Instructions for Octenisept solution, 50 ml bottle with sprayer
Composition
active ingredients: 100 g of solution contain octenidine dihydrochloride 0.10 g, 2-phenoxyethanol 2.00 g;
Excipients: cocamidopropyl betaine; sodium gluconate; glycerin 85%; sodium hydroxide; purified water.
Dosage form
Solution.
Main physicochemical properties: transparent or almost transparent, colorless liquid, almost odorless.
Pharmacotherapeutic group
Antiseptics and disinfectants/quaternary ammonium compounds/octenidine, combinations.
ATX code D08A J57.
Pharmacological properties
Pharmacodynamics
Octenisept is an antiseptic for treating mucous membranes, skin, and wounds.
Mechanism of action
Octenidine dihydrochloride is a representative of cationic compounds and, due to its two cationic centers, has pronounced surface-active properties. It reacts with components of the microbial cell wall and membrane, which leads to disruption of cell functioning.
The mechanism of antimicrobial action of phenoxyethanol lies, in particular, in increasing the permeability of the cell membrane to potassium ions.
Pharmacodynamic properties
Antimicrobial activity includes bactericidal and fungicidal activity, as well as activity against lipophilic viruses and hepatitis B virus. The efficacy spectra of phenoxyethanol and octenidine dihydrochloride complement each other.
In quantitative and qualitative in vitro studies without protein loading, the drug Octenisept, applied for 1 minute, exhibited bactericidal and antifungal activity against bacteria and fungi Candida albicans with a reduction factor (RF) of 6–7 lg.
Under the conditions of adding 10% defibrinated sheep blood, 10% bovine albumin or 1% mucin, or a mixture of 4.5% defibrinated sheep blood, 4.5% bovine albumin and 1% mucin, the drug Octenisept caused a decrease in the number of bacteria at RF at the level of 6–7 lg and Candida albicans fungi at the level of > 3 lg after exposure for at least 1 minute.
In quantitative and qualitative in vitro studies in the presence of 0.1% albumin with the addition of 50% and 75% solutions of Octenisept, good activity was observed within 1 minute of contact against gram-positive and gram-negative bacteria, yeasts and fungi.
In vitro studies have tested the activity of Octenisept against selected viruses. It has been shown to be effective against lipophilic viruses such as herpes simplex virus, HIV and hepatitis B virus.
The development of primary resistance to Octenisept, as well as secondary resistance in case of prolonged use, is not expected due to non-specific efficacy.
Clinical studies on the effective action on the vaginal mucosa and oral mucosa have demonstrated a significant reduction in the number of microorganisms both with short-term and long-term use.
Pediatric population
The efficacy and tolerability of Octenisept were demonstrated in 347 children aged 6 days to 12 years, as well as in 73 premature infants with a gestational age of less than 36 weeks.
A study of umbilical cord stump treatment with Octenisept in 1725 newborns demonstrated its good tolerability.
Pharmacokinetics
Absorption.
Animal studies with 14C-labeled material have demonstrated that octenidine dihydrochloride is not absorbed from the gastrointestinal tract or through the skin or mucous membranes.
When administered orally, radiolabeled octenidine dihydrochloride was absorbed through the gastrointestinal mucosa in mice, rats, and dogs only to a very small extent (0–6%). It was found that in mice, when topically applied octenidine dihydrochloride was applied for 24 hours under an occlusive dressing, no absorption was observed.
Based on in vitro data, the possibility of octenidine dihydrochloride crossing the placenta can be excluded.
In studies in rats, orally administered 14C-labeled phenoxyethanol was almost completely absorbed and excreted in the urine as phenoxyacetic acid.
Octenidine dihydrochloride from Octenisept was not absorbed through the vaginal mucosa (rabbits) or through wounds (humans, rats).
Pediatric population
The oxidative metabolism of 2-phenoxyethanol was studied in 4 infants aged 1 week to 11 months and in 24 premature infants with a gestational age of less than 36 weeks. This study demonstrated that 2-phenoxyethanol is absorbed through the skin and completely or almost completely metabolized by oxidation to phenoxyacetic acid and excreted by the kidneys, demonstrating the safety of Octenisept application.
Indication
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.
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 area of the eardrum and for instillation into the bladder.
When used in the vaginal area: do not use in the first trimester of pregnancy, do not use in children under 8 years of age.
Interaction with other medicinal products and other types of interactions
Do not apply Octenisept to adjacent areas of skin treated with PVP-iodine-based antiseptics due to the possibility of a pronounced change in skin color in adjacent areas from brown to purple.
Application features
Ingestion of Octenisept or its entry into the bloodstream, for example as a result of accidental injection, should be avoided.
