Names and pronunciation
(toe-bra-mye′sin) Bethkis, Kitabis Pak, Nebcin TOBI, TOBI Podhaler
Source page 1303
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Individual generic drug information
Extracted information for tobramycin only.
(toe-bra-mye′sin) Bethkis, Kitabis Pak, Nebcin TOBI, TOBI Podhaler
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Func. class.: Antiinfective
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Chem. class.: Aminoglycoside
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ACTION: Interferes with protein synthesis in bacterial cell by binding to ribosomal subunits, thereby causing inaccurate peptide sequences to form in protein chain causing bacterial death
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USES: Severe systemic infections of CNS, respiratory, GI, urinary tract, bone, skin, soft tissues; cystic fibrosis (nebu- lizer) for Acinetobacter calcoaceticus, Citrobacter sp., Enterobacter aero- genes, Enterobacter sp., Enterococcus sp., Escherichia coli, Haemophilus aegyptius, Haemophilus influenzae (beta-lactamase negative), Haemophilus influenzae (beta-lactamase positive), Klebsiella pneumoniae, Klebsiella sp., Moraxella lacunata, Morganella mor- ganii, Neisseria sp., Proteus mirabilis, Proteus vulgaris, Providencia sp., Pseudomonas aeruginosa, Serratia sp., Staphylococcus aureus (MSSA), Staph- ylococcus epidermidis, Staphylococcus sp., Streptococcus pneumoniae, Strep- tococcus sp.; may also be used for the following: Acinetobacter sp., Aeromo- nas sp., Bacillus anthracis, Salmonella sp., Shigella sp.
Source page 1303
Extracted information for tobramycin only.
CONTRAINDICATIONS: Hyper- sensitivity to aminoglycosides
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Black Box Warning: Pregnancy, severe renal disease Precautions: Breastfeeding, geriatric patients, neonates, mild renal disease, myasthenia gravis, Parkinson’s disease T Black Box Warning: Hearing deficits, neuromuscular disease Black Box Warning: Increase: ototoxicity, neurotoxicity, nephrotoxicity—other ami- noglycosides, amphotericin B, polymyxin, vancomycin, ethacrynic acid, furose mide, mannitol, methoxyflurane, CISplatin, cephalosporins, bacitracin, acyclovir, peni- cillins, cidofovir Drug/Lab Test Increase: eosinophils, BUN, creatinine, AST, ALT, LDH, alk phos, glucose Decrease: potassium, calcium, sodium, magnesium, WBC, granulocytes, platelets Black Box Warning: Serum amino- glycoside concentration; serum peak drawn at 30-60 min after IV infusion or 60 min after IM inj, trough drawn just before next dose, peak 4-10 mcg/mL, trough 0.5-2 mcg/mL, increased level may lead to serious toxicity Black Box Warning: Renal impairment: CCr, BUN, serum creatinine; lower dos- age should be given in renal impairment (CCr <80 mL/min); monitor electrolytes: potassium, sodium, chloride, magnesium monthly if patient receiving long-term therapy Black Box Warning: Deafness by audio- metric testing; ringing, roaring in ears; vertigo; assess hearing before, during, after treatment • Overgrowth of infection: fever, mal aise, redness, pain, swelling, perineal itching, diarrhea, stomatitis, change in T cough, sputum • Vestibular dysfunction: nausea, vomit- ing, dizziness, headache; product should be discontinued if severe • Adequate fluids of 2-3 L/day unless contraindicated to prevent irritation of tubules Black Box Warning: Pregnancy: identify if pregnancy is planned or suspected; do not use in pregnancy, breastfeeding Black Box Warning: To report loss of hearing; ringing, roaring in ears; feeling of fullness in head Black Box Warning: To notify prescriber if pregnancy is planned or suspected; not to use in pregnancy, breastfeeding • To avoid hazardous activities until re- sponse is known Nebulizer • To use other therapies first, then to- bramycin, not to use if cloudy or contains particulates
Source pages 1303, 1305, 1306
SIDE EFFECTS CNS: Confusion, depression, numbness, tremors, seizures, muscle twitching, neu rotoxicity, dizziness, vertigo CV: Hypo/hypertension, palpitation EENT: Ototoxicity, deafness, visual distur- bances, tinnitus GI: Nausea, vomiting, anorexia; increased ALT, AST, bilirubin, hepato- megaly, hepatic necrosis, splenomegaly GU: Oliguria, hematuria, renal damage, azotemia, renal failure, nephrotoxicity HEMA: Agranulocytosis, thrombocytope nia, leukopenia, eosinophilia, anemia INTEG: Rash, burning, urticaria, derma- titis, alopecia
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INTERACTIONS
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TREATMENT OF OVERDOSE: Hemodialysis; monitor serum levels of product See Appendix B
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Extracted information for tobramycin only.
