Tobramycin Inhaled

Tobramycin Inhaled is a prescription medication used for the management of pseudomonas aeruginosa infection in patients with cystic fibrosis. 

• Tobramycin Inhaled is available under the following different brand names: TOBI, Bethkis, TOBI Podhaler, Kitabis Pak

Common side effects of Tobramycin Inhaled include:

• Cough,
• Sore throat,
• Hoarse voice,
• Shortness of breath,
• Noisy breathing,
• Worsening of lung problems or cystic fibrosis,
• Coughing up mucus or blood,
• Altered sense of taste,
• Fever,
• Headache, and
• Rash

Serious side effects of Tobramycin Inhaled include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• New or worsening breathing problems,
• Wheezing,
• Cough,
• Chest tightness,
• Trouble breathing,
• Hearing problems,
• Ringing in your ears,
• Hoarse voice,
• Severe dizziness,
• Spinning sensation,
• Balance problems,
• Weak or shallow breathing,
• Muscle weakness,
• Little or no urination,
• Swelling of the feet or ankles,
• Tiredness, and
• Shortness of breath

Rare side effects of Tobramycin Inhaled include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Solution for nebulization

• 300 mg/4 mL ampule (Bethkis)
• 300 mg/5 mL ampule (TOBI, Kitabis Pak)
• NOTE: Kitabis Pak includes tobramycin solution and nebulizer (PARI LC PLUS reusable nebulizer and DeVilbiss Pulmo-Aide compressor)

Powder for inhalation

• 28 mg/capsule

Pseudomonas aeruginosa Infection

Adult dosage

• Nebulizer: 300 mg inhaled orally via nebulizer two times a day
• Powder for inhalation: 4 capsules (28 mg/capsule) inhaled orally two times a day
• Nebulizer or powder for inhalation: Use in repeated cycles of 28 days on the drug, followed by 28 days off the drug, then resume therapy with the next 28-day on/28-day off cycle

Pediatric dosage

• Below 6 years: Safety and efficacy not established
• Above 6 years
  • Nebulizer: 300 mg inhaled orally via nebulizer two times a day
  • Powder for inhalation: 4 capsules (28 mg/capsule) inhaled orally two times a day
  • Nebulizer or powder for inhalation: Use in repeated cycles of 28 days on the drug, followed by 28 days off the drug, then resume therapy with the next 28-day on/28-day off cycle

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Tobramycin Inhaled has severe interactions with no other drugs.
• Tobramycin Inhaled has serious interactions with no other drugs.
• Tobramycin Inhaled has moderate interactions with at least 88 other drugs.
• Tobramycin Inhaled has minor interactions with the following drug
  • entecavir

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Tobramycin Inhaled?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Tobramycin Inhaled?”

Cautions

• Known or suspected renal, auditory, vestibular, or neuromuscular dysfunction
• Carefully monitor if on concomitant parenteral aminoglycosides; therapy should be monitored as clinically appropriate for toxicities associated with aminoglycosides as a class; serum tobramycin levels should be monitored
• Tinnitus occurred in clinical trials of inhaled tobramycin; however, ototoxicity did not occur; postmarketing experience, patients receiving therapy have reported hearing loss; vestibular toxicity may be manifested by vertigo, ataxia or dizziness; patients with known or suspected auditory or vestibular dysfunction should be closely monitored when receiving therapy; monitoring might include obtaining audiometric evaluations and serum tobramycin levels; if ototoxicity is noted, the patient should be managed as medically appropriate, including potentially discontinuing therapy
• Nephrotoxicity not observed in clinical trials, but has been associated with aminoglycosides as a class; patients with known or suspected renal dysfunction or taking concomitant nephrotoxic drugs should have serum concentrations of tobramycin and laboratory measurements of the renal function obtained at the discretion of the treating physician; if nephrotoxicity develops, the patient should be managed as medically appropriate, including potentially discontinuing therapy
• May exacerbate muscular disorders (. g, myasthenia gravis, Parkinson’s disease); therapy may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function; neuromuscular blockade, respiratory failure, and prolonged respiratory paralysis may occur more commonly in patients with underlying neuromuscular disorders, such as myasthenia gravis or Parkinson’s disease
• Bronchospasm can occur; prolonged respiratory paralysis may occur in patients receiving concomitant neuromuscular blocking agents; if neuromuscular blockade occurs, it may be reversed by administration of calcium salts, but mechanical assistance may be necessary; bronchospasm that occurs during therapy should be treated as medically appropriate

Pregnancy and Lactation

• Aminoglycosides can cause fetal harm; aminoglycosides cross the placenta; published literature reports that the use of streptomycin, an aminoglycoside, can cause total, irreversible, bilateral congenital deafness when administered to a pregnant woman; although there is no available data on ophthalmic use of tobramycin in pregnant women to inform a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes, systemic absorption of tobramycin following inhaled administration is expected to be minimal
• There are risks to the mother associated with cystic fibrosis in pregnancy; in animal reproduction studies with subcutaneous administration of tobramycin in pregnant rats and rabbits during organogenesis, there were no adverse developmental outcomes; however, ototoxicity was not evaluated in the offspring from these studies; advise pregnant women of the potential risk to a fetus
• Cystic fibrosis may increase the risk of preterm delivery
• Lactation
  • There are no data on the presence of the drug in either human or animal milk, the effects on the breastfed infant, or the effects on milk production; limited published data on other formulations of tobramycin in lactating women indicate that tobramycin is present in human milk; however, systemic absorption of tobramycin following inhaled administration is expected to be minimal; therapy may cause alteration in intestinal flora of breastfeeding infant; the developmental and health benefits of breastfeeding should be considered along with mother's clinical need for therapy and any potential adverse effects on the breastfed infant from the drug or underlying maternal condition
  • Therapy may cause intestinal flora alteration; advise a woman to monitor the breastfed infant for loose or bloody stools and candidiasis (thrush, diaper rash)