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TOBI Podhaler(trade name)
Pregnancy Category: D
ClassificationTherapeutic: anti infectives
Treatment of serious Gram-negative bacterial infections and infections caused by staphylococci when penicillins or other less toxic drugs are contraindicated. Inhalation: Management of cystic fibrosis patients with Pseudomonas aeruginosa.
Inhibits protein synthesis in bacteria at level of 30S ribosome.
Bactericidal action.Most aminoglycosides notable for activity against:
- Pseudomonas aeruginosa,
- Klebsiella pneumoniae,
- Escherichia coli,
- Staphylococcus aureus.
Absorption: Well absorbed after IM administration. IV administration results in complete bioavailability. Low absorption follows administration by inhalation.
Distribution: Widely distributed throughout extracellular fluid; crosses the placenta; small amounts enter breast milk. Poor penetration into CSF.
Metabolism and Excretion: Excretion is >90% renal.
Half-life: Neonates: 2–11 hr; Infants: 3–5 hr; Children: 1–3 hr; Adolescents: 0.5–2.5 hr; Adults: 2–4 hr (↑ in renal impairment to 5–70 hr).
Time/action profile (blood levels†)
|IM||rapid||30–90 min||6–24 hr|
|IV||rapid||end of infusion‡||6–24 hr|
Contraindicated in: Hypersensitivity; Most parenteral products contain bisulfites and should be avoided in patients with known intolerance; Cross-sensitivity among aminoglycosides may occur.
Use Cautiously in: Renal impairment (dose adjustments necessary; blood level monitoring useful in preventing ototoxicity and nephrotoxicity); Hearing impairment; Geriatric: Difficulty in assessing auditory and vestibular function; age-related renal impairment;; Pediatric: Neonates (↑ risk of neuromuscular blockade; difficulty in assessing auditory and vestibular function; immature renal function); Neuromuscular diseases such as myasthenia gravis; Obese patients (dosage should be based on ideal body weight); Obstetric: May cause congenital deafness; Lactation: Lactation.
Adverse Reactions/Side Effects
Ear, Eye, Nose, Throat
- ototoxicity (vestibular and cochlear) (most frequent) Inhalation only:
- voice alteration
- pseudomembranous colitis (life-threatening)
- nephrotoxicity (most frequent)
Fluid and Electrolyte
- muscle paralysis (high parenteral doses)
- Inhalation only:
- hypersensitivity reactions
Drug-Drug interactionInactivated by penicillins and cephalosporins when coadministered to patients with renal insufficiency.Possible respiratory paralysis after inhalation anesthetics orneuromuscular blockers.↑ risk of ototoxicity withloop diuretics.↑ risk of nephrotoxicity with othernephrotoxic drugs.
Intramuscular Intravenous (Adults) 3–6 mg/kg/day in 3 divided doses, or 4–6.6 mg/kg once daily.
Intramuscular Intravenous (Children > 5 yr) 6–7.5 mg/kg/day divided q 8 hr, up to 13 mg/kg/day divided q 6–8 hr in cystic fibrosis patients (dosing interval may vary from q 6 hr–q 24 hr, depending on clinical situation).
Intramuscular Intravenous (Children 1 mo-5 yr) 7.5 mg/kg/day divided q 8 hr, up to 13 mg/kg/day divided q 6–8 hr in cystic fibrosis.
Intramuscular Intravenous (Neonates ) Preterm <1000 g-3.5 mg/kg/dose q 24 hr 0–4 wk, <1200 g—2.5 mg/kg/dose q 18 hr Postnatal age <7 days-2.5 mg/kg/dose q 12 hr Postnatal age > 7 days,1200–2000 g-2.5 mg/kg/dose q 8–12 hr Postnatal age > 7 days, >2000 g-2.5 mg/kg/dose q 8 hr.
