Keep out of reach of children.
Read the directions carefully before use.
For prescription only.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
Tobramycin ........................ 15 mg
Excipients q.s ……………….. 1 tablet
Eye drops.
Product description: Colorless to light yellow aqueous solution.
Box of 1 vial x 5 ml.
Pharmacotherapeutic group: ophthalmic antibiotics, ATC code: S01AA12.
Tobramycin is an antibiotic belonging to the aminoglycoside family and has a bactericidal effect by interfering with protein synthesis in bacterial cells. Tobramycin belongs to the group of antibiotics which cause a post-antibiotic effect which maintains the suppression of bacterial growth after cessation of treatment and the absence of blood antibiotic concentration.
Cross resistance with other aminoglycosides (neomycin, gentamicin) is possible.
Spectrum of anti-bacterial activity
Critical concentrations separate susceptible strains from intermediate susceptibility strains and the latter from resistant strains:
S ≤ 4 mg/l and R> 8 mg/l.
The prevalence of acquired resistance may vary with geography and time for some species. It is therefore useful to have information on the prevalence of local resistance, especially for the treatment of severe infections. These data can only provide guidance on the probabilities of the susceptibility of a bacterial strain to this antibiotic.
When the variability of the prevalence of resistance in Europe is known for a bacterial species, it is indicated in the table below:
Categories
Frequency of resistance acquired in Europe (> 10%) (extreme values)
SUSCEPTIBLE SPECIES
Gram-positive aerobes
Corynebacterium
Listeria monocytogenes
Methicillin-susceptible Staphylococcus aureus
0 - 12%
Coagulase-negative methicillin-susceptible staphylococcus
0 - 20%
Gram-negative aerobes
Acinetobacter
Acinetobacter baumanii
0 - 40%
Branhamella catarrhalis
Campylobacter
Citrobacter freundii
0 - 16%
Citrobacter koseri
Enterobacter aerogenes
0 - 65%
Enterobacter cloacae
0 - 14%
Escherichia coli
Haemophilus influenzae
Klebsiella
0 - 11%
Morganella morganii
Proteus mirabilis
0 - 12%
Proteus vulgaris
Pseudomonas aeruginosa
0 - 36%
Salmonella
Serratia
0 - 66%
Shigella
Yersinia
MODERATE SUSCEPTIBLE SPECIES
(in vitro of intermediate susceptibility)
Gram-negative aerobes
Pasteurella
Categories
SPECIES RESISTANT
Gram-positive aerobes
Enterococci
Nocardia asteroids
Staphylococcus meti-R *
Streptococcus
Gram-negative aerobes
Alcaligenes denitrificans
Burkholderia cepacia
Flavobacterium sp.
Providencia stuartii
Stenotrophomonas maltophilia
Anaerobic
Obligately anaerobic bacteria
Other
Chlamydia
Mycoplasmas
Rickettsia
* The frequency of resistance to methicillin can reach 50% of all staphylococci in some European countries and is mostly found in hospitals.
Note: This spectrum corresponds to that of the systemic forms of tobramycin. With local pharmaceutical presentations, the concentrations obtained in situ are much higher than the plasma concentrations. Some uncertainties remain on the kinetics of the in situ concentrations, on the local physicochemical conditions which can modify the activity of the antibiotic and on the stability of the product in situ.
Pediatric population
Over 600 pediatric patients have received tobramycin as in the form of eye drops or eye ointments in 10 clinical studies for the treatment of bacterial conjunctivitis, blepharitis, or blepharoconjunctivitis. These patients were aged 1 to 18 years. Overall, the safety profile in pediatric patients was comparable to that in adult patients. For children under 1 year of age, no dosage recommendation can be made due to the lack of data.
Tobramycin passes extremely weakly into the aqueous humor and is therefore poorly absorbed in the systemic circulation.
Tobramycin eye drops has no or negligible influence on the ability to drive and use machines.
However, transient blurred vision or other visual disturbances may occur and affect the ability to drive or use machines. If blurred vision occurs during instilling, the patient should wait until their vision returns to normal before driving or using machinery.
There are no data or there are limited data on the use of tobramycin in pregnant women. However, cases of cochleovestibular diseases have been reported in newborns of mothers systemically treated with other aminoglycosides. Tobramycin crosses the placenta following intravenous administration in pregnant women. Studies in animals have shown reproductive toxicity. Tobramycin eye drops is not recommended during pregnancy.
Breast-feeding
Tobramycin is excreted in human milk following systemic administration. The passage of aminoglycosides into breast milk after ophthalmic administration is poorly understood but probably low. The absorption of these substances from the digestive tract of the newborn is considered negligible. Their presence in the intestine of the newborn can destroy the digestive flora and lead to the occurrence of candidiasis or diarrhea. In addition, the otonephrotoxicity of aminoglycosides constitutes an additional potential risk. Consequently, if this medicine is prescribed, breast-feeding is not recommended.
Fertility
No studies have been performed to assess the effect of tobramycin eye drops on human fertility.
No interaction studies have been performed.
Although tobramycin passes very weakly into the systemic circulation after instillation in the eye, the interactions reported for tobramycin used systemically should be taken into account.
The ototoxic and/or nephrotoxic potential of tobramycin may be increased when used concomitantly with other aminoglycosides used systemically, polymyxins, cefalotin, loop diuretics, amphotericin B and organoplatins.
