Product Details: Divigel (Estradiol Gel)

Brand Name Options - Manufacturer: Orion Pharma

Description

Divigel (Estradiol Gel) 01% is indicated for the treatment of moderate to severe vasomotor symptoms associated with the menopause.

Directions

Read the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Use this medication exactly as prescribed. Learn all usage instructions for your product. This medication is usually applied in a thin layer once daily according to product instructions or as directed by your doctor. If you shower or bathe before applying this medication, allow the skin to dry completely before use. Apply this drug to clean, unbroken skin. Do not apply to irritated skin. Do not apply this medication to the face or breasts or in/around the vagina. It is not necessary to rub this medicine into the skin. Allow this medication to dry on your skin before dressing. Wash your hands with soap and water after each application. Wait at least 1 hour before getting the area wet or swimming. To prevent others from being exposed to this drug, allow the medicine to dry completely, then cover the area with clothing. Wait at least 1 hour before allowing others to touch the skin where you applied the drug. If this drug accidentally gets on others, have them wash the area with soap and water as soon as possible. Avoid getting this medication in the eyes. If this medication gets in the eyes, rinse them immediately with warm water. Tell your doctor if the eyes become irritated. Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day. Tell your doctor if your condition does not improve or if it worsens.

Cautions

Before using this product, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: vaginal bleeding of unknown cause, certain cancers (e.g., breast cancer, cancer of the uterus or ovaries), blood clots, recent stroke or heart attack (within 1 year), liver disease. Before using this medication, tell your doctor or pharmacist your medical history, especially of: family medical history (especially breast lumps and cancer), asthma, diabetes, seizures, migraine headaches, heart disease (e.g., high blood pressure, past heart attacks, congestive heart failure), past strokes, kidney disease, underactive thyroid (hypothyroidism), mineral imbalance (low or high levels of calcium in the blood), mental/mood disorders (e.g., dementia, depression), high blood pressure during pregnancy (toxemia), yellowing eyes/skin (cholestatic jaundice) during pregnancy or with past estrogen use, uterus tissue problems (e.g., uterine fibroids, endometriosis), high levels of blood fats (cholesterol, triglycerides), gallbladder disease, obesity, certain blood disorder (porphyria), lupus. This drug may make you dizzy. Use caution while driving, using machinery, or doing any activity that requires alertness. Limit alcoholic beverages. If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye doctor if these problems occur. This drug may cause a patchy darkening of the skin on the face (melasma). Sunlight may worsen this darkening. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors. Do not smoke cigarettes or use tobacco. Estrogens combined with smoking further increase your risk for stroke, blood clots, high blood pressure, and heart attacks, especially in women older than 35. If you will be having surgery or will be confined to a chair or bed for a long time (e.g., a long plane flight), tell your doctor beforehand. Special precautions may need to be taken because of the increased risk for blood clots. This product is not meant for children. This medication must not be used during pregnancy. It may result in birth defects or cancer later in the child's life. If you become pregnant or think you may be pregnant, tell your doctor immediately. This medication may pass into breast milk. It may reduce the quality and amount of breast milk. Consult your doctor before breast-feeding.

Side Effects

Dizziness, lightheadedness, headache, stomach upset, bloating, nausea, weight changes, increased/decreased interest in sex, breast tenderness, or skin redness/irritation at the application site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., severe depression, memory loss), breast lumps, swelling hands/feet, unusual vaginal bleeding (e.g., spotting, breakthrough bleeding, prolonged/recurrent bleeding), unusual vaginal discharge/itching/odor, yellowing eyes/skin, stomach/abdominal pain, persistent nausea/vomiting, dark urine, worsening of seizures, signs of worsening diabetes control (e.g., increased thirst and urination). This medication may infrequently cause serious problems such as heart attacks, stroke, and blood clots. Seek immediate medical attention if you experience any of the following: chest/jaw/left arm pain, sudden severe headache, weakness on one side of the body, confusion, slurred speech, sudden vision changes (e.g., double vision, loss of vision), pain/redness/swelling of legs, trouble breathing, coughing up blood, sudden dizziness/fainting. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Active Ingredients

Estradiol Gel