Orniona, vaginal cream 0.1% 15 g

The Orniona® cream contains oestriol, an analog of the natural female hormone. Estriol is used to correct estrogen deficiency in pre- and postmenopausal women.

Effective in the treatment of urogenital disorders. In case of epithelium atrophy it stops these disorders, promotes restoration of normal microflora and physiological pH of the vagina thus increasing resistance of the vaginal epithelium to infectious and inflammatory processes. </Unlike other estrogens, estriol interacts with endometrial cell nuclei 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 cyclic supplemental progestagen administration, and there are no withdrawal bleeding in the postmenopausal period.

Pharmacokinetics

The introduction of estriol into the vagina provides optimal local bioavailability of the drug. 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 plasma estriol is bound to albumin rather than to hGH.

The metabolism of estriol in the body is reduced to its conjugation and deconjugation during enterohepatic circulation. Because 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 intestine, mostly in the unconjugated form.

Indications

Active ingredient

Composition

Composition (100 g):

How to take, the dosage

Intravaginally.

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

Lower urinary tract mucosal atrophy caused by estrogen deficiency: one intravaginal injection of the cream daily for not more than 2 weeks, until relief of symptoms. Thereafter, the dose is gradually reduced to a maintenance dose, depending on the clinical picture (e.g. one injection twice a week).

Pre- and postoperative therapy in postmenopausal women who are about to undergo or have undergone vaginal surgery: 1 intravaginal injection of the cream daily for 2 weeks before surgery; 1 injection 2 times a week for 2 weeks after surgery.

For diagnostic purposes if the results of cervical cytology are unclear with atrophic changes of epithelium: we administer 1 intravaginal injection of the cream every other day for a week before the next smear.

If the next dose of the drug was missed, the drug should be continued according to the usual schedule without making up for the missed dose earlier. Do not give two doses of the drug in the same day.

When starting or continuing treatment for postmenopausal symptoms, the lowest effective dose should be used for the shortest time possible.

In women who are not receiving OST medications or who are transitioning from continuous oral combination OST medications, treatment with Ornion® can be started on any day.

Women who are changing from a cyclic regimen of oral combination oral hypertension drugs should begin treatment with Ornion® one week after withdrawal of these drugs.

The administration technique:

Interaction

In clinical practice, no interactions between topical estriol preparations and other drugs have been noted.

. Estrogen metabolism may be increased when used in combination with compounds that induce enzymes involved in drug metabolism (especially cytochrome P450 enzymes), such as anticonvulsants (e.g. phenobarbital, phenytoin, carbamazepine), antimicrobials (e.g. rifampicin, rifabutin, nevirapine, efavirenz, ritonavir, nelfinavir), barbiturates.

The herbal preparations containing St. John’s wort (Hypericum perforatum) may induce estrogen metabolism.

Elevated estrogen metabolism may decrease their clinical effect.

Estriol increases the effect of hypolipidemic drugs, reduces the effects of male sex hormones, anticoagulants, antidepressants, diuretics, hypotensive, hypoglycemic drugs.

The drugs for general anesthesia, narcotic analgesics, anxiolytics, some hypotensive drugs, ethanol reduce the effectiveness of the drug.

Special Instructions

To treat postmenopausal symptoms, ZGT should be started only for symptoms that adversely affect quality of life. In all cases, a thorough risk-benefit assessment should be performed at least once a year. ZGT should be continued only for a period of time when the benefits outweigh the risks.

Medical examination/surveillance:

Therapy should be discontinued if contraindications are identified and/or if the following conditions/diseases occur:

Other conditions:

Contraindications

Side effects

Orniona® cream may cause local irritation or itching.

Acyclic bleeding, breakthrough bleeding, and metrorrhagia may occur.

In rare cases, tightness or soreness of the mammary glands may occur.

In general, these side effects usually disappear after the first weeks of treatment, except that they may be an indication that too high a dose of the drug has been prescribed.

Overdose

In intravaginal administration, the likelihood of overdose of Ornion® cream is small.

Symptoms: Inadvertent ingestion – nausea, vomiting, bleeding withdrawal.

Treatment:There is no specific antidote. If necessary, symptomatic therapy should be carried out.

Similarities