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Active ingredients
Release form
Composition
Ingredients (100 g):
active ingredient: estriol 0.1 g;
excipients: cetyl palmitate - 1.5 g; glycerol (glycerin) - 12 g; cetyl alcohol - 3.67 g; stearyl alcohol (krodacol) - 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 g; lactic acid - 0.4 g; chlorhexidine dihydrochloride - 0.01 g; sodium hydroxide - 0.12 g; purified water - up to 100 g
Pharmacological effect
Ornion® Cream contains estriol - an analogue of the natural female hormone. Estriol is used to correct estrogen deficiency in women in the period of pre- and postmenopause. Effective in the treatment of urogenital disorders. In the case of epithelial atrophy, these disorders stop, it helps to restore normal microflora and the 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 the recommended daily dose is applied (1 time per day), endometrial proliferation does not occur. Thus, there is no need for cyclic additional administration of progestogens, and in the postmenopausal period no withdrawal bleeding is observed.
Pharmacokinetics
The introduction of estriol into the vagina ensures optimal local bioavailability of the drug substance. Estriol is also absorbed into the bloodstream, which is manifested by a rapid increase in the concentration of unconjugated estriol in plasma with a maximum value of 1–2 h after administration. Unlike other estrogens, up to 90% of estriol in blood plasma is associated with albumin, and not with SHBG.
The metabolism of estriol in the body is reduced to its conjugation and deconjugation during enterohepatic circulation. Since estriol is the end product of metabolism, it is mainly excreted by the kidneys in conjugated form. Only a small proportion (2%) is excreted through the intestines, mostly in an unconjugated form.
Indications
- atrophy of the mucous membrane of the lower urogenital tract caused by estrogen deficiency (which manifests unpleasant sensations in the vagina: pain during intercourse, vaginal dryness, itching, urination disorders (increased urinary frequency and dysuria) and mild urinary incontinence) as a substitution hormone therapy (HRT);
- pre- and postoperative therapy in postmenopausal women who are to or have already undergone an operation with vaginal access;
- for diagnostic purposes with unclear results of cytological examination of the cervical epithelium on the background of atrophic changes.
Contraindications
- established hypersensitivity to the active substance or to any of the excipients of the drug;
- untreated endometrial hyperplasia;
- an established, history or suspected breast cancer;
- diagnosed estrogen-dependent tumors or suspicion of them (for example, endometrial cancer);
- bleeding from the vagina of unknown etiology;
- the presence of venous thrombosis at the present time and / or in history;
- active or recent thromboembolic arterial disease (for example, angina pectoris, myocardial infarction);
- liver disease in the acute stage or a liver disease in history, after which the indicators of liver function did not return to normal;
- porphyria;
- pregnancy;
- lactation period.
Precautionary measures
With caution: the presence of any of the following conditions / diseases at present, or in cases where such a condition / disease was noted earlier and / or worsened during previous pregnancies or hormone treatment carried out before - the patient should be under the direct supervision of a physician. It must be borne in mind that these conditions / diseases may recur or worsen during treatment with Ornion®, especially if present:
- leiomyoma (uterine fibroma) or endometriosis;
- history of thromboembolic disorders or existing risk factors for such disorders;
- risk factors for estrogen-dependent tumors, for example, 1st degree of heredity for breast cancer;
- arterial hypertension;
- benign liver tumors (for example, liver adenoma);
- diabetes mellitus with or without angiopathy;
- cholelithiasis;
- jaundice, pruritus, herpes (including a history of the previous pregnancy);
- liver failure;
- migraine or headache (severe);
- systemic lupus erythematosus;
- endometrial hyperplasia in history;
- epilepsy;
- bronchial asthma;
- otosclerosis;
- familial hyperlipoproteinemia;
- pancreatitis.
Use during pregnancy and lactation
Ornion® is contraindicated during pregnancy. In the event of pregnancy during treatment with Ornion®, treatment should be canceled immediately. The results of most epidemiological studies conducted to date regarding the unintended effects of estrogen on the fetus, indicate the absence of teratogenic or fetotoxic effects.
Ornion® is not recommended during lactation. Estriol is excreted in breast milk and reduces the formation of milk.
Dosage and administration
Intravaginally.
Ornion® cream should be inserted into the vagina before bedtime with a calibrated applicator. One dose (when filling the applicator to the ring mark) contains 0.5 g of Ornion® cream, which corresponds to 0.5 mg of estriol.
Atrophy of the mucous membrane of the lower urogenital tract caused by estrogen deficiency: one intravaginal cream is administered daily for no more than 2 weeks, until symptoms are relieved. Further, the dose is gradually reduced to maintenance, depending on the clinical picture (for example, one administration 2 times a week).
