Label: TOBRAMYCIN solution/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 10544-883-99 - Packager: Blenheim Pharmacal, Inc.
- This is a repackaged label.
- Source NDC Code(s): 17478-290
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 15, 2015
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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 C 18H 37N 5O 9, 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 Purified Water USP. Preservative: Benzalkonium Chloride 0.1 mg (0.01%).
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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 betahemolytic 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.
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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.
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- WARNINGS:
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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 wellcontrolled 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.
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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:
- DOSAGE AND ADMINISTRATION:
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TOBRAMYCIN
tobramycin solution/ dropsProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10544-883(NDC:17478-290) 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 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10544-883-99 1 in 1 CARTON 05/15/2015 1 5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA064096 05/15/2015 Labeler - Blenheim Pharmacal, Inc. (171434587) Registrant - Blenheim Pharmacal, Inc. (171434587) Establishment Name Address ID/FEI Business Operations Blenheim Pharmacal, Inc. 171434587 repack(10544-883)
