Sinalar® Otic
Ear drops, solution
Active substances: 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 anti-itching effects and has been proven to be effective in cases where other agents have been ineffective.
- Neomycin sulfate is an antibiotic with effective topical antimicrobial activity 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 external otitis), Escherichia coli and Aerobacter aerogenes.
- Neomycin sulfate and Polymyxin B sulfate additionally act against pathogens such as Haemophilus, Corynebacterium, Neisseria, Klebsiella and Pneumoniococcus.
- Propylene glycol is a hydrophilic excipient with low surface tension, which facilitates the diffusion and penetration of the preparation.
- The active substances of the solution are soluble and stable in the excipient. The relatively slow evaporation rate ensures that the solution remains for sufficient time for distribution and contact with all infected areas.
Indications:
External otitis with an intact tympanic membrane, eczema of the external auditory canal.
Contraindications:
Hypersensitivity to any component of the preparation. Perforation of the tympanic membrane of traumatic or inflammatory etiology.
Special instructions and warnings:
- The condition of the tympanic membrane should always be checked before use.
- Sinalar Otic should be prescribed with caution in individuals who have perforation of the tympanic membrane or chronic otitis. If the local infection persists or worsens, appropriate systemic antibacterial therapy should be prescribed according to sensitivity testing.
- Like all medicines containing antimicrobial agents, prolonged use may cause the growth 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.
Main recommendation: Avoid the use of topical corticosteroids for more than three weeks without consultation.
Elderly: There are no reports about the need for special precautions when using the medicine in elderly patients.
Pregnancy and lactation:
- During pregnancy the medicine should not be used in large quantities or for a prolonged period, especially during the first three months.
- During lactation there are no reports about the need for special precautions when using the medicine.
Children: Long-term treatment in children should be avoided.
Driving: There are no reports about the effect of the medicine on the ability to drive or operate machines.
In rare cases of allergy to the excipient, the use of the preparation should be avoided.
Dosage and method of 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; after drying, instill the solution into the affected area using a dropper or a cotton swab soaked with the solution, which is inserted into the external auditory canal.
- The recommended dose is 3-4 drops, 2-4 times a day, or according to the patient’s needs.
- Before using the ear drops, they should be warmed to body temperature to avoid thermal effect.
- Turn the upper part of the white cap to the right and left until the protective 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 carried out. There is no specific antidote.
Side effects:
As a result of antibiotic use, allergic skin reactions may rarely develop. In case of perforation of the tympanic membrane, use creates a risk of vestibular and cochlear toxicity. Treatment should be carried out only under medical supervision due to the risk of development of otomicosis.
In case of a missed dose:
If you miss a dose, continue taking the prescribed dose while ignoring the missed one. However, to achieve the therapeutic result, regular use of the product is desirable.
Expiry date: Indicated on the primary and secondary packaging. Do not use the medicine after the expiry date.
Special storage conditions: Do not store in a refrigerator.
Information on the proper use of medicines:
- This medicine is prescribed only for you, for a specific disease by a doctor. Do not share it with others and do not use it to treat other diseases without prior consultation with a doctor.
- If you experience any problem related to this medicine during treatment, immediately inform your doctor or pharmacist.
- If you have any questions about the medicine, you are taking or if you need additional information about your medical condition, do not hesitate to consult your doctor or pharmacist.
- The medicine prescribed for you will be effective and safe only if it is taken according to the given instructions.
- For your safety and health, it is necessary to carefully read all the information about the medicine prescribed to you.
- Do not store medicines in bathroom cabinets, because heat and humidity may spoil them and make them harmful to health.
- Do not keep medicines that are no longer useful for you or whose expiry date has passed.
- For safety reasons, keep all medicines out of the reach of children.
Dispensing rule: The medicine is dispensed only by prescription.
Marketing authorization holder:
GALENICA S.A.
4 Eleftheris Street, 145 64 Kifisia, Greece
Tel: +30 210 52 81 700
Manufacturer:
Galenica Pharmaceutical Industry S.A.
3 km Old National Road Athens, Glyfa Chalkida
