Product Information
Registration Status: ActiveSIN04358P
MAXITROL STERILE OPHTHALMIC SUSPENSION is approved to be sold in Singapore with effective from 1990-02-05. It is marketed by NOVARTIS (SINGAPORE) PTE LTD, with the registration number of SIN04358P.
This product contains Dexamethasone 1mg/ml,Neomycin 3500 iu/ml, and Polymyxin B 6000 iu/ml in the form of SOLUTION. It is approved for OPHTHALMIC use.
This product is manufactured by ALCON-COUVREUR NV 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.
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}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
A component of neomycin that is produced by Streptomyces fradiae. On hydrolysis it yields neamine and neobiosamine B. (From Merck Index, 11th ed)
Indication
For the treatment of bacterial blepharitis, bacterial bonjunctivitis, corneal injuries, corneal ulcers and meibomianitis. For the prophylaxis of ocular infections following foreign body removal
Mechanism of Action
Framycetin binds to specific 30S-subunit proteins and 16S rRNA, four nucleotides of 16S rRNA and a single amino acid of protein S12. This interferes with decoding site in the vicinity of nucleotide 1400 in 16S rRNA of 30S subunit. This region interacts with the wobble base in the anticodon of tRNA. This leads to interference with the initiation complex, misreading of mRNA so incorrect amino acids are inserted into the polypeptide leading to nonfunctional or toxic peptides and the breakup of polysomes into nonfunctional monosomes.
Active Ingredient/Synonyms
Fradiomycin B | Framicetina | Framycetin | Framycétine | Framycetinum | Neomycin B | Framycetin |
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
Polymyxin B sulfate is a mixture of polymyxins B1 and B2, obtained from Bacillus polymyxa strains. They are basic polypeptides of about eight amino acids and have cationic detergent action on cell membranes. Polymyxin B is used for infections with gram-negative organisms, but may be neurotoxic and nephrotoxic. All gram-positive bacteria, fungi, and the gram-negative cocci, N. gonorrhea and N. menigitidis, are resistant. It is appropriate for treatment of infections of the urinary tract, meninges, and blood stream, caused by susceptible strains of Pseudomonas aeruginosa.
Indication
For treatment of infections of the urinary tract, meninges, and blood stream, caused by susceptible strains of Pseudomonas aeruginosa.
Mechanism of Action
Polymyxin B sulfate has a bactericidal action against almost all gram-negative bacilli except the Proteus group. Polymyxin B sulfate interacts with the lipopolysaccharide of the cytoplasmic outer membrane of Gram-negative bacteria, altering membrane permeability and causing cell death. It does not need to enter the cell.
Pharmacokinetics
- Absorption
- Not absorbed from the normal alimentary tract.
- Distribution
- Metabolism
- Elimination
Toxicity
Overdose can cause stomach pains, vomiting, and diarrhea.
Active Ingredient/Synonyms
Polimixina B | Polymyxin B | Polymyxin B Sulphate | Polymyxin-B-Sulfat | Polymyxine B | Polymyxine B (sulfate de) | Polymyxini B sulfas | Polymyxinum B | Polymyxin B Sulfate |
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.