Local treatment in adults and children with acute otitis externa with intact tympanic membrane caused by microorganisms sensitive to ciprofloxacin. The official guidelines for the correct use of antibacterial drugs should be taken into account.
Composition:
1 ml of solution contains 3 mg Ciprofloxacin (as hydrochloride) and 0.25 mg fluocinolone (as acetonide); The drug contains p-hydroxybenzoates.
Action:
A topical drug - a combination of a chemotherapeutic with a corticosteroid. Ciprofloxacin is an antibacterial drug from the group of fluoroquinolones, it works on aerobic Gram-negative bacteria:Proteus vulgaris; acquired resistance may show:Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Enterobacter cloacae, Pseudomonas aeruginosa; methicillin-resistant strainsStaphylococcus aureus (MRSA) should be considered resistant to ciprofloxacin. Fluocinolon is a synthetic fluorinated glucocorticosteroid with anti-inflammatory, antipruritic and vasoconstrictive effects. After administration of ciprofloxacin in the form of ear drops, it reaches very low levels in the blood. Absorption of fluocinolone acetonide after topical administration is generally small, may vary depending on the site of administration.
Contraindications:
Hypersensitivity to cipr Ofloxacin, fluocinolone, other quinolones or to any of the excipients. Viral infections of the external auditory canal, including infection with chickenpox and herpes simplex. Fungal infection of the ear.
Precautions:
The drug should be used with caution in patients with perforated or suspected perforation or if there is a risk of perforation of the tympanic membrane. In patients who develop symptoms after one week of treatment, further tests are recommended to reassess the diagnosis and to verify treatment. The drug should be discontinued after the first appearance of a rash on the skin or any other hypersensitivity symptom. As with other antibiotics, the use of the drug may cause excessive growth of non-susceptible organisms, including bacteria, yeasts and fungi; if superinfection occurs, appropriate treatment should be implemented. When using glucocorticoids on a large area, systemic side effects may occur on damaged skin or under occlusive dressing. Symptoms of hypercortisolemia (Cushing's syndrome) and reversible suppression of the hypothalamic-pituitary-adrenal axis leading to glucocorticoid deficiency may occur in some individuals due to the increased systemic absorption of topical glucocorticosteroids. If any of the above symptoms occur, the medicine should be gradually withdrawn by reducing the frequency of use. Abrupt discontinuation of treatment may cause a deficiency of glucocorticoids. Due to the content of methyl and propyl p-hydroxybenzoates, the drug may cause allergic reactions (also of late type).
Pregnancy and lactation:
In animal studies, teratogenic effects of systemic glucocorticosteroids, administered at relatively low doses, have been demonstrated. Teratogenic effects of some glucocorticoids have been found in animals after application to the skin. Before pregnancy, it should be evaluated whether the benefits of treatment outweigh the potential risk. Caution should be exercised when administering the drug to breastfeeding women.
Side effects:
Common: dysgeusia, earache, discomfort in the ear, pruritus of the ear. Uncommon: Candidiasis, fungal otitis, paresthesia (tingling in the ears), headache and dizziness, crying, hearing loss, tinnitus, ear leaking, ear congestion, redness, vomiting, peeling skin, erythematous rash, irritability, fatigue, remaining remnants of the medicinal product, obstruction of the drain (obstruction of the middle ear tube). Frequency unknown: allergic reactions.
Dosage:
Outwardly. Adults: 4-6 drops, instilled in a sick external auditory canal every 8 hours.Apply 8 days. Children: use the dose as for adults. The safety and efficacy of the medicine has been established in children from 7 years of age. Despite the lack of tests, there are no known safety concerns or differences in the course of the disease that would exclude the use of this drug in children from 2 years of age.
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