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Tobramycin Ophthalmic
Solution, USP

Description

Tobramycin Ophthalmic Solution is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external infections.

Each mL contains: Tobramycin 3 mg (0.3%), Boric Acid, Sodium Sulfate, Sodium Chloride, Tyloxapol, with Benzalkonium Chloride 0.01% (0.1 mg) as preservative, in Water for Injection. Sodium Hydroxide and/or Sulfuric Acid may have been used to adjust pH. pH range is 7.0 to 8.0.

Tobramycin is a water-soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens. The structural formula of tobramycin is:

C18H37N5O9         MW = 467.52

Chemical Name: 0-3-amino-3-deoxy-α-D-glucopyranosyl-(1→4)-O-[2,6-diamino-2,3,6-trideoxy-α-D-ribo-hexopyra-nosyl-(1→6)]-2-deoxy-L-streptamine.

CLINICAL 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 beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae. Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, and Acinetobacter calcoaceticus and some Neisseria species. Bacterial susceptible 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 AND USAGE

Tobramycin ophthalmic solution 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 tobramycin. Clinical studies have shown tobramycin to be safe and effective for use in children.

CONTRAINDICATIONS

Tobramycin ophthalmic solution is contraindicated in patients with known hypersensitivity to any of the components.

WARNINGS

NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients. If a sensitivity reaction to tobramycin ophthalmic solution occurs, discontinue use.

PRECAUTIONS

General

As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated.

Information For Patients

Do not touch dropper tip to any surface as this may contaminate the solution.

Pregnancy

Category B: Reproduction studies in three types of animals at doses up to thirty-three times the normal human systemic dose have revealed no evidence of impaired fertility or harm to the fetus due to tobramycin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

Because of the potential for adverse reactions in nursing infants from tobramycin ophthalmic solution, 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.

ADVERSE REACTIONS

The most frequent adverse reactions to tobramycin 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 tobramycin ophthalmic solution. Similar reactions may occur with the topical use of other aminoglycoside antibiotics. Other adverse reactions have not been reported from tobramycin ophthalmic solution therapy; however, if topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration.

OVERDOSAGE

Clinically apparent signs and symptoms of an overdose of tobramycin ophthalmic solution (punctate keratitis, erythema, increased lacrimation, edema and lid itching) may be similar to adverse reaction effects seen in some patients.

DOSAGE AND ADMINISTRATION

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 ophthalmic solution may be used in conjunction with tobramycin ophthalmic ointment.

HOW SUPPLIED

Tobramycin Ophthalmic Solution 0.3% is supplied in 5 mL plastic squeeze dropper bottles, individually boxed.

Store between 8° - 27°C (46° - 80°F). Avoid exposure to excessive heat.

CAUTION: Federal law prohibits dispensing without prescription.

Literature revised: April 1994

Product No.: 0914-05

Mfd. By Steris Laboratories, Inc.

Phoenix, Arizona 85043 USA