Terra-Cortril

Terra-Cortril is a brand name medication included in the following groups of medications: Corticosteroids acting locally, Corticosteroids for local oral treatment, Antiinflammatory Corticosteroids, Corticosteroids, weak group I, Corticosteroids, weak, other combinations, Corticosteroids/antiinfectives/mydriatics in combination, Glucocorticoids, Tetracycline and derivatives, TETRACYCLINES. For more information about Terra-Cortril see its generics Hydrocortisone, Oxytetracycline

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.

Secondary Infection

The development of secondary 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. 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.

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

LAB-0194-2.0

TERRA-CORTRIL  oxytetracycline hydrochloride and hydrocortisone acetate suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0049-0670 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength oxytetracycline hydrochloride (oxytetracycline) oxytetracycline 5 mg  in 1 mL hydrocortisone acetate (hydrocortisone) hydrocortisone 15 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength mineral oil   aluminum tristearate

Packaging # Item Code Package Description 1 NDC:0049-0670-48 5 mL (5 MILLILITER) in 1 VIAL

Labeler - Roerig

Revised: 04/2006   Roerig