Lidocaine + Phenazone (Drops) Instructions for Use
Marketing Authorization Holder
Sintez PJSC (Russia)
ATC Code
S02DA30 (Analgesics and anesthetics in combination)
Active Substances
Lidocaine (Rec.INN registered by WHO)
Phenazone (Rec.INN registered by WHO)
Dosage Form
 |
Lidocaine + Phenazone | Ear drops 40 mg+10 mg/1 g: fl. 16 g |
Dosage Form, Packaging, and Composition
| Ear drops | 1 g |
| Phenazone | 40 mg |
| Lidocaine hydrochloride | 10 mg |
16 g – plastic bottles (1) with a dosing nozzle – cardboard boxes.
Clinical-Pharmacological Group
A drug with anti-inflammatory and local anesthetic action for topical use in ENT practice
Pharmacotherapeutic Group
Topical anti-inflammatory agent
Pharmacological Action
A combined drug that has anti-inflammatory, local anesthetic, and analgesic effects.
Pharmacokinetics
Due to low systemic absorption, data on pharmacokinetics are not available.
Indications
- Acute otitis media;
- Otitis as a complication after influenza;
- Paratraumatic otitis.
ICD codes
| ICD-10 code | Indication |
| H66 | Suppurative and unspecified otitis media |
| ICD-11 code | Indication |
| AA9Z | Unspecified suppurative otitis media |
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. |
Instill 4 drops into the external auditory canal 2-3 times a day.
Administer the drops while the patient is lying on their side with the affected ear facing upwards; remain in this position for several minutes after instillation.
The course of treatment should not exceed 10 days. Do not use beyond the recommended duration.
Adverse Reactions
Local adverse reactions may include allergic reactions, irritation, and hyperemia of the auditory canal.
Discontinue use immediately and consult a physician if any signs of hypersensitivity, such as itching, rash, or burning sensation, occur.
Drug Interactions
No specific drug interaction studies have been conducted.
Due to the topical application and low systemic absorption, clinically significant interactions with other medicinal products are considered unlikely.
Contraindications
- hypersensitivity to lidocaine, phenazone, or any other component of the drug;
- mechanical damage to the eardrum or perforation of the tympanic membrane.
Overdose
No data available on overdose due to topical application and minimal systemic absorption.
In case of accidental ingestion, seek medical attention immediately; symptoms may be related to the systemic effects of lidocaine and phenazone.
Use in Pregnancy and Lactation
Use during pregnancy and breastfeeding is possible according to indications, provided the eardrum is intact.
Pediatric Use
Can be used in infants.
Special Precautions
Can be used in infants.
After opening the bottle, the drug is suitable for reuse.
Storage Conditions
At a temperature not exceeding 25°C (77°F). Keep out of reach of children.
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.
Medical Disclaimer![Lidocaine + Phenazone [Drops] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Lidocaine + Phenazone [Drops] 2")