Divigel

Divigel is an anti-menopausal drug belonging to the estrogen group, which has a feminizing effect on the woman’s body.

Release form and composition

Divigel dosage form - 0.1% gel for external use.

The active ingredient of the drug is synthetic 17β-estradiol, biologically and chemically identical to endogenous human estradiol, which is produced in a woman's body from the first day of menstruation until menopause (produced by the ovaries).

Divigel is produced in multi-layered packets of 0.5 and 1 gram containing, respectively, 500 μg and 1 mg of estradiol (in the form of hemihydrate).

Indications for use

According to the instructions to Divigel, the drug is used:

• For the treatment of menopausal syndrome associated with natural or developed as a result of surgery artificial menopause;
• For hormone replacement therapy for conditions characterized by estrogen deficiency.

Contraindications

The use of Divigel, according to the instructions, is contraindicated in:

• The presence of hypersensitivity to estradiol or any excipient of the drug;
• Disorders of cerebral circulation (including hemorrhagic and ischemic stroke);
• Vaginal bleeding of unknown origin;
• Inclination to uterine bleeding;
• Malignant estrogen-dependent tumors of the ovaries, uterus, endometrium, or when they are suspected;
• Diagnosed or suspected breast cancer;
• Endometrial hyperplasia;
• Spontaneous vein thromboembolic diseases, including a history of;
• Inflammatory diseases of the female genital organs (including endometritis and salpingo-oophoritis);
• Pituitary tumors;
• Diabetes;
• Congenital hyperbilirubinemia;
• Angiopathy;
• Diffuse connective tissue diseases;
• Retinopathy;
• Liver tumors;
• Hyperestrogenic stage of menopause;
• Otosclerosis, as well as in cases where an exacerbation of this disease was observed during pregnancy;
• Thrombophlebitis, including a history;
• Deep vein thrombosis, pulmonary embolism, or with a history of these pathologists;
• Sickle cell anemia;
• Genital neoplasms (both malignant and benign) in women under 60 years of age, including uterine myoma, cancer of the vulva, ovaries, cervix and uterus;
• Disorders of fat metabolism;
• Cholestatic jaundice and severe cholestatic pruritus, as well as if the increased symptoms of these diseases were noted in the period of a previous pregnancy or during the use of steroid drugs.

It is possible to use Divigel, but under careful medical supervision and after a thorough assessment of the benefit / risk ratio with:

• Endometriosis;
• Heart failure;
• Fibrocystic mastopathy;
• Porphyria;
• Migraine;
• Renal / hepatic failure;
• Epilepsy;
• Edematous syndrome;
• Bronchial asthma;
• Hypertension;
• Ischemic heart disease.

Divigel should not be applied on the genital area and mammary glands, on the skin of the face and irritated areas of the body.

Dosing and Administration

According to the abstract, Divigel is intended for long-term cyclic therapy. Apply the gel on clean skin in the lower abdomen, waist, shoulders and forearm, or on the right and left buttock alternately. Places of application are recommended to alternate periodically. The area to be treated should correspond to the size of 1–2 palms. After applying for 2-3 minutes, the agent is left to dry. For at least one hour after the procedure, this place should not be rinsed. It is necessary to apply the gel once a day at the same time.

The initial dosage of Divigel depends on the severity of the symptoms, but is usually 1 mg of estradiol (1 g of gel). After 2-3 cycles of use, if necessary, the dose may be reduced to 500 μg or increased to 1.5 mg of estradiol (500 mg or 1.5 g of gel).

With an intact (non-operated) uterus, treatment with Divigel is supplemented with the use of a progestogen (for example, norethisterone, norethisterone acetate, dihydrogesterone or medroxyprogesterone acetate) for 10-12 days of each cycle. After the course of use of the progestogen, menstrual-like bleeding should occur - this is considered normal. However, if uterine bleeding is long or extraordinary, additional examination of the patient is required to determine their cause.

In the postmenopausal period, the duration of one cycle can be increased to 3 months.

In case of missing another application of Divigel, the procedure should be carried out as soon as possible, but no later than 12 hours after the last application of the gel, or wait until the next application.

Side effects

Divigel can have these side effects:

• Libido changes, poor bleeding, increased uterine leiomyoma size, metrorrhagia;
• Vaginal candidiasis;
• Increase, tension, engorgement of the mammary glands;
• Irritation and hyperemia of the skin, rash, contact dermatitis;
• Nausea, vomiting, stomach cramps, flatulence, epigastric pain, cholestatic jaundice, cholelithiasis;
• Headache, chorea, dizziness, migraine, depression;
• Reduced tolerance to carbohydrates;
• Endometrial carcinoma (in women with an intact uterus during menopause);
• Increased blood pressure, thrombophlebitis;
• Weight gain;
• Bouts of porphyria;
• Chloasma;
• Blurred vision;
• Melasma.

With long-term use Divigel possible water retention in the body, calcium and sodium, sclerosis of the ovaries.

special instructions

It is necessary to try not to allow gaps in the application of the gel, because this can lead to breakthrough menstrual uterine bleeding.

Analogs

Estrofem, Proginova, Estrozhel, Klimara, Estradiol dipropionate.

Terms and conditions of storage

Store at temperatures up to 25 ºС. Divigel's shelf life is 3 years.