BORIC ACID

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BORIC ACID

Composition:

Active substance: boric acid;

1 jar or container or packet contains 10 g of boric acid.

1 packet contains 30 g of boric acid.

Pharmaceutical form. Crystalline powder.

Main physicochemical properties: crystalline powder or crystals of white color, or colorless shiny greasy-to-touch plates.

Pharmacotherapeutic group. Antiseptics and disinfectants. ATC code D08AD.

Pharmacological properties.

Pharmacodynamics.

Boric acid has antiseptic and fungistatic activity, as well as an astringent effect. It coagulates proteins (including enzymatic proteins) of microbial cells and disrupts the permeability of the cell membrane. A 5% aqueous solution inhibits phagocytosis, while 2–4% solutions inhibit the growth and development of bacteria. It has a weak irritant effect on granulation tissues.

Pharmacokinetics.

It is absorbed through the affected area of skin and through the mucous membranes of the gastrointestinal tract (in case of accidental ingestion).

The drug penetrates well through the skin and mucous membranes; it is poorly excreted from the body and may accumulate in internal organs and tissues.

Clinical characteristics.

Indications.

Conjunctivitis, dermatitis, eczema, including weeping eczema, intertrigo, pyoderma, acute and chronic otitis, colpitis.

Contraindications.

Hypersensitivity to boric acid, impaired kidney function, chronic mesotympanitis with normal or slightly altered mucosa, traumatic perforations of the tympanic membrane; pregnancy or breastfeeding period, for treatment of mammary glands.

Special precautions.

Do not apply the drug to large areas of skin. Do not use for irrigation of body cavities – absorption may occur. Avoid contact of the drug with eyes.

Aqueous solutions should be prepared extemporaneously from powder.

Interaction with medicinal products and other types of interactions.

Interaction is currently unknown.

When using any other medicinal products concurrently, inform your physician.

Instructions for use.

Use during pregnancy or breastfeeding.

The drug is contraindicated during pregnancy or breastfeeding.

Ability to affect reaction rate when driving or operating machinery.

Not studied.

Method of Administration and Dosage

Boric acid should be used in adults, taking into account that it should be applied only to limited areas of the skin. 0.5%, 1%, 2%, and 3% alcoholic solutions (0.5 g, 1 g, 2 g, or 3 g of boric acid, ethanol 70% up to 100 mL) are used for otitis: moistened pledgets should be inserted into the external auditory canal, and 2–3 drops should be administered 2–3 times daily.

For dermatitis and weeping eczema, 3% aqueous solution (3 g of boric acid in 100 mL of water) is used for compresses. Aqueous solutions should be prepared extemporaneously from powder.

For pyoderma and intertrigo, a 10% solution in glycerin (10 g of boric acid, glycerin up to 100 mL) is also used for application to affected areas. This solution may also be used to apply to mucous membranes in cases of colpitis. For washing the conjunctival sac in conjunctivitis, a 2% aqueous solution (2 g of boric acid in 100 mL of water) is indicated.

Duration of treatment course – no more than 3–5 days.

Children

The drug is not intended for use in children.

Overdose

Symptoms of acute poisoning: nausea, vomiting, diarrhea, circulatory disturbances, central nervous system depression, hypothermia, shock, coma, and erythematous rash. In cases of severe poisoning, measures should be taken to support vital functions; hemodialysis or peritoneal dialysis, as well as blood transfusion, may be required.

With prolonged use of the drug on large skin areas, symptoms of chronic intoxication may develop: tissue edema, exhaustion, stomatitis, eczema, menstrual cycle disturbances in women, anemia, convulsions, and alopecia. In such cases, the drug should be discontinued and symptomatic treatment administered.

Side effects.

Acute and chronic reactions are possible (especially in cases of overdose, prolonged use, or impaired kidney function): nausea, vomiting, headache, confusion, seizures, diarrhea, skin rash, epithelial desquamation.

Allergic reactions are possible, including skin redness, itching, urticaria, swelling, and development of anaphylactic reactions, including shock; oliguria is also possible.

If any adverse events occur, it is necessary to consult a physician!

Shelf life. 5 years.

The drug must not be used after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging.

10 g in containers or bottles. 10 g or 30 g in sachets. 10 g per sachet, 10 sachets per pack; 10 g per sachet, 20 sachets per pack; 10 g per sachet, 50 sachets per pack.

Availability. Over-the-counter.

Manufacturer. JSC Pharmaceutical Factory "Viola".

Manufacturer's address.

75 Amosova Akademika Street, Zaporizhzhia, Ukraine, 69063.

Marketing Authorization Holder. JSC Pharmaceutical Factory "Viola".

Address of the Marketing Authorization Holder.

75 Amosova Akademika Street, Zaporizhzhia, Ukraine, 69063.