Notify your doctor if you experience severe depression,
pain in the groin or calf, sudden severe headache,
chest pain,
shortness of breath,
lumps in the breast,
weakness or tingling in the arm or leg,
or yellowing of the eyes or skin while taking this medication.

Precautions:

Before you use this medication, tell your doctor your entire medical history, including family medical history, especially breast lumps and cancer;

high blood pressure;

diabetes;

asthma;

epilepsy (seizures);

migraine headaches;

liver, heart or kidney disease;

depression; toxemia (high blood pressure during pregnancy);

jaundice (yellowing of skin or eyes) during pregnancy;

excessive weight gain and fluid retention (bloating) during the menstrual cycle or if you have uterine fibroid tumors.

Before having surgery, tell the doctor that you use this drug.

Do not use this medication if you are pregnant or breast-feeding.

If you become pregnant while using this drug, stop using it and contact your doctor.

This medication may cause fetal harm.

Cigarette smoking can increase the chance of blood clots while using this medication (especially in women past the age of 35).

Depending on strength, this drug may cause a patchy, darkening of the skin on the face (melasma).

Higher strengths are more likely to cause melasma.

Sunlight may intensify this darkening and you may need to avoid prolonged sun exposure and sunlamps.

Consult your doctor regarding use of sunscreens and protective clothing.

Generic Name: Estradiol

Estrace 1 mg Tablet - Prescription

Estradiol 1 mg Tablet - Prescription

Estrace 2 mg Tablet - Prescription

Estradiol 2 mg Tablet - Prescription

Estrace 0.5 mg Tablet - Prescription

Estradiol 0.5 mg Tablet - Prescription

Estraderm 0.05 mg/24 hr Adhesive Patch, Medicated - Prescription

Vivelle 0.05 mg/24 hr Adhesive Patch, Medicated - Prescription

Alora 0.05 mg/24 hr Adhesive Patch, Medicated - Prescription

Vivelle-DOT 0.05 mg/24 hr Adhesive Patch, Medicated - Prescription

Estraderm 0.1 mg/24 hr Adhesive Patch, Medicated - Prescription

Vivelle 0.1 mg/24 hr Adhesive Patch, Medicated - Prescription

Alora 0.1 mg/24 hr Adhesive Patch, Medicated - Prescription

Vivelle-DOT 0.1 mg/24 hr Adhesive Patch, Medicated - Prescription

Vivelle 0.075 mg/24 hr Adhesive Patch, Medicated - Prescription

Alora 0.075 mg/24 hr Adhesive Patch, Medicated - Prescription

Vivelle-DOT 0.075 mg/24 hr Adhesive Patch, Medicated - Prescription

Climara 0.1 mg/24 hr Patch, Transdermal weekly - Prescription

Climara 0.05 mg/24 hr Patch, Transdermal weekly - Prescription

Vivelle 0.0375 mg/24 hr Adhesive Patch, Medicated - Prescription

Vivelle-DOT 0.0375 mg/24 hr Adhesive Patch, Medicated - Prescription

Fempatch 0.025 mg/24 hr Patch, Transdermal weekly - Prescription

Climara 0.075 mg/24 hr Patch, Transdermal weekly - Prescription

Estrace 0.01% Cream with Applicator - Prescription

t20323slr017,025,030_vivelle_lbl

http://www.fda.gov/cder/foi/label/2004/20323slr017,025,030_vivelle_lbl.pdf

NDA, estrogens, cancer, treatment, patients, breast cancer, estradiol, Vivelle, doses, placebo, risk.

Close clinical surveillance of all women taking estrogens is important.

The Vivelle® (estradiol transdermal system) contains estradiol in a multipolymeric adhesive.

The absolute excess risk of events included in the "global index" was 19 per 10,000 person-years.

There appears to be little or no increased risk of birth defects in women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy (see PRECAUTIONS).

For treatment of moderate-to-severe vasomotor symptoms and vulvar and vaginal atrophy associated with the menopause, start therapy with Vivelle estradiol transdermal system 0.0375 mg/day applied to the skin twice weekly.

In women not currently taking oral estrogens or in women switching from another estradiol transdermal therapy, treatment with the Vivelle estradiol transdermal system may be initiated at once.

NovenDoc1.pdf

http://www.noven.com/NovenDoc1.pdf

formulation, Vivelle, pharmacokinetics, skin, permeation, estradiol, delivery, in-vitro, ratio, in-vivo, donors.

product, minor changes in the formulation and their impact on the new product s pharmacokinetics can be evaluated and adjusted, as needed, prior to embarking on more extensive pharmacokinetic trials.

Human cadaver skin, when used as a qualitative tool over a series of permeation studies with multiple donors and multiple cells per donor, can be used as an effective tool to predict IVIVC for Noven s estradiol drug-in-adhesive transdermal drug delivery systems.

Hence, formulation changes as well as process changes and their subsequent effect on pharmacokinetics can be appropriately monitored with the use of a control formulation over three to five invitro studies with different skin donors.