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Terra-Cortril

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Terra-Cortril

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

WARNINGS

Corneal ulceration may be aggravated by the presence of the steroid. It is important that corneal ulcers are correctly diagnosed before treatment with Terra-Cortril (oxytetracycline and hydrocortisone) is initiated.

Prolonged use of ophthalmic cortiocosteroids may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation.

A steroid-glaucoma may be induced after a week or more of treatment in patients predisposed to chronic simple glaucoma. Furthermore, topical corticosteroid therapy frequently induces intraocular hypertension in normal eyes and increases pressure in eyes with initially elevated pressure. Intraocular pressure should be monitored frequently during therapy. In those diseases causing thinning of the cornea, perforation has been shown to have occurred with the use of topical steroids.

In acute purulent conditions, steroids may mask infection or enhance existing infection.

Local application of corticosteroids to the eyes of patients with bacterial, viral and fungal conjunctivitis may mask evidence of progression of infection until sight is lost.

Corticosteroids may cause progression of dendritic keratitis (herpes simplex infection) resulting in irreversible clouding of the cornea.

Prolonged use may supress the host response and thus increase the hazard of secondary ocular infections.

As with other antibiotic preparations, Terra-Cortril (oxytetracycline and hydrocortisone) may result in overgrowth of resistant organisms, particularly Candida and staphylococci.

Constant observation of the patient is essential.

If new infections of the cornea due to non-susceptible bacteria or fungi appear during therapy, appropriate measures should be taken.

If a favourable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

If irritation develops the product should be discontinued and appropriate therapy instituted.

If these products are used for 10 days or longer, intraocular pressure should be routinely monitored.

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

The possibility of persistent fungal infections of the cornea should be considered after prolonged steroid dosing.
Supplemental therapy with oral oxytetracycline is advisable in the treatment of severe infections or those which may become systemic.

PREGNANCY AND LACTATION

†?The safety in pregnancy and lactation has not been established†

USE IN CHILDREN

Systemic administration of tetracyclines during tooth development (last half of pregnancy, infancy, and childhood to the age of 8 years) may cause permanent discoloration of the teeth as well as retardation in the development of the skeleton. Enamel hypoplasia has also been reported. Although these effects are unlikely following topical application of tetracyclines because of the low doses used, the possibility that these effects could occur should be considered.

PRECAUTIONS

Allergic reactions due to individual hypersensitivity including contact dermatitis may occur but are rare.

Reactions occurring most often from the presence of the oxytetracycline are allergic sensitizations.

Increased Lacrimation, a transient stinging or burning sensation, and a foreign body sensation have been reported occasionally with opthalmic tetracycline products.

The reactions due to the steroid component in decreasing order of frequency are: elevation of intraocular pressure with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing.

Should signs of local irritation occur, discontinue treatment immediately.

Elevation of intraocular pressure - see †?Warnings†.

Secondary infection: The development of secondary bacterial or fungal infection has occurred after use of combinations containing steroids and antimicrobials.

Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroid. With long-term applications of steroids, the cornea is particularly prone to develop fungal infections. The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used.

Secondary bacterial ocular infection following suppression of host responses also occurs.

The use of Terra-Cortril (oxytetracycline and hydrocortisone) Eye/Ear Suspension with Polymixin B and Terra-Cortril (oxytetracycline and hydrocortisone) Eye/Ear ointment with Polymixin B should be discontinued if such reactions occur.

Last reviewed on RxList: 2/15/2005
This monograph has been modified to include the generic and brand name in many instances.

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