Tobradex - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Undesirable Effects Shelf life and Storage Composition and pharmaceutical form

Active ingredients: Tobramycin, Dexamethasone

TobraDex 0.3% + 0.1% EYE DROPS, SUSPENSION
TobraDex 0.3% + 0.1% OPHTHALMIC OIL

Why is Tobradex used? What is it for?

PHARMACOTHERAPEUTIC CATEGORY

Corticosteroids and antimicrobials in combination.

INDICATIONS

TobraDex eye drops and ophthalmic ointment are indicated for the treatment of eye inflammation when a corticosteroid is needed and when there is an eye infection or risk of eye infections in adults and children from two years of age onwards.

Contraindications When Tobradex should not be used

TobraDex is contraindicated in the following cases:

a) Do not use TobraDex if you are allergic (hypersensitive) to tobramycin, dexamethasone or any of the other ingredients of this medicine (listed in the "Composition" section)

b) Herpes Simplex Keratitis

c) Smallpox vaccine, chicken pox and other viral infections of the cornea or conjunctiva

d) Mycosis of the eye

e) Mycobacterial eye infections (tuberculosis of the eye)

f) Intracular hypertension

g) Acute purulent ophthalmias, purulent conjunctivitis and purulent and herpetic blepharitis which may be masked or aggravated by corticosteroids

h) Sty.

Precautions for use What you need to know before taking Tobradex

Before using TobraDex consult your doctor.

  • Sensitization to topically administered aminoglycoside antibiotics may occur in some patients. If hypersensitivity develops during use of this medicinal product, treatment should be discontinued.
  • Cross-hypersensitivity to other aminoglycosides may occur, therefore the possibility that patients sensitized to topically administered tobramycin may also be sensitive to other topically and / or systemically administered aminoglycosides should be considered.
  • Serious adverse reactions such as neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients treated with systemic aminoglycoside therapy. Caution is advised when TobraDex is administered concomitantly with systemic aminoglycoside therapy.
  • Prolonged use of topical ophthalmic corticosteroids could cause ocular hypertension and / or glaucoma with optic nerve damage, decreased visual acuity and visual field defects, and posterior sub-capsular cataract formation. In patients on prolonged ophthalmic corticosteroid therapy, intraocular pressure should be monitored regularly and frequently. This is particularly important in pediatric patients treated with dexamethasone-containing products, as the risk of corticosteroid-induced ocular hypertension may be greater in children under the age of six and may occur earlier than when steroid response occurs in adults. The frequency and duration of treatment should be carefully evaluated, and intraocular pressure (IOP) should be monitored from the start of treatment, considering that the risk of a corticosteroid-induced increase in IOP is greater and occurs earlier in pediatric patients. The risk of corticosteroid-induced elevation of intraocular pressure and / or cataract formation is increased in predisposed patients (eg diabetic patients).
  • Corticosteroids can reduce resistance to bacterial, viral or fungal infections and promote their development, and can mask the clinical signs of infection.
  • In patients with persistent corneal ulcer mycosis should be suspected. If mycosis occurs, corticosteroid therapy should be discontinued.
  • Prolonged use of antibiotics such as tobramycin can induce abnormal growth of non-susceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be instituted.
  • In diseases that cause thinning of the cornea or sclera, perforation may occur with the use of topical corticosteroids.
  • Topical ophthalmic corticosteroids can slow corneal wound healing. Topical NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical corticosteroids can potentially increase wound healing problems (see "Interactions" section).
  • It is recommended not to wear contact lenses when treating an "inflammation or" eye infection.
  • Avoid contact of TobraDex eye drops with soft contact lenses. If patients are allowed to wear contact lenses, they should be instructed to remove them before applying TobraDex eye drops and to wait at least 15 minutes after instillation of the dose before reinserting them.

To be used under direct medical supervision. For ophthalmic use only.

Interactions Which drugs or foods can change the effect of Tobradex

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. Tell your doctor especially if you are taking topical NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Concomitant use of topical NSAIDs and topical corticosteroids can potentially increase corneal wound healing problems.

If you are using other eye drops or ophthalmic ointments, allow at least 5 minutes between instillation of each medication. Ophthalmic ointment should be used last.

Incompatibility

The tyloxapol component, contained in the eye drops, is incompatible with tetracycline.

