Otics plus

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT OTIX PLUS (OTIX PLUS)

Composition:

Active substances: phenazone, lidocaine hydrochloride, nitrofurazone;

1 g of ear drops, solution, contains: phenazone 70 mg, lidocaine hydrochloride 25 mg, nitrofurazone 2 mg;

Excipient: glycerin.

Pharmaceutical form. Ear drops, solution.

Main physicochemical properties: clear, viscous, yellow solution with a greenish tint.

Pharmacotherapeutic group. Agents used in otology.

ATC code S02D A30.

Pharmacological Properties

Pharmacodynamics

The therapeutic effect of the medicinal product Otyks Plus is due to the anti-inflammatory action of phenazone, the antibacterial action of nitrofurazone, and the local anesthetic effect of lidocaine hydrochloride. Nitrofurazone is an antiseptic with antibacterial activity.

It is active against various Gram-positive and Gram-negative bacteria.

Phenazone has anti-inflammatory, analgesic, and antipyretic effects. Its mechanism of action is associated with inhibition of prostaglandin synthesis due to cyclooxygenase inhibition.

Lidocaine hydrochloride is a local anesthetic. It blocks the transmission of nerve impulses, including pain signals, along nerve fibers to their endings. As a result of depolarization and inhibition of ionic exchange, pain and itching sensations at the site of application gradually disappear.

Pharmacokinetics

Due to negligible systemic absorption, routine pharmacokinetic studies of the topical action of phenazone have not been conducted. The analgesic effect, associated with inhibition of pain mediator synthesis primarily in the central nervous system, occurs as the drug is absorbed. The product is intended for topical use, and systemic absorption of nitrofurazone is minimal. When absorbed systemically, it readily crosses histohematogenous barriers and is evenly distributed in body fluids and tissues. The main metabolic pathway in the body is reduction of the nitro group. It is excreted by the kidneys and partially with bile. Lidocaine does not penetrate intact skin but acts relatively effectively through mucous membranes. The effect of Otyks Plus begins within 5–10 minutes after instillation and lasts up to 2–5 hours. Most of the drug is eliminated unchanged with earwax.

Clinical characteristics.

Indications.

A topical medication for symptomatic treatment of pain and inflammation associated with non-perforated acute otitis media.

Contraindications.
Hypersensitivity to any component of the medicinal product or to amide-type local anesthetics. Perforation of the tympanic membrane of traumatic or infectious origin (see section "Precautions").

Allergic dermatoses.

Precautions.

Do not exceed the recommended dose or duration of treatment.

Do not use in chronic otitis, as systemic effects may occur: central nervous system stimulation (nervousness, restlessness, disorientation, blurred vision), or depression (drowsiness, respiratory depression).

Prior to administration, the physician should examine the integrity of the tympanic membrane (as a precautionary measure). If the tympanic membrane is perforated, instillation of the medication may result in contact with middle ear structures and lead to adverse reactions in these tissues.

If the patient has experienced allergic reactions, this should be reported to the physician.

Interaction with other medicinal products and other forms of interaction.

The anesthetic effect of lidocaine hydrochloride is enhanced and prolonged when used concomitantly with vasoconstrictors such as epinephrine and norepinephrine, analgesics, and tranquilizers. The activity of lidocaine hydrochloride is significantly reduced in an acidic environment. When used in combination with salicylates and sulfonamides, a reduction in the antimicrobial and anesthetic effects of the drug may occur. Due to possible interactions, other medicinal products should be administered no sooner than 15 minutes after instillation of Otix Plus into the ear.

Special precautions.

Use during pregnancy or breastfeeding. Data are lacking.

Ability to affect reaction rate while driving or operating machinery.

The medicinal product does not affect the ability to drive or operate machinery.

Method of Administration and Dosage.

For children aged 4 years and older — 2–3 drops 2–3 times daily.

To prevent discomfort caused by contact of the ear canal skin with cold solution, warm the bottle to body temperature (37 °C) by holding it in the hand prior to administration. To administer the drops, tilt the head sideways toward the unaffected side, pull the earlobe backward and upward, and slowly instill the solution. The patient should remain seated with head tilted for 2–3 minutes. The treatment course should not exceed 7 days.

Children. The medication may be used in children aged 4 years and older.

Overdose.

Symptoms of overdose may occur when the drug is used in patients with perforated eardrum: dizziness, general weakness, excitement, respiratory disturbances, seizures, nausea, vomiting.

Treatment: irrigation of the middle ear with physiological saline; if necessary, administer barbiturates, caffeine, nitroglycerin.

Side effects.

Auditory and vestibular system: local reactions: allergic reactions, including irritation, hyperemia of the external auditory canal, itching, skin rashes, contact dermatitis, burning sensation.

If the drug penetrates into the inner ear due to sudden perforation, dizziness, nausea, and nystagmus related to drug absorption through the mucous membrane may occur.

If symptoms of an allergic reaction occur, discontinue use of the medicinal product.

Shelf life. 3 years. Shelf life after first opening of the bottle — 6 months.

Storage conditions.

Store in the original packaging, in a place inaccessible to children, at a temperature not exceeding 25 °C.

The bottle must be kept tightly closed.

Packaging. 5 g or 15 g in a plastic bottle; 1 bottle per cardboard box.

Prescription status. Prescription only.

Manufacturer: LLC "Arpimed".

Manufacturer's address and place of business.

19, 2nd microdistrict, city of Abovyan, Kotayk region, Republic of Armenia.