DOSAGE AND ROUTES Serious infection • Adult: IM/IV 3 mg/kg/day in divided doses q8hr; may give up to 6 mg/kg/day in divided doses q8-12hr; once-daily dosing (pulse dosing) (unlabeled) IV 5-7 mg/kg, dosing intervals determined using nomogram, based on random lev- els drawn 8-12 hr after 1st dose • Child ≥6 yr: NEB 300 mg bid in re- peating cycles of 28 days on/28 days off of product; give INH over 10-15 min us- ing a handheld PARI LC PLUS reusable nebulizer with DeVilbiss Pulmo-Aide compressor • Neonate <1 wk: IM/IV ≤4 mg/kg/day divided q12hr Cystic fibrosis with Pseudomonas aeruginosa • Child: IM/IV 6-7.5 mg/kg/day in 3-4 equal divided doses Renal dose Conventional dosing: • Multiply the serum creatinine (mg/100 mL) by 6 to determine the dosing; to de crease the dose, divide the standard dose by the serum creatinine (mg/100 mL) to determine the lower recommended dose
Source pages 1303, 1304
Available forms: Inj 10, 40 mg/mL; powder for inj 1.2 g; neb sol 300 mg/5 mL; powder for inh 28 mg
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Administer: • After obtaining specimen for C&S; be- gin treatment before results • Product in evenly spaced doses to maintain blood level; separate aminogly- cosides and penicillins by ≥1 hr • Use only on susceptible organisms to prevent development of product-resistant bacteria IM route • IM inj in large muscle mass; rotate inj sites, aspirate Draw peak 1 hr after dose, trough right before next dose; absorption erratic Inhalation route: (TOBI Podhaler) • Use with Podhaler device; do not swallow caps; use device for 7 days, then discard • Keep caps in blister pack until ready to use; administer other inhaled products or chest physiotherapy before Intermittent IV INFUSION route • Visually inspect sol; do not use if dis- colored or particulate is present • Vantage vials are for IV only and only for exactly 60 or 80 mg • Diluted in 50-100 mL 0.9% NaCl, D5W (D10W, Ringer’s, LR); infuse over 20-60 min; volume for pediatric patients needs to be sufficient to allow for 20-60 min infusion Y-site compatibilities: Acyclovir, aldes- leukin, alfentanil, alprostadil, amifostine, aminophylline, amiodarone, amsacrine, anidulafungin, ascorbic acid, atracurium, atropine, aztreonam, bivalirudin, bretyl ium, bumetanide, buprenorphine, butor- phanol, calcium chloride/gluconate, CAR- BOplatin, caspofungin, chloramphenicol, cimetidine, ciprofloxacin, cisatracurium, CISplatin, clindamycin, cyanocobalamin, cyclophosphamide, cycloSPORINE, cytara- bine, DACTINomycin, DAPTOmycin, dex- medetomidine, digoxin, diltiaZEM, diphen- hydrAMINE, DOBUTamine, DOCEtaxel, DOPamine, doripenem, doxacurium, DOXOrubicin hydrochloride, DOXOrubicin liposome, doxycycline, enalaprilat, ePHEDrine, EPINEPHrine, epiRUBicin, epoetin alfa, ertapenem, esmolol, etoposide, etoposide phosphate, famoti- dine, fenoldopam, fentaNYL, filgrastim, fluconazole, fludarabine, fluorouracil, fos- carnet, furosemide, gemcitabine, gentami- cin, glycopyrrolate, granisetron, HYDRO- morphone, ifosfamide, imipenem/ cilastatin, isoproterenol, ketorolac, labet- alol, levoFLOXacin, lidocaine, linezolid, LORazepam, magnesium sulfate, mannitol, mechlorethamine, melphalan, meperi- dine, metaraminol, methicillin, metho- trexate, methoxamine, methyldopate, methylPREDNISolone, metoclopramide, metoprolol, metroNIDAZOLE, miconazole, midazolam, milrinone, minocycline, mitoXANTRONE, morphine, moxalactam, multiple