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Terra-Cortril (Oxytetracycline Hydrochloride / Hydrocortisone Acetate Ophthalmic) - Indications and Dosage

 
 



INDICATIONS AND USAGE

For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists.

Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical radiation, thermal burns, or penetration of foreign bodies.

The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.

The particular anti-infective drug in this product is active against the following common bacterial eye pathogens:

  • Staphylococcus aureus
  • Streptococci, including Streptococcus pneumoniae
  • Escherichia coli
  • Neisseria species

The product does not provide adequate coverage against:

  • Haemophilus influenzae
  • Klebsiella/Enterobacter species
  • Pseudomonas aeruginosa
  • Serratia marcescens

DOSAGE AND ADMINISTRATION

Instill 1 or 2 drops of Terra-Cortril Ophthalmic Suspension into the affected eye three times daily.

Not more than 20 milliliters should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in "Precautions" above.

HOW SUPPLIED

Terra-Cortril Ophthalmic Suspension (NDC 0049-0670-48) is supplied in 5 ml vials with separate sterile dropper.

LAB-0194-2.0

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