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NDC 00404-7196-01 Tobramycin 3 mg/mL Details

Tobramycin 3 mg/mL

Tobramycin is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Henry Schein Inc.. The primary component is TOBRAMYCIN.

MedlinePlus Drug Summary

Ophthalmic tobramycin is used to treat eye infections. Tobramycin is in a class of medications called antibiotics. It works by killing bacteria that cause infections.

Related Packages: 00404-7196-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Tobramycin Ophthalmic

Product Information

NDC	00404-7196
Product ID	0404-7196_e59394a3-3474-4186-9986-5c589cd851ed
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Tobramycin
Proprietary Name Suffix	n/a
Non-Proprietary Name	Tobramycin
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	SOLUTION/ DROPS
Route	OPHTHALMIC
Active Ingredient Strength	3
Active Ingredient Units	mg/mL
Substance Name	TOBRAMYCIN
Labeler Name	Henry Schein Inc.
Pharmaceutical Class	Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA064096
Listing Certified Through	2023-12-31

Package

Package Images

NDC 00404-7196-01 (00404719601)

Pricing Information	N/A
NDC Package Code	0404-7196-01
Billing NDC	00404719601
Package	1 BOTTLE, DROPPER in 1 CARTON (0404-7196-01) / 5 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2015-05-13
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 019172e3-bf24-4b76-9253-f58765d7b4f3 Details

SPL UNCLASSIFIED SECTION

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.

Tobramycin is a water soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens. The molecular formula is C18H37N5O9, the molecular weight is 467.52 and the structural formula is:

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.

Each mL contains:

Active: Tobramycin 3 mg (0.3%). 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 0.1 mg (0.01%).

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 pediatric patients.

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, 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 the elderly and other adult 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.

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.

HOW SUPPLIED:

Tobramycin Ophthalmic Solution USP, 0.3% is supplied as a sterile solution in plastic dropper bottles in two sizes:

NDC 0404-7196-01 . . . . . . . . . . . . 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.

Distributed by (in US only):

HENRY SCHEIN INC.

135 DURYEA ROAD

MELVILLE, NY 11747 USA

BTM00N Rev. 08/14

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

HENRY SCHEIN Logo

NDC 0404-7196-01

112-7196

TOBRAMYCIN

OPHTHALMIC

SOLUTION, USP

0.3%

Sterile 5 mL

Rx only

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

HENRY SCHEIN Logo

NDC 0404-7196-01

112-7196

TOBRAMYCIN

OPHTHALMIC

SOLUTION, USP

0.3%

Sterile

Rx only 5 mL

Principal Display Panel Text for Carton Label

INGREDIENTS AND APPEARANCE

TOBRAMYCIN

tobramycin solution/ drops

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0404-7196
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Tobramycin (UNII: VZ8RRZ51VK) (Tobramycin - UNII:VZ8RRZ51VK)	Tobramycin	3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Boric Acid (UNII: R57ZHV85D4)
Sodium Chloride (UNII: 451W47IQ8X)
Sodium Sulfate (UNII: 0YPR65R21J)
Tyloxapol (UNII: Y27PUL9H56)
Sodium Hydroxide (UNII: 55X04QC32I)
Sulfuric Acid (UNII: O40UQP6WCF)
Water (UNII: 059QF0KO0R)
Benzalkonium Chloride (UNII: F5UM2KM3W7)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0404-7196-01	1 in 1 CARTON	05/13/2015
1		5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA064096	05/13/2015

Labeler - Henry Schein Inc. (012430880)

Registrant - Akorn Operating Company LLC (117693100)

Revised: 2/2022

Document Id: e59394a3-3474-4186-9986-5c589cd851ed

Set id: 019172e3-bf24-4b76-9253-f58765d7b4f3

Version: 4

Effective Time: 20220207

Search by Drug Name or NDC

NDC 00404-7196-01 Tobramycin 3 mg/mL Details

Tobramycin 3 mg/mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 00404-7196-01 (00404719601)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 019172e3-bf24-4b76-9253-f58765d7b4f3 Details

SPL UNCLASSIFIED SECTION

DESCRIPTION:

CLINICAL PHARMACOLOGY:

INDICATIONS AND USAGE:

CONTRAINDICATIONS:

WARNINGS:

PRECAUTIONS:

General:

ADVERSE REACTIONS:

OVERDOSAGE:

DOSAGE AND ADMINISTRATION:

HOW SUPPLIED:

STORAGE:

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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