Boric acid + Procaine (Drops) Instructions for Use

Instructions
Dosage forms

ATC Code

S02AA30 (Combination of antimicrobial drugs)

Active Substances

Procaine (Rec.INN registered by WHO)

Boric acid (Ph.Eur. European Pharmacopoeia)

Clinical-Pharmacological Group

Drug with antimicrobial and local anesthetic action for topical use in ENT practice

Pharmacotherapeutic Groups

Antimicrobial drugs in combination
Means for the treatment of ear diseases; other means for the treatment of ear diseases; analgesics and anesthetics

Pharmacological Action

A combined drug for topical use, has antiseptic, disinfectant and local anesthetic action.

Boric acid has antiseptic, fungistatic action. It has a weak irritating effect on granulation tissues.

Procaine is a local anesthetic agent with moderate anesthetic activity and a wide therapeutic range. Being a weak base, it blocks sodium channels, prevents the generation of impulses in the endings of sensory nerves and the conduction of impulses along nerve fibers. It alters the action potential in the membranes of nerve cells without a pronounced effect on the resting potential. It suppresses the conduction of not only pain but also impulses of other modalities.

Pharmacokinetics

Boric acid is absorbed through damaged skin, wound surfaces, mucous membranes. In young children, it penetrates especially well through the skin and mucous membranes (fatal outcomes have been described with accidental ingestion or application to damaged skin). It is excreted slowly (accumulates with repeated administration). About 50% is excreted in the urine within 12 hours, the remainder within 5-7 days.

Procaine undergoes complete systemic absorption. The degree of absorption depends on the site and route of administration (especially on the vascularization and blood flow rate in the area of administration) and the final dose (amount and concentration). It is rapidly hydrolyzed by plasma and liver esterases to form two main pharmacologically active metabolites: diethylaminoethanol (has a moderate vasodilating effect) and para-aminobenzoic acid (PABA) (is a competitive antagonist of sulfonamide chemotherapeutic drugs and may weaken their antimicrobial effect). T_1/2 is 30-50 s, in the neonatal period – 54-114 s. It is excreted mainly by the kidneys in the form of metabolites, no more than 2% is excreted unchanged.

Indications

External acute and chronic otitis without damage to the tympanic membrane.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
H60	Otitis externa

ICD-11 code	Indication
AA3Z	Otitis externa, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Drops

The drug is used topically, by instillation into the external auditory canal.

To avoid unpleasant sensations associated with cold liquid entering the ear canal, it is recommended to warm the bottle by holding it in your hand before using the ear drops.

Adults are prescribed 2-3 drops 2-3 times/day; children – 1-2 drops 2-3 times/day. A tampon soaked in the solution can be placed in the external auditory canal.

The duration of the course of therapy is no more than 7 days.

The drops should be instilled to the patient lying on their side so that the affected ear is on top. After the procedure, the patient should remain in this position for several minutes.

Adverse Reactions

Systemic reactions possibly – allergic reactions (skin rash, epithelial desquamation, confusion, convulsions, oliguria, rarely – anaphylactic shock); with prolonged use, headache, nausea, vomiting, diarrhea may be observed.

Local reactions itching, burning, which disappear on their own after 1-2 minutes and do not require discontinuation of the drug.

Toxic reactions in case of use with a perforated tympanic membrane nausea, vomiting, skin redness, itching, urticaria, swelling, deafness, balance disorder, confusion.

Contraindications

Violation of the integrity of the tympanic membrane, chronic renal failure, pregnancy, lactation period, children under 1 year of age, hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

The use of the drug during pregnancy and breastfeeding is contraindicated.

Use in Renal Impairment

The use of the drug is contraindicated in chronic renal failure.

Pediatric Use

The use of the drug is contraindicated in children under 1 year of age.

Special Precautions

Avoid contact with mucous membranes.

Before starting to use the drug, it is necessary to ensure the integrity of the tympanic membrane. In case of use with a perforated tympanic membrane, the drug may lead to toxic reactions.

Effect on the ability to drive vehicles and mechanisms

During treatment with the drug, caution should be exercised when engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

The metabolite of procaine (para-aminobenzoic acid) is an antagonist of sulfonamides, so a decrease in the antimicrobial effect of sulfonamide drugs is possible in case of simultaneous use with the drug.

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

Over-the-Counter

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Boric acid + Procaine [West, LLC (Russia)]
Ear drops 30 mg/ml+20 mg/ml

Marketing Authorization Holder

West, LLC (Russia)

Manufactured By

Samaramedprom, OJSC (Russia)

Dosage Form

Boric acid + Procaine

Ear drops 30 mg/ml+20 mg/ml

Dosage Form, Packaging, and Composition

Ear drops

	1 ml
Boric acid	30 mg
Procaine	20 mg

10 ml – dropper bottle – cardboard packs – Over-the-Counter
10 ml – bottles – cardboard packs – Over-the-Counter
15 ml – dropper bottle – cardboard packs – Over-the-Counter
15 ml – bottles – cardboard packs – Over-the-Counter
20 ml – dropper bottle – cardboard packs – Over-the-Counter
20 ml – bottles – cardboard packs – Over-the-Counter
25 ml – dropper bottle – cardboard packs – Over-the-Counter
25 ml – bottles – cardboard packs – Over-the-Counter

Boric acid + Procaine [West, LLC (Russia)]
Ear drops 20 mg+30 mg/1 ml: 10 ml, 15 ml, 20 ml or 25 ml bottle

Marketing Authorization Holder

West, LLC (Russia)

Manufactured By

Samaramedprom, OJSC (Russia)

Dosage Form

Boric acid + Procaine

Ear drops 20 mg+30 mg/1 ml: 10 ml, 15 ml, 20 ml or 25 ml bottle

Dosage Form, Packaging, and Composition

Ear drops in the form of a transparent, colorless or slightly yellowish or yellowish-brown liquid with a characteristic odor.

	1 ml
Procaine hydrochloride	20 mg
Boric acid	30 mg

Excipients : ethanol 70% – up to 1 ml.

10 ml – orange glass dropper bottles (1) – cardboard packs.
15 ml – orange glass dropper bottles (1) – cardboard packs.
20 ml – orange glass dropper bottles (1) – cardboard packs.
25 ml – orange glass dropper bottles (1) – cardboard packs.
10 ml – polymer bottles (1) – cardboard packs.
15 ml – polymer bottles (1) – cardboard packs.
20 ml – polymer bottles (1) – cardboard packs.
25 ml – polymer bottles (1) – cardboard packs.

Boric acid + Procaine [Dalkhimpharm, JSC (Russia)]
Ear drops 3%+2%: 10 ml or 25 ml bottle or dropper bottle

Marketing Authorization Holder

Dalkhimpharm, JSC (Russia)

Dosage Form

Boric acid + Procaine

Ear drops 3%+2%: 10 ml or 25 ml bottle or dropper bottle

Dosage Form, Packaging, and Composition

Ear drops transparent colorless or slightly colored solution with a characteristic odor.

	1 ml
Boric acid	30 mg
Procaine hydrochloride	20 mg

Excipients : ethanol (ethyl alcohol) 70% – up to 1 ml.

10 ml – dropper bottle (1) – cardboard packs.
10 ml – bottles (1) – cardboard packs.
25 ml – dropper bottle (1) – cardboard packs.
25 ml – bottles (1) – cardboard packs.

Boric acid + Procaine [Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)]
Ear drops 20 mg/1 ml+30 mg/1 ml: 10 ml bottle