Tobramycin

Name: Tobramycin

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Tobi Interactions

Tell your doctor(s) and pharmacist about all prescription, over-the-counter, illegal, recreational, herbal, nutritional, or vitamin-containing drugs and supplements you're taking.

You shouldn't take Tobi if you are taking the following drugs:

Aridol (mannitol)
Diuretics ("water pills") such as Bumex (bumetanide), Demadex (torsemide), Edacryn (ethacrynic acid), and Lasix (furosemide)

Other drugs that may have serious interactions with Tobi include:

ACE inhibitors, including Vasotec (enalapril) and Zestril (lisinopril)
Certain cancer drugs, like carboplatin, Eloxatin (oxaliplatin), Marqibo (vincristine), and Platinol (cisplatin)
Certain diabetes medications, like Jardiance (empagliflozin), Tanzeum (albiglutide), and Trulicity (dulaglutide)
Drugs for erectile dysfunction, like Cialis or Adcirca (tadalafil), Levitra or Staxyn (vardenafil), and Viagra (sildenafil)
Fluoroquinolone antibiotics, like Avelox (moxifloxacin), Cipro (ciprofloxacin), and Levaquin (levofloxacin)
HIV/AIDS medications, like Baraclude (entecavir) and Zidovir (zidovudine)
Other aminoglycoside antibiotics, like amikacin, Garamycin (gentamicin), and kanamycin

In addition, many medications and food products contain the preservative sodium benzoate, which can interact with Tobi.

Tobi and Alcohol

Both Tobi and alcohol can cause problems with maintaining your balance, and drinking while using Tobi or other drugs containing tobramycin may worsen these side effects.

For best results, try to avoid — or at least limit — drinking alcohol while using Tobi.

Tobi and Grapefruit Juice

Scientists know that the liver breaks down Tobi, but they aren't sure whether it breaks down certain chemicals found in grapefruit the same way.

To avoid any possible interactions, try to steer clear of grapefruit and grapefruit juice while taking Tobi.

Warnings

Caution should be exercised when prescribing TOBI to patients with known or suspected renal, auditory, vestibular, or neuromuscular dysfunction. Patients receiving concomitant parenteral aminoglycoside therapy should be monitored as clinically appropriate.

Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycosides cross the placenta, and streptomycin has been associated with several reports of total, irreversible, bilateral congenital deafness in pediatric patients exposed in utero. Patients who use TOBI during pregnancy, or become pregnant while taking TOBI should be apprised of the potential hazard to the fetus.

Ototoxicity

Ototoxicity, as measured by complaints of hearing loss or by audiometric evaluations, did not occur with TOBI therapy during clinical studies. However, transient tinnitus occurred in eight TOBI-treated patients versus no placebo patients in the clinical studies. Tinnitus may be a sentinel symptom of ototoxicity, and therefore the onset of this symptom warrants caution (see ADVERSE REACTIONS). Ototoxicity, manifested as both auditory and vestibular toxicity, has been reported with parenteral aminoglycosides. Vestibular toxicity may be manifested by vertigo, ataxia or dizziness.

In postmarketing experience, patients receiving TOBI have reported hearing loss. Some of these reports occurred in patients with previous or concomitant treatment with systemic aminoglycosides. Patients with hearing loss frequently reported tinnitus.

Nephrotoxicity

Nephrotoxicity was not seen during TOBI clinical studies but has been associated with aminoglycosides as a class. If nephrotoxicity occurs in a patient receiving TOBI, tobramycin therapy should be discontinued until serum concentrations fall below 2 mcg/mL.

Muscular Disorders

TOBI should be used cautiously in patients with neuromuscular disorders, such as myasthenia gravis or Parkinson's disease, since aminoglycosides may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function.

Bronchospasm

Bronchospasm has been reported with inhalation of TOBI. In clinical studies of TOBI, changes in FEV1 measured after the inhaled dose were similar in the TOBI and placebo groups. Bronchospasm should be treated as medically appropriate.

