Tobrex

Tobrex

tobramycin

Manufacturer:

Novartis Healthcare

Distributor:

Mundipharma
Full Prescribing Info
Contents
Tobramycin.
Description
Each mL of solution contains: Active: Tobramycin 0.3 % (3 mg/mL).
Preservative: benzalkonium chloride 0.01 % (0.1 mg/mL).
Each gram of ointment contains: Tobramycin 0.3% (3 mg/g), Mineral Oil, Petroleum Base and Chlorobutanol 0.5% as a preservative.
Tobramycin is a water-soluble aminoglycoside antibiotic, active against a wide variety of gram-negative and gram-positive ophthalmic pathogens.
TOBREX is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external infections.
Excipients: Drops: boric acid, sodium sulfate, sodium chloride, tyloxapol, sodium hydroxide and/or sulfuric acid (to adjust pH) and purified water.
Action
Pharmacology: In Vitro Data: In vitro studies have demonstrated tobramycin is active against susceptible strains of the following microorganisms: Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains.
Streptococci, including some of the Group A-betahemolytic species, some non-hemolytic species, and some Streptococcus pneumoniae.
Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis (indole-negative) and indole-positive Proteus species, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, and Acinetobacter calcoaceticus (Herellea vaginacola) and some Neisseria species. Bacterial susceptibility studies demonstrate that in some cases, microorganisms resistant to gentamicin retain susceptibility to tobramycin. A significant bacterial population resistant to tobramycin has not yet emerged; however, bacterial resistance may develop upon prolonged use.
Indications/Uses
TOBREX is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of TOBREX. Clinical studies have shown tobramycin to be safe and effective for use in children.
Dosage/Direction for Use
As indicated by physician: Drops: In mild to moderate disease, instill one or two drops into the affected eye(s) every four hours. In severe infections, instill two drops into the eye(s) hourly until improvement, following which treatment should be reduced prior to discontinuation.
Tobramycin 0.3% (TOBREX) ointment may be used in conjunction with Tobramycin 0.3% (TOBREX) Solution.
Ointment: In mild to moderate disease, apply a 1.5 centimetre ribbon into the affected eye(s) two or three times per day. In severe infections, instill a 1.5 centimetre ribbon into the affected eye(s) every three to four hours until improvement, following which treatment should be reduced prior to discontinuation.
Tobramycin 0.3% Eye Solution (TOBREX) may be used in conjunction with Tobramycin 0.3% Eye Solution (TOBREX).
Overdosage
Clinically apparent signs and symptoms of an overdose of TOBREX (punctate keratitis, erythema, increased lacrimation, edema and lid itching) may be similar to adverse reaction effects seen in some patients.
Drops: Due to the characteristics of this preparation, 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 one bottle or tube.
Contraindications
TOBREX is contraindicated in patients with known hypersensitivity to the active substance or to any of the excipients.
Warnings
NOT FOR INJECTION INTO THE EYE. Sensitivity to topically administered aminoglycosides may occur in some patients.
Drops: If hypersensitivity develops during use of this medicine, treatment should be discontinued. Cross-hypersensitivity to other aminoglycosides can occur, and the possibility that patients who become sensitized to topical ocular tobramycin may also be sensitive to other topical and/or systemic aminoglycosides should be considered.
Contact lens wear is not recommended during treatment of an ocular infection.
Tobramycin 0.3 % (TOBREX) Ophthalmic Solution contains benzalkonium chloride which may cause eye irritation and is known to discolor soft contact lenses. Avoid contact with soft contact lenses. In case patients are allowed to wear contact lenses, they must be instructed to remove contact lenses prior to application of this product and wait at least 15 minutes before reinsertion.
Ointment: Severity of hypersensitivity reactions may vary from local effects to generalized reactions such as erythema, itching, urticarial, skin rash, anaphylaxis, anaphylactoid reactions, or bullous reactions. If a sensitivity reaction to Tobramycin 0.3% Eye Ointment (TOBREX) occurs, discontinue use.
Special Precautions
As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated.
Drops: Serious adverse reactions including neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients receiving systemic tobramycin therapy. Caution is advised when used concomitantly.
