Elvagin - instructions for use, dose, side effects, contraindications

Excipients: cetyl palmitate 1.5 g, glycerol (glycerol) 12.0 g, cetyl alcohol 3.67 g, stearic alcohol (crodacol) 8.84 g, sorbitan stearate 0.76 g, macrogol 25 cetostearate (macrogol 25 cetostearyl ether, Cremophor A25 ) 3.24 g, ethanol 95% (ethyl alcohol 95%) 5.0 g, lactic acid 0.4 g, chlorhexidine dihydrochloride 0.01 g, sodium hydroxide 0.12 g, water purified to 100.0 g.

Description:

Homogeneous cream of white or almost white color with a weak specific smell.

Pharmacotherapeutic group:estrogen

ATX: & nbsp

G.03.C.A Natural and semi-synthetic estrogens

G.03.C.A.04 Estriol

Pharmacodynamics:

Elvagin® cream contains estriol - an analog of the natural female hormone. Estriol It is used to correct the deficiency of estrogens in women during pre- and postmenopausal periods. Effective in the treatment of urogenital disorders. In case of atrophy, the epithelium stops these disorders, helps restore normal microflora and physiological pH of the vagina, thereby increasing the resistance of the vaginal epithelium to infectious and inflammatory processes. Unlike other estrogens, estriol interacts with the nuclei of endometrial cells for a short period of time, so that when using the recommended daily dose (once a day), there is no proliferation of the endometrium. Thus, there is no need for a cyclic additional appointment of progestogens, and in the postmenopausal period there is no bleeding of cancellation.

Pharmacokinetics:

The introduction of estriol into the vagina provides optimal local bioavailability of the drug substance. Estriol is also absorbed into the blood, which is manifested by a rapid increase in the concentration of unconjugated estriol in plasma with a maximum value 1-2 hours after administration. Unlike other estrogens, up to 90% of estriol, in the blood plasma binds to albumin, and not to globulin, binding sex hormones (SHGG).

The metabolism of estriol in the body is reduced to its conjugation and deconjugation during enterohepatic circulation. Because the estriol - the final product of metabolism, it is mainly excreted by the kidneys in a conjugated form. Only a small fraction (2%) is excreted through the intestine, mainly in unconjugated form.

Indications:

- Atrophism of the mucous membrane of the lower parts of the genito-urinary tract caused by a deficiency of estrogens (which is manifested by unpleasant sensations in the vagina: pain during intercourse, dryness in the vagina, pruritus, urination disorder (increased frequency of urination and dysuria), and incontinence of urine of mild degree) as hormone replacement therapy (HRT);

- pre- and postoperative therapy in postmenopausal women who are or have already undergone vaginal surgery;

- with a diagnostic purpose for unclear results of cytological examination of the cervical epithelium against the background of atrophic changes.

Contraindications:

- An established hypersensitivity to the active substance or to any of the excipients of the drug;

- untreated endometrial hyperplasia;

- established, history of, or suspected breast cancer;

- diagnosed or suspected estrogen-dependent tumors (eg, endometrial cancer);

- bleeding from the vagina of an unclear etiology;

- presence of venous thrombosis at present and / or in anamnesis;

- active or recent thromboembolic disease of the arteries (eg, angina pectoris, myocardial infarction);

- liver disease in acute stage or liver disease in anamnesis, after which the liver function indicators did not return to normal;

- porphyria;

- pregnancy and lactation.

Carefully:

If any of the following conditions / conditions are present, or if this condition / illness was previously noted and / or worsened during previous pregnancies or previous hormonal treatment, the patient should be under direct medical supervision. It must be borne in mind that these conditions / diseases can recur or worsen during treatment with Elvagin®, especially if there are:

- leiomyoma (uterine fibroids) or endometriosis;

- thromboembolic abnormalities in the anamnesis or the available risk factors for such disorders;

- risk factors for estrogen-dependent tumors, for example, the first degree of heredity in breast cancer;

- arterial hypertension;

- Benign tumors of the liver (eg, liver adenoma);

- diabetes mellitus with or without angiopathy;

- cholelithiasis;

- jaundice, itching, herpes (including in anamnesis during previous pregnancy);

- liver failure;

- migraine or (severe) headache;

- systemic lupus erythematosus;

- endometrial hyperplasia in the anamnesis;

- epilepsy;

- bronchial asthma;

- otosclerosis;

- familial hyperlipoproteinemia;

- pancreatitis.

Pregnancy and lactation:

Elvagin® is contraindicated during pregnancy. In case of pregnancy during therapy with Elvagin®, treatment should be immediately canceled. The results of most epidemiological studies conducted so far on the unintended impact of estrogen on the fetus indicate the absence of teratogenic or fetotoxic effects.

Elvagin® is not recommended during lactation. Estriol is excreted in breast milk and reduces the formation of milk.

Dosing and Administration:

Elvagin® cream should be injected into the vagina before bedtime with a calibrated applicator. One dose (when the applicator is filled to the ring mark) contains 0.5 g of Elvagin® cream, which corresponds to 0.5 mg of estriol.

With atrophy of the mucous membrane of the lower sections of the genito-urinary tract, caused by a deficiency of estrogens One intravaginal administration of the cream is given daily for no more than 2 weeks until the symptoms improve. Further, the dose gradually decreases to maintenance, depending on the clinical picture (for example, one administration twice a week).

With pre- and postoperative therapy in postmenopausal women, who have already undergone an operation with vaginal access, 1 intravaginal administration of the cream is carried out daily for 2 weeks before the operation; 1 administration 2 times a week for 2 weeks after the operation.