What should i discuss with my healthcare provider before using tobramycin (tobi)?

Do not use tobramycin without first talking to your doctor if you have had an allergic reaction to an aminoglycoside antibiotic such as tobramycin (Nebcin, Tobi), gentamicin (Garamycin, others), amikacin (Amikin), kanamycin (Kantrex), streptomycin, paromomycin, or neomycin.

Talk to your doctor before using tobramycin if you have

hearing problems;
a neuromuscular disease such as myasthenia gravis or Parkinson's disease; or
kidney disease.

You may not be able to use tobramycin, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Tobramycin is in the FDA pregnancy category D. This means that it is known to be harmful to an unborn baby. Tobramycin is known to cause deafness in the baby when taken during pregnancy. Do not use tobramycin without first talking to your doctor if you are pregnant or could become pregnant during treatment.

It is not known whether tobramycin passes into breast milk. Do not use tobramycin without first talking to your doctor if you are breast-feeding a baby.

Where can i get more information?

Your pharmacist has additional information about tobramycin written for health professionals that you may read.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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Tobramycin Food Interactions

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of tobramycin, there are no specific foods that you must exclude from your diet when receiving this medication.

Tobramycin Overdose

If you take too much tobramycin, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If tobramycin is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Forms of Medication

Tobramycin Dosage and Administration

Tobramycin may be given intramuscularly or intravenously. Recommended dosages are the same for both routes. The patient's pretreatment body weight should be obtained for calculation of correct dosage. It is desirable to measure both peak and trough serum concentrations (see WARNINGS box and PRECAUTIONS).

Administration for Patients with Normal Renal Function

Adults with Serious Infections: 3 mg/kg/day in 3 equal doses every 8 hours (see Table 3).

Adults With Life-Threatening Infections: Up to 5 mg/kg/day may be administered in 3 or 4 equal doses (see Table 3). The dosage should be reduced to 3 mg/kg/day as soon as clinically indicated. To prevent increased toxicity due to excessive blood levels, dosage should not exceed 5 mg/kg/day unless serum levels are monitored (see WARNINGS box and PRECAUTIONS).

Table 3 DOSAGE SCHEDULE GUIDE FOR ADULTS WITH NORMAL RENAL FUNCTION (Dosage at 8-Hour Intervals)

* Applicable to all product forms except the Tobramycin Injection Pediatric, 10 mg/mL (see HOW SUPPLIED)
For Patient Weighing		Usual Dose for Serious Infection 1 mg/kg q8h (Total, 3mg/ kg/day/)
kg	lb	mg/dose	mL/dose*
		q8h
120	264	120 mg	3 mL
115	253	115 mg	2.9 mL
110	242	110 mg	2.75 mL
105	231	105 mg	2.6 mL
100	220	100 mg	2.5 mL
95	209	95 mg	2.4 mL
90	198	90 mg	2.25 mL
85	187	85 mg	2.1 mL
80	176	80 mg	2 mL
75	165	75 mg	1.9 mL
70	154	70 mg	1.75 mL
65	143	65 mg	1.6 mL
60	132	60 mg	1.5 mL
55	121	55 mg	1.4 mL
50	110	50 mg	1.25 mL
45	99	45 mg	1.1 mL
40	88	40 mg	1 mL
For Patient Weighing		Maximum Dose for Life- Threatening Infections (Reduce as soon as possible)
		1.66 mg/kg q8h (Total, 5 mg/kg/day)
kg	lb	mg/dose	mL/dose*
		q8h
120	264	200 mg	5 mL
115	253	191 mg	4.75 mL
110	242	183 mg	4.5 mL
105	231	175 mg	4.4 mL
100	220	166 mg	4.2 mL
95	209	158 mg	4 mL
90	198	150 mg	3.75 mL
85	187	141 mg	3.5 mL
80	176	133 mg	3.3 mL
75	165	125 mg	3.1 mL
70	154	116 mg	2.9 mL
65	143	108 mg	2.7 mL
60	132	100 mg	2.5 mL
55	121	91 mg	2.25 mL
50	110	83 mg	2.1 mL
45	99	75 mg	1.9 mL
40	88	66 mg	1.6 mL

Pediatric Patients (greater than 1 week of age): 6 to 7.5 mg/kg/day in 3 or 4 equally divided doses (2 to 2.5 mg/kg every 8 hours or 1.5 to 1.89 mg/kg every 6 hours).

