Contents: Estradiol
Indications/Uses: Treatment of the climacteric syndrome associated with natural or artificial menopause (estrogenic deficiency eg, hot flushes, night sweatings, urogenital atrophy) and prevention of postmenopausal (type I) osteoporosis.
Dosage/Direction for Use
- Divigel can be used for continuous, cyclical or sequential treatment.
- The usual starting dose is estradiol 1 mg (1 g gel) daily but the selection of the initial dose can be based on the severity of the patients’ symptoms.
- Depending on the clinical response, the dosage can be re-adjusted after 2-3 cycles individually from 0.5-1.5 g/day, corresponding to estradiol 0.5-1.5 mg/day.
- In patients with an intact uterus, it is recommended to combine Divigel, with an adequate dose of progestin for adequate duration eg, 12-14 consecutive days per month/28 day cycle or to oppose estrogen-stimulated hyperplasia of the endometrium.
- Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestagen in hysterectomised women.
Administration:
- Divigel is a gel for transdermal use.
- Apply on dry and clean skin.
- The Divigel dose is applied once daily, on the skin of the lower trunk or the right or left thigh, on alternate days.
- The application surface should be 1-2 times the size of a hand. Divigel should not be applied on the breasts, on the face or irritated skin.
- After application, the gel should be allowed to dry for a few minutes and the application site should not be washed within 1 hr.
- Contact of the gel with the eyes should be avoided.
- Hands should be washed after application.
- In women who are not using HRT, or women transferring from continuous combined HRT-product, treatment with Divigel may be started on any convenient day.
- In women transferring from a sequential or cyclic HRT regimen, treatment should begin the day following completion of the prior 28 days regimen.
- For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see Precautions) should be used.
- If the patient has forgotten to apply a dose, the forgotten dose is to be applied as soon as possible if the dose is not >12 hrs late. If the dose is >12 hrs late, the dose should be forgotten and continue as normal.
- Forgetting a dose may increase the likelihood of breakthrough bleeding and spotting.
