Properties
What is it?
SINALAR® OTIC EAR DROPS, SOLUTION Active Ingredients: Each ml of solution contains: Fluocinolone acetonide 0.25 mg, Neomycin sulfate 5.00 mg (Neomycin 3.50 mg), Polymyxin B sulfate 10,000 units. Excipients: Citric acid, propylene glycol, purified water, sodium hydroxide. Pharmacotherapeutic Category: Topical corticosteroid / antimicrobial agent. General Information: Sinalar Otic is a combination of corticosteroids and antimicrobial agents. - Fluocinolone acetonide is a potent topical corticosteroid with anti-inflammatory and antipruritic action, proven effective in cases where other agents have failed. - Neomycin sulfate is an antibiotic with effective topical antimicrobial action against many gram-positive and gram-negative pathogens such as Staphylococcus aureus, Streptococci, and Proteus vulgaris, which cause local infections of the ear and surrounding structures. - Polymyxin B sulfate is an antibacterial agent that acts against many gram-negative microorganisms, including Pseudomonas aeruginosa (a common cause of otitis externa), Escherichia coli, and Aerobacter aerogenes. - Neomycin sulfate and Polymyxin B sulfate act synergistically against pathogens such as Haemophilus, Corynebacterium, Neisseria, Klebsiella, and Pneumoniococcus. - Propylene glycol is a hydrophilic excipient with low surface tension, which aids in the diffusion and penetration of the preparation. - The active ingredients of the solution are soluble and stable in the excipient. The relatively slow evaporation rate ensures that the solution remains in contact with the affected and infected areas for a sufficient time. Indications: Otitis externa with an intact tympanic membrane, eczema of the external auditory canal. Contraindications: Hypersensitivity to any of the ingredients of the preparation. Perforation of the tympanic membrane of traumatic or inflammatory etiology. Special Precautions and Warnings: - The condition of the tympanic membrane should always be checked before use. - Sinalar Otic should be prescribed with caution in individuals with a perforated tympanic membrane or chronic otitis. If the local infection persists or worsens, appropriate systemic antibacterial therapy should be prescribed according to sensitivity testing. - As with all medications containing an antimicrobial agent, prolonged use may lead to the overgrowth of non-susceptible microorganisms, after which appropriate treatment is recommended. - Since Polymyxin B sulfate is an ototoxic antibacterial agent, it should not be used for more than 10 days without medical supervision. General Recommendation: Avoid the use of topical corticosteroids for more than three weeks without consultation. Elderly: There are no reports of the need for special precautions when using the medication in elderly patients. Pregnancy and Lactation: - The medication should not be used in pregnant women in large quantities or for prolonged periods, especially during the first three months. - There are no reports of the need for special precautions when using the medication during lactation. Children: Long-term treatment in children should be avoided. Driving: There are no reports on the effect of the medication on the ability to drive and use machinery. In rare cases of allergy to excipients, the use of the preparation should be avoided. Dosage and Administration: - The condition of the tympanic membrane should be checked before use. - Sinalar Otic is intended for topical use only. - Before use, it is recommended to clean the external auditory canal, and after drying, instill the solution into the affected area, either by drops or as a cotton swab moistened with the solution, which is inserted into the external auditory canal. - The recommended dose is 3-4 drops, 2-4 times a day, or as needed by the patient. - Before using ear drops, they should be warmed to body temperature to avoid thermal shock. - Turn the top of the white cap to the right and left until the safety ring breaks. Overdose: In case of overdose, side effects characteristic of topical corticosteroids may occur. In case of accidental oral intake, appropriate symptomatic treatment and gastric emptying should be performed. There is no specific antidote. Side Effects: Allergic skin reactions may rarely develop as a result of antibiotic use. In case of perforation of the eardrum, use poses a risk of vestibular and cochlear toxicity. Treatment should only be carried out under medical supervision due to the risk of developing otomycosis. Missed Dose: If a dose is missed, continue taking the prescribed dose, disregarding the missed dose. However, regular intake of the product is desirable to achieve the therapeutic effect. Expiration Date: Indicated on the primary and secondary packaging. Do not use the medication after the expiration date. Special Storage Conditions: Do not refrigerate. Information on the Proper Use of Medications: - This medication is prescribed for you only by your doctor for a specific condition. Do not share it with others and do not use it to treat other conditions without prior consultation with your doctor. - If you experience any problems with this medication during treatment, inform your doctor or pharmacist immediately. - If you have any questions about the medication you are taking or need more information about your medical condition, do not hesitate to consult your doctor or pharmacist. - The medication prescribed for you will be effective and safe only if taken according to the given instructions. - For your safety and health, it is essential to carefully read all information about the medication prescribed for you. - Do not store medications in bathroom cabinets, as heat and humidity can spoil them and make them harmful to health. - Do not store medications that are no longer useful to you or whose expiration date has passed. - For safety reasons, keep all medications out of the reach of children. Dispensing Rule: The preparation is dispensed by prescription only. Marketing Authorization Holder: GALENICA S.A. 4 Eleftheriou Street, 145 64 Kifissia, Greece Tel: +30 210 52 81 700 Manufacturer: Galenica Pharmaceutical Industry S.A. 3rd km Old National Road Athens, Glyfa Chalkida