The drug "Divigel" is used for the following indications:
symptoms associated with estrogen deficiency, in natural or artificial menopause; for the prevention of postmenopausal osteoporosis with a high risk of fracture, when other drugs for the prevention of osteoporosis are contraindicated or unsuitable.
Composition
Active ingredient: estradiol (1 sachet contains estradiol hemihydrate equivalent to 0.5 mg of estradiol).
Excipients: carbomer 974P, triethanolamine, propylene glycol, ethanol 96%, purified water.
Contraindication
breast cancer (diagnosed, suspected or in history); diagnosed or suspected estrogen-dependent malignant tumors (e.g. endometrial cancer); vaginal bleeding of unknown etiology; untreated endometrial hyperplasia; thromboembolic venous diseases, including a history (deep vein thrombosis (DVT), pulmonary embolism); diagnosed increased blood clotting (e.g. protein C, protein S or antithrombin deficiency); acute arterial thromboembolism, including a history (e.g. angina, myocardial infarction); acute liver disease, including a history (until normalization of laboratory liver function tests); hypersensitivity to the active substance or to any of the excipients; porphyria.
Method of application
The usual initial dose is 1 g of gel per day, which corresponds to one mg of estradiol. The duration of use and dose are selected by the doctor taking into account the individual characteristics of the patient (depending on the clinical condition, after 2-3 cycles the dose can be adjusted: from 0.5 g to 1.5 g of gel per day, which corresponds to 0.5-1.5 mg of estradiol per day).
For patients with an intact uterus, this drug should be combined with progestogen therapy at 1-month intervals, using, for example, medroxyprogesterone acetate, norethindrone, norethindrone acetate, or dydrogesterone, for at least 12-14 days.
Progestogens are not recommended for women after hysterectomy unless they have been diagnosed with endometriosis.
Patients who have not previously used hormone replacement therapy (HRT) or who are switching to Divigel after long-term combination therapy can start treatment with Divigel on any day. Patients who are switching to Divigel after continuous hormone replacement therapy can start treatment with Divigel after the end of the last treatment cycle.
When treating postmenopausal symptoms, the lowest effective dose should be used, and the duration of treatment should be as short as possible.
If the patient forgets to apply the gel on time, treatment should be continued, usually the next day.
With irregular use of the drug, menstrual-like uterine bleeding may occur.
Method of use
Divigel should be applied to clean, dry skin.
Apply the dose of the drug once a day to the skin of the thighs or lower body, regularly changing the application site. The application area is 1-2 palms in size. "Divigel" should not be applied to the mammary glands, face, genitals, as well as to areas of skin with irritation. After applying the drug, you need to wait a few minutes until the gel dries. The application site should not be washed for one hour. Accidental contact of the drug "Divigel" with the eyes should be avoided. Hands should be washed immediately after applying the gel.
Application features
Pregnant women
The use of the drug during pregnancy or breastfeeding is not indicated. If the patient becomes pregnant during therapy, treatment with this drug should be discontinued immediately. According to the results of most epidemiological studies, accidental use of estrogen during pregnancy does not have teratogenic or fetotoxic effects.
Children
Do not use the medicine on children.
Drivers
The drug does not affect the reaction speed when driving or working with other mechanisms.
Overdose
Acute toxicity studies do not indicate a risk of acute adverse reactions after administration of a dose several times higher than the recommended dose.
Some women may experience nausea, headache, vomiting, and withdrawal bleeding.
According to several reports, no serious side effects have been observed in children who took oral contraceptives with a high dose of estrogen.
With transdermal application, an overdose of estradiol is unlikely. There is no specific antidote. Treatment is symptomatic. The gel should be washed off.
Side effects
During the first few months of treatment, breakthrough bleeding and spotting, breast tenderness or enlargement may occur. These symptoms are usually short-lived and disappear during treatment.
Storage conditions
Store at a temperature not exceeding + 25 °C, out of the reach of children.
Shelf life - 3 years.
