Otocerol

Instructions for use of the drug (for patients)

OTOSEROL   ear drops
OTOCEROL

International non-proprietary name:Ciprofloxacin + Hydrocortisone

Composition
Active ingredient:1 ml of solution contains 2 mg of ciprofloxacin (in the form of hydrochloride), 10 mg
contains hydrocortisone.
Aids: benzyl alcohol, sodium chloride, glacial acetic acid, sodium acetate trihydrate, sodium
hydroxide or hydrochloric acid, polysorbate 20, polyvinyl alcohol, hydrogenated
phosphatidylcholine, purified water.

Description
It is a white, homogeneous, suspension.

Pharmacotherapeutic group
Antibiotic, anti-inflammatory for use in the ears.
ATC code:S02CA03.

Pharmacological properties
Pharmacodynamics
Ciprofloxacin is a synthetic fluoroquinolone with in vitro activity against a broad spectrum of gram-positive and gram-negative microorganisms. The bactericidal effect of ciprofloxacin is related to its binding to the enzyme DNA gyrase, which is necessary for the synthesis of bacterial DNA. Hydrocortisone is an anti-inflammatory corticosteroid.
Spectrum of antimicrobial action:
Ciprofloxacin was effective both in vitro and clinically in acute otitis externa against most strains of the following microorganisms:

• Gram-positive aerobes:Staphylococcus aureus
• Gram-negative aerobes:Proteus mirabilis, Pseudomonas aeruginosa

Pharmacokinetics
The predicted plasma concentration of ciprofloxacin after otic administration of the 0.2% suspension (total otic dose of approximately 180 (g) at a single dose will be below the detection limits of the assay (quantity limit of 0.5 g/L)). Even with complete local absorption of the dose, data suggest that a steady-state peak ciprofloxacin concentration of only about 3 (g/L) is expected following oral administration.
Absorption of hydrocortisone after topical application is usually low and varies greatly depending on the site of application. By plasma analysis, the very small contribution of exogenous hydrocortisone (a commonly used ear dose of 0.9 mg) will not be distinguishable from the contribution of endogenous cortisol production.
It is not known if measurements were taken after ear use.

Instructions for use
OTOSEROL ear drops for the treatment of acute otitis externa caused by susceptible microorganisms in adults and children over one year of age.

Contraindications
OTOSEROL ear drops are contraindicated in patients with a history of hypersensitivity to hydrocortisone, ciprofloxacin, other quinolones, or any component of the suspension. It should not be used during perforation of the eardrum, viral infections of the outer ear, including chicken pox and herpes simplex, fungal, tuberculosis infections.

Special instructions and precautions
If skin rash or other signs of sensitivity occur, stop treatment immediately and consult a doctor. Very rarely, severe (anaphylactoid) hypersensitivity reactions, sometimes fatal after the first dose, have been reported in patients receiving systemic quinolone therapy. These reactions may require immediate treatment. As with all antibiotics, use of this product may result in the development of resistant organisms, including fungi. If the infection does not subside after one week of treatment, bacteriological culture should be performed. Do not use as eye drops.

Interaction with other drugs
Tell your doctor or pharmacist before using:
• You are allergic to any other drugs or substances such as foods, preservatives or dyes.
• If you are using or have recently used or may use any other medicines.
• If you have any disease, especially perforation of the eardrum.
• If you are currently using any other type of ear drops.

Use during pregnancy and lactation
Pregnancy
Animal reproduction studies have not been conducted with ciprofloxacin and hydrocortisone in the ear. No controlled studies have been conducted in pregnant women. It is recommended to use with strict instructions and caution during pregnancy.
Lactation
Ciprofloxacin is excreted in breast milk when taken systemically. It is not known whether it passes into breast milk after use in the ear. Taking into account the possibility of serious adverse reactions in the baby during breastfeeding and the importance of treatment for the mother, the doctor should stop the treatment or decide whether to stop breastfeeding.

Use in pediatrics
It should not be used in children under one year of age.

Method of use and dosage
Adults and children over 1 year old: instill 3 drops into the affected ear 2 times a day for 7 days.
It is recommended to warm the suspension by holding the dropper in your hand for a minute or two to avoid possible reactions to the cold liquid entering the ear canal. To facilitate the expulsion of drops, the patient is advised to lie with the affected ear elevated and maintain this position for 30-60 seconds after instillation. If necessary, repeat the procedure in the other ear.
Do not contaminate the dropper with your hands, ear secretions or other items.
Protect the bottle from light by keeping it in a box. Discard any unused liquid at the end of treatment.

Side effects
Common: May affect 1 in 10 people
• Effects on the ear:earache.
Rare: may affect up to 1 in 100 people
• Effects on the ear:discomfort in the ear, blockage of the ear drainage tube, ringing in the ear, congestion, itching, discharge, crusting, fungal infection of the outer ear.
• Common side effects:Candida infection, irritability, crying, flushed skin, vomiting, bad taste, fatigue.
Rare side effects:May affect up to 1 in 1,000 people
Effects on the ear:hearing loss, ringing in the ears, drug residues.
•Common side effects:dizziness, headache, ear redness.
Frequency cannot be estimated based on available data
•Effects on the eyes:blurred vision.
•Effects on the ear:ear infection.
•Common side effects:allergies.

Overdose
Cases of overdose have not been described. If necessary, your doctor may wash the affected ear with saline solution.

Release form
1 vial in a plastic vial with a dropper of 10 ml solution in a cardboard box together with a leaflet
packed.

Storage conditions
It should be stored at a temperature not higher than 30oC, dry and out of the reach of children.

Shelf life
2 years.
Do not use after the expiration date.

Condition of release from pharmacy
It is released on the basis of a prescription.

Manufacturer
LAFEDAR S.A., Argentina.
Valentin Torra 4880, Argentina.

Holder of registration card
LN company LLC, Republic of Azerbaijan.
Khirdalan city, Baku-Guba highway, 12th km,
building 2, No. 3, Republic of Azerbaijan.