Ointment: Ophthalmic ointments may retard corneal wound healing.
Effects on Ability to Drive and Use Machines: Drops: Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at application, the patient must wait until the vision clears before driving or using machinery.
Fertility: Studies have not been performed to evaluate the effect of topical ocular administration of Tobramycin Eye Drops/Ointment on human fertility.
Use in Pregnancy: There are no or limited amount of data from the use of topical ocular tobramycin in pregnant women. Tobramycin does cross the placenta into the fetus after intravenous dosing in pregnant women. Tobramycin is not expected to cause ototoxicity from in utero exposure. Studies in animals have shown reproductive toxicity at dosages considered sufficiently in excess of the maximal human dose derived from Tobramycin Eye Drops/Ointment so as to have limited clinical relevance. Tobramycin has not been shown to induce teratogenicity in rats or rabbits. TOBREX should be used during pregnancy only if clearly needed.
Use in Lactation: Because of the potential for adverse reactions in nursing infants from TOBREX, a decision should be made whether to discontinue nursing the infant or discontinue the drug, taking into account the importance of the drug to the mother. Tobramycin is excreted in human milk after systemic administration. It is unknown whether tobramycin is excreted in human milk following topical ocular administration. It is not likely that the amount of Tobramycin would be detectable in human milk or be capable of producing clinical effects in the infant following topical use of the product. However, a risk to the suckling child cannot be excluded.
Use In Pregnancy & Lactation
Use in Pregnancy: There are no or limited amount of data from the use of topical ocular tobramycin in pregnant women. Tobramycin does cross the placenta into the fetus after intravenous dosing in pregnant women. Tobramycin is not expected to cause ototoxicity from in utero exposure. Studies in animals have shown reproductive toxicity at dosages considered sufficiently in excess of the maximal human dose derived from Tobramycin Eye Drops/Ointment so as to have limited clinical relevance. Tobramycin has not been shown to induce teratogenicity in rats or rabbits. TOBREX should be used during pregnancy only if clearly needed.
Use in Lactation: Because of the potential for adverse reactions in nursing infants from TOBREX, a decision should be made whether to discontinue nursing the infant or discontinue the drug, taking into account the importance of the drug to the mother. Tobramycin is excreted in human milk after systemic administration. It is unknown whether tobramycin is excreted in human milk following topical ocular administration. It is not likely that the amount of Tobramycin would be detectable in human milk or be capable of producing clinical effects in the infant following topical use of the product. However, a risk to the suckling child cannot be excluded.
Adverse Reactions
The most frequent adverse reactions to TOBREX Ophthalmic Solution are localized ocular toxicity and hypersensitivity, including lid itching and swelling, and conjunctival erythema. These reactions occur in less than three of 100 patients treated with TOBREX. Similar reactions may occur with the topical use of other aminoglycoside antibiotics. Other adverse reactions have not been reported from TOBREX; however, if topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration.
The following adverse reactions have been reported during clinical trials with TOBREX and are classified according to the subsequent 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). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. (See Table 1.)

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Additional adverse reactions identified from post-marketing surveillance include the following.
Frequencies cannot be estimated from the available data. (See Table 2 and 3.)
Drops:
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Ointment:
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Drug Interactions
Drops: No clinically relevant interactions have been described with topical ocular dosing.
Storage
Store at temperatures not exceeding 25°C. Keep container tightly closed.
ATC Classification
S01AA12 - tobramycin ; Belongs to the class of antibiotics. Used in the treatment of eye infections.
Presentation/Packing
Eye drops 3 mg/mL x 5 mL. Eye oint 3 mg/g x 3.5 g.
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