FROM diagnostic purpose with unclear results of cytological examination from the cervix of the uterus against the background of atrophic changes in the epithelium 1 intravaginal cream is administered every other day, for a week before taking the next smear.

If the next dose of the drug has been missed, you should continue using the drug according to the usual scheme, not replacing the previously missed dose. Do not administer two doses of the drug on the same day.

When starting or continuing treatment for postmenopausal symptoms, the lowest effective dose should be administered within the shortest period of time.

Women who do not receive hormone replacement therapy (HRT) or women who are taken with continuous intake of oral combination drugs for HRT, treatment with Elvagin® can be started any day.

Women who switch from a cyclic regimen of oral medication to HRT should begin treatment with Elvagin® one week after the withdrawal of these drugs.

The technique of introduction

The patient should:

- unscrew the cap from the tube, turn it over and open the tube with a sharp tip;

- Screw the applicator onto the tube;

- squeeze the tube so that the applicator is filled with cream until the piston stops;

- unscrew the applicator from the tube and close the tube with a lid;

- lying on the back, insert the applicator deep into the vagina and smoothly push out the entire contents of the applicator with the piston;

- after using the applicator, remove the piston from the body and wash the plunger and the applicator body in warm water with soap. Do not use detergent for this purpose. After washing, rinse the applicator with clean water.

Do not stop the applicator in hot water or boiling water!

Side effects:

Like any drug applied to the mucous membrane, Elvagin® cream can cause local irritation or itching.

Possible acyclic spotting, breakthrough bleeding, metrorrhagia.

In rare cases, the intensity or tenderness of the mammary glands is possible.

As a rule, these side effects disappear after the first weeks of treatment, in addition, they may indicate the appointment of too high a dose of the drug.

Overdose:

With intravaginal injection, the probability of an overdose of the cream is small.

Symptoms (with occasional ingestion): nausea, vomiting, bleeding "cancellation."

There is no specific antidote. If necessary, symptomatic treatment should be performed.

Interaction:

In clinical practice, there was no interaction between estriol preparations for topical administration and other drugs.

Estrogen metabolism can be enhanced when used in combination with compounds that induce enzymes involved in the metabolism of drugs (especially cytochrome P450 enzymes), for example, such as anticonvulsants (eg, phenobarbital, phenytoin, carbamazepine), antimicrobial agents (for example, rifampicin, rifabutin, nevirapine, efavirenz, ritonavir, nelfinavir), barbiturates.

Herbal preparations containing St. John's Wort (perforated)Hypericum perforatum), can induce estrogen metabolism.

Elevated estrogen metabolism can lead to a decrease in their clinical effect.

Estriol enhances the action of lipid-lowering drugs; weakens the effects of male sex hormones, anticoagulants, antidepressants, diuretic, hypotensive, hypoglycemic drugs.

Medicines for general anesthesia, narcotic analgesics, anxiolytics, certain antihypertensive drugs, ethanol reduce the effectiveness of the drug.

Folic acid and thyroid medications strengthen the estrogenic effect of estriol.

There is evidence that estrogens, including estriol, can enhance the pharmacological action of corticosteroids and increase the activity of suxamethonium, theophylline and oleandomycin.

Special instructions:

For the treatment of postmenopausal symptoms, HRT should only be started with symptoms that adversely affect the quality of life. In all cases, it is necessary at least once a year to conduct a thorough assessment of the risk and benefits of treatment. HRT should only be continued for a period of time when the benefit exceeds the risk.

Medical examination / observation:

- Before starting or resuming HRT, you must collect a detailed individual and family history. Based on anamnesis, contraindications and warnings on the use of the drug, it is necessary to conduct a clinical examination, including examination of pelvic organs and mammary glands;

- it is recommended that a general medical and gynecological examination, including examination of the mammary glands, is recommended during treatment. The frequency and nature of the examinations are individual, but not less than once in 6 months.Women should be informed of the need to inform the doctor about changes in the mammary glands. Studies, including mammography, should be conducted in accordance with generally accepted survey standards.

Reasons for immediate withdrawal of therapy

Therapy should be discontinued if there is a contraindication and / or if the following conditions / diseases occur:

- jaundice and / or impaired liver function;

- significant increase in blood pressure;

- the onset or relapse of a migraine headache;

- pregnancy;

- endometrial hyperplasia.

Other conditions:

- estrogens can cause fluid retention, and therefore patients with impaired renal function and cardiovascular insufficiency should be under close medical supervision;

- estriol is a weak inhibitor of gonadotropin and has no other significant effects on the endocrine system;

- There is no convincing confirmation of the improvement in cognitive function;

- In the presence of vaginal infections, concomitant specific treatment is recommended.

To prevent stimulation of the endometrium, the dose of the cream of Elvagin should not exceed 1 administration (0.5 mg of estriol) per day,and this dose should not be administered daily for more than 3 consecutive weeks.

Effect on the ability to drive transp. cf. and fur:

Estriol does not affect the coordination of movement, the concentration of attention and the ability to drive vehicles and other mechanisms.

Form release / dosage:The cream is vaginal, 0,1%.

Packaging:

For 15 g or 30 g in tubes of aluminum.

Each tube together with the applicator and instructions for use in a pack of cardboard.

Storage conditions:

In a dry place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-000248

Date of registration:16.02.2011

Date of cancellation:2016-02-16

The owner of the registration certificate:VERTEKS, AO VERTEKS, AO Russia

Manufacturer: & nbsp

VERTEKS, AO Russia

Representation: & nbspVERTEKS CJSC VERTEKS CJSC Russia

Information update date: & nbsp02.10.2015

Illustrated instructions

Instructions

Elvagin® (Elvagine®)