Product Information
Registration Status: ActiveTOBRADEX STERILE OPHTHALMIC SUSPENSION is approved to be sold in Singapore with effective from 1990-05-21. It is marketed by NOVARTIS (SINGAPORE) PTE LTD, with the registration number of SIN04438P.
This product contains Dexamethasone 0.1%, and Tobramycin 0.3% in the form of SOLUTION. It is approved for OPHTHALMIC use.
This product is manufactured by ALCON-COUVREUR NV in SINGAPORE, andALCON SINGAPORE MANUFACTURING PTE. LTD. in BELGIUM.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Description
An anti-inflammatory 9-fluoro-glucocorticoid. [PubChem]
Indication
Injection: for the treatment of endocrine disorders, rheumatic D=disorders, collagen diseases, dermatologic diseases, allergic statesc, ophthalmic diseases, gastrointestinal diseases, respiratory diseases, hematologic disorders, neoplastic diseases, edematous states, cerebral edema.
Ophthalmic ointment and solution: for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.
Ophthalmic solution only: for the treatment of steroid responsive inflammatory conditions of the external auditory meatus
Topic cream: for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses
Oral aerosol: for the treatment of bronchial asthma and related corticosteroid responsive bronchospastic states intractable to adequate trial of conventional therapy
Intranasal aerosol: for the treatment of allergic ot inflammatory nasal conditions, and nasal polyps
Mechanism of Action
Dexamethasone is a glucocorticoid agonist. Unbound dexamethasone crosses cell membranes and binds with high affinity to specific cytoplasmic glucocorticoid receptors. This complex binds to DNA elements (glucocorticoid response elements) which results in a modification of transcription and, hence, protein synthesis in order to achieve inhibition of leukocyte infiltration at the site of inflammation, interference in the function of mediators of inflammatory response, suppression of humoral immune responses, and reduction in edema or scar tissue. The antiinflammatory actions of dexamethasone are thought to involve phospholipase A2 inhibitory proteins, lipocortins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes.
Pharmacokinetics
- Absorption
- 80-90%
- Distribution
- Metabolism
- Hepatic.
- Elimination
Toxicity
Oral, rat LD50: >3 gm/kg. Signs of overdose include retinal toxicity, glaucoma, subcapsular cataract, gastrointestinal bleeding, pancreatitis, aseptic bone necrosis, osteoporosis, myopathies, obesity, edemas, hypertension, proteinuria, diabetes, sleep disturbances, psychiatric syndromes, delayed wound healing, atrophy and fragility of the skin, ecchymosis, and pseudotumor cerebri.
Active Ingredient/Synonyms
1-Dehydro-16alpha-methyl-9alpha-fluorohydrocortisone | 1-Dehydro-16α-methyl-9α-fluorohydrocortisone | 16alpha-Methyl-9alpha-fluoro-1-dehydrocortisol | 16α-Methyl-9α-fluoro-1-dehydrocortisol | 9alpha-Fluoro-16alpha-methylprednisolone | 9α-Fluoro-16α-methylprednisolone | Dexametasona | Dexamethasone | Dexamethasonum | Dexamethasone |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.
Description
An aminoglycoside, broad-spectrum antibiotic produced by Streptomyces tenebrarius. It is effective against gram-negative bacteria, especially the pseudomonas species. It is a 10% component of the antibiotic complex, nebramycin, produced by the same species. [PubChem]
Indication
For the treatment of pseudomonas aeruginosa lung infections. Also being investigated for use in the treatment of sinus infections.
Mechanism of Action
Tobramycin binds irreversibly to one of two aminoglycoside binding sites on the 30 S ribosomal subunit, inhibiting bacterial protein synthesis. Tobramycin may also destabilize bacterial memebrane by binding to 16 S 16 S r-RNA. An active transport mechanism for aminoglycoside uptake is necessary in the bacteria in order to attain a significant intracellular concentration of tobramycin.
Pharmacokinetics
- Absorption
- The bioavailability of tobramycin may vary because of individual differences in nebulizer performance and airway pathology.
- Distribution
- Metabolism
- Elimination
Toxicity
LD50=441mg/kg (s.c. in mice)
Active Ingredient/Synonyms
3'-Deoxykanamycin b | Nebramycin 6 | Nebramycin factir 6 | Nebramycin-Faktor 6 | O-3-Amino-3-deoxy-alpha-D-glucopyranosyl-(1-4)-O-(2,6-diamino-2,3,6-trideoxy-alpha-D-ribohexopyranosyl-(1-4))-2-deoxy-D-streptamine | Tobracin (tn) | Tobramicina | Tobramycin | Tobramycine | Tobramycinum | Tobrex (tn) | Tobramycin |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.