Indications

Estradiol vaginal cream, 0.01% is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.

Composition

Pharmacology

Endogenous estrogens are largely responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. Although circulating estrogens exist in a dynamic equilibrium of metabolic interconversions, estradiol is the principal intracellular human estrogen and is substantially more potent than its metabolites, estrone and estriol at the receptor level.

Dosage & Administration

The usual dosage range is 2 to 4 g (marked on the applicator) daily for one or two weeks, then gradually reduced to one half initial dosage for a similar period. A maintenance dosage of 1g, one to three times a week, may be used after restoration of the vaginal mucosa has been achieved.

Contraindications

Estradiol vaginal cream should not be used in women with any of the following conditions: Undiagnosed abnormal genital bleeding. Known, suspected, or history of cancer of the breast. Known or suspected estrogen-dependent neoplasia. Active deep vein thrombosis, pulmonary embolism or history of these conditions. Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction). Liver dysfunction or disease. Estradiol vaginal cream should not be used in patients with known hypersensitivity to its ingredients. Known or suspected pregnancy. There is no indication for estradiol vaginal cream in pregnancy. There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy.

Side Effects

Headache, Breast pain, Irregular vaginal bleeding or spotting, Stomach or abdominal cramps, bloating, Nausea and vomiting, Hair loss, Fluid retention, Vaginal yeast infection. Reactions from inserting ValenaTM Vaginal Cream, such as vaginal burning, irritation, itching etc.

Pregnancy & Lactation

Valena should not be used during pregnancy. There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins as an oral contraceptive inadvertently during early pregnancy.

Precautions & Warnings

Patient taking an additional progestin with Valena may have endometrial hyperplasia which is a precursor to endometrial cancer. These include a possible increased risk of breast cancer. Patients may also face Elevated Blood Pressure, Hypertriglyceridemia (If she has pre-existing hypertriglyceridemia). Caution should be taken for patients who have Hepatic Impairment and/or Past History of Cholestatic Jaundice, Hypothyroidism, Hypocalcemia. Estrogen may cause exacerbation of endometriosis, asthma, diabetes mellitus, epilepsy, migraine or porphyria, systemic lupus erythematosus, and hepatic hemangiomas. So, ValenaTM should be used with caution in women with these conditions.

Therapeutic Class

Drugs used in Vaginal and Vulval condition

Storage Conditions

Do not store above 30°C. Keep away from light and out of the reach of children.