Description:

Estriol 1mg cream is a topical vaginal estrogen hormone replacement therapy (HRT) used to treat symptoms of vaginal atrophy (atrophic vaginitis) in postmenopausal women. It relieves vaginal dryness, itching, burning, irritation, soreness, and painful intercourse (dyspareunia) caused by low estrogen levels after menopause. The cream restores local estrogen to vaginal tissues with minimal systemic absorption compared to oral HRT, making it suitable for localized symptom relief.

Prescription:

• Yes

Therapeutic Category:

• Hormone Replacement Therapy / Local Estrogen / Vaginal Estrogen

Active Ingredients/Composition:

• Estriol 1 mg per gram (0.1% w/w) of cream (active estrogen hormone). Excipients typically include octyldodecanol, cetyl palmitate, glycerol (glycerin), cetyl alcohol, stearyl alcohol, polysorbate 60, sorbitan stearate (or monostearate), lactic acid, chlorhexidine dihydrochloride (preservative), sodium hydroxide (pH adjuster), and purified water.

Variant:

• Standard 1 mg/g (0.1%) vaginal cream (white to off-white homogeneous cream); tube sizes commonly 15 g or 30 g, supplied with a calibrated applicator (filled to 0.5 g mark for 0.5 mg estriol dose). Preservative-free or generic versions may exist in some markets, but this is the standard preserved formulation.

Consume Type:

• Topical (vaginal – intravaginal application via applicator)

Directions/Usage:

Use the provided applicator to insert the cream deeply into the vagina (preferably at bedtime).

• Initial treatment: 1 applicator-dose (0.5 g cream = 0.5 mg estriol) daily for 2–3 weeks (up to 4 weeks max).
• Maintenance: Reduce to 1 applicator-dose twice weekly (e.g., every 3–4 days).
• For pre/post-vaginal surgery: 1 applicator-dose daily for 2 weeks before surgery, then twice weekly for 2 weeks after. Apply the lowest effective dose for the shortest duration needed. Re-evaluate periodically with a doctor. Clean applicator with warm water and mild soap after use (do not boil). Follow doctor’s exact prescription; often used without progestin due to low systemic absorption.

Common Side Effects:

• Local irritation/itching/burning/stinging in the vagina or vulva (especially at start), increased vaginal discharge, breast tenderness/pain, headache, nausea, abdominal cramps/bloating, or spotting/breakthrough bleeding. Less common: rash, swelling, or mild systemic estrogen effects (e.g., fluid retention). Serious (rare): increased risk of endometrial hyperplasia (if no progestin in women with uterus), blood clots, or breast changes.

Package Type:

• Tube (aluminum or plastic tube with screw cap; includes calibrated reusable applicator; boxed with patient information leaflet and usage instructions)

Storage Advice:

• Store at room temperature (below 25–30°C), in a cool, dry place away from direct sunlight and heat. Do not freeze. Keep tightly closed after use. Keep out of reach of children.

Safety Advice:

• Prescription only; requires medical supervision and periodic review (e.g., every 3–6 months). Contraindicated in undiagnosed vaginal bleeding, known/suspected estrogen-dependent cancers (breast/endometrial), active/thrombotic disorders (DVT/PE/stroke/MI), untreated endometrial hyperplasia, acute liver disease, or pregnancy (may harm fetus). Caution in women with uterus (monitor for endometrial effects; progestin may be added if needed). Report immediately: unusual vaginal bleeding, chest pain, shortness of breath, leg swelling/pain, severe headache, vision changes, or breast lumps. Minimal systemic absorption, but still consider overall HRT risks (e.g., cardiovascular, breast cancer). Not for primary prevention of diseases; use lowest dose/shortest time. Safe in breastfeeding only if benefits outweigh risks (limited data). Avoid if allergic to ingredients.

Product Substitutes:

• Ovestin Cream (original brand, same formulation; rebranded as Estriol 1mg/g cream in some markets)
• Generic Estriol 1mg/g Vaginal Cream (various manufacturers)
• Vagifem (estradiol vaginal tablets/inserts)
• Imvexxy (estradiol vaginal inserts)
• Estrace Vaginal Cream (estradiol 0.01%)
• Other local vaginal estrogens (e.g., estriol or estradiol generics in Ghana markets)

Manufacturer/Marketer:

• Aspen Pharma Trading Limited

Country of Origin:

• Ireland