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Ovestin Cream 1mg (15g)

Ovestin Cream 1mg (15g)

Ovestin

Hormone Replacement Therapy (HRT)
  • MHRA Authorised prescription medicine in the UK (estriol 1 mg/g vaginal cream/Ovestin heritage product)
  • CE Marked vaginal applicator supplied with the product
  • HPRA Authorised product in Ireland (Ovestin 1 mg per gram vaginal cream)
  • ARTG Registered medicine in Australia (Ovestin estriol 1 mg/g cream tube)
  • Manufactured according to Good Manufacturing Practice (GMP) for medicinal products
Vaginal oestrogen cream for postmenopausal vaginal atrophy

Description

Ovestin Cream 1mg (15g) is a prescription-only vaginal hormone replacement therapy (HRT) containing estriol 1 mg/g. It is applied intravaginally using a reusable applicator to relieve symptoms of vaginal atrophy due to oestrogen deficiency in postmenopausal women, such as vaginal dryness, irritation, itching and pain during intercourse. It may also be used as pre- and post-operative therapy in postmenopausal women undergoing vaginal surgery and as a diagnostic aid in cases of atrophic cervical smears.

Bnefits

  • Provides local oestrogen replacement directly to the vaginal tissues
  • Relieves symptoms of vaginal atrophy such as dryness, irritation, itching and dyspareunia
  • Improves lubrication, elasticity and thickness of the vaginal epithelium
  • Helps restore normal vaginal flora and pH
  • Used as pre- and post-operative therapy for vaginal surgery in postmenopausal women
  • Can aid in the assessment of atrophic cervical smears in postmenopausal women
  • Lower systemic exposure compared with systemic HRT because of local application

Indications

  • Treatment of symptoms of vaginal atrophy due to oestrogen deficiency in postmenopausal women (e.g. dryness, burning, itching, irritation, dyspareunia)
  • Vulvo-vaginal complaints related to oestrogen deficiency during the climacteric and postmenopause
  • Atrophic vaginitis associated with menopause or oestrogen deficiency
  • Pre-operative therapy before vaginal surgery in postmenopausal women
  • Post-operative therapy after vaginal surgery in postmenopausal women
  • Adjunctive diagnostic aid in cases of doubtful or atrophic cervical smears in postmenopausal women

Composition

  • Active ingredient: Estriol 1 mg per gram of cream (1 mg/g)
  • Excipients: Octyldodecanol
  • Excipients: Cetyl palmitate
  • Excipients: Glycerol
  • Excipients: Cetyl alcohol
  • Excipients: Stearyl alcohol
  • Excipients: Polysorbate 60
  • Excipients: Sorbitan stearate
  • Excipients: Lactic acid
  • Excipients: Chlorhexidine dihydrochloride
  • Excipients: Sodium hydroxide (for pH adjustment)
  • Excipients: Purified water

Formulation

  • Pharmaceutical form: Vaginal cream
  • Strength: 1 mg estriol per gram of cream (0.1%)
  • Appearance: Homogeneous, smooth, white to nearly white cream
  • Route of administration: Intravaginal via calibrated applicator

Packaging

  • 15 g collapsible aluminium tube of vaginal cream
  • Tube with polyethylene screw cap
  • Supplied with a reusable CE-marked vaginal applicator
  • Packed in a cardboard carton with patient information leaflet

Usage

  • For intravaginal use only. Do not take by mouth.
  • Usual starting dose for vaginal atrophy: 1 applicator dose (0.5 g cream containing 0.5 mg estriol) once daily for 2–3 weeks (maximum 4 weeks).
  • After the initial phase, reduce to a maintenance dose, for example 1 applicator dose twice weekly, according to symptom control and medical advice.
  • Pre-surgery vaginal therapy: 1 applicator dose once daily for 2 weeks before vaginal surgery.
  • Post-surgery therapy: restart after at least 2 weeks following surgery with 1 applicator dose twice weekly, or as advised by the prescriber.
  • Use the supplied calibrated applicator, filling it up to the marked ring/red line to obtain the correct dose.
  • Best applied at bedtime: insert the applicator high into the vagina before gently expelling the cream.
  • If a dose is missed and it is within about 12 hours of the usual time, apply it as soon as remembered; otherwise skip the missed dose and continue with the usual schedule. Do not use two doses on the same day.
  • Use the lowest effective dose for the shortest duration necessary to relieve symptoms.
  • Regular medical review (typically every 3–6 months) is recommended to reassess the need for ongoing therapy.

Contraindications

  • Known, past or suspected breast cancer
  • Known or suspected oestrogen-dependent malignant tumours (e.g. endometrial carcinoma)
  • Undiagnosed vaginal bleeding
  • Untreated endometrial hyperplasia
  • Current or history of venous thromboembolism (e.g. deep vein thrombosis, pulmonary embolism)
  • Active or recent arterial thromboembolic disease (e.g. myocardial infarction, stroke)
  • Acute liver disease or a history of liver disease as long as liver function tests have not returned to normal
  • Known thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency) when systemic oestrogen is contraindicated, unless specifically assessed as safe by a specialist
  • Porphyria cutanea tarda or active porphyria
  • Known hypersensitivity to estriol or to any of the excipients (such as chlorhexidine or cetyl/stearyl alcohols)
  • Pregnancy and lactation (not indicated for use in these populations)

Adverse Effects

  • Local vaginal irritation, itching, burning or discomfort at the site of application
  • Increased vaginal discharge
  • Spotting or breakthrough vaginal bleeding, particularly during the first months of treatment
  • Breast tenderness or breast discomfort
  • Abdominal pain or cramps
  • Headache or migraine
  • Nausea
  • Oedema (fluid retention)
  • Skin reactions such as rash, pruritus or urticaria
  • Rare: venous thromboembolism (e.g. deep vein thrombosis, pulmonary embolism)
  • Rare: arterial thromboembolic events (e.g. stroke, myocardial infarction)
  • Potential long-term risks associated with oestrogen exposure (e.g. endometrial hyperplasia or carcinoma if used inappropriately), particularly with higher doses or prolonged unsupervised use

Storage Conditions

  • Store below 25°C (commonly 2–25°C depending on local licence).
  • Do not freeze.
  • Keep the tube tightly closed when not in use.
  • Store in the original carton to protect from light where applicable.
  • Keep out of the sight and reach of children.
  • Do not use after the expiry date printed on the tube and carton.

Duration

Initial daily treatment is usually 2\u20133 weeks (up to a maximum of 4 weeks), followed by long-term maintenance dosing (for example, twice weekly) as required to control symptoms, with regular medical review (commonly every 3\u20136 months) to determine whether continuation of therapy is still appropriate.

Onset

Symptom relief may begin within several days, with maximal improvement typically occurring within a few weeks and generally within about 4 weeks of starting treatment.

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