Ovestin vaginal cream is used for the treatment of atrophy of the lower urinary and genital tract mucosa associated with estrogen deficiency in postmenopausal women.
Each gram of cream contains:
Active substance: Estriol (micronized estriol) 1.0 mg
Excipients: Octyldodecanol 50 mg, cetyl palmitate 15 mg, glycerol 120 mg, cetyl alcohol 36.7 mg, stearyl alcohol 88.4 mg, polysorbate 60 32.4 mg, sorbitan stearate 7.6 mg, lactic acid 4.0 mg, chlorhexidine dihydrochloride 0.1 mg, sodium hydroxide (to adjust pH to ~4.0), purified water up to 1 g.
Hormone Replacement Therapy (HRT): Treatment of atrophy of the mucous membranes in the lower urinary and genital tracts associated with estrogen deficiency in postmenopausal women.
Pre‑ and post‑operative therapy in postmenopausal women for surgical procedures via vaginal access.
As an adjunctive diagnostic aid when cytological results from the cervix are suspicious (PAP test class III) in postmenopausal women with pathological (atrophic) changes.
Do not use if any of the following apply:
Hypersensitivity to estriol or any component of the cream
Known, or suspected, breast cancer
Known, or suspected, estrogen‑dependent cancer (e.g., endometrial cancer)
Undiagnosed vaginal bleeding
Untreated endometrial hyperplasia
Active or history of venous thromboembolism (deep vein thrombosis, pulmonary embolism)
Known thrombophilic disorders
Arterial thrombotic disease, myocardial infarction, stroke, or history thereof (including transient ischemic attack, angina)
Significant liver disease (acute or persistent functional impairment)
Porphyria
Pregnancy or breastfeeding
One application (one filled applicator) contains 0.5 g cream (≈ 0.5 mg estriol).
For treatment of vaginal atrophy in postmenopausal women: apply once daily intravaginally for the first 2–3 weeks (maximum 4 weeks), then reduce dose gradually as symptoms improve to a maintenance regimen (usually one application twice weekly).
Pre‑ and post‑operative therapy in postmenopausal women having vaginal surgery: one application per day for 2 weeks before surgery; after surgery, one application twice weekly for 2 weeks
As adjunct in diagnostic situations (e.g., suspicious cervical cytology in postmenopausal women with atrophic changes): 1 application every other day for one week before taking the next smear.
Intravaginal use, preferably at night before bedtime.
Use the applicator to insert the cream deeply into the vagina in a lying position.
After use, remove, wash applicator parts with warm soapy water (not boiling), rinse thoroughly.
Use thelowest effective dose for the shortest durationnecessary.
Women who switch from cyclic HRT should wait one week after finishing their previous HRT cycle to start Ovestin.
If not using any systemic HRT, treatment may be started any day once decision made.
Store at temperature not exceeding 25 °C.
Do not freeze.
Keep out of reach of children.
