Septol-Sol (Concentrate) Instructions for Use

Marketing Authorization Holder

Nizhpharm LLC (Russia)

ATC Code

D08AX08 (Ethanol)

Active Substance

Ethanol (Grouping name)

Dosage Form

Septol-Sol

Concentrate for solution for external use 95%: 25 ml, 50 ml, or 100 ml bottle

Dosage Form, Packaging, and Composition

Concentrate for preparation of solution for external use in the form of a colorless, transparent, mobile, volatile liquid with a characteristic odor of alcohol.

25 ml – glass bottles (1) – cardboard packs.
50 ml – glass bottles (1) – cardboard packs.
100 ml – glass bottles (1) – cardboard packs.
100 ml – polymer bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Antiseptic for external use

Pharmacotherapeutic Group

Antiseptic

Pharmacological Action

Antiseptic agent. When applied externally, it has an antimicrobial effect. It is active against gram-positive and gram-negative bacteria and viruses. It denatures microbial proteins.

Antiseptic activity increases with increasing ethanol concentration.

For skin disinfection, a 70% solution is used, which penetrates into the deeper layers of the epidermis better than 95%, and has a tanning effect on the skin and mucous membranes.

When used systemically, it has the ability to cause analgesia and general anesthesia. The cells of the central nervous system (CNS) are most sensitive to ethanol, especially the cells of the cerebral cortex, upon which Ethanol acts, causing characteristic alcoholic excitation associated with the weakening of inhibition processes. This is followed by a weakening of excitation processes in the cortex, depression of the spinal cord and medulla oblongata with suppression of the respiratory center activity.

It is a solvent for a number of medicinal products, as well as an extractant for a number of substances contained in medicinal plant materials.

Pharmacokinetics

Ethanol is metabolized in the liver with the participation of the isoenzyme CYP2E1, of which it is an inducer.

Indications

Treatment of initial stage inflammatory skin diseases (furuncle, felon, mastitis); surgical hand scrubbing (Fürbringer’s method, Alfred’s method), surgical field disinfection (including in persons with hypersensitivity to other antiseptics, in children, and during operations on areas with thin skin in adults – in the neck and face area).

As a topical irritant medicinal product.

For the manufacture of dosage forms for external use, tinctures, extracts.

Preservation of biological material.

ICD codes

Dosage Regimen

Use the concentrate to prepare a 70% ethanol solution for skin antisepsis; this concentration provides optimal antimicrobial efficacy and skin penetration.

For surgical hand scrubbing, apply the prepared 70% solution according to the standardized Fürbringer or Alfred methods.

For disinfection of the surgical field, apply the 70% solution, particularly for patients with hypersensitivity to other antiseptics, in pediatric patients, and for operations on areas with thin skin such as the neck and face.

For the treatment of initial inflammatory skin diseases (e.g., furuncle, felon, mastitis), apply the appropriately diluted solution topically to the affected area.

Use as a topical irritant as clinically directed.

For the manufacture of external dosage forms, tinctures, or extracts, use the concentrate as a solvent according to official formulations.

For the preservation of biological material, use the concentrate as specified by laboratory protocols.

Avoid any contact with flames or ignition sources during use and storage due to the high flammability of the concentrate and its vapors.

Apply only externally; do not ingest the concentrate or prepared solutions.

Adverse Reactions

Allergic reactions, skin burns, hyperemia and skin soreness at the compress site. When applied externally, it is partially absorbed through the skin and mucous membranes and can have a systemic toxic effect (CNS depression).

Contraindications

Hypersensitivity to ethanol.

Pediatric Use

Ethanol, when applied externally, is partially absorbed through the skin and mucous membranes, which should be taken into account when used in children.

Special Precautions

It should not be taken orally during treatment with medicinal products.

Ethanol, when applied externally, is partially absorbed through the skin and mucous membranes, which should be taken into account when used in children.

Drug Interactions

When used concomitantly, it enhances the effect of drugs that have a depressant effect on the CNS, cardiovascular system, and respiratory center.

When taken orally with drugs that have an inhibitory effect on the enzyme aldehyde dehydrogenase (which is involved in the metabolism of ethyl alcohol), the concentration of ethanol’s metabolite, acetaldehyde, increases, causing facial flushing, nausea, vomiting, general malaise, tachycardia, and decreased blood pressure.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.