Divigel

The gel is usually applied once daily. The recommended starting dose is 0.25 mg daily. Your doctor may adjust your dose based on your response.

To apply the estradiol gel, open the foil packet and squeeze the entire contents onto the skin of the upper thigh. Spread the gel in a thin layer over an area of about 5 to 7 inches or the size of two palm prints. Allow the gel to dry completely before dressing. To avoid skin irritation, rotate between the right and the left thigh each day.

Do not apply the gel to the breasts, face, vagina or to irritated or damaged skin.

Discard the empty foil packet into a garbage container that cannot be accessed by pets or others in the household. Wash your hands when you are finished. Do not let others come in contact with the area of skin where you applied the gel for at least one hour after you apply the gel.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important that Divigel (Estradiol-topical) be used exactly as prescribed by your doctor. Apply the gel at the same time each day. If you miss a dose, do not double the dose the next day. If your next dose is less than 12 hours away, wait and apply your next dose the next day, as usual. If it is more than 12 hours until the next dose, apply the dose you missed, and resume your normal dosage the next day. If you accidentally spill some of the contents of a packet, do not open a new packet. Apply your normal dose the next day.

Divigel (Estradiol-topical) is flammable because the gel contains alcohol. Avoid fire, flame, or smoking until the gel has dried. Allow the gel to dry for approximately 2 minutes before covering it with clothing.

Store Divigel (Estradiol-topical) at room temperature, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause headaches; it may affect menstruation (irregular or absence of menses); it may cause nausea or, rarely, vomiting; it could cause water retention and swelling; it may increase breast size. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

The clear, colourless, smooth, opalescent gel contains estradiol 0.1% supplied in single dose foil packets containing 0.25 mg, 0.5 mg or 1.0 mg of estradiol. Nonmedicinal ingredients: carbomer, ethanol, propylene glycol, purified water, and triethanolamine.

Do not use estradiol gel if you:

• are allergic to estradiol gel or any ingredients of the medication
• are or may be pregnant or breast-feeding
• experience migraines that are accompanied by a visual aura or disturbance
• have active Phlebitis (inflamed Varicose Veins)
• have heart disease or have had a Stroke
• have had breast or endometrial cancer, except in special circumstances
• have liver dysfunction or disease, especially of the obstructive type
• have or have had Blood Clots in the legs (deep vein thrombosis), lungs (pulmonary Embolism), or heart (Heart Attack)
• have partial or complete loss of vision, or double vision from eye disease related to circulation problems
• have unusual vaginal bleeding and have not consulted a doctor about it
• have excessive growth of tissue in the uterus

There may be an interaction between estradiol gel and any of the following:

• Abiraterone
• Amiodarone
• Anastrozole
• Apixaban
• Aprepitant
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• Bosentan
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, Verapamil)
• Carbamazepine
• Carvedilol
• Celecoxib
• Cobicistat
• conivaptan
• corticosteroids (e.g., Dexamethasone, Hydrocortisone, Prednisone)
• Crizotinib
• Cyclosporine
• dabigatran
• Dabrafenib
• Deferasirox
• dehydroepiandrosterone
• Desipramine
• desiccated thyroid
• diabetes medications (e.g., chlorpropamide, Glyburide, insulin, Metformin, Rosiglitazone)
• Dipyridamole
• Dronedarone
• Edoxaban
• Elagolix
• Eliglustat
• Exemestane
• Flibanserin
• grapefruit juice
• Haloperidol
• Heparin
• Hepatitis C antivirals (dasabuvir, ombitasvir, paritaprevir)
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• Lamotrigine
• Levothyroxine
• low molecular weight heparins (e.g., Dalteparin, Enoxaparin, Tinzaparin)
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• Mefloquine
• mifepristone
• Mitotane
• Modafinil
• Nilotinib
• Oxcarbazepine
• Phenobarbital
• Phenytoin
• Prazosin
• primidone
• Progesterone
• quinidine
• quinine
• rifabutin
• rifampin
• Rivaroxaban
• Ropinirole
• St. John's wort
• saw palmetto
• Somatropin
• soybean
• Tacrolimus
• thalidomide
• Theophylline
• Tizanidine
• Tocilizumab
• Topiramate
• Trazodone
• Ursodiol
• vitamin C
• Warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. In many cases, interactions are intended or are managed by close monitoring. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Divigel (Estradiol-topical). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Divigel (Estradiol-topical).

Important information about estrogen:

• Divigel (Estradiol-topical) should be used at the lowest dose that relieves your menopausal symptoms for the shortest time period possible.
• Estrogens should not be used to prevent heart disease, heart attacks, or strokes.

Blood clotting disorders: Estrogens should not be used by people with active Thrombophlebitis (inflammation of a vein leading to a clot) or thromboembolic disorders (diseases of blood clotting and abnormal circulation). Some studies have suggested that there is an increased risk for healthy women to develop blood clots in the groin, legs, or lungs (conditions called deep vein thrombosis or pulmonary embolism) when taking hormone replacement therapy.

Women with severe varicose veins or severe Obesity (body mass index (BMI) more than 30 kg/m²), and those needing to stay in bed for 3 weeks or more, are generally considered to be at increased risk of blood clots.

If you have a family history of thromboembolic disorders (see above), or have experienced a blood clot either during pregnancy or while taking estrogens, inform your doctor so that you can be monitored closely. Women with cerebrovascular disease (such as stroke) or Coronary Artery Disease (such as Angina) should use estrogens with caution, and only if clearly needed.

