Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
DEXAMETHASONE; TOBRAMYCIN
NOVARTIS (SINGAPORE) PTE LTD
S01CA01
0.10%
OINTMENT
DEXAMETHASONE 0.1%; TOBRAMYCIN 0.3%
OPHTHALMIC
Prescription Only
ALCON-COUVREUR NV
ACTIVE
1990-04-16
KAPVORM 140 x 335 / 140 x 22 mm AANTAL KLEUREN : 1 WS / 10.01.2012 SGP recto-verso Tobradex 5 ml / 3,5 g -DRAFT- 35701-1 BELGIUM V4 PMS ZWART à 100 % 35701-1 TobraDex ® (Tobramycin and Dexamethasone) Sterile Ophthalmic Suspension and Ointment DESCRIPTION : TOBRADEX ® (Tobramycin* and Dexamethasone) Ophthalmic Suspension and Ointment are sterile, multiple dose antibiotic and steroid combinations for topical ophthalmic use. The chemical structures for tobramycin and dexamethasone are presented below : Each ml of TOBRADEX ® Suspension contains : Actives : Tobramycin 0.3 % (3 mg) and Dexamethasone 0.1 % (1 mg). Preservative : Benzalkonium Chloride 0.01 %. Inactives : Tyloxapol, Edetate Disodium, Sodium Chloride, Hydroxyethyl Cellulose, Sodium Sulfate, Sulfuric Acid and /or Sodium Hydroxide (to adjust pH) and Purified Water. Each gram of TOBRADEX ® Ointment contains : Actives : Tobramycin 0.3 % (3 mg) and Dexamethasone 0.1 % (1 mg). Preservative : Chlorobutanol 0.5 %. Inactives : Mineral Oil and White Petrolatum. CLINICAL PHARMACOLOGY: Corticoids 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. Dexametha- sone is a potent corticoid. The antibiotic component in the combination (tobramycin) is included to provide action against susceptible organisms. In vitro studies have demonstrated that tobramycin is active against susceptible strains of the following microorganisms : Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains. Streptococci, including some of the Group A beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae. Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Mo Read the complete document
Tobradex May 2021.SIN Page 1 of 14 1. NAME OF THE MEDICINAL PRODUCT TOBRADEX STERILE OPHTHALMIC SUSPENSION TOBRADEX OPHTHALMIC OINTMENT TOBRADEX ® (Tobramycin ® and Dexamethasone) Ophthalmic Suspension and Ointment are sterile, multiple dose antibiotic and steroid combinations for topical ophthalmic use. 2. QUALITATIVE AND QUANTITAVE COMPOSITION TOBRADEX ® OPHTHALMIC SUSPENSION 1 mL of suspension contains 3 mg of tobramycin and 1 mg of dexamethasone. Preservative: 1 mL of suspension contains 0.1 mg benzalkonium chloride. TOBRADEX ® OPHTHALMIC OINTMENT 1 gram of ointment contains 3 mg of tobramycin and 1 mg of dexamethasone. Preservative: 1 g of ointment contains 5 mg chlorobutanol. For the full list of excipients, see section 6.1. The chemical structures for tobramycin and dexamethasone are presented below: Empirical Formula : C18H37N5O9 Chemical Name : 0-3-Amino-3-deoxy-α-D-glucopyranosyl-(1-.4)-0- (2,6-diamino-2,3,6-trideoxy-α-D-ribo-hexopyra- nosyl-(1-.6)-2-deoxy-L-streptamine Empirical Formula : C22H29FO5 Chemical name: 9-Fluoro-11β,17,21-trihydroxy- 16αmethylpregna- 1,4-diene-3,20- dione Tobradex May 2021.SIN Page 2 of 14 3. PHARMACEUTICAL FORM TOBRADEX OPHTHALMIC SUSPENSION Sterile ophthalmic suspension. White to off-white suspension. TOBRADEX OPHTHALMIC OINTMENT Sterile ophthalmic ointment. White to off-white homogeneous ointment 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TOBRADEX ® contains tobramycin, an antibiotic, and dexamethasone, a corticosteroid. TOBRADEX ® is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular 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 conjunctivitis is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis Read the complete document