Premature or Full-Term Neonates 1 Week of Age or Less: Up to 4 mg/kg/day may be administered in 2 equal doses every 12 hours.

It is desirable to limit treatment to a short term. The usual duration of treatment is 7 to 10 days. A longer course of therapy may be necessary in difficult and complicated infections. In such cases, monitoring of renal, auditory, and vestibular functions is advised, because neurotoxicity is more likely to occur when treatment is extended longer than 10 days.

Dosage in Patients with Cystic Fibrosis

In patients with cystic fibrosis, altered pharmacokinetics may result in reduced serum concentrations of aminoglycosides. Measurement of Tobramycin serum concentration during treatment is especially important as a basis for determining appropriate dose. In patients with severe cystic fibrosis, an initial dosing regimen of 10 mg/kg/day in 4 equally divided doses is recommended. This dosing regimen is suggested only as a guide. The serum levels of Tobramycin should be measured directly during treatment due to wide interpatient variability.

Administration for Patients with Impaired Renal Function

Whenever possible, serum Tobramycin concentrations should be monitored during therapy.

Following a loading dose of 1 mg/kg, subsequent dosage in these patients must be adjusted, either with reduced doses administered at 8-hour intervals or with normal doses given at prolonged intervals. Both of these methods are suggested as guides to be used when serum levels of Tobramycin cannot be measured directly. They are based on either the creatinine clearance level or the serum creatinine level of the patient because these values correlate with the half-life of Tobramycin. The dosage schedule derived from either method should be used in conjunction with careful clinical and laboratory observations of the patient and should be modified as necessary.

Neither method should be used when dialysis is being performed.

Reduced dosage at 8-hour intervals: When the creatinine clearance rate is 70 mL or less per minute or when the serum creatinine value is known, the amount of the reduced dose can be determined by multiplying the normal dose from Table 3 by the percent of normal dose from the accompanying nomogram.

* Scales have been adjusted to facilitate dosage calculations.

REDUCED DOSAGE NOMOGRAM *

An alternate rough guide for determining reduced dosage at 8-hour intervals (for patients whose steady-state serum creatinine values are known) is to divide the normally recommended dose by the patient's serum creatinine.

Normal dosage at prolonged intervals: If the creatinine clearance rate is not available and the patient's condition is stable, a dosage frequency in hours for the dosage given in Table 3can be determined by multiplying the patient's serum creatinine by 6.

Dosage in Obese Patients

The appropriate dose may be calculated by using the patient's estimated lean body weight plus 40% of the excess as the basic weight on which to figure mg/kg.

Intramuscular Administration

Tobramycin may be administered by withdrawing the appropriate dose directly from a vial.

Intravenous Administration

For intravenous administration, the usual volume of diluent (0.9% Sodium Chloride Injection or 5% Dextrose Injection) is 50 to 100 mL for adult doses. For pediatric patients, the volume of diluent should be proportionately less than that for adults. The diluted solution usually should be infused over a period of 20 to 60 minutes. Infusion periods of less than 20 minutes are not recommended because peak serum levels may exceed 12 mcg/mL (see WARNINGS box).

Tobramycin injection should not be physically premixed with other drugs but should be administered separately according to the recommended dose and route.

Prior to administration, parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.

How is Tobramycin Supplied

Tobramycin Injection, USP, in multiple dose vials, is supplied as follows:

For IV or IM Multiple-Dose Use:

NDC 36000-244-05 40 mg/mL, 2 mL vial; Open blister Pack of 05 Vials
NDC 36000-244-10 40 mg/mL, 2 mL vial; Open blister Pack of 10 