Octenisept solution is used:
for repeated, time-limited treatment of mucous membranes and surrounding skin before diagnostic and surgical procedures in the anogenital area: vagina, vulva, glans penis, before catheterization of the bladder for treatment of the oral cavity; for antiseptic treatment of local bacterial and fungal infections in the vaginal area; for time-limited maintenance therapy of mycosis of the interdigital spaces and for antiseptic treatment of wounds and burns of various origins.
Composition
100 g of solution contain (active ingredients):
octenidine dihydrochloride - 0.10 g; 2-phenoxyethanol - 2.00 g
Excipients: cocamidopropyl betaine, sodium gluconate, glycerin 85%, sodium hydroxide, purified water.
Contraindication
hypersensitivity to the active substances or to any of the excipients of the drug; do not use in the nose, for washing the abdominal cavity (e.g. during surgery), in the eardrum area and for instillation into the bladder.
Method of application
Use for the treatment of local bacterial and fungal infections in the vaginal area is limited to adults and children aged 8 years and over. For all other indications, Octenisept can be used in adults and children without age restrictions.
The mixture is intended for topical use only and should not be injected into the tissues, for example using a syringe.
"Octenisept" is used undiluted, applied to the affected areas until completely moistened.
Further procedures, such as applying a surgical dressing, can be carried out at least two minutes after application of the drug. Rinsing the mouth is also possible, but this method of application is limited to cases when it is necessary to treat the entire oral cavity. In this case, 20 ml of the drug should be applied for 20 seconds.
For maintenance therapy in cases of interdigital mycoses, the drug should be sprayed onto the affected areas in the morning and evening.
Treatment of local bacterial and fungal infections of the vaginal area
Before first use, remove the applicator from the packaging and place it on the bottle after removing the transparent protective cover and the spray head. The spray mechanism can work when the bottle is held in different positions (vertically or upside down). To insert the applicator deep into the vagina, it is recommended to sit on the toilet or lie in bed. Press the applicator cap with your index finger 10 times to distribute the drug deep into the vagina. After use, wipe the applicator and press the spray once or twice, directing the applicator downwards, for example over the sink. The duration of treatment should be 7 days, on the first day the drug should be applied in the morning and evening, and then once a day in the evening. Before the next use, press the spray once or twice, directing the applicator downwards, and carry out the procedure as described. The applicator can be used throughout the entire course of treatment. After completing the treatment of a vaginal infection, the applicator should be disposed of.
To achieve the desired effect, you must carefully follow these instructions.
Since the experience of continuous use is no more than 14 days, Octenisept should be used for a limited period of treatment.
Application features
Pregnant women
A moderate amount of data from pregnant women (300 to 1000 pregnancy outcomes, gestational age ≥ 12 weeks) indicates no effect of Octenisept solution on the development of congenital anomalies and its toxicity to the embryo/fetus. Animal studies have not revealed any signs of reproductive toxicity. Octenisept can be used during pregnancy if necessary. Since clinical data for the first 3 months of pregnancy are lacking, as a precautionary measure, Octenisept solution should not be used during the first 3 months of pregnancy.
There are no comprehensive data on the use of the drug during lactation from experimental animal studies and clinical trials. Since octenidine dihydrochloride is absorbed in very small amounts or not absorbed at all, it is assumed that it does not enter breast milk. Phenoxyethanol is rapidly and almost completely absorbed, and is excreted almost entirely as an oxidized product by the kidneys. Therefore, its accumulation in breast milk is unlikely. As a precautionary measure, Octenisept should not be applied to the mammary glands during breastfeeding.
Children
The dosage of Octenisept solution is identical for adults and children.
Drivers
The drug does not affect the reaction speed when driving or working with other mechanisms.
Overdose
There are no data on overdose. However, with topical application, the probability of overdose is very low. In case of local overdose, the affected area can be washed with a large amount of Ringer's solution.
Octenidine dihydrochloride is more toxic after intravenous administration than after oral administration. Therefore, it is necessary to avoid the introduction of large amounts of this solution into the bloodstream, for example as a result of an accidental injection. However, since this solution contains only 0.1% octenidine dihydrochloride, the occurrence of intoxication is very unlikely.
Side effects
General disorders and administration site reactions: rare (≥ 1/10,000 to < 1/1,000) - burning, redness, itching, feeling of warmth at the application site.
Skin and subcutaneous tissue disorders: very rare (<1/10,000) - allergic contact reaction, such as temporary redness at the site of application.
Musculoskeletal and connective tissue disorders: frequency unknown (cannot be estimated from the available data) - after flushing deep wounds with a syringe, persistent swelling, erythema, and tissue necrosis were observed, in some cases requiring surgical revision.
When rinsing the mouth, a bitter taste may appear.
The following side effects may occur: swelling, induration, pain, blisters, eczema in the area of application.
Storage conditions
Store at a temperature not exceeding 25 °C, protected from light and out of the reach of children.
Shelf life - 5 years.