Blood pressure: Increased blood pressure is not uncommon for women using Divigel (Estradiol-topical). Blood pressure should be monitored with estrogen use, especially if high doses are used.

Bone disease: Estrogen can change the way your body uses calcium and phosphorus. If you have bone disease due to cancer or a metabolic condition causing too much calcium in your body, discuss with your doctor how Divigel (Estradiol-topical) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Divigel (Estradiol-topical), and whether any special monitoring is needed.

Breast Cancer: Studies indicate an increased risk of breast cancer with long-term use of estrogen replacement therapy. Women who have breast nodules, fibrocystic disease, abnormal mammograms, or a strong family history of breast cancer should approach the use of estrogens with caution. Women taking estrogens should have regular breast examinations and should be instructed in breast self-examination. Divigel (Estradiol-topical) must not be applied to the breasts, as it may have harmful effects on the breast tissue.

Diabetes: Estradiol may cause a change in blood sugar levels and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using Divigel (Estradiol-topical).

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how Divigel (Estradiol-topical) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Divigel (Estradiol-topical), and whether any special monitoring is needed.

Dementia: Recent studies have indicated that the use of estrogen, with or without a progestin may contribute to the development of dementia for women over the age of 65. If this is a concern, contact your doctor.

Endometrial cancer: There is evidence from several studies that estrogen replacement therapy, including estradiol, can increase the risk of cancer of the endometrium (lining of the uterus). Taking a progestin at the right time along with the estrogen reduces the risk of endometrial cancer to the same level as that of a woman who does not take estrogen. For this reason, all women who have not had their uterus removed should also take a progestin if they are using estrogens.

Endometriosis and fibroids: Divigel (Estradiol-topical) may worsen fibroids, causing sudden enlargement, pain, or tenderness. It may also cause worsening symptoms of endometriosis. If you have had endometriosis or fibroids in the past, discuss with your doctor how Divigel (Estradiol-topical) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Divigel (Estradiol-topical), and whether any special monitoring is needed. If you notice any abdominal tenderness or pain, contact your doctor as soon as possible.

Fluid retention: Estrogen may cause fluid retention, which may cause worsening symptoms of heart or kidney dysfunction, or Asthma. If you have any of these conditions, discuss with your doctor how Divigel (Estradiol-topical) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Divigel (Estradiol-topical), and whether any special monitoring is needed.

Gall bladder disease: Estrogens may increase the risk of gall bladder disease. If you have a history of gall bladder disease, discuss with your doctor how Divigel (Estradiol-topical) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Divigel (Estradiol-topical), and whether any special monitoring is needed.

Heart disease: There is evidence from recent studies that the use of estrogen plus progestin may cause an increase in the risk of heart disease. If you have heart disease or are at risk of heart disease, discuss with your doctor how Divigel (Estradiol-topical) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Divigel (Estradiol-topical), and whether any special monitoring is needed.

High Cholesterol or triglycerides: Estrogen may increase triglyceride levels in those who already have high levels. This has been observed particularly when estrogen is taken orally (by mouth); the risk is reduced with use of the gel. Ask your doctor to monitor your cholesterol levels.

Kidney function: Estrogen can affect how calcium and phosphorus are metabolized by your body, which may be a concern if you have Kidney Disease. If you have decreased kidney function or kidney disease, discuss with your doctor how Divigel (Estradiol-topical) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Divigel (Estradiol-topical), and whether any special monitoring is needed.

Liver function: Estrogens may cause liver problems or make existing liver problems worse. If you have a history of reduced liver function or liver disease, discuss with your doctor how Divigel (Estradiol-topical) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Divigel (Estradiol-topical), and whether any special monitoring is needed.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Migraine headaches: Estrogen can cause an increase in migraine headaches or cause migraine headaches to develop. If you have a history of migraine headaches, discuss with your doctor how Divigel (Estradiol-topical) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Divigel (Estradiol-topical), and whether any special monitoring is needed. If you develop worsening symptoms of migraine headaches or develop headaches with an aura (flashes of light, halos) contact your doctor as soon as possible.

Ovarian Cancer: There is evidence from several studies that the use of estrogen replacement therapy for a long period of time (particularly 5 or more years) may increase the risk of cancer of the ovaries.

Seizures: Estrogen can increase the frequency of seizures for people with Epilepsy. If you have a seizure disorder such as epilepsy, discuss with your doctor how Divigel (Estradiol-topical) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Divigel (Estradiol-topical), and whether any special monitoring is needed.

Thyroid disease: Estrogen affects how your body uses thyroid hormone. If you take thyroid replacement therapy, discuss with your doctor how Divigel (Estradiol-topical) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Divigel (Estradiol-topical), and whether any special monitoring is needed.

Pregnancy: Estrogen should not be used during pregnancy as it may be harmful to the developing baby. If you become pregnant while taking Divigel (Estradiol-topical), contact your doctor immediately.

Breast-feeding: Taking estrogen while breast-feeding may decrease the amount and quality of breast milk. Estrogen is also passed through breast milk to your breast-feeding child. Breast-feeding is not advised while taking Divigel (Estradiol-topical).

Children: The safety and effectiveness of Divigel (Estradiol-topical) have not been established for use by children.

This product is an odourless, non-staining gel. Apply the gel on the upper left or right thigh. Allow the gel to dry before getting dressed. Wash your hands immediately with soap and water after application of the gel. This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Apply it regularly and continuously to maintain its beneficial effect. If you forget a dose, apply it as soon as you remember -- unless it is almost time for your next dose. In that case, skip the missed one. Do not apply more to try to catch up.