Divigel 0.1% 1g pack #28

Divigel – Composition, Use, and Storage

Active Ingredient

Estradiol Hemihydrate

Clinical-Pharmacological Group

Estrogen

Composition and Dosage Form

Topical gel for external use: 28 sachets per package

• 1 sachet: Estradiol Hemihydrate 0.5 mg

• 1 sachet: Estradiol Hemihydrate 1 mg

Indications

• Hormone replacement therapy for symptoms of estrogen deficiency

• Treatment of climacteric syndrome associated with natural or surgical menopause

Dosage and Administration

• Divigel is used transdermally for cyclic, long-term treatment

• Typical starting dose: 1 mg estradiol per day (equivalent to 1 g gel)

• Dose adjustment may be made individually after 2–3 cycles to 0.5–1.5 g gel per day (0.5–1.5 mg estradiol per day)

• Patients with an intact uterus should receive a progestogen (e.g., medroxyprogesterone acetate, norethisterone, norethisterone acetate, or dydrogesterone) for 10–12 days each cycle

• Withdrawal bleeding occurs after each progestogen treatment cycle

• Apply once daily to clean skin: lower abdomen, lower back, shoulders, forearms, or alternating left/right buttocks; rotate the application site daily (area equivalent to 1–2 palms)

• Allow gel to dry for 2–3 minutes

• If a dose is missed, apply as soon as possible within 12 hours; if more than 12 hours have passed, skip and continue with the next scheduled application

Storage Conditions

• Store at ≤ 5 °C, out of reach of children

Shelf Life

3 years

Prescription Status

• Dispensed only with a doctor’s prescription