Jazz Pharmaceuticals Commercial Corp.

Adults – One tablet orally 4 times per day followed by liberal fluid intake.

Pediatric – Dosage must be individualized by a physician for older children. Urelle® is not recommended for use in children 6 years of age or younger.

NOT FOR INHALATION OR INJECTION. SEE DIRECTIONS FOR USE.

The usual starting dose is as follows:

Adults and Adolescents (13 Years and Older)

Two ampules four times daily, taken one-half hour before meals and at bedtime.

Children 2-12 Years

One ampule four times daily, taken one-half hour before meals and at bedtime.

Pediatric Patients Under 2 Years

Not recommended.

If satisfactory control of symptoms is not achieved within two to three weeks, the dosage may be increased but should not exceed 40 mg/kg/day.

Patients should be advised that the effect of GASTROCROM therapy is dependent upon its administration at regular intervals, as directed.

Maintenance Dose

Once a therapeutic response has been achieved, the dose may be reduced to the minimum required to maintain the patient with a lower degree of symptomatology. To prevent relapses, the dosage should be maintained.

Administration

GASTROCROM should be administered as a solution at least 1/2 hour before meals and at bedtime after preparation according to the following directions:

One capsule daily, or as directed by a physician.

One Gesticare® tablet and one DHA capsule daily or as directed by a physician.

When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be re-evaluated periodically as clinically appropriate (e.g., 3-month to 6-month intervals) to determine if treatment is still necessary (see BOXED WARNINGS and WARNINGS). For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.

Elestrin® is applied once daily to the upper arm for the treatment of moderate to severe vasomotor symptoms associated with menopause using a metered-dose pump which delivers 0.87 gram of estradiol gel per actuation.

Patients should be started with the lowest effective dose of Elestrin®, which is one pump actuation per day (0.87 g/day, which contains 0.52 mg of estradiol).

Subsequent dosage adjustment may be made based upon the individual patient response. This dose should be periodically reassessed by the healthcare provider.

Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be considered to reduce the risk of endometrial cancer.

A woman without a uterus does not need progestin. In some cases, however, hysterectomized women with a history of endometriosis may need a progestin [see Warnings and Precautions (5.2), (5.14)]. 

Use of estrogen-alone, or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.

2.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause

ELESTRIN is applied once daily to the upper arm for the treatment of moderate to severe vasomotor symptoms due to menopause using a metered-dose pump which delivers 0.87 gram of estradiol gel per actuation.

Patients should be started with the lowest effective dose of ELESTRIN, which is one pump per day (0.87 g per day, which contains 0.52 mg of estradiol).

Subsequent dosage adjustment may be made based upon the individual patient response. This dose should be periodically reassessed by the healthcare provider.

One applicatorful (about 6g) intravaginally once or twice daily. Improvements in symptoms should occur within a few days, but treatment should be continued for a period of 30 days.

Douching with a suitable solution before insertion may be recommended for hygienic purposes.