Warnings It is important to know that:

Pregnancy, breastfeeding and fertility

Ask your doctor for advice before taking any medicine. If you are pregnant or conceiving possible, or if you are breastfeeding, ask your doctor for advice before using this drug. Pregnancy Data from topical ocular use of tobramycin or dexamethasone in pregnant women do not exist or are limited in number. Studies in animals have shown reproductive toxicity following systemic administration of corticosteroids and tobramycin. Tobradex is not recommended during treatment. pregnancy.

Feeding time

It is unknown whether tobramycin or topical ophthalmic dexamethasone are excreted in human milk. Corticosteroids and tobramycin are excreted in breast milk after systemic administration. A risk to infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue TobraDex therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Fertility

No studies have been performed to evaluate the effect on human fertility of topical ocular administration of TobraDex eye drops and TobraDex ophthalmic ointment.

Driving and using machines

TobraDex does not affect or transiently affect the ability to drive and use machines. However, transient blurred vision or other visual disturbances may affect the ability to drive and use machines. If blurred vision occurs after instillation, the patient should wait for the vision to clear before driving and using machinery.

Important information regarding an excipient contained in TobraDex 0.3% + 0.1% eye drops, suspension

TobraDex eye drops contain benzalkonium chloride, which can cause eye irritation and is known to discolour soft contact lenses.

The use of contact lenses (soft or hard) is not recommended when treating an eye infection. If patients still wear contact lenses, they should remove them before applying TobraDex eye drops and wait at least 15 minutes after instillation of the dose before reinserting them.

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Dosage and method of use How to use Tobradex: Dosage

For ophthalmic use only.

Always use this medicine as directed by your doctor or pharmacist.

Eye drops, suspension: Instill 1 or 2 drops 4-5 times a day according to medical prescription. If a drop misses your eye, try again. Shake before use.

Ophthalmic ointment: Apply a small amount (about 1cm of ophthalmic ointment) into the conjunctival sac 3-4 times a day as prescribed. Ophthalmic ointment can be used instead of eye drops in the evening before bedtime.

Pediatric population

TobraDexcollirio and TobraDex ointment can be used in children from two years of age onwards at the same doses as for adults. Safety and efficacy in children less than two years of age have not been established and no data are available.

Overdose What to do if you have taken too much Tobradex

OVERDOSE

Taking into account the route of administration, topical ocular, cases of overdose are unlikely to occur. However, should this happen, wash the eye thoroughly with running water.

Do not use the medicine again until it is time for the next administration.

WHAT TO DO IF YOU HAVE FORGOTTEN TO TAKE ONE OR MORE DOSES

If you forget to use TobraDex eye drops or TobraDex ointment, continue with the next dose as scheduled. However, if it is almost time for the next dose, skip the missed dose and return to the regular dosing schedule.

Do not use a double dose to make up for a forgotten dose.

IF YOU ARE IN ANY DOUBT ABOUT THE USE OF THIS MEDICINAL PRODUCT, CONTACT YOUR DOCTOR OR PHARMACIST

Side Effects What are the side effects of Tobradex

Like all medicines, TobraDex eye drops and eye ointment can cause side effects, although not everybody gets them.

The following adverse reactions listed in the table below were reported during clinical studies with TobraDex eye drops and ophthalmic ointment and are classified according to the following convention: very common (≥1 / 10), common (≥1 / 100,

System and organ classification Adverse reactions Eye disorders Uncommon: increased intraocular pressure, eye pain, eye itching, eye discomfort, eye irritation.
Rare: eye surface inflammation, eye allergy, blurred vision, dry eye, eye redness. Gastrointestinal disorders Rare: unpleasant taste

The table below lists additional adverse reactions identified from post-marketing experience. Frequency cannot be estimated from the available data.


System and organ classification Adverse reactions Disorders of the immune system hypersensitivity Nervous system disorders dizziness, headache Eye disorders swelling of the eyelids, erythema of the eyelids, increased size of the pupils, increased lacrimation Gastrointestinal disorders nausea, abdominal discomfort Skin and subcutaneous tissue disorders Skin inflammation, swelling of the face, itching

Description of the adverse events highlighted

Prolonged use of topical ophthalmic corticosteroids can cause increased intraocular pressure with optic nerve damage, decreased visual acuity and visual field defects, subcapsular cataract formation and delayed wound healing.