Inhalation (Adults and Children ≥6 yr) Nebulizer solution—300 mg twice daily for 28 days, then off for 28 days, then repeat cycle; Powder for inhalation—Inhale contents of four 28–mg capsules twice daily for 28 days, then off for 28 days, then repeat cycle
Renal ImpairmentIntramuscular Intravenous (Adults) 1 mg/kg initially, further dosing determined by blood level monitoring and assessment of renal function.
Availability (generic available)
Injection: 10 mg/mL, 40 mg/mL, 1.2 g/vial
Nebulizer solution (TOBI): 300 mg/5 mL
Nebulizer solution (Bethkis): 300 mg/4 mL
Powder for inhalation (TOBI Podhaler): 28 mg/capsule
- Assess patient for infection (vital signs, wound appearance, sputum, urine, stool, WBC) at beginning of and throughout therapy.
- Obtain specimens for culture and sensitivity before initiating therapy. First dose may be given before receiving results.
- Evaluate eighth cranial nerve function by audiometry before and throughout therapy. Hearing loss is usually in the high-frequency range. Prompt recognition and intervention are essential in preventing permanent damage. Also monitor for vestibular dysfunction (vertigo, ataxia, nausea, vomiting). Eighth cranial nerve dysfunction is associated with persistently elevated peak aminoglycoside levels. Aminoglycosides should be discontinued if tinnitus or subjective hearing loss occurs.
- Monitor intake and output and daily weight to assess hydration status and renal function.
- Assess patient for signs of superinfection (fever, upper respiratory infection, vaginal itching or discharge, increasing malaise, diarrhea).
- Monitor bowel function. Diarrhea, abdominal cramping, fever, and bloody stools should be reported to health care professional promptly as a sign of pseudomembranous colitis. May begin up to several weeks following cessation of therapy.
- Lab Test Considerations: Monitor renal function by urinalysis, specific gravity, BUN, creatinine, and CCr before and during therapy.
- May cause ↑ BUN, AST, ALT, serum alkaline phosphatase, bilirubin, creatinine, and LDH concentrations.
Blood levels should be monitored periodically during therapy. Timing of blood levels is important in interpreting results. Draw blood for peak levels 1 hr after IM injection and 30 min after a 30-min IV infusion is completed. Trough levels should be drawn just before next dose. Peak level should not exceed 10 mcg/mL; trough level should not exceed 2 mcg/mL.
- May cause ↓ serum calcium, magnesium, potassium, and sodium concentrations.
Potential Nursing DiagnosesRisk for infection (Indications)
Disturbed sensory perception (auditory) (Side Effects)
Deficient knowledge, related to medication regimen (Patient/Family Teaching)
- Keep patient well hydrated (1500–2000 mL/day) during therapy.
- Intramuscular: Administration should be deep into a well-developed muscle. Alternate injection sites.
- pH: 3.0–6.5.
- Intermittent Infusion: Diluent: Dilute each dose of tobramycin in 50–100 mL of D5W, D10W, D5/0.9% NaCl, 0.9% NaCl, Ringer’s or lactated Ringer’s solution. Concentration: not >10 mg/mL. Pediatric doses may be diluted in proportionately smaller amounts. Stable for 24 hr at room temperature, 96 hr if refrigerated. Also available in commercially mixed piggyback injections.
- Rate: Infuse slowly over 30–60 min in both adult and pediatric patients.
