Otindol (Drops) Instructions for Use

Marketing Authorization Holder

Ivanovo Pharmaceutical Factory PJSC (Russia)

ATC Code

S02D (Other drugs for the treatment of ear diseases)

Active Substances

Procaine (Rec.INN registered by WHO)

Boric acid (Ph.Eur. European Pharmacopoeia)

Dosage Form

Otindol

Ear drops 2 g+3 g/100 ml: bottle or dropper bottle 10 ml, 15 ml, 20 ml or 25 ml

Dosage Form, Packaging, and Composition

Ear drops as a transparent, colorless liquid with a characteristic odor.

Excipients: ethanol 70% – up to 100 ml.

10 ml – orange glass bottles (1) with a dropper cap – cardboard packs.
15 ml – orange glass bottles (1) with a dropper cap – cardboard packs.
20 ml – orange glass bottles (1) with a dropper cap – cardboard packs.
25 ml – orange glass bottles (1) with a dropper cap – cardboard packs.
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 – dark glass bottles (1) with a dropper or dosing pipette – cardboard packs.
15 ml – dark glass bottles (1) with a dropper or dosing pipette – cardboard packs.
20 ml – dark glass bottles (1) with a dropper or dosing pipette – cardboard packs.
25 ml – dark glass bottles (1) with a dropper or dosing pipette – cardboard packs.
10 ml – dark glass dropper bottles (1) – cardboard packs.
15 ml – dark glass dropper bottles (1) – cardboard packs.
20 ml – dark glass dropper bottles (1) – cardboard packs.
25 ml – dark glass dropper bottles (1) – cardboard packs.
10 ml – polyethylene bottles (1) – cardboard packs.
15 ml – polyethylene bottles (1) – cardboard packs.
20 ml – polyethylene bottles (1) – cardboard packs.
25 ml – polyethylene bottles (1) – cardboard packs.
10 ml – polyethylene dropper bottles (1) – cardboard packs.
15 ml – polyethylene dropper bottles (1) – cardboard packs.
20 ml – polyethylene dropper bottles (1) – cardboard packs.
25 ml – polyethylene dropper bottles (1) – cardboard packs.
10 ml – polyethylene terephthalate bottles (1) – cardboard packs.
15 ml – polyethylene terephthalate bottles (1) – cardboard packs.
20 ml – polyethylene terephthalate bottles (1) – cardboard packs.
25 ml – polyethylene terephthalate bottles (1) – cardboard packs.

Clinical-Pharmacological Group

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

Pharmacotherapeutic Group

Antiseptic + local anesthetic agent

Pharmacological Action

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

Boric acid has antiseptic and 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 impulses but also impulses of other modalities.

Pharmacokinetics

Boric acid is absorbed through damaged skin, wound surfaces, and mucous membranes. In young children, it penetrates especially well through the skin and mucous membranes (fatal outcomes have been described after accidental ingestion or application to damaged skin). It is eliminated 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 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 agents 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 eardrum.

ICD codes

Dosage Regimen

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 with 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 resolve on their own within 1-2 minutes and do not require discontinuation of the drug.

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

Contraindications

Impaired integrity of the eardrum, 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 eardrum. In case of use with a perforated eardrum, 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, therefore 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.