Description

SYNTEMAX Sterile Eye Drops are ophthalmic eye drops for inflammatory and antibacterial combination. For the treatment of infectious ocular inflammations produced by organisms sensitive to Neomycin Base and Polymyxin B Sulfate.

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:

One to two drops topically in the conjunctival sac 4-6 times daily. Or as prescribed by a physician

• Instruct patient on proper instillation of eye solution and suspension.
• Wash hands before and after use.
• Do not touch the tip of the dropper to the eye, fingertips, or other surfaces to prevent contamination.
• Shake the suspension well prior to each use.
• Tilt the head back slightly and pull the lower eyelid down with the index finger to form a pouch. Squeeze the prescribed number of drops into the
• pouch. Close eyes to spread drops. To avoid excessive systemic absorption, apply finger pressure on the lacrimal sac for 1—2 minutes following application to the eye.
• To avoid contamination or the spread of infection, do not use dropper for more than one person.
• NOTE: Contact Lenses should not be worn during therapy

CONTRAINDICATIONS:

General: Known hypersensitivity to dexamethasone or to any of the formulations’ components. Tuberculous, fungal and most viral lesions of the eye: vaccina, varicella, acute purulent conjunctivitis, and acute purulent blepharitis; hypersensitivity to any of its components.

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 eye in 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 for milder eye conditions probably poses little risk to the nursing infant.

SPECIAL PRECAUTIONS:

In those diseases causing thinning of the cornea, perforation occurs with the use of topical steroids. Prolonged use may result in overgrowth of non-susceptible organisms. If sensitivity occurs, discontinue 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 Sterile Eye Drops contact us or for more drug-related information see Drugs.com and Prescriber’s Digital Reference.