Lorotox^® (Drops) Instructions for Use

Marketing Authorization Holder

Grotex, LLC (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

Lorotox®

Ear drops 10 mg+40 mg/1 g: bottle 8 g or 16 g 1 pc.

Dosage Form, Packaging, and Composition

Ear drops as a clear, colorless or colored liquid with an odor of alcohol.

Excipients: ethanol 95% – 221.8 mg, water for injections – 18.2 mg, sodium thiosulfate pentahydrate – 1 mg, 1M sodium hydroxide solution – to pH 5.0-7.5, anhydrous glycerol – to 1 g.

8 g – glass bottles (1) with a screw-on dropper* – cardboard boxes.
16 g – glass bottles (1) with a screw-on dropper* – cardboard boxes.

* polymer dropper, packaged in a blister made of polymer film or without it.

Clinical-Pharmacological Group

A drug with anti-inflammatory and local anesthetic action for topical use in ENT practice

Pharmacotherapeutic Group

Drugs for the treatment of ear diseases; other drugs for the treatment of ear diseases; analgesics and anesthetics

Pharmacological Action

Phenazone has anti-inflammatory and analgesic action.

Lidocaine has a local anesthetic action.

Pharmacokinetics

The drug does not penetrate into the systemic circulation with an intact tympanic membrane.

Indications

Local symptomatic treatment and pain relief in children from birth and adults with otitis media with an intact tympanic membrane, including

• Acute exudative otitis media;
• Otitis as a complication after influenza;
• Exudative viral otitis;
• Barotraumatic otitis.

If necessary, a doctor should be consulted before using the medicinal product.

ICD codes

Dosage Regimen

Topically.

Into the external auditory canal on the affected side for adults and children 4 drops 2-3 times/day.

The duration of the course of therapy is no more than 10 days.

Before use, 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 turned upward; after the procedure, the patient should remain in this position for several minutes.

The patient should consult a doctor if symptoms worsen or do not improve after 2-3 days of treatment.

If improvement does not occur after treatment or new symptoms appear, it is necessary to consult a doctor.

Should be used only according to the method of application and in the doses indicated in the instructions.

Adverse Reactions

Local reactions there is a risk of local allergic reactions, irritation and hyperemia of the auditory canal.

If any of the specified side effects worsen, or the patient notices any other side effects not listed in the instructions, they should inform the doctor.

Contraindications

• Hypersensitivity to lidocaine, phenazone and/or pyrazolone derivatives (medicinal products containing metamizole sodium, phenylbutazone) or to any of the excipients;
• Perforation of the tympanic membrane (including of infectious or traumatic origin);

With caution

It is necessary to ensure the integrity of the tympanic membrane before starting use. In case of use with a perforated tympanic membrane, the drug may come into contact with the organs of the middle ear and lead to complications.

Use in Pregnancy and Lactation

With an intact tympanic membrane and correct method of application, the likelihood of active substances entering the systemic circulation is extremely low. In this regard, in the absence of contraindications, use by pregnant women and women during breastfeeding is possible.

Before use, in case of an existing, suspected or planned pregnancy, as well as during breastfeeding, it is necessary to consult a doctor.

Special Precautions

For the prevention of complications, before starting use, it is recommended to consult an otorhinolaryngologist to exclude perforation of the tympanic membrane.

The duration of use is no more than 10 days, after which the prescribed treatment should be reviewed.

When used in combination with other ear drops, it is necessary to maintain an interval of at least 30 minutes between instillations.

Information for athletes contains an active component that can give a positive reaction during doping control.

Effect on the ability to drive vehicles and mechanisms

Does not affect the ability to drive vehicles, mechanisms and engage in other potentially hazardous activities requiring increased concentration and speed of psychomotor reactions.

Drug Interactions

Currently, there is no information on interaction with other medicinal products.

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.