Due to the presence of the corticosteroid, there is an increased risk of perforation in disorders that cause thinning of the cornea or sclera, especially after prolonged treatment. Following the use of combinations containing corticosteroids and antimicrobials, the development of secondary infections has occurred. Long-term application of corticosteroids can facilitate the development of fungal infections of the cornea. Serious adverse reactions such as neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients treated with systemic tobramycin.

Sensitization to topically administered aminoglycoside antibiotics may occur in some patients.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Italian Medicines Agency, website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

By reporting side effects you can help provide more information on the safety of this medicine.

Expiry and Retention

Eye drops: Store at a temperature not exceeding 25 ° C. Do not freeze. The product should not be used more than 30 days after first opening the container.

Ointment: store at a temperature not exceeding 25 ° C. Do not refrigerate. The product should not be used more than 28 days after first opening the container.

Do not use after the expiry date indicated on the outer package and on the label. The expiry date refers to the last day of the month.

The expiry date refers to the product in intact packaging, correctly stored.

Keep this medicine out of the sight and reach of children.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

Composition and pharmaceutical form

COMPOSITION

Eye drops, suspension - 1 ml contains:

Active ingredients: tobramycin 3 mg, dexamethasone 1 mg.

Excipients: benzalkonium chloride, disodium edetate, sodium chloride, sodium sulfate, tyloxapol, hydroxyethylcellulose, purified water.

Ophthalmic ointment - 1 g contains:

Active ingredients: tobramycin 3 mg, dexamethasone 1 mg.

Excipients: anhydrous chlorobutanol, vaseline oil, white vaseline.

PHARMACEUTICAL FORM AND CONTENT

Eye drops, suspension, 5 ml dropper bottle.

Ophthalmic ointment, 3.5g tube.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

Further information on Tobradex can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction 04.6 Pregnancy and lactation 04.7 Effects on ability to drive and use machines 04.8 Undesirable effects 04.9 Overdose 05.0 PHARMACOLOGICAL PROPERTIES 05.1 Pharmacodynamic properties 05.2 Pharmacokinetic properties 05.3 Preclinical safety data 06.0 PHARMACEUTICAL PARTICULARS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the primary packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER 08.0 MARKETING AUTHORIZATION NUMBER CIO 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIO DRUGS, FULL DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON PREPARATION AND QUALITY CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

TOBRADEX 0.3% + 0.1%

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

TobraDex 0.3% + 0.1% eye drops, suspension

1 ml of eye drops contains: tobramycin 3 mg, dexamethasone 1 mg

Excipients with known effect: benzalkonium chloride

TobraDex 0.3% + 0.1% ophthalmic ointment

1 g of ointment contains: tobramycin 3 mg, dexamethasone 1 mg

For the full list of excipients, see section 6.1.

03.0 PHARMACEUTICAL FORM

Eye drops, suspension: white to off-white suspension.

Ophthalmic ointment: homogeneous white to off-white ointment.

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

Treatment of eye inflammation when a corticosteroid is needed and when there is an eye infection or risk of eye infections in adults and children two years of age and older.

04.2 Posology and method of administration

Eye drops: instill 1 or 2 drops 4-5 times a day according to medical prescription.

Shake before using.

Ointment: apply a small amount (about 1 cm of ointment) in the conjunctival sac 3-4 times a day according to medical prescription.

The ointment can be used instead of eye drops in the evening before bedtime.

Pediatric population

TobraDex eye drops and TobraDex ointment can be used in children from two years of age onwards at the same doses as for adults. Currently available data are described in section 5.1. Safety and efficacy in children less than two years of age have not been established and no data are available.

Method of administration

For ophthalmic use only.

04.3 Contraindications

- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1

- Herpes Simplex Keratitis

- Smallpox vaccine, chicken pox or other viral infections of the cornea and conjunctiva

- Mycosis of the eye

- Mycobacterial eye infections (tuberculosis of the eye)

- Intracular hypertension

- Acute purulent ophthalmias, purulent conjunctivitis and purulent and herpetic blepharitis which can be masked or aggravated by corticosteroids

- Sty.

04.4 Special warnings and appropriate precautions for use

- Sensitization to topically administered aminoglycoside antibiotics may occur in some patients. If hypersensitivity develops during use of the medicinal product, treatment should be discontinued.

