Synalar Otic

Synalar Otic Solution combines the potent topical anti-inflammatory activity of fluocinolone acetonide 250 mcg (0.025% w/w) with the antibacterial activity of polymyxin B sulfate (10,000 IU/mL) and Neomycin sulfate (5% w/w) in an aqueous propylene glycol solution.

Anti-inflammatory; Antipruritic; Antibacterial.

Otitis externa and other steroid responsive inflammatory conditions where bacterial infection is present or suspected.

Synalar Otic Solution is intended for topical use only. Prior to use the ear should be carefully cleansed and dried. Synalar Otic Solution may then be applied to the affected ear with the dropper or it may be used to saturate a wick placed in the external auditory canal.
The suggested dosage is 3 to 4 drops, 2 to 4 times daily.
There is no evidence that exceeding the maximum recommended dosage is more effective higher dosage should, therefore, be avoided.
It is advisable to warm the drops to body temperature before they are placed in the ear in order to avoid caloric stimulation of the vestibular apparatus.

Untreated fungal or viral ear infections.
Herpes simplex, vaccinia and varicella.
Hypersensitivity to any component of this medication.
Use in the ear when the eardrum is perforated.
This preparation is not for ophthalmic use.

Prolonged use of topical corticosteroids may produce atrophy of the skin. Glucocorticoids may mask some signs of infection, and new infections may appear during their use.
Prolonged treatment may result in overgrowth of non-susceptible organisms and fungi.
Since systemic activity has not been seen with therapeutic doses of Synalar Otic Solution, care must be taken when transferring patients from systemic steroid therapy to Synalar Otic Solution if there is reason to suspect that their adrenal function is impaired.
Allergic cross-reactions may occur which could prevent future use of kanamycin, paromomycin and streptomycin.
Use in Pregnancy: See Use in Pregnancy & Lactation section for further information.
Use in Children: Administration of topical corticosteroids to children should be limited to a short time period and to the smallest amount of the product compatible with an effective therapeutic regimen.

Synalar Otic Solution is not recommended in the first three months of pregnancy. If used in the second or third trimester, the expected benefits should be weighed against the potential hazards to the fetus.

Burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, allergic contact dermatitis, secondary infection, skin atrophy have been reported with topical corticosteroids.
Ototoxicity and nephrotoxicity have been reported with the topical use of Neomycin.

Store below 25°C.

Ear Antiseptics with Corticosteroids

S02CA05 - fluocinolone acetonide and antiinfectives ; Belongs to the class of combinations of corticosteroids and antiinfectives used in the treatment of ear diseases.

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