Oesclim (Estradiol)

Description

Oesclim is a transdermal hormone replacement therapy (HRT) patch that delivers estradiol, a bioidentical form of the primary endogenous estrogen. It is indicated for the treatment of estrogen deficiency symptoms in postmenopausal women, including vasomotor symptoms (e.g., hot flushes), vaginal dryness, and prevention of postmenopausal osteoporosis in women at high risk who cannot tolerate or do not respond to other options. The transdermal route allows for continuous systemic delivery of estradiol with avoidance of first-pass hepatic metabolism, offering a favorable profile in terms of lipid metabolism and clotting factors.

Directions

Oesclim patches are applied once or twice weekly, depending on the prescribed regimen and individual patient response. The patch should be applied to clean, dry, hairless skin on the lower abdomen or buttocks, avoiding the breasts. Each patch delivers a fixed dose of estradiol (e.g., 25 mcg/day, 50 mcg/day, or 100 mcg/day). Patches should be replaced regularly, rotated to different sites to reduce skin irritation, and not reapplied to the same site within a week. In women with an intact uterus, a progestogen must be added to reduce the risk of endometrial hyperplasia.

Ingredients

Each Oesclim patch contains:

• Estradiol (in varying strengths depending on dosage: 25 mcg, 50 mcg, or 100 mcg per day release rates)

• Adhesive matrix formulation including acrylate copolymers and silicone-based excipients

• Polyester or ethylene vinyl acetate backing layer

The patch is a semi-permeable system designed for sustained transdermal drug delivery.

Contraindications

Oesclim is contraindicated in women with:

• Known, suspected, or history of breast cancer or estrogen-dependent malignancy

• Active or recent thromboembolic disease (e.g., DVT, pulmonary embolism)

• Known thrombophilic disorders (e.g., protein C, S, or antithrombin deficiency)

• Active liver disease or unexplained liver function abnormalities

• Known or suspected pregnancy

• Undiagnosed abnormal genital bleeding

• Hypersensitivity to estradiol or any patch components

Cautions

HRT should be used at the lowest effective dose for the shortest duration consistent with treatment goals. Use with caution in women with a history of endometriosis, uterine fibroids, gallbladder disease, or risk factors for cardiovascular disease. Periodic re-evaluation of the need for continued therapy is essential. Women should be monitored for signs of thromboembolic events, breast changes, or abnormal bleeding. Estradiol may interact with cytochrome P450-modulating drugs, which could alter hormone levels.

Side Effects

Common side effects of Oesclim include:

• Skin irritation at application site

• Breast tenderness

• Headache

• Nausea

• Bloating

• Mood changes

• Vaginal bleeding or spotting

• Weight changes

Serious adverse effects may include:

• Venous thromboembolism

• Stroke

• Myocardial infarction

• Endometrial hyperplasia or carcinoma (if used without progestogen in women with a uterus)

• Gallbladder disease

• Breast cancer (risk may increase with prolonged use)

Product Code : 14586