Divigel Transdermal

Divigel (estradiol gel) is a clear, colorless gel, which is odorless when dry. Estradiol is a form of estrogen, a female sex hormone that regulates many processes in the body.

Divigel is used to treat certain symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation.

Divigel may also be used for purposes not listed in this medication guide.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, stomach pain, breast tenderness, drowsiness, and vaginal bleeding.

Do not apply sunscreen to your skin at the same time you apply Divigel.

Avoid getting this medicine in your eyes. If this does happen, rinse with water.

Grapefruit and grapefruit juice may interact with estradiol and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

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

Stop using Divigel and call your doctor at once if you have:

• abnormal vaginal bleeding;

• a lump in your breast;

• confusion, problems with memory or concentration;

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

• liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• 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; or

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

Topical estradiol is absorbed through the skin of a child who comes into contact with this medicine. Call your doctor if a child who has close contact with you develops swollen nipples or enlarged breasts.

Common Divigel side effects may include:

• breast pain;

• headache;

• vaginal itching or discharge, changes in your menstrual periods, light vaginal bleeding or spotting;

• thinning scalp hair; or

• nausea, vomiting, bloating, stomach cramps.

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.

Oral:
1 to 2 mg orally once a day.

Parenteral:
10 to 20 mg of estradiol valerate IM every 4 weeks.

Vaginal Ring:
0.05 mg/day or 0.1 mg/day vaginal ring. The ring should remain in place for 3 months and then be replaced by a new ring if therapy is to continue.

Topical:
0.025 to 0.1 mg/day (transdermal film) applied topically 1 or 2 times a week. Application sites vary according to manufacturer formulation and include the lower abdomen, upper thigh, buttocks, or upper arm. Systems should not be applied to the breasts.
1.25 g/day (estradiol gel) applied topically at the same time daily. If used solely for the treatment of vulvar and vaginal atrophy, topical vaginal products should be considered.

Women currently on oral estrogen therapy and changing to a transdermal estradiol system should initiate transdermal therapy 1 week following discontinuation of oral estrogens (sooner if menopausal symptoms reappear). Changes between transdermal systems may be initiated without interruption of therapy.

Because of the potential increased risks of cardiovascular events, breast cancer and venous thromboembolic events, use should be limited to the shortest duration consistent with treatment goals and risks for the individual woman, and should be periodically reevaluated. When used solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
In general, the duration of hormone therapy for the treatment of postmenopausal symptoms like atrophic vaginitis, kraurosis vulvae, or atrophic urethritis should be limited. Treatment for one to five years is generally sufficient.

Oral:
1 to 2 mg orally once a day.

Parenteral:
10 to 20 mg of estradiol valerate by IM every 4 weeks.

Topical:
0.025 to 0.1 mg/day (transdermal film) applied topically 1 or 2 times a week. Application sites vary according to manufacturer formulation and include the lower abdomen, upper thigh, buttocks, or upper arm. Systems should not be applied to the breasts.

Women currently on oral estrogen therapy and changing to a transdermal estradiol system should initiate transdermal therapy 1 week following discontinuation of oral estrogens (sooner if menopausal symptoms reappear). Changes between transdermal systems may be initiated without interruption of therapy.

Oral:
1 to 2 mg orally once a day.

Parenteral:
10 to 20 mg of estradiol valerate by IM every 4 weeks.

Topical:
0.025 to 0.1 mg/day (transdermal film) applied topically 1 or 2 times a week. Application sites vary according to manufacturer formulation and include the lower abdomen, upper thigh, buttocks, or upper arm. Systems should not be applied to the breasts.

Women currently on oral estrogen therapy and changing to a transdermal estradiol system should initiate transdermal therapy 1 week following discontinuation of oral estrogens (sooner if menopausal symptoms reappear). Changes between transdermal systems may be initiated without interruption of therapy.

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Data not available