- Y-Site Compatibility: acyclovir, aldesleukin, alfentanil, alprostadil, amifostine, aminophylline, amiodarone, amsacrine, anidulafungin, ascorbic acid, atropine, aztreonam, bivalirudin, bumetanide, buprenorphine, butorphanol, calcium chloride, calcium gluconate, carboplatin, caspofungin, chloramphenicol, ciprofloxacin, cisatracurium, cisplatin, clindamycin, cyanocobalamin, cyclophosphamide, cyclosporine, cytarabine, dactinomycin, daptomycin, dexmedetomidine, digoxin, diltiazem, diphenhyrdamine, dobutamine, docetaxel, dopamine, doripenem, doxorubicin hydrochloride, doxorubicin liposome, doxycycline, enalaprilat, ephedrine, epinephrine, epirubicin, epoetin alfa, ertapenem, esmolol, etoposide, etoposide phosphate, famotidine, fenoldopam, fentanyl, filgrastim, fluconazole, fludarabine, fluorouracil, foscarnet, furosemide, gemcitabine, gentamicin, glycopyrrolate, granisetron, hydromorphone, ifosfamide, imipenem/cilastatin, isoproterenol, ketorolac, labetalol, levofloxacin, lidocaine, linezolid, lorazepam, magnesium sulfate, mannitol, mechlorethamine, melphalan, meperidine, metaraminol, methcillin, methotrexate, methyldopate, methylprednisolone, metoclopramide, metoprolol, metronidazole, miconazole, midazolam, milrinone, minocycline, mitoxantrone, morphine, multiple vitamins, nalbuphine, naloxone, nicardipine, nitroglycerin, nitroprusside, norepinephrine, octreotide, ondansetron, oxaliplatin, oxytocin, paclitaxel, palonosetron, pantoprazole, papaverine, pentazocine, phenobarbital, phentolamine, phenylephrine, phytonadione, potassium chloride, procainamide, prochlorperazine, promethazine, propranolol, protamine, pyridoxime, quinapristin/dalfopristin, ranitidine, remifentanil, rituximab, rocuronium, sodium acetate, sodium bicarbonate, streptokinase, succinylcholine, sufentanil, tacrolimus, teniposide, theophylline, thiamine, thiotepa, tigecycline, tirofiban, tolazoline, trastuzumab, vancomycin, vasopressin, vecuronium, verapamil, vincristine, vinorelbine, voriconazole, zidovudine
- Y-Site Incompatibility: allopurinol, amphotericin B cholesteryl, amphotericin B colloidal, amphotericin B liposome, azathioprine, azithromycin, cefazolin, cefoperazone, cefotetan, ceftriaxone, dantrolene, dexamethasone, diazepam, diazoxide, folic acid, ganciclovir, heparin, hetastarch, indomethacin, oxacillin, pemetrexed, pentamidine, pentobarbital, phenytoin, piperacillin/tazobactam, propofol, sargramostim, trimethoprim/sulfamethoxazole
- Inhalation: Do not mix TOBI with dornase alpha in nebulizer.
- TOBI Podhaler capsules are not for oral use. Store capsules in blister until immediately before use. Use new Podhaler device provided with each weekly packet. Check to see capsule is empty after inhaling. If powder remains in capsule, repeat inhalation until capsule is empty.
- Instruct patient to report signs of hypersensitivity, tinnitus, vertigo, hearing loss, rash, dizziness, or difficulty urinating.
- Advise patient of the importance of drinking plenty of liquids.
- Instruct patient to notify health care professional immediately if rash, diarrhea, abdominal cramping, fever, or bloody stools occur and not to treat with antidiarrheals without consulting health care professionals.
- Inhalation: Instruct patient to take inhalation twice daily as close to 12 hrs apart as possible; not <6 hrs apart. Solution is colorless to pale yellow and may darken with age without effecting quality. Administer over 15 min period using a hand-held PARI LC PLUS reusable nebulizer with a PARI VIOS (for Bethkis) or DeVibiss Pulmo Aide (for TOBI) compressor. Instruct patient on multiple therapies to take others first and use tobramycin last. Tobramycin-induced bronchospasm may be reduced if tobramycin is administered following bronchodilators. Instruct patient to sit or stand upright during inhalation and breathe normally through mouthpiece of nebulizer. Nose clips may help patient breathe through mouth. Store at room temperature for up to 28 days. Advise patient to disinfect the nebulizer parts (except tubing) by boiling them in water for a full 10 minutes every other treatment day.
- Instruct patient in correct technique for use of TOBI Podhaler. Wipe mouthpiece with clean, dry cloth after use; do not wash with water.
- Advise female patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
- Resolution of the signs and symptoms of infection. If no response is seen within 3–5 days, new cultures should be taken.