INFORMATION FOR HEALTH PROFESSIONALS
Home | Consumers | Health Professionals | Regulatory | Other | Hot Topics | Search
Home | Consumers | Health Professionals | Regulatory | Other | Hot Topics | Search
ACETOPT EYE DROPS is a slightly clear to slightly hazy liquid which froths on shaking. Odourless. Each ml contains 10mg sulphacetamide sodium (10% w/v), as well as sodium thiosulfate, hypromellose (4000), water and two preservatives: sodium methyl hydroxybenzoate and sodium propyl hydroxybenzoate.
Sulphonamides are usually bacteriostatic; however, in extremely high concentrations, they may be bactericidal. Sulphonamides interfere with utilization of para-aminobenzoic or para-aminobenzoic glutamic acids by bacteria, thus inhibiting the biosynthesis of folic acid which is essential for the growth of susceptible micro-organisms. Only micro-organisms that synthesize their own folic acid are inhibited by sulphonamides; animal cells and bacteria that are capable of utilizing folic acid precursors or preformed folic acid are not affected by these agents. The antibacterial activity of the sulphonamides is decreased in the presence of blood or purulent exudates which contain para-aminobenzoic acid.
Sulphonamides have a broad antimicrobial spectrum in vitro against gram-positive and gram-negative micro-organisms. Topically applied sulphonamides are considered active against susceptible strains of the following common bacterial eye pathogens: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species and Enterobacter species.
Topically applied sulphonamides do not provide adequate coverage against Neisseria species, Serratia marcescens and Pseudomonas aeruginosa. A significant percentage of staphylococcal isolates are completely resistant to sulphur agents.
Not available.
For the treatment of acute and chronic bacterial conjunctivitis, corneal ulcer, and other superficial ocular infections from susceptible micro-organisms, and as an adjunct to systemic sulphonamide therapy of trachoma.
Instil 1 or 2 drops into the lower conjunctival sac of the affected eye(s) every two to three hours during the day, less often at night.
Instil two drops in the affected eyes every two hours: concomitant systemic sulphonamide therapy is indicated.
The usual duration of treatment is seven to ten days.
The systemic absorption of ACETOPT EYE DROPS can be minimised by applying gentle pressure on the tear duct for approximately one minute immediately after application.
Hypersensitivity to sulphonamide or any of the excipients present in the preparation. Contact lenses should not be worn in the presence of ocular infection or throughout treatment with ACETOPT EYE DROPS.
The solutions are incompatible with silver preparations. They are also incompatible with other eye drops due to the anionic sulphacetamide in Acetopt which can cause precipitation if used with other eye drops, since most eye drops are cationic. Non-susceptible micro-organisms, including fungi, may proliferate with use of this preparation. Sulphonamides are inactivated by the aminobenzoic acid present in purulent exudates.
The patient should be re-examined if significant improvement of symptoms has not been achieved after two to three days of treatment.
There are no published studies in animals or in humans that evaluate the possibility of these effects with ocularly administered sulfacetamide. Rats appear to be especially susceptible to the goitrogenic effects of sulphonamides and long-term oral administration of sulphonamides has resulted in thyroid malignancies in these animals.
Sulphonamides cross the placenta and may cause jaundice and haemolytic anaemia in the newborn.
Systemically administered sulphonamides are capable of producing kernicterus in infants of lactating mothers. Because of the potential for the development of kernicterus in neonates, a decision should be made whether to discontinue nursing or discontinue the agent, taking into account the benefit of the agent to the mother.
Safety and effectiveness in children below the age of two months have not been established.
The most common adverse reactions are local conjunctival irritation, burning and stinging. While the irritation may be transient, occasionally use of the medication has to be discontinued.
Although sensitivity reactions to sulphacetamide sodium are rare, an isolated incident of Stevens-Johnson syndrome was reported in a patient who has experienced a previous blistering agent reaction to an orally administered sulphonamide, and a single instance of local hypersensitivity was reported which progressed to a fatal syndrome resembling systemic lupus erythematosus.
Not available.
Accidental ingestion of the agent is unlikely to cause any toxicity due to low content of the medicine. It contains low quantities of preservatives (sodium methyl hydroxybenzoate: 0.13mg/ml and sodium propyl hydroxybenzoate 0.25mg/ml). If the eye drops are accidentally ingested by infants or young children, Poisons Information Centre should be contacted. The medication should be kept out of reach of children.
If irritation, pain, swelling, lacrimation or photophobia occur after undesired eye contact, the exposed eye(s) should be irrigated with copious amounts of room temperature water for at least 15 minutes. If symptoms persist after 15 minutes of irrigation, an ophthalmological examination should be considered.
Store below 25°C. Keep the container tightly closed. Protect from excessive light and heat. Discard one month after opening. Do not use if the solution is darkened or discoloured.
Restricted Medicine.
15ml plastic ophthalmic dropper bottle with tamper-evident screw cap.
The molecular formula is C8H9N2NaO3S,H2O and is called N-sulfanilylacetamide monosodium salt monohydrate. Molecular weight is 254.2.
Sulfacetamide sodium is a white or yellowish white, crystalline powder; odourless. 1.19g of sulfacetamide sodium BP is approximately equivalent to 1g of sulfacetamide.
Sulfacetamide sodium is freely soluble in water (1 in 2.5); slightly soluble in ethanol (96%); practically insoluble in chloroform and ether. A 5% solution in water has a pH of 8.0 to 9.5. Store in airtight containers. Protect from light.
When solutions are heated, hydrolysis occurs forming sulphanilamide which may be deposited as crystals, especially from concentrated solutions and under cold storage conditions.
Pharmacy Retailing (NZ) Limited
Trading as Healthcare Logistics
58 Richard Pearce Drive
Airport Oaks
Auckland
Ph (09) 918 5100
Fax (09) 901 5101
3 August 2006