BORIC ACID

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BORIC ACID (BORIC ACID)

Composition:

Active substance: boric acid;

1 container contains 30 g of boric acid.

Pharmaceutical form. Powder.

Main physicochemical properties: crystalline powder white or almost white in color, or colorless, shiny, greasy to the touch plates or crystals white or almost white in color.

Pharmacotherapeutic group. Antiseptics and disinfectants. ATC code D08A D.

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 cell membrane permeability. A 5% aqueous solution inhibits phagocytosis, while 2–4% solutions inhibit bacterial growth and development. It has a weak irritant effect on granulation tissues.

Pharmacokinetics.

The drug is absorbed through damaged areas of skin and gastrointestinal mucosa (in case of accidental ingestion).

The medicinal product penetrates well through 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.

Do not use for treatment of mammary glands.

Special precautions.

Do not apply the medicinal product to large skin areas or for prolonged periods. Do not use for irrigation of body cavities — absorption may occur. Avoid getting the drug into the eyes in powder form; use only aqueous 2% solution (2 g boric acid in 100 mL water).

Prepare aqueous solutions from powder ex tempore.

When using the drug, strictly follow the information provided in the section «Method of administration and dosage».

Interaction with other medicinal products and other types of interactions.

Interaction is currently unknown.

Inform your doctor about simultaneous use of any other medicinal products.

Special precautions for use.

The medicinal product is a traditional medicinal product for use according to indications supported by long-standing use.

Use during pregnancy or breastfeeding.

The medicinal product is contraindicated during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

Not studied.

Method of Administration and Dosage

Boric acid should be applied to adults, taking into account that the medicinal product can only be applied 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: insert tampons moistened with the solution into the external auditory canal, and also instill 3–5 drops 2–3 times daily.

For dermatitis and weeping eczema, use a 3% aqueous solution (3 g of boric acid in 100 ml of water) for compresses. Aqueous solutions should be prepared from powder ex tempore.

For pyoderma and intertrigo, apply as a 10% solution in glycerin (10 g of boric acid, glycerin up to 100 ml). This solution can also be used to apply to mucous membranes in cases of colpitis.

For irrigation of the conjunctival sac in conjunctivitis, use a 2% aqueous solution (2 g of boric acid in 100 ml of water).

The duration of treatment should not exceed 3–5 days.

The patient should consult a physician if symptoms of the disease do not resolve during treatment or if adverse reactions not listed in the instructions for medical use occur.

Children

The medicinal product 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, take measures to support vital functions, perform hemodialysis or peritoneal dialysis, and exchange blood transfusion.

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

Side effects.

Possible development of acute and chronic reactions (especially in cases of overdose, prolonged use, or impaired kidney function): nausea, vomiting, headache, confusion, seizures, diarrhea, skin rash, desquamation of the epithelium.

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, consult a physician immediately!

Shelf life. 2 years.

The medicinal product 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.

30 g per container.

Dispensing category. Over-the-counter.

Manufacturer.

JSC "VITAMINS".

Manufacturer's address and place of business.

31 Uspenska Street, Uman, Cherkasy region, 20300, Ukraine.

Marketing Authorization Holder.

JSC "VITAMINS".

Address of the Marketing Authorization Holder.

31 Uspenska Street, Uman, Cherkasy region, 20300, Ukraine.