Tobramycin

TOBRAMYCIN- tobramycin solution/ drops
Akorn

DESCRIPTION

Tobramycin Ophthalmic Solution USP, 0.3% is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections.

Each mL contains:

Active: tobramycin 0.3% (3 mg). Inactives: boric acid, sodium chloride, sodium sulfate, tyloxapol, sodium hydroxide and/or sulfuric acid to adjust pH (7.0 to 8.0), and water for injection. Preservative: benzalkonium chloride 0.01% (0.1 mg).

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

The chemical structure of tobramycin is:

Molecular Weight = 467.52

Molecular Formula: C18 H37 N5 O9

Structural Formula

Chemical Name:

O-{3-amino-3-deoxy-α-D-gluco-pyranosyl-(1→4)}-O-{2,6-diamino-2,3,6-trideoxy-α-D-ribohexo-pyranosyl-(1→6)}-2- deoxystreptamine.

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, Acinetobacter calcoaceticus and some Neisseria species. Bacterial susceptibility studies demonstrate that in some cases, microorganisms resistant to gentamicin retain susceptibility to tobramycin.

INDICATIONS AND USAGE

Tobramycin ophthalmic solution 0.3% 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 ophthalmic solution. Clinical studies have shown tobramycin to be safe and effective for use in children.

CONTRAINDICATIONS

Tobramycin ophthalmic solution 0.3% is contraindicated in patients with known hypersensitivity to any of its components.

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 to tobramycin ophthalmic solution 0.3% 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.

Cross-sensitivity to other aminoglycoside antibiotics may occur; if hypersensitivity develops with this product, discontinue use and institute appropriate therapy. Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial ocular infection.

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

Pregnancy: Reproduction studies in 3 types of animals at doses up to 33 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, 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.

Pediatric Use: Safety and effectiveness in pediatric patients below the age of 2 months has not been established.

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

ADVERSE REACTIONS:

The most frequent adverse reactions to tobramycin ophthalmic solution 0.3% are hypersensitivity and localized ocular toxicity, including lid itching and swelling, and conjunctival erythema. These reactions occur in less than three of 100 patients treated with tobramycin.

Postmarketing Experience: Additional adverse reactions identified from postmarketing use include anaphylactic reaction, Stevens-Johnson syndrome, and erythema multiforme.

The following additional adverse reactions have been reported with systemic aminoglycosides: Neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients receiving systemic aminoglycoside therapy. Aminoglycosides may aggravate muscle weakness in patients with known or suspected neuromuscular disorders, such as myasthenia gravis or Parkinson’s disease, because of their potential effect on neuromuscular function.

DOSAGE AND ADMINISTRATION

In mild to moderate disease, instill 1 or 2 drops into the affected eye(s) every 4 hours. In severe infections, instill 2 drops into the eye(s) hourly until improvement, following which treatment should be reduced prior to discontinuation.

HOW SUPPLIED

Tobramycin Ophthalmic Solution USP, 0.3% is supplied as a sterile solution in white low-density polyethylene (LDPE) plastic dropper bottles in two sizes:

NDC 17478-290-20 . . . . . . . . . . . . 2 mL

NDC 17478-290-10 . . . . . . . . . . . . 5 mL

STORAGE

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from excessive heat.

AKORN
Manufactured by: Akorn
Lake Forest, IL 60045

GTM00N Rev. 06/21

Principal Display Panel Text for Container Label:

NDC 17478-290-10

Tobramycin

Ophthalmic

Solution, USP

0.3%

Sterile

Rx only 5mL

Principal Display Panel Text for Container Label
(click image for full-size original)

Principal Display Panel Text for Carton Label:

NDC 17478-290-10

Tobramycin

Ophthalmic

Solution, USP

0.3%

Sterile

5 mL

Rx only Akorn

Principal Display Panel Text for Carton Label
(click image for full-size original)
TOBRAMYCIN
tobramycin solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:17478-290
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tobramycin (Tobramycin) Tobramycin 3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Boric Acid
Sodium Chloride
sodium Sulfate
Tyloxapol
Sodium Hydroxide
Sulfuric Acid
WATER
Benzalkonium Chloride
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:17478-290-10 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
1 5 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (17478-290-10)
2 NDC:17478-290-20 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
2 2 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (17478-290-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA064096 01/31/1996
Labeler — Akorn (117693100)
Establishment
Name Address ID/FEI Operations
Akorn 117696832 MANUFACTURE (17478-290), ANALYSIS (17478-290), STERILIZE (17478-290)
Establishment
Name Address ID/FEI Operations
Akorn 117696790 PACK (17478-290), LABEL (17478-290)

Revised: 09/2022 Akorn

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.