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Logo ESTRING® (Vaginal Ring)
SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

ESTRING® (Vaginal Ring)

COMPOSITION:
Each vaginal ring contains 2,0 mg estradiol hemihydrate

PHARMACOLOGICAL CLASSIFICATION:
A 21.8.1 Oestrogens

PHARMACOLOGICAL ACTION:
ESTRING is a vaginal ring which, after a brief initial peak, delivers approximately 7,5 micrograms 24 hours of the naturally occurring hormone, estradiol, for 3 months.
Pharmacokinetics:
After a brief initial peak, the release of estradiol from ESTRING is constant (7,5 micrograms/24 hr), for at least 90 days. As a consequence of the initial release peak, plasma levels of estradiol reach about 200 pmol/L within 3 hours. After this, levels decline rapidly and constant levels are achieved after 2 - 3 days. These levels are maintained at, or near, 20 - 30 pmol/L throughout the rest of the treatment period. These levels are considerably lower than the lowest levels commonly detected in pre-menopausal women, i.e. during the early follicular phase.
ESTRING presumably increases local oestradiol target concentrations, while maintaining very low and stable systemic plasma concentrations.

INDICATIONS:
Treatment of post-menopausal atrophic vaginitis.

CONTRA-INDICATIONS:
Known or suspected estrogen-dependent malignancy, e.g. endometrial carcinoma or other estrogen-dependent tumours.
Undiagnosed genital bleeding.
Known or suspected pregnancy.

WARNINGS:
During long-term treatment with estrogens, periodic medical examinations are advisable.
ESTRING is only suitable for the treatment of urogenital complaints due to oestrogen deficiency. There is no significant systemic effect and therefore it is not suitable for post-menopausal complaints which require a systemically active dose of estrogen (e.g. vasomotor symptoms), neither is it suitable for osteoporosis prophylaxis.

DOSAGE AND DIRECTIONS FOR USE:
Adults (Post-menopausal women only):
One ring to be inserted into the upper third of the vagina, to be worn continuously for 3 months, then replaced by a new ring.
The estradiol from the ring acts locally to eliminate or reduce symptoms and signs of post-menopausal urogenital estrogen deficiency. ESTRING therapy restores vaginal pH to premenopausal values and returns the histology and physiology of the vaginal and urethral epithelia to premenopausal states.
ESTRING can be used continuously without the addition of progestogens and consequently, no uterine bleeding will result from treatment.
The maximum recommended duration of continuous therapy is two years.
Instructions for use are available in a Patient Information Leaflet enclosed in each pack.
The ring is easy to insert and remove. It lies in the posterior vaginal vault in contact with the vaginal mucosa and remains intact.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
Adverse reactions reported during clinical trials include in decreasing frequency: vaginal irritation, abdominal pain or discomfort, vulvovaginal infection, urogenital pruritus, pressure symptoms in vagina or on bladder or rectum, generalized pruritus, urinary tract infection and increased sweating. However, some of these symptoms occur more frequently in untreated post-menopausal women.
A few cases of vaginal ulceration were reported in clinical trials. While these were minor and transient it is recommended that any patient who develops an ulcer should be withdrawn from treatment.
Special Precautions:
Some women may be unsuitable for treatment with ESTRING, particularly those with short narrow vaginas due to previous surgery or the effect of atrophy, or those with uterovaginal prolapse severe enough to prevent retention of the ring.
Any woman with symptoms/signs of abnormal vaginal discharge, vaginal discomfort or bleeding, should be examined fully, to exclude ulceration, infection or unresponsive atrophic vaginitis. Minor signs are often transient. Any woman experiencing persistent or severe discomfort due to the presence of the ring or excessive movement of the ring should be withdrawn from treatment. Patients with unresponsive atrophic vaginitis should also be withdrawn from treatment. Patients with vaginal infection should be treated appropriately.
Patients on long-term corticosteroid treatment of Cushing’s Disease, may be unsuitable for treatment as they may have vaginal atrophy unresponsive to estrogen therapy.
Patients with endometrial hyperplasia, thromboembolic disease, acute or chronic liver disease or acute intermittent porphyria should be carefully assessed prior to treatment and monitored during therapy.
There have been incidences of both the ring falling out and of movement of the ring, generally during defaecation. Therefore, if the woman is constipated, she should remove the ring before defaecation. Removal of the ring prior to sexual intercourse may also be preferred. Advice for removal and reinsertion of the ring are provided in the Patient Information Leaflet.
Interactions:
Removal of ESTRING should be considered while using other vaginal preparations.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Not relevant due to mode of administration.

IDENTIFICATION:
A slightly opaque ring made of a silicone elastomer with a whitish core.

PRESENTATION:
Each ring is packed in a heat sealed pouch consisting of the following layers: polyester/aluminium foil/polyethylene. Each pouch is packed in a carton together with a Patient Information Leaflet and a Package Insert.

STORAGE INSTRUCTIONS:
Store below 30°C.
Keep out of reach of children.

REGISTRATION NUMBER:
29/21.8.1/0720

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Pharmacia South Africa (Pty) Limited
Alphen West G
George Street
Midrand
1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
October 1995

New addition to this site: February 2005
Source: Pharmaceutical Industry

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