- Cross-hypersensitivity to other aminoglycosides may occur, therefore the possibility that patients sensitized to topically administered tobramycin may also be sensitive to other topically and / or systemically administered aminoglycosides should be considered.

- Serious adverse reactions such as neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients treated with systemic aminoglycoside therapy. Caution is advised when TobraDex is administered concomitantly with systemic aminoglycoside therapy.

- Prolonged use of topical ophthalmic corticosteroids may cause ocular hypertension and / or glaucoma with optic nerve damage, decreased visual acuity and visual field defects, and posterior sub-capsular cataract formation. In patients on prolonged ophthalmic corticosteroid therapy, intraocular pressure should be monitored regularly and frequently. This is particularly important in pediatric patients treated with dexamethasone-containing products, as the risk of corticosteroid-induced ocular hypertension may be greater in children under the age of six and may occur earlier than when steroid response occurs in adults. The frequency and duration of treatment should be carefully evaluated, and intraocular pressure (IOP) should be monitored from the start of treatment, considering that the risk of a corticosteroid-induced increase in IOP is greater and occurs earlier in pediatric patients. .

The risk of corticosteroid-induced elevation of intraocular pressure and / or cataract formation is increased in predisposed patients (e.g. diabetic patients).

- Corticosteroids can reduce resistance to bacterial, viral or fungal infections and promote their development, and can mask the clinical signs of infection

- In patients with persistent corneal ulcer mycosis should be suspected. If mycosis occurs, corticosteroid therapy should be discontinued.

- Prolonged use of antibiotics such as tobramycin can induce abnormal growth of non-sensitive organisms, including fungi. If superinfection occurs, appropriate therapy should be instituted.

- It is known that in diseases that cause thinning of the cornea or sclera, perforation can occur with the use of topical corticosteroids.

- Topical ophthalmic corticosteroids can slow corneal wound healing. Topical NSAIDs are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical corticosteroids can potentially increase wound healing problems (see section 4.5).

- It is recommended not to wear contact lenses when treating an "inflammation or" eye infection.

- TobraDex eye drops contain benzalkonium chloride, which may cause irritation

of the eye and known to be able to discolour soft contact lenses.

- Avoid contact with soft contact lenses. If patients are allowed to wear contact lenses, they should be instructed to remove them before administering TobraDex eye drops and to wait at least 15 minutes after instillation of the dose before reinserting them.

- To be used under direct medical supervision.

- For ophthalmic use only.

04.5 Interactions with other medicinal products and other forms of interaction

Concomitant use of topical corticosteroids and topical NSAIDs can potentially increase corneal wound healing problems.

If you are using more than one eye topical medicine, allow at least 5 minutes between instillation of each medicine. Eye ointment should be used last.

04.6 Pregnancy and breastfeeding

Fertility

No studies have been performed to evaluate the effect on human fertility of topical ocular administration of TobraDex eye drops and TobraDex ophthalmic ointment.

Pregnancy

Data from topical ophthalmic use of tobramycin or dexamethasone in pregnant women do not exist or are limited in number. Studies in animals have shown reproductive toxicity following systemic administration of corticosteroids and tobramycin.

TobraDex is not recommended during pregnancy.

Feeding time

It is unknown whether tobramycin or topical ophthalmic dexamethasone are excreted in human milk. Corticosteroids and tobramycin are excreted in breast milk after systemic administration. A risk to infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue TobraDex therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

04.7 Effects on ability to drive and use machines

TobraDex does not affect or transiently affect the ability to drive and use machines. However, transient blurred vision or other visual disturbances may affect the ability to drive and use machines. If blurred vision occurs after instillation, the patient should wait for the vision to clear before driving and using machinery.

04.8 Undesirable effects

The following adverse reactions listed in the table below were reported during clinical studies with TobraDex eye drops and ophthalmic ointment and are classified according to the following convention: very common (≥1 / 10), common (≥1 / 100,

System and organ classification Adverse reactions Eye disorders Uncommon: increased intraocular pressure, eye pain, eye itching, eye discomfort, eye irritation. Rare: keratitis, ocular allergy, blurred vision, dry eye, ocular hyperaemia. Gastrointestinal disorders Rare: dysgeusia

The table below lists additional adverse reactions identified from post-marketing experience. Frequency cannot be estimated from the available data.


