tobramycin 0.3 % / dexamethasone 0.1 % Ophthalmic Suspension

Generic Name: TOBRAMYCIN AND DEXAMETHASONE
Brand Name: Tobramycin and Dexamethasone
  • Substance Name(s):
  • TOBRAMYCIN
  • DEXAMETHASONE

WARNINGS

FOR TOPICAL OPHTHALMIC USE.

NOT FOR INJECTION INTO THE EYE.

Sensitivity to topically applied aminoglycosides may occur in some patients.

Severity of hypersensitivity reactions may vary from local effects to generalized reactions, such as erythema, itching, urticaria, skin rash, anaphylaxis, anaphylactoid reactions, or bullous reactions.

If a sensitivity reaction does occur, discontinue use.

Prolonged use of steroids may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation.

Intraocular pressure (IOP) should be routinely monitored even though it may be difficult in pediatric patients and uncooperative patients.

Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections.

In acute purulent conditions and parasitic infections of the eye, steroids may mask infection or enhance existing infection.

In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids.

DESCRIPTION

Tobramycin and dexamethasone ophthalmic suspension is a sterile, multiple dose antibiotic and steroid combination for topical ophthalmic use.

The chemical structures for tobramycin and dexamethasone are presented below: Tobramycin Empirical Formula: C 18 H 37 N 5 O 9 Chemical Name: O -3-Amino-3-deoxy-α- D-glucopyranosyl-(1→4)- O -[2,6-diamino-2,3,6-trideoxy-α-D- ribo -hexopyranosyl- (1→6)]-2-deoxy-L-streptamine Molecular Weight: 467.52 Dexamethasone Empirical Formula: C 22 H 29 FO 5 Chemical Name: 9-Fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione Molecular Weight: 392.47 Each mL of tobramycin and dexamethasone ophthalmic suspension contains: Actives: tobramycin 0.3% (3 mg) and dexamethasone 0.1% (1 mg).

Preservative: benzalkonium chloride 0.01%.

Inactives: tyloxapol, edetate disodium, sodium chloride, hydroxyethyl cellulose, sodium sulfate, sulfuric acid and/or sodium hydroxide (to adjust pH) and purified water.

tobramycin dexamethasone

HOW SUPPLIED

Sterile ophthalmic suspension in 2.5 mL (NDC 61314-647-25), 5 mL (NDC 61314-647-05) and 10 mL (NDC 61314-647-10) dispensers.

STORAGE Store at 8°C to 27°C (46°F to 80°F).

Store suspension upright and shake well before using.

After opening, tobramycin and dexamethasone ophthalmic suspension can be used until the expiration date on the bottle.

Distributed by Sandoz Inc.

Princeton, NJ 08540 Rev.

04/2020 T2020-73 300038446 USG

GERIATRIC USE

Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.

INDICATIONS AND USAGE

Tobramycin and dexamethasone ophthalmic suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.

Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation.

They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies.

The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.

The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: 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, Acinetobacter calcoaceticus and some Neisseria species.

PEDIATRIC USE

Pediatric Use Safety and effectiveness in pediatric patients below the age of 2 years have not been established.

PREGNANCY

Pregnancy Corticosteroids have been found to be teratogenic in animal studies.

Ocular administration of 0.1% dexamethasone resulted in 15.6% and 32.3% incidence of fetal anomalies in two groups of pregnant rabbits.

Fetal growth retardation and increased mortality rates have been observed in rats with chronic dexamethasone therapy.

Reproduction studies have been performed in rats and rabbits with tobramycin at doses up to 100 mg/kg/day parenterally and have revealed no evidence of impaired fertility or harm to the fetus.

There are no adequate and well-controlled studies in pregnant women.

However, prolonged or repeated corticoid use during pregnancy has been associated with an increased risk of intra-uterine growth retardation.

Tobramycin and dexamethasone ophthalmic suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism.

NUSRING MOTHERS

Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk.

Because many drugs are excreted in human milk, caution should be exercised when tobramycin and dexamethasone ophthalmic suspension is administered to a nursing woman.

INFORMATION FOR PATIENTS

Information for Patients Do not touch dropper tip to any surface, as this may contaminate the contents.

Contact lenses should not be worn during the use of this product.

DOSAGE AND ADMINISTRATION

One or two drops instilled into the conjunctival sac(s) every four to six hours.

During the initial 24 to 48 hours, the dosage may be increased to one or two drops every two (2) hours.

Frequency should be decreased gradually as warranted by improvement in clinical signs.

Care should be taken not to discontinue therapy prematurely.

Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.