Avoid contact of Octenisept with the eyes. If the drug gets into the eyes, rinse them immediately with plenty of water.
The use of aqueous solutions of octenidine (0.1% with/without phenoxyethanol) for skin disinfection before invasive procedures has been associated with serious skin reactions in premature, low birth weight infants.
Any soaked materials, wipes or clothing should be removed before applying the product. Do not apply an excessive amount and do not allow the solution to accumulate in skin folds or under the patient or to drip onto a sheet or other material in direct contact with the patient. If it is necessary to apply an occlusive dressing to areas previously treated with Octenisept, care should be taken to ensure that there is no excess product before applying the dressing.
After irrigation of deep wounds with a syringe, persistent edema, erythema, and tissue necrosis were observed, which in some cases required surgical revision (see section "Adverse reactions").
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug does not affect the reaction speed when driving or working with other mechanisms.
Use during pregnancy or breastfeeding
Fertility
No adverse effects of octenidine dihydrochloride on the fertility of rats were observed.
There are no data on the effects of phenoxyethanol on fertility.
Pregnancy
A moderate amount of data on pregnant women (300 to 1000 pregnancy outcomes, gestational age ≥ 12 weeks) indicate no effect of Octenisept on the development of congenital anomalies and its toxicity to the embryo/fetus.
Animal studies have not shown any signs of reproductive toxicity.
If necessary, Octenisept can be used during pregnancy. As clinical data for the first 3 months of pregnancy are lacking, as a precautionary measure, Octenisept solution should not be used in the vaginal area during the first 3 months of pregnancy.
Breast-feeding
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 at all, it is assumed that it does not enter breast milk.
Phenoxyethanol is rapidly and almost completely absorbed and 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 gland area during breastfeeding.
Method of administration and doses
The solution 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 area until it is completely moistened. The drug Octenisept is applied once a day to the area to be treated, using swabs impregnated with the drug or using a sprayer to irrigate hard-to-reach skin surfaces. Application with a swab should be preferred.
Further procedures, such as applying a surgical dressing, can be carried out at least 2 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 mycosis, the drug should be sprayed onto the affected areas in the morning and evening.
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.
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 holding the bottle 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 used 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 prevent re-infection, it is also necessary to involve the patient's partner in the treatment. After removing the applicator from the bottle, replace it with a spray nozzle. The male genitals are irrigated with the drug until they are completely moistened.
To achieve the desired effect, you must carefully follow these instructions.
In case of persistence and recurrence of symptoms, a gynecological examination is mandatory, including microbiological diagnostics. If necessary, appropriate antibacterial therapy should be carried out.
Children
The dosage of Octenisept is identical for adults and children.
For the treatment of local bacterial and fungal infections in the vaginal area, use is limited to adults and children 8 years of age and older.
For all other indications, Octenisept can be used in adults and children without age restrictions.
Overdose
There is no information on overdose. However, with topical application, the likelihood of overdose is very low. In case of local overdose, the affected area can be washed with large amounts of Ringer's solution.
Accidental ingestion of Octenisept is not considered dangerous. Octenisept dihydrochloride is not absorbed and is excreted in the feces. In the event of oral ingestion of large amounts of Octenisept, irritation of the gastrointestinal mucosa cannot be ruled out.
Octenidine dihydrochloride is more toxic after intravenous administration than after oral administration. Therefore, it is necessary to avoid large amounts of Octenisept entering the bloodstream, for example as a result of accidental injection. However, since Octenisept contains only 0.1% octenidine dihydrochloride, intoxication is very unlikely.
Adverse reactions
The assessment of undesirable effects is based on the following frequency of occurrence: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000), frequency unknown (cannot be estimated from the available data).
General disorders and administration site conditions
Rare: burning, redness, itching, feeling of warmth at the site of application.
Very rare: allergic contact reaction, such as temporary redness at the site of application.
Frequency unknown: persistent edema, erythema, and tissue necrosis, which in some cases required surgical revision, have been observed after irrigation of deep wounds using a syringe (see section "Special instructions").
When rinsing the mouth, a bitter taste may appear.
Undesirable effects such as swelling, induration, pain, blisters, and eczema at the site of application may also occur.
Pediatric population
The frequency, type and severity of adverse reactions in children are the same as in adults.
Adverse reaction reporting
Reporting of suspected adverse reactions during post-marketing use of a medicinal product is important. This allows for continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national pharmacovigilance system.
Expiration date
3 years.
Storage conditions
In a dry, dark place, out of reach of children, at a temperature not exceeding 25°C.
Packaging
50 ml in a spray bottle
Vacation category
Without a prescription.
Producer
Schülke and Mayr GmbH.
Location of the manufacturer and its business address
Robert-Koch Strasse 2, 22851 Norderstedt, Germany.