vitamins, nafcillin, nalbuphine, naloxone, niCARdipine, nitroglycerin, nitroprusside, norepinephrine, octreo- tide, ondansetron, oxaliplatin, oxytocin, PACLitaxel, palonosetron, pantoprazole, papaverine, penicillin G, pentazocine, per- phenazine, PHENobarbital, phentolamine, phenylephrine, phytonadione, potassium chloride, procainamide, prochlorpera- zine, promethazine, propranolol, protamine, pyridoxime, quinupristin/dal- fopristin, raNITIdine, remifentanil, riTUX- imab, rocuronium, sodium acetate/bicar- bonate, succinylcholine, SUFentanil, tacrolimus, teniposide, theophylline, thia- mine, thiotepa, ticarcillin/clavulanate, tige- cycline, tirofiban, tolazoline, trastuzumab, trimethaphan, urokinase, vancomycin, vasopressin, vecuronium, verapamil, vinCRIStine, vinorelbine, voriconazole, zidovudine
Source pages 1304, 1305
Extracted information for tobramycin only.
Assess: • Weight before treatment; dosage is usually based on ideal body weight but may be calculated on actual body weight • Fluid balance: I&O ratio, urinalysis daily for proteinuria, cells, casts; report sudden change in urine output • VS during infusion; watch for hypoten- sion, change in pulse • IV site for thrombophlebitis, including pain, redness, swelling; change site if needed; apply warm compresses to dis- continued site
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Evaluate: • Therapeutic response: absence of fe- ver, draining wounds, negative C&S after treatment
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • To promptly report headache, dizzi- ness, symptoms of overgrowth of infec- tion, renal impairment
Source page 1306
Extracted information for tobramycin only.
PHARMACOKINETICS Plasma half-life 2-3 hr, prolonged in neonates; not metabolized; excreted unchanged in urine; crosses placental barrier; poor penetration into CSF IM: Onset rapid, peak 1 hr, duration 8 hr IV: Onset immediate, peak 30 min, dura- tion 8 hr
Source page 1305
Filter the extracted dose blocks for this individual drug.
Serious infection
• Adult: IM/IV 3 mg/kg/day in divided doses q8hr; may give up to 6 mg/kg/day in divided doses q8-12hr; once-daily dosing (pulse dosing) (unlabeled) IV 5-7 mg/kg, dosing intervals determined using nomogram, based on random lev- els drawn 8-12 hr after 1st dose
Candidate age grouping · source pages 1303, 1304
Serious infection
• Child ≥6 yr: NEB 300 mg bid in re- peating cycles of 28 days on/28 days off of product; give INH over 10-15 min us- ing a handheld PARI LC PLUS reusable nebulizer with DeVilbiss Pulmo-Aide compressor
Candidate age grouping · source pages 1303, 1304
Serious infection
• Neonate <1 wk: IM/IV ≤4 mg/kg/day divided q12hr Cystic fibrosis with Pseudomonas aeruginosa
Candidate age grouping · source pages 1303, 1304
Serious infection
• Child: IM/IV 6-7.5 mg/kg/day in 3-4 equal divided doses Renal dose Conventional dosing:
Candidate age grouping · source pages 1303, 1304
Serious infection
• Multiply the serum creatinine (mg/100 mL) by 6 to determine the dosing; to de crease the dose, divide the standard dose by the serum creatinine (mg/100 mL) to determine the lower recommended dose
Candidate age grouping · source pages 1303, 1304