TOBRAMYCIN

Main information

  • Trade name:
  • TOBRAMYCIN solution
  • Composition:
  • TOBRAMYCIN 3 mg in 1 mL
  • Prescription type:
  • PRESCRIPTION DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TOBRAMYCIN solution
    United States
  • Language:
  • English

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • Abbreviated New Drug Application
  • Last update:
  • 06-11-2017

Summary of Product characteristics: dosage, interactions, side effects

TOBRAMYCIN- tobramycin solution

Preferred Pharmaceuticals, Inc

----------

Tobramycin

Ophthalmic Solution, USP

0.3% (Sterile)

Rx only

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 3 mg (0.3%). Inactives: Boric Acid, Sodium Sulfate, Sodium Chloride, Tyloxapol

and Purified Water. Sodium Hydroxide and/or Sulfuric Acid (to adjust pH). Tobramycin Ophthalmic

Solution, USP 0.3% has a pH range between 7.0 and 8.0.

Preservative Added: Benzalkonium Chloride 0.1 mg (0.01%).

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: C

H N O

Chemical name:

(2S,3R,4S,5S,6R)-4-amino-2-[(1S,2S,3R,4S,6R)-4,6-diamino-3-[(2R,3R,5S,6R)-3-amino-6-

(aminomethyl)-5-hydroxyoxan-2-yl]oxy-2-hydroxycyclohexyl]oxy-6-(hydroxymethyl)oxane-3,5-

diol;sulfuric acid

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, USP 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,

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

CONTRAINDICATIONS

Tobramycin Ophthalmic Solution, USP 0.3% is contraindicated in patients with known hypersensitivity

to any of its components.

WARNINGS

FOR TOPICAL OPHTHALMIC USE ONLY - NOT FOR INJECTION INTO THE EYE

Sensitivity to topically applied aminoglycosides may occur in some patients. If a sensitivity reaction to

Tobramycin Ophthalmic Solution, USP 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 conjunctivitis.

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,

USP 0.3%, 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 two months has not been established.

Geriatric Use

No overall clinical differences in safety or effectiveness have been observed between elderly and

younger patients.

ADVERSE REACTIONS

The most frequent adverse reactions to Tobramycin Ophthalmic Solution 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. Similar reactions may occur with the

topical use of other aminoglycoside antibiotics. Other adverse reactions have not been reported from

tobramycin therapy; however, if topical ocular tobramycin is administered concomitantly with systemic

aminoglycoside antibiotics, care should be taken to monitor the total serum concentration.

To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant

Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or

www.fda.gov/medwatch.

OVERDOSAGE

Clinically apparent signs and symptoms of an overdose of Tobramycin Ophthalmic Solution, USP 0.3%

(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.

DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.

FOR TOPICAL OPHTHALMIC USE ONLY

HOW SUPPLIED

Tobramycin Ophthalmic Solution, USP 0.3% is supplied in a plastic bottle with a controlled drop tip and

a white polypropylene cap in the following size:

NDC 68788-9870-5- 10 mL bottle (5 mL fill)

Storage

Store at 2°-25°C (36°-77°F). Avoid excessive heat.

KEEP OUT OF REACH OF CHILDREN.

Revised June 2017

Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807

©Bausch & Lomb Incorporated

9116805 (folded)

9116905 (flat)

Relabeled By: Preferred Pharmaceuticals Inc.

Principal Display Panel

NDC 68788-9870-5

Tobramycin

Ophthalmic

Solution, USP

0.3%

(Sterile)

FOR TOPICAL OPHTHALMIC

USE ONLY

Rx only

5 mL

Bausch + Lomb

Relabeled By: Preferred Pharmaceuticals Inc.

TOBRAMYCIN

tobramycin solution

Product Information

Product T ype

HUMAN PRESCRIPTION

DRUG

Ite m Code

(S ource )

NDC:6 8 78 8 -9 8 70 (NDC:2420 8 -29 0 )

Route of Administration

OPHTHALMIC

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

TO BRAMYCIN (UNII: VZ8 RRZ51VK) (TOBRAMYCIN - UNII:VZ8 RRZ51VK)

TOBRAMYCIN

3 mg in 1 mL

Preferred Pharmaceuticals, Inc

Inactive Ingredients

Ingredient Name

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7)

0 .1 mg in 1 mL

BO RIC ACID (UNII: R57ZHV8 5D4)

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

SO DIUM SULFATE (UNII: 0 YPR6 5R21J)

SULFURIC ACID (UNII: O40 UQP6 WCF)

TYLO XAPO L (UNII: Y27PUL9 H56 )

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 8 78 8 -9 8 70 -

5 mL in 1 BOTTLE, DROPPER; Type 0 : No t a Co mbinatio n

Pro duc t

0 2/28 /20 12

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 6 40 52

0 2/28 /20 12

Labeler -

Preferred Pharmaceuticals, Inc (791119022)

Registrant -

Preferred Pharmaceuticals, Inc (791119022)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Preferred Pharmaceuticals, Inc

79 1119 0 22

RELABEL(6 8 78 8 -9 8 70 )

Revised: 11/2017