Classes
DEA Class; Rx
Common Brand Names; Nebcin injection
- Aminoglycosides
tobramycin ophthalmic (Rx)
- Classes: Aminoglycosides, Ophthalmic
tobramycin inhaled (Rx)
- Classes: Aminoglycosides
Description
Parenteral, inhaled, or ophthalmic aminoglycoside antibiotic
Most active against aerobic gram-negative rods
Risk of ototoxicity and renal toxicity with high serum concentration
Indications
Indicated for Bacterial Infections
Also indicated for Eye Infection
Indicated for management Pseudomonas aeruginosa in patients with cystic fibrosis
TOBI: Orphan designation for treatment of bronchiectasis patients infected with Pseudomonas aeruginosa
Other Indications & Uses
May have increase activity against resistant Gram negatives
Citrobacter spp., E. coli, P. aeruginosa, Proteus spp. (indole-positive and negative), Providencia spp. (including Klebsiella-Enterobacter-Serratia), S. aureus (coagulase-positive and negative)
Contraindications
Documented hypersensitivity to any aminoglycoside or history of hypersensitivity or serious toxic reactions to aminoglycosides
Adverse Effects
- Ototoxicity
- Nephrotoxicity
- Neurotoxicity (neuromuscular blockade)
- Hypotension
- Drug fever
- Drowsiness
- Headache
- Paresthesia
- Tremor
- Rash
- Nausea
- Vomiting
- Anemia
- Eosinophilia
- Arthralgia
- Weakness
- Eyelid edema
- Itching eyes
- Keratitis
- Lacrimation
- Dyspnea
- Localized ocular toxicity and hypersensitivity, including increased lacrimation, itching and edema of eyelid, and conjunctival erythema (<3%)
- Sensitivity reaction, punctate keratitis
- Voice alteration (12.8%)
- Myalgia (4.7%)
- Laryngitis (4.3%)
- Tinnitus (3%)
Warnings
Serious allergic sometimes fatal reactions including anaphylaxis and dermatologic reactions including exfoliative dermatitis, toxic epidermal necrolysis, erythema multiforme, and Stevens-Johnson Syndrome reported rarely; discontinue therapy If allergic reaction occurs, drug should be discontinued and appropriate therapy instituted
Serum and urine specimens for examination should be collected during therapy; serum calcium, magnesium, and sodium should be monitored
Cross-allergenicity among aminoglycosides has been demonstrated
In patients with extensive burns or cystic fibrosis, altered pharmacokinetics may result in reduced serum concentrations of aminoglycosides; in such patients treated with tobramycin, measurement of serum concentration is especially important as a basis for determination of appropriate dosage
Elderly patients may have reduced renal function that may not be evident in results of routine screening tests, such as BUN or serum creatinine; a creatinine clearance determination may be more useful; monitoring of renal function during treatment with aminoglycosides is particularly important in such patients
An increased incidence of nephrotoxicity reported following concomitant administration of aminoglycoside antibiotics and cephalosporins
Aminoglycosides should be used with caution in patients with muscular disorders, such as myasthenia gravis or parkinsonism, since these drugs may aggravate muscle weakness because of potential curare-like effect on neuromuscular function
Aminoglycosides may be absorbed in significant quantities from body surfaces after local irrigation or application and may cause neurotoxicity and nephrotoxicity
Aminoglycosides have not been approved for intraocular and/or subconjunctival use; physicians are advised that macular necrosis has been reported following administration of aminoglycosides, including tobramycin, by these routes
The inactivation of tobramycin and other aminoglycosides by ß-lactam-type antibiotics (penicillins or cephalosporins) has been demonstrated in vitro and in
patients with severe renal impairment; such inactivation has not been found in patients with normal renal function who have been given the drugs by separate routes of administration
Therapy with tobramycin may result in overgrowth of nonsusceptible organisms; if overgrowth of nonsusceptible organisms occurs, appropriate therapy should be initiated
Pregnancy and Lactation
Therapy, can cause fetal harm when administered to a pregnant woman; published literature reports that use of streptomycin, an aminoglycoside, can cause total, irreversible, bilateral congenital deafness when administered to a pregnant woman
Limited published data with tobramycin for injection in lactating women indicate that tobramycin is present in human milk; there are no data on effects of drug on milk production; drug may cause alteration in the intestinal flora of breastfeeding infant; advise a woman to monitor breastfed infant for loose or bloody stools and candidiasis (thrush, diaper rash).
Maximum Dosage
Injectable aminoglycoside dosing is highly variable and dependent on several factors. The FDA-approved maximum is 10 mg/kg/day IV/IM; 48 drops/day ophthalmic solution; 600 mg/day nebulized solution for inhalation; 224 mg/day oral powder for inhalation. Maximum dosage of ophthalmic ointment not established.
Injectable aminoglycoside dosing is highly variable and dependent on several factors. The FDA-approved maximum is 7.5 mg/kg/day IV/IM; 48 drops/day ophthalmic solution; 600 mg/day nebulized solution for inhalation; 224 mg/day oral powder for inhalation. Maximum dosage of ophthalmic ointment not established.
Injectable aminoglycoside dosing is highly variable and dependent on several factors. The FDA-approved maximum is 10 mg/kg/day IV/IM; 48 drops/day ophthalmic solution; 600 mg/day nebulized solution for inhalation; 224 mg/day oral powder for inhalation. Maximum dosage of ophthalmic ointment not established.
6 to 12 years: Injectable aminoglycoside dosing is highly variable and dependent on several factors. The FDA-approved maximum is 10 mg/kg/day IV/IM; 48 drops/day ophthalmic solution; 600 mg/day nebulized solution for inhalation; 224 mg/day oral powder for inhalation. Maximum dosage of ophthalmic ointment not established.
1 to 5 years: Injectable aminoglycoside dosing is highly variable and dependent on several factors. The FDA-approved maximum is 10 mg/kg/day IV/IM; 48 drops/day ophthalmic solution. Maximum dosage of ophthalmic ointment not established. The safety and efficacy of the nebulized or oral inhalation products have not been established.
2 to 12 months: Injectable aminoglycoside dosing is highly variable and dependent on several factors. The FDA-approved maximum is 10 mg/kg/day IV/IM; 48 drops/day ophthalmic solution. Maximum dosage of ophthalmic ointment not established. The safety and efficacy of the nebulized or oral inhalation products have not been established.
1 month: Injectable aminoglycoside dosing is highly variable and dependent on several factors. The FDA-approved maximum is 10 mg/kg/day IV/IM. The safety and efficacy of the ophthalmic, nebulized, or oral inhalation products have not been established.
8 to 29 days: Injectable aminoglycoside dosing is highly variable and dependent on several factors. The FDA-approved maximum is 7.5 mg/kg/day IV/IM. The safety and efficacy of the ophthalmic, nebulized, or oral inhalation products have not been established.
0 to 7 days: Injectable aminoglycoside dosing is highly variable and dependent on several factors. The FDA-approved maximum is 4 mg/kg/day IV/IM. The safety and efficacy of the ophthalmic, nebulized, or oral inhalation products have not been established.
How supplied
Tobramycin