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| NDC | 17478-290-10, 17478-290-20 |
| Set ID | c91db5e0-f6b8-40d7-b307-b24073b9705e |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | Akorn, Inc. |
| Generic Name | |
| Product Class | Aminoglycoside Antibacterial |
| Product Number | |
| Application Number | ANDA064096 |
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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.
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: C18H37N5O9
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.
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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 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.
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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
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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.
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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 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.
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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
- HOW SUPPLIED
- STORAGE
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TOBRAMYCIN
tobramycin solution/ dropsProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) 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:17478-290-10 1 in 1 CARTON 01/31/1996 1 5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 2 NDC:17478-290-20 1 in 1 CARTON 01/31/1996 2 2 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 01/31/1996 Labeler - Akorn, Inc. (117696770) Registrant - Akorn Operating Company LLC (117693100) Establishment Name Address ID/FEI Business Operations Akorn, Inc. 117696832 MANUFACTURE(17478-290) , ANALYSIS(17478-290) , STERILIZE(17478-290) Establishment Name Address ID/FEI Business Operations Akorn, Inc. 117696790 PACK(17478-290) , LABEL(17478-290)
