OESCLIM Transdermal patch Ref.[27878] Active ingredients: Estradiol

Dosing Considerations

The treatment is generally initiated with OESCLIM 25, 37.5 or 50. The initial selection of the dose of estradiol can be based on the type and severity of the patient’s symptomatology. Depending on the clinical response to treatment, the dosage must then be adjusted to the individual’s needs. If the chosen dose does not correct the symptoms of estrogen deficiency, the dose may be increased. Breast tenderness and/or metrorrhagia in general indicates that the dose is too high and needs to be lowered.

Two therapeutic schedules can be used with OESCLIM:

Discontinuous (cyclic): 24-28 days treatment followed by a two to seven day treatment-free period;

Continuous (noncyclic): no treatment-free period.

Continuous, noncyclic therapy may be indicated in hysterectomized women or in cases where the signs and symptoms of estrogen deficiency become problematic during the treatment-free interval.

In women with an intact uterus, sequential treatment with sufficient progestogen to inhibit endometrial hyperplasia and to induce secretory transformation of the endometrium is mandatory. The progestogen may be administered according to one of the two following regimens:

• If OESCLIM is administered on a discontinuous schedule, the progestogen should be administered for at least the last 12 days of the estradiol treatment; thus there is no hormone administration during the treatment-free period of each cycle.
• If OESCLIM is administered on a continuous schedule, the progestogen is recommended for at least 12 sequential days per month.

In both cases breakthrough bleeding may occur after the progestogen is stopped. Unexpected or abnormal bleeding in such patients is an indication for prompt diagnostic measures.

The lowest clinically effective dose of each hormone should be used.

Recommended Dose and Dosage Adjustment

Apply OESCLIM twice a week, i.e. apply one patch for a three day application period and the next for a four day application period.

Administration

Remove the OESCLIM transdermal system from its pouch only just before using. Once the protective liner has been removed, OESCLIM must be applied immediately onto the buttock, the torso (iliac fossa, abdomen) or the upper part of the arm or thigh at a site free of major folds and away from areas where the system can be rubbed off by tight clothing.

The skin must be dry and free from any irritation and not treated with oily or greasy products.

Do not apply OESCLIM to the abdomen, if a dose of OESCLIM has been previously adjusted with the patch applied to other sites of the body, as this might change the amount of hormone delivered.

OESCLIM must not be applied to the breasts. When a patch is removed, the next patch should not be applied to the same site.

It is possible to shower or take a bath while wearing an OESCLIM transdermal system. In the exceptional circumstance that a transdermal system should fall off (hyperperspiration, abnormal rubbing by clothing), it is recommended that the same system be reapplied on dry skin. If this is not possible, use a new transdermal patch which will be removed on the anticipated date. Thereafter the cycle of changing of the patch will continue according to the original schedule.

Symptoms

Numerous reports of ingestion of large doses of estrogen products and estrogen-containing oral contraceptives by young children have not revealed acute serious ill effects. Overdosage with estrogen may cause nausea, breast discomfort, fluid retention, bloating or vaginal bleeding in women.

Treatment

Owing to the mode of administration (transdermal), plasma levels of estradiol-17β can be rapidly reduced by removal of the patch. Symptomatic treatment should be given.

For management of a suspected drug overdose, contact your regional Poison Control Centre.

Store at room temperature (15–25°C). Avoid freezing. Do not store unpouched. Apply immediately upon removal from the protective pouch. Keep out of the reach of children both before and after use. After removal of the patch fold it in half, with the adhesive side inwards, before discarding.