TOBRAMYCIN OPHTHALMIC SOLUTION solution/ drops

Tobramycin Ophthalmic Solution by

Drug Labeling and Warnings

Tobramycin Ophthalmic Solution by is a Prescription medication manufactured, distributed, or labeled by Alembic Pharmaceuticals Inc., Gland Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 of Tobramycin ophthalmic solution USP contains: Active: tobramycin 0.3 % (3 mg). Preservative: benzalkonium chloride 0.01 % (0.1 mg). Inactives: boric acid, sodium sulfate decahydrate, sodium chloride, tyloxapol, sodium hydroxide and/or sulfuric acid (to adjust pH) and water for injection. Tobramycin ophthalmic solution USP, 0.3 % has a pH range between 7.0 and 8.0 and an osmolality of 260 to 320 mOsm/kg.

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 = 467.51
Molecular Formula: C18H37N5O9

Chemical name:
0-13-amino-3-dexoy-α-D-gluco-pyranosyl-(1→4)}-0-[2,6-diamino-2,3,6-trideoxyl-α-D-ribohexo-pyranosol-(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 mirabillis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzea 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. 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, 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 USP 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 ophthalmic solution USP. Similar reactions may occur with the topical use of other aminoglycoside antibiotics. Other adverse reactions have not been reported from tobramycin ophthalmic solution USP, 0.3 % 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 USP, 0.3 % (punctate keratitis, erythema, increased lacrimation, edema and lid itching) may be similar to adverse reaction effects seen in some patients

DOSAGE & 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 in opaque white low density polyethylene bottle which is closed with natural low density polyethylene nozzle and then with tan colored high density polyethylene cap  containing tobramycin 0.3% (3 mg/mL).

5 mL in a 5 mL bottle (NDC: 62332-518-05).

Storage:  Store at 2 to 25°C (36 to 77°F).

Manufactured for:
Alembic Pharmaceutical, Inc.
750 Route 202, Bridgewater, NJ 08807
USA
Made in India

Manufactured by:
Gland Pharma Limited
Survey No. 143 – 148, 150 & 151, Near Gandimaisamma Cross Roads, D.P. Pally, Dundigal Post, Dundigal - Gandimaisamma Mandal, Medchal - Malkajgiri District,
Hyderabad-500 043, Telangana,
India (IND)

Revised: 06/ 2018.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tobramycin Ophthalmic Solution USP, 0.3 % - Bottle Label:


Tobramycin Ophthalmic Solution USP, 0.3 % - Carton Label:

INGREDIENTS AND APPEARANCE

TOBRAMYCIN OPHTHALMIC SOLUTION 
tobramycin ophthalmic solution solution/ drops

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 62332-518
Route of Administration	OPHTHALMIC

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

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
TYLOXAPOL (UNII: Y27PUL9H56)
SODIUM SULFATE (UNII: 0YPR65R21J)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SULFURIC ACID (UNII: O40UQP6WCF)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62332-518-05	1 in 1 CARTON	04/19/2019
1		5 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA211847	04/19/2019

Labeler - Alembic Pharmaceuticals Inc. (079288842)

Establishment
Name	Address	ID/FEI	Business Operations
Gland Pharma Limited		918601238	MANUFACTURE(62332-518)