System and organ classification Adverse reactions Disorders of the immune system hypersensitivity Nervous system disorders dizziness, headache Eye disorders eyelid edema, erythema of the eyelids, mydriasis, lacrimation increased Gastrointestinal disorders nausea, abdominal discomfort Skin and subcutaneous tissue disorders rash, facial swelling, itching

Description of the adverse events highlighted

Prolonged use of topical ophthalmic corticosteroids may cause increased intraocular pressure with optic nerve damage, decreased visual acuity and visual field defects, subcapsular cataract formation and delayed wound healing (see section 4.4). .

Due to the presence of the corticosteroid, there is an increased risk of perforation in disorders causing thinning of the cornea or sclera, especially after prolonged treatment (see section 4.4).

Following the use of combinations containing corticosteroids and antimicrobials, the development of secondary infections has occurred. Long-term application of corticosteroids may facilitate the development of fungal infections of the cornea (see section 4.4).

Serious adverse reactions such as neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients treated with systemic tobramycin (see section 4.4).

Sensitization to topically administered aminoglycoside antibiotics may occur in some patients (see section 4.4).

Reporting of suspected adverse reactions.

The reporting of suspected adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Italian Medicines Agency. , Website: www.aifa.gov.it/responsabili.

04.9 Overdose

Due to the characteristics of this medicine, no toxic effects are expected in case of ophthalmic overdose or accidental ingestion of a whole bottle of eye drops or ointment tube.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Therapeutic drug category: S01CA01 tobramycin + dexamethasone

Combined anti-inflammatory and anti-infectives; corticosteroids and anti-infectives in combination; dexamethasone and anti-infectives.

Mechanism of action

TobraDex eye drops and ophthalmic ointment contain tobramycin, a fast-acting bactericidal aminoglycoside antibiotic. It exerts its primary effect on bacterial cells by inhibiting the synthesis and assembly of peptides in the ribosome.

Resistance mechanism

Resistance to tobramycin develops through several mechanisms which include: 1) alterations of the ribosomal subunit in the bacterial cell; 2) interference with the transport of tobramycin inside the cell; 3) inactivation of tobramycin through a set of adenyl, phosphoryl and acetyl enzymes. The genetic information for the production of inactivating enzymes can be transported on bacterial chromosomes or on plasmids. Cross-resistance with other aminoglycosides may occur.

Breakpoints

The breakpoints and the spectrum in vitro The following are based on systemic use. These breakpoints may not be applicable to the topical ocular use of the medicinal product because locally higher concentrations are obtained and the physical / chemical characteristics may influence the activity of the drug at the administration site. In accordance as established by the European Committee on Antimicrobial Susceptibility Tests, the following breakpoints are defined for tobramycin:

Enterobacteriaceae S ≤ 2 mg / l, R> 4 mg / l

Pseudomonas spp. S ≤ 4 mg / l, R> 4 mg / l

Acinetobacter spp. S ≤ 4 mg / l, R> 4 mg / l

Staphylococcus spp. S ≤ 1 mg / l, R> 1 mg / l

• Not species-related S ≤ 2 mg / l, R> 4 mg / l

The information listed below only provides a rough guide as to the likelihood that microorganisms are susceptible to the tobramycin present in TobraDex. Bacterial species that have been found in external eye infections such as conjunctivitis are reported here.

The prevalence of acquired resistance for the identified species can vary geographically and over time; Local information on resistance is therefore desirable, especially when treating severe infections. As necessary, expert advice should be sought if the prevalence of local resistance is such that the utility of tobramycin in at least some type of infection is questionable.


COMMONLY SUSCEPTIBLE SPECIES Aerobic Gram-positive microorganisms Bacillus megaterium Bacillus pumilus Corynebacterium accolens Corynebacterium bovis Corynebacterium macginleyi Corynebacterium pseudodiphtheriticum Kocuria kristinae Staphylococcus aureus (susceptible to methicillin - MSSA) Staphylococcus haemolyticus (susceptible to methicillin - MSSH) Aerobic Gram-negative microorganisms Acinetobacter junii Acinetobacter ursingii Citrobacter koseri Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Moraxella catarrhalis Moraxella oslonensis Morganella morganii Neisseria perflava Proteus mirabilis Pseudomonas aeruginosa Serratia liquifaciens SPECIES FOR WHICH ACQUIRED RESISTANCE MAY BE A PROBLEM Acinetobacter baumanii Bacillus cereus Bacillus thuringiensis Kocuria rhizophila Staphylococcus epidermidis Staphylococcus haemolyticus (resistant to methicillin -MRSH) Staphylococcus aureus (resistant to methicillin - MRSA) Staphylococcus, other coaugulase negative species Serratia marcescens
INHERENTLY RESISTANT ORGANISMS Aerobic Gram-positive microorganisms Enterococcus faecalis Streptococcus mitis Streptococcus pneumoniae Streptococcus pyogenes Streptococcus sanguis Aerobic Gram-negative microorganisms Chryseobacterium indologenes Haemophilus influenzae Stenotrophomonas maltophilia Anaerobic bacteria Propionibacterium acnes

