Prescription Drugs

CLINICAL PHARMACOLOGY Oxytetracycline is a product of the metabolism of Streptomyces rimosus and is one of the family of tetracycline antibiotics. It is primarily bacteriostatic and is thought to exert its antimicrobial effect by the inhibition of protein synthesis. Oxytetracycline is effective against a wide range of gram-negative and gram-positive organisms. Polymyxin B sulphate is one of a group of related antibiotics derived from Bacillus polymyxa. It is rapidly bactericidal but exclusively against gram-negative organisms . It is particularly effective against Pseudomonas aeruginosa and Haemophilus aegyptius (Koch-Weeks bacillus) frequently found in local infections of the eye and ear. Hydrocortisone acetate is a corticosteroid with anti-inflammatory, anti-pruritic and vasoconstrictive actions.

TERRA-CORTRIL ® (oxytetracycline and hydrocortisone) 10 mg/mL Oxytetracycline 5 mg/mL Hydrocortisone Acetate 10000 u/mL Polymyxin B Sulphate TERRA-CORTRIL (oxytetracycline and hydrocortisone) EYE/EAR SUSPENSION 5 mg/g Oxytetracycline 10 mg/g Hydrocortisone Acetate 10000 u/g Polymyxin B Sulphate TERRA-CORTRIL (oxytetracycline and hydrocortisone) EYE/EAR OINTMENT DESCRIPTION TERRA-CORTRIL (oxytetracycline and hydrocortisone) Eye/Ear Suspension. TERRA-CORTRIL (oxytetracycline and hydrocortisone) Eye/Ear Ointment. COMPOSITION Terra-Cortril (oxytetracycline and hydrocortisone) Eye/Ear Suspension contains 10 mg oxytetracycline, 5 mg hydrocortisone acetate and 10000 units polymyxin B sulphate per mL of sterile oily suspension. It contains the following inert ingredients: Aluminium tristearate and Mineral oil Terra-Cortril (oxytetracycline and hydrocortisone) Eye/Ear Ointment contains 5 mg oxytetracycline, 10 mg hydrocortisone acetate and 10000 units polymyxin B sulphate per gram of sterile petroleum base. PHARMACOLOGICAL CLASSIFICATION A.15.3 Ophthalmic preparations: Combination antibiotics and corticosteroids.

INDICATIONS Terra-Cortril (oxytetracycline and hydrocortisone) Eye/Ear applications are indicated in the topical treatment of corticosteroid-responsive inflammatory conditions of the eye and ear in which infection due to organisms susceptible to oxytetracycline and/or polymyxin B sulphate exist. DOSAGE AND ADMINISTRATION DOSAGE AND DIRECTIONS FOR USE Terra-Cortril (oxytetracycline and hydrocortisone) Eye/Ear Suspension: Eye: Instil one to two drops into the affected eye three times daily. Ear: Instil two to four drops into the affected ear three times daily. Terra-Cortril (oxytetracycline and hydrocortisone) Eye/Ear Ointment: Eye: Instil a small quantity (approximately 1 cm) of the ointment into the affected eye two or three times daily. Ear: Instil a small quantity (approximately 1 cm) into the affected ear three or four times daily. The patient should be instructed to avoid contamination of the tip of the tube when instilling the suspension or the ointment. The suspension should be shaken well before use. The dropper should be replaced in the bottle immediately after use. HOW SUPPLIED IDENTIFICATION Terra-Cortril (oxytetracycline and hydrocortisone) Eye/Ear Suspension is a light yellow, homogenous, viscous suspension. Terra-Cortril (oxytetracycline and hydrocortisone) Eye/Ear Ointment is a light yellow, homogenous ointment. PRESENTATION Terra-Cortril (oxytetracycline and hydrocortisone) Eye/Ear Suspension: Aluminium tubes each containing 5 mL (4,4g). Terra-Cortril (oxytetracycline and hydrocortisone) Eye/Ear Ointment: Aluminium tubes each containing 5g. STORAGE INSTRUCTIONS Store below 30°C. Keep out of reach of children. REGISTRATION NUMBERS Terra-Cortril (oxytetracycline and hydrocortisone) Eye/Ear Suspension: H1178 (Act 101/1965). Terra-Cortril (oxytetracycline and hydrocortisone) Eye/Ear Ointment: H1179 (Act 101/1965). Pfizer Laboratories (Pty) Ltd, 102 Rivonia Road, SANDTON, 2196 30 September 1986 Updated on this site: April 2002

PATIENT INFORMATION No information available. Please refer to the WARNINGS and PRECAUTIONS sections.

SIDE EFFECTS 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. DRUG INTERACTIONS No information 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.