Pre- and postoperative therapy in postmenopausal women who are to have or have already undergone surgery with vaginal access: 1 intravaginal cream is administered daily for 2 weeks before the surgery; 1 administration 2 times a week for 2 weeks after surgery.
For diagnostic purposes with unclear results of cytological examination of the cervix on the background of atrophic changes in the epithelium: 1 intravaginal injection of the cream every other day for a week before taking the next smear.
If the next dose of the drug was missed, you should continue using the drug in the usual way, without replenishing the previously missed dose. You can not enter two doses of the drug in one day.
When initiating or continuing the treatment of postmenopausal symptoms, it is necessary to apply the lowest effective dose for the shortest amount of time.
In women who do not receive drugs intended for HRT, or women who are transferred from the continuous intake of oral combination drugs for HRT, Ornion® treatment can be started on any given day.
Women who are switching from a cyclic regimen of oral medications for HRT should begin treatment with Ornion® 1 week after discontinuation of these drugs.
Introduction technique:
- unscrew the cap from the tube, turn it over and open the tube with a sharp tip;
- Screw the tube applicator;
- 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 your back, insert the applicator deep into the vagina and gently push the piston all the contents of the applicator;
- After using the applicator, remove the piston from the housing and wash the piston and applicator housing in warm water and soap. Do not use washing powder for this purpose. After washing, rinse the applicator with clean water. Do not put the applicator in hot water or boiling water.
Side effects
Ornion® Cream may cause local irritation or itching.
Possible acyclic bleeding, breakthrough bleeding, metrorrhagia.
In rare cases, there may be tension or tenderness of the mammary glands.
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 administration, the probability of an overdose of Ornion® cream is low.
Symptoms: in case of accidental ingestion - nausea, vomiting, withdrawal bleeding.
Treatment: there is no specific antidote. If necessary, symptomatic therapy should be carried out.
Interaction with other drugs
In clinical practice, no interaction between estriol preparations for topical use and other drugs has been observed.
Estrogen metabolism may be enhanced when used in combination with compounds that induce the enzymes involved in the metabolism of drugs (in particular the cytochrome P450 enzymes), such as anticonvulsants (such as phenobarbital, phenytoin, carbamazepine), antimicrobials (e.g. rifampin, rifabutin, nevirapine , efavirenz, ritonavir, nelfinavir), barbiturates.
Herbal preparations containing Hypericum perforatum (Hypericum perforatum) can induce estrogen metabolism.
Increased 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.
Drugs for general anesthesia, narcotic analgesics, anxiolytics, some antihypertensive drugs, ethanol reduce the effectiveness of the drug.
Folic acid and thyroid preparations enhance the estrogenic effect of estriol.
There is evidence that estrogen, incl. estriol, can enhance the pharmacological action of corticosteroids and increase the activity of suxamethonia, theophylline and oleandomycin.
special instructions
For the treatment of postmenopausal symptoms of HRT, it is necessary to begin only in relation to symptoms that adversely affect the quality of life. In all cases, it is necessary to conduct a thorough assessment of the risk and benefits of treatment at least once a year. HRT should be continued only during the period of time when the benefit exceeds the risk.
Medical examination / observation:
- Before starting or resuming HRT, a detailed individual and family history should be collected. Based on the history, contraindications and warnings on the use of the drug, it is necessary to conduct a clinical examination, including examination of the pelvic organs and mammary glands;
- during treatment, it is recommended to conduct a general medical and gynecological examination, including the examination of the mammary glands. The frequency and nature of surveys are individual, but at least 1 time in 6 months. Women should be informed about the need to inform the doctor about changes in the mammary glands. Research, including mammography, should be carried out in accordance with generally accepted examination standards.
Therapy should be discontinued if a contraindication is detected and / or if the following conditions / diseases occur:
- jaundice and / or impaired liver function;
- a significant increase in blood pressure;
- the occurrence or recurrence of migraine-type headache;
- pregnancy;
- endometrial hyperplasia.
Other states:
- estrogens can cause fluid retention, and therefore patients with impaired renal function and cardiovascular insufficiency should be under the close supervision of a physician;
- estriol is a weak inhibitor of gonadotropin and does not have other significant effects on the endocrine system;
- no convincing confirmation of cognitive improvement;
- in the presence of vaginal infections, concomitant specific treatment is recommended.
To prevent endometrial stimulation, the dose of Ornion® cream should not exceed 1 administration (0.5 mg of estriol) per day, and this dose should not be administered daily for more than 3 weeks in a row.
Influence on ability to drive vehicles and work with mechanisms
Estriol does not affect movement coordination, concentration, and ability to drive vehicles and other mechanisms.
Storage conditions
In a dry place, at a temperature not higher than 25 ° C.
Keep out of the reach of children.