Dexamethasone is a moderately potent corticosteroid which has good penetration into the eye tissue. Corticosteroids have both anti-inflammatory and vasoconstrictive properties. They suppress the inflammatory response and symptoms associated with various ailments without ultimately curing the ailments themselves.

Pediatric population

The safety and efficacy of TobraDex eye drops and TobraDex ointment in children have been established on the basis of extensive clinical experience, but only limited data are available. In a clinical study with TobraDex eye drops in the treatment of bacterial conjunctivitis, 29 pediatric patients, aged 1 to 17 years, were treated with 1 or 2 drops of TobraDex every 4 or 6 hours for 5 or 7 days. In this study, no differences were observed between adults and pediatric patients in the safety profile.

05.2 Pharmacokinetic properties

TobraDex eye drops and ointment are administered directly into the conjunctival sac. Bioavailability studies in rabbits show that, following topical ocular administration, tobramycin is absorbed in the cornea and dexamethasone in the cornea and aqueous humor.

The efficacy and safety of the TobraDex eye drops and ointment specialty have been demonstrated following repeated topical ocular administration in rabbits for one month and in monkeys for three months. From these studies, it was found that the TobraDex eye drops and ointment specialty has no irritating power. in rabbits and monkeys when treated topically according to the human regimen.

05.3 Preclinical safety data

Tobramycin: Animal studies have shown that tobramycin has a qualitatively similar toxicological profile to gentamicin with less severe side effects. No serious ocular toxicity was found in rabbits and humans either after topical ocular administration or after subconjunctival injection, either in healthy eyes than in eyes with induced keratitis.

Dexamethasone: the toxicity of dexamethasone is well documented in the literature. Like all corticosteroids, when administered systemically in high doses, dexamethasone inhibits pituitary gland activity, electrolyte disturbances, hyperglycemia and glycosuria, increased risk of infection, peptic ulcer, Cushing's syndrome, posterior subcapsular cataract. of dexamethasone present in TobraDex (0.1%), the frequency of administration and dosage show a low incidence of systemic effects following clinical use of the product.

06.0 PHARMACEUTICAL INFORMATION

06.1 Excipients

Eye drops: benzalkonium chloride, disodium edetate, sodium chloride, sodium sulfate, tyloxapol, hydroxyethylcellulose, purified water.

Ointment: anhydrous chlorobutanol, vaseline oil, white vaseline.

06.2 Incompatibility

Eye drops: the tyloxapol component is incompatible with tetracycline.

06.3 Period of validity

2 years.

Eye drops: do not use more than 30 days after first opening the container.

Ointment: do not use more than 28 days after first opening the container.

06.4 Special precautions for storage

Eye drops: Do not store above 25 ° C. Do not freeze.

Ointment: Store at a temperature not exceeding 25 ° C. Do not refrigerate.

For storage conditions after first opening, see section 6.3.

06.5 Nature of the immediate packaging and contents of the package

Eye drops: 5 ml dropper bottle in low density polyethylene.

Ointment: 3.5 g aluminum tube with ophthalmic tip.

06.6 Instructions for use and handling

Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.

07.0 MARKETING AUTHORIZATION HOLDER

S.A. ALCON Couvreur N.V., 2870 PUURS (Belgium).

Exclusive representative for sales in Italy

ALCON Italia S.p.A., Viale Giulio Richard 1 / B, 20143 Milan.

08.0 MARKETING AUTHORIZATION NUMBER

AIC n. 027457011 5 ml dropper bottle.

AIC n. 027457023 3.5 g ophthalmic ointment.

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION

First authorization: January 1993

Renewal: January 2008

10.0 DATE OF REVISION OF THE TEXT

10/2014

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL

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