Summary of safety profile
In clinical trials involving 1016 patients, the most common adverse reactions were ocular hyperemia and ocular discomfort occurring in approximately 1.4% and 1.2% of patients, respectively.
Summary table of adverse reactions
The following side effects have been reported with tobramycin eye drops and are classified according to the following convention: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1,000 to <1/100), rare (≥ 1/10,000 to <1/1,000) and very rare (<1/10,000), or frequency not known (could not be assessed on the database).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. The side effects are based on clinical trials and have been derived from post-marketing.
Immune system disorders
Uncommon: hypersensitivity.
Not known: anaphylactic reaction.
Nervous system disorders
Uncommon: headache.
Eye disorders
Common: eye discomfort, ocular hyperemia.
Uncommon: keratitis, corneal abrasion, visual impairment, blurred vision, eyelid erythema, conjunctival edema, eyelid edema, eye pain, dry eye, eye discharge, eye itching, increased lacrimation.
Not known: eye allergy, eye irritation, eyelid pruritus.
Skin and subcutaneous tissue disorders
Uncommon: urticaria, dermatitis, madarosis, pruritus, dry skin.
Not known: rash.
Description of selected adverse reactions
Serious adverse reactions including neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients receiving systemic tobramycin therapy.
Sensitivity to topically administered aminoglycosides may occur in some patients. The severity of hypersensitivity reactions may vary from localized to generalized reactions such as erythema, itching, urticaria, rash, anaphylaxis, anaphylactoid reactions.
Please inform your doctor of all undesirable effects upon drug administration.
No toxic effects are to be expected with an ocular overdose of this product, or in the event of accidental ingestion of the contents of the bottle.
An ocular overdose of tobramycin eye drops can be rinsed off with lukewarm water.
Store in dry places, not exceeding 30°C, protect from light.
Sensitivity to topically administered aminoglycosides may occur in some patients. The severity of hypersensitivity reactions may vary from localized to generalized reactions such as erythema, itching, urticaria, skin rash, anaphylaxis, anaphylactoid reactions. If hypersensitivity occurs while using this medicine, treatment should be discontinued.
Cross hypersensitivity to other aminoglycosides may occur, and the possibility that patients who have become sensitive to ocular tobramycin may also be sensitive to other topical and/or systemic aminoglycosides.
Serious adverse reactions, including neurotoxicity, ototoxicity and nephrotoxicity have been reported in patients treated with systemic tobramycin. Caution should be taken when tobramycin is used concomitantly with systemic aminoglycosides.
Caution should be exercised when prescribing tobramycin eye drops to patients with known or suspected neuromuscular disorders, such as myasthenia gravis or Parkinson's disease. Aminoglycosides can worsen muscle weakness due to their potential effects on neuromuscular function.
As with other antibiotic preparations, prolonged use of tobramycin eye drops can result in overgrowth of resistant microorganisms, including fungi. If superinfection occurs, appropriate treatment should be initiated.
In the absence of symptomatic improvement or in the event of prolonged treatment, regular medical supervision including bacteriological checks and bacterial susceptibility study that helps to detect drug resistance and possibly to adapt the treatment.
Contact lens wear is not recommended during the treatment of an ocular infection.
The eye drops should not be used by peri or intraocular injection.
Excipients
This medicine contains 30 mg propylene glycol in each 5 ml vial.
This medicine contains 0.5 mg benzalkonium chloride in each 5 ml vial. Benzalkonium chloride can be absorbed and is known to discolor contact lenses. Contact lenses should be removed before application and put them back at least 15 minutes afterward. Benzalkonium chloride may also cause eye irritation, especially if the patient has dry eye syndrome or corneal disorders. If there is any abnormal sensation, stinging, or pain in the eye after using this medicine, a doctor should be consulted.
Local antibacterial treatment of conjunctivitis, keratitis, and corneal ulcers due to tobramycin susceptible bacteria in adults and children over 1 year of age.
Consideration should be given to official guidance regarding the appropriate use of antibacterial agents.
Hypersensitivity to the active substance or to any of the excipients of the medicinal product.
DOSAGE
Adults
Instill 1 drop 3 to 8 times a day in the lower conjunctival cul-de-sac of the eye.
In more severe infections, instill 1 drop in each eye every hour until improvement, then gradually reduce the dose.
Duration of treatment: 5 to 15 days.
Pediatric population
Tobramycin eye drops can be administered to children aged one year and older at the same dose as that recommended for adults. The safety and efficacy of this medicine in children younger than one year of age have not been established and no data are available.
METHOD OF ADMINISTRATION
For ocular instillation.
After opening the cap, if the safety device on the vial’s neck has broken, remove it before using this product.
The systemic passage of the medicine can be reduced by nasolacrimal occlusion or by closing the eyelids for 2 minutes. This method can help reduce systemic side effects and increase local efficacy.
If more than one eye drop are used, the instillations should be spaced at least 5 minutes apart. Eye ointments should be given last.
Or as directed by the physician.
Register an account - receive thousands of information
You will be one of the first to receive information, news, recruitment news... from Hau Giang Pharmaceutical as soon as possible. Register today to enjoy thousands of incentives from Hau Giang Pharmaceutical.
