopping, or changing medications while using EstroGel. It is recommended to use this medication at the lowest dose that provides relief for the shortest duration of time. Consult your healthcare provider regularly about the dose you are using, changes in your symptoms, and whether you still require EstroGel.

EstroGel should not be used in pregnancy. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant.

The active ingredient in EstroGel can pass into the 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.