Ottoslavin^® (Drops) Instructions for Use

Marketing Authorization Holder

Slavic Pharmacy, LLC (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

Ottoslavin®

Ear drops 30 mg+20 mg/1 ml: 5 ml, 10 ml, or 15 ml bottle

Dosage Form, Packaging, and Composition

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

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

10 ml – bottles made of glass tubing (1) complete with a dropper cap – cardboard packs.
5 ml – glass bottles (1) with a cap with a glass pipette – cardboard packs.
10 ml – glass bottles (1) with a cap with a glass pipette – cardboard packs.
15 ml – glass bottles (1) with a cap with a glass pipette – cardboard packs.
5 ml – dark glass bottles (1) with a cap with a rubber bulb and a glass pipette – cardboard packs.
10 ml – dark glass bottles (1) with a cap with a rubber bulb and a glass pipette – cardboard packs.
15 ml – dark glass bottles (1) with a cap with a rubber bulb and a glass pipette – cardboard packs.

Clinical-Pharmacological Group

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

Pharmacotherapeutic Group

Antiseptic + local anesthetic

Pharmacological Action

The pharmacological action is due to the composition of the drug. The solution applied topically has an antiseptic effect and moderately relieves pain.

Indications

• Acute and chronic external otitis without damage to the tympanic membrane.

ICD codes

Dosage Regimen

Before using the ear drops, it is recommended to warm the bottle by holding it in your hand to avoid unpleasant sensations associated with cold liquid entering the ear. The drops should be instilled into the patient lying with the affected ear facing up; after the procedure, the patient should remain in this position for several minutes.

Adults – 2-3 drops into the ear 2-3 times a day. Children – 1-2 drops 2-3 times a day. It can be used in the form of tampons soaked in the solution, which are inserted into the ear canal.

Adverse Reactions

Allergic reactions; with prolonged use, headache, nausea, vomiting, diarrhea may be observed, and in rare cases, a state of shock.

When using the drug, local reactions in the form of itching and burning are possible, which disappear on their own after 1-2 minutes and do not require discontinuation of the drug.

Contraindications

• Pregnancy;
• Period of breastfeeding;
• Children under 1 year of age;
• Chronic renal failure;
• Violation of the integrity of the tympanic membrane;
• Individual intolerance.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and the period of breastfeeding.

Use in Renal Impairment

Contraindicated in chronic renal failure.

Pediatric Use

Contraindicated in children under 1 year of age.

Overdose

In case of overdose, prolonged use, and in case of impaired renal function, acute and chronic toxic reactions may occur: nausea, vomiting, diarrhea, skin rash, headache, confusion, impaired urination, and in rare cases, a state of shock.

Storage Conditions

In a place protected from light, out of the reach of children, at a temperature not exceeding 25°C (77°F), away from fire.

Shelf Life

Shelf life – 3 years.

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.