TOBRADEX OPHTHALMIC OINTMENT

OINTMENT

**4.2 Posology and method of administration** **TOBRADEX® ophthalmic Suspension** Adolescents and adults, including the elderly 1 or 2 drops instilled into the conjunctival sac(s) every 4 to 6 hours. During the initial 24 to 48 hours, the dosage may be increased to 1 or 2 drops every 2 hours. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely. Pediatric patients The safety and efficacy of TOBRADEX® ophthalmic suspension in children have not been established. Hepatic or renal impairment The safety and efficacy of TOBRADEX® ophthalmic suspension in patients with hepatic or renal impairment have not been established. Method of administration - For ocular use only. - The bottle must be well shaken before use. - After cap is removed, if tamper evident snap collar is loose, it should be removed before using product. - Keep the bottle tightly closed when not in use. - To avoid contamination, the dropper tip should not touch any surface. The tip of the dropper/ tube should also not come into contact with the eye as this may cause injury to the eye. - Either nasolacrimal occlusion or gently closing the eyelid(s) after administration is recommended. This may reduce the systemic absorption of medicinal products administered via ocular route and result in a decrease in systemic adverse reactions. - If more than one topical ophthalmic medicinal products is being used, the medicines must be administered at least 5 minutes apart. Eye ointments should be administered last. **TOBRADEX® ophthalmic ointment** Posology Apply a small amount (approximately 1cm of the ointment), into the conjunctival sac(s) up to 3 or 4 times daily. TOBRADEX® ophthalmic ointment may be used at bedtime in conjunction with TOBRADEX ophthalmic suspension used during the day. Not more than 20 ml or 8 g should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. Pediatric patients The safety and efficacy of TOBRADEX® ophthalmic ointment in children have not been established. Hepatic or renal impairment The safety and efficacy of TOBRADEX® ophthalmic ointment in patients with hepatic or renal impairment have not been established. Method of administration - For ocular use only. - To prevent contamination of the tube tip and ointment, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the tube tip. Keep the tube tightly closed when not in use. - Do not let the tip of the tube touch your eye. - Gently closing the eyelid and nasolacrimal occlusion after instillation is recommended. This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic side effects. - In case of concomitant therapy with other topical ocular medicinal products, an interval of 5 minutes should be allowed between successive applications. Eye ointments should be administered last.