Terra-Cortril suspension combines the antibiotic, oxytetracycline HCl (C22H24N2O9•HCl) and the adrenocorticoid, hydrocortisone acetate (C23H32O6). Each ml of Terra-Cortril contains Terramycin (oxytetracycline HCl) equivalent to 5 mg of oxytetracycline, and 15 mg of Cortril (hydrocortisone acetate) incorporated in mineral oil with aluminum tristearate.

For Ophthalmic Use Only.

Corticosteroids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticoids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant in a particular case.

The anti-infective component in the combination is included to provide action against specific organisms susceptible to it.

Terramycin is considered active against the following microorganisms:

• Rickettsiae (Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers),
• Mycoplasma pneumoniae (PPLO, Eaton Agent),
• Agents of psittacosis and ornithosis,
• Agents of lymphogranuloma venereum and granuloma inguinale,
• The spirochetal agent of relapsing fever (Borrelia recurrentis).

The following gram-negative microorganisms:

• Haemophilus ducreyi (chancroid),
• Pasteurella pestis and Pasteurella tularensis,
• Bartonella bacilliformis,
• Bacteroides species,
• Vibrio comma and Vibrio fetus,
• Brucella species (in conjunction with streptomycin).

Because many strains of the following groups of microorganisms have been shown to be resistant to tetracyclines, culture and susceptibility testing are recommended.

Oxytetracycline is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug:

• Escherichia coli,
• Enterobacter aerogenes (formerly Aerobacter aerogenes),
• Shigella species,
• Mima species and Herellea species,
• Haemophilus influenzae (respiratory infections),
• Klebsiella species (respiratory and urinary infections).

Oxytetracycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:

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

Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva. Mycobacterial infection of the eye. Fungal diseases of ocular structures. Hypersensitivity to a component of the medication. (Hypersensitivity to the antibiotic component occurs at a higher rate than for other components.)

The use of these combinations is always contraindicated after uncomplicated removal of a corneal foreign body.

Prolonged use may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation. Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection. If these products are used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients.

Employment of steroid medication in the treatment of herpes simplex requires great caution.

The initial prescription and renewal of the medication order beyond 20 milliliters should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.

The possibility of persistent fungal infections of the cornea should be considered after prolonged steroid dosing.

Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination. Exact incidence figures are not available since no denominator of treated patients is available.

Reactions occurring most often from the presence of the anti-infective ingredient are allergic sensitizations. The reactions due to the steroid component in decreasing order of frequency are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.

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.

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

LAB-0194-2.0