In the course of preparing requirements for the safety and efficacy of medicines,based on up-to-date scientifically grounded information on the experience of clinical use of drugs containing as an active substance estriol, vaginal cream, 1.0 mg / 1.0 g, it was found necessary to unify and supplement the instructions for the use of these medications with the following information.
In the section "Contraindications" it is necessary to additionally include:
"- pregnancy and the period of breastfeeding".
The section "With caution" should be supplemented with the following information:
"- jaundice (including in the anamnesis during the previous pregnancy);
- chronic heart or kidney failure. "
The section "Method of administration and dose" should be submitted in the following edition:
"The drug should be injected into the vagina in the evening before bedtime with a calibrated applicator.One application (dose when filling the applicator to the annular mark) contains 0.5 g of cream, which corresponds to 0.5 mg of estriol.
In the treatment of mucosal atrophy of the lower parts of the urinary and genital tract associated with estrogen deficiency in postmenopausal women:
For 0.5 mg (one intravaginal cream application) per day daily for the first 2-3weeks (up to 4 weeks), then gradually reduce the dose based on the dynamics of symptoms, 0.5 mg (1 application) - 2 times a week.
Pre and postoperative therapy for postmenopausal women with vaginal interventions:
0.5 mg (1 application) per day for 2 weeks before surgery; 0.5 mg (1 application) 2 times a week for 2 weeks after the operation.
As an auxiliary tool for diagnosis of atrophic cervical smear:
For 0.5 mg (1 application) every other day for 1 week before taking the next smear.
In case of a miss, it is necessary to perform the application immediately, as soon as the patient remembers it (no two applications per day should be performed), then the administration of the drug is carried out in accordance with the usual dosing regimen.
For the treatment of symptoms of estrogen deficiency in postmenopausal women, the lowest effective dose should be administered within the shortest period of time. "
In the "Leave Conditions" section, you must specify "Let's go by prescription". The basis for making changes to this section (transfer from OTC to prescription status) is as follows:
1. The main area of application of drugs containing estriol, vaginal cream, - hormone replacement therapy (HRT). Therefore, before using the drug estriol, consult a doctor, tk. There is a fairly wide range of possible serious adverse reactions, including, for example:
- 1.3-fold relative increase in the risk of venous thromboembolism (deep vein thrombosis or pulmonary embolism);
- a 1.5-fold increase in the relative risk of ischemic stroke in HRT using an estrogen mono-drug or a combination of estrogen and progestogen;
- fluid retention in the use of estrogens, and therefore patients with chronic cardiac and renal insufficiency should be under close medical supervision.
2. The use of estriol, a vaginal cream, also involves a preliminary consultation with a doctor to exclude, including in a history, a number of diseases / conditions or risk factors that are reflected in the "Contraindications" and "With caution" sections. It is also necessary to conduct a general and gynecological examination (including examination of the mammary glands and pelvic organs).During the period of therapy it is recommended to conduct periodic medical examinations and at least once a year, a thorough evaluation of the "benefit-risk" ratio should be carried out. The continuation of estrogen treatment is justified only if the benefit of the drug over the risk is exceeded.
3. Prolonged monotherapy with estrogen (at least for 5-10 years) is associated with a small increase in the risk of ovarian cancer. In women receiving combined estrogen plus progestogen therapy for more than 5 years, the risk of developing breast cancer increased by a factor of 2. According to the epidemiological study, prolonged oral administration of estriol in low doses may increase the risk of endometrial cancer.
4. Status of reference preparation Ovestin, cream vaginal 1.0 mg / 1.0 g, (Aspen Pharma Trading Limited, Ireland) in the country of the manufacturer and a number of other countries of the world (Ireland, Germany, Switzerland, New Zealand, etc.).