Description

SYTEMAX Otic Solution is used for allergic and inflammatory conditions of the external ear canal complicated by infections. Adjunctive management for acute or chronic steroid-responsive dermatoses of the external ear.

FORMULATION:

Each ml contains Dexamethasone Sodium Phosphate…1.0 mg, Neomycin Base (as Sulfate) … 3.5 mg, Polymyxin B Sulfate … 10,000 I.U.

DOSAGE AND ADMINISTRATION:

Initially, 3-4 drops 2-3 times a day, then maybe reduced gradually. Or as prescribed by a physician.

• Shake suspension prior to each use
• Warm the preparation by holding the bottle in the hands for 1–2 minutes prior to administration to avoid dizziness that may result from instilling a cold preparation into the ear
• Dry and clean the ear canal prior to administration. The pH of otic preparations should be neutral or acidic
• Lie with the affected ear upward and instill drops or pediatric patients with otitis media and tympanostomy tubes, pump the tragus 5 times to ease penetration of drops into the middle ear. For acute otitis externa, pull outer ear lobe upward and backward to facilitate entry of the drug into the ear canal.
• Keep affected ear upward for ≥60 seconds following drug administration If necessary, repeat procedure for the opposite ear.
• Use otic corticosteroids sparingly to prevent the accumulation of excess debris in the ear canal.

CONTRAINDICATIONS:

General: Known hypersensitivity to dexamethasone or to any of the formulations’ components. Infectious tuberculous lesions of the ear, chickenpox, vaccina and herpes simplex, fungal diseases of auricular structures.

Pregnancy:

No adequate studies in pregnant women are available with dexamethasone; neomycin; polymyxin B. In animal studies, ophthalmic administration of corticosteroids, such as dexamethasone, have been shown to be teratogenic in rabbits and mice. In mice, corticosteroids resulted in fetal resorption and an increased incidence of the cleft palate; rabbits receiving corticosteroids experienced fetal resorption and abnormalities involving the head, ears, limbs, and palate. Administer dexamethasone; neomycin; polymyxin B during pregnancy only when the benefits clearly outweigh the potential risk to the fetus. Consider monitoring for signs of hypoadrenalism in infants born to mothers who received substantial doses during pregnancy.

Breastfeeding:

It is not known if ophthalmic administered dexamethasone is detectable in human milk; however, systemically administered corticosteroids do appear in human milk and may suppress infant growth and endogenous corticosteroid production. Topically applied dexamethasone to the ear of the mother is unlikely to cause significant concern to the infant with limited dosage and duration of use. Neomycin and polymyxin B are both poorly absorbed orally, so whatever minor systemic exposure may occur maternally would be unlikely to cause infant harm during nursing. Short term use of usual moderate ocular doses probably poses little risk to the nursing infant.

SPECIAL PRECAUTIONS:

Perforated tympanic membrane or eardrum. Avoid prolonged use.

CAUTION:

Foods, Drugs, Devices, and Cosmetics Act prohibits dispensing without prescription. STORE AT TEMPERATURES NOT EXCEEDING 25C. Do not use one month after opening.

AVAILABILITY:

Plastic squeeze bottle of 5ml

ADDITIONAL INFORMATION:

For additional information regarding SYNTEMAX Otic Solution contact us or for more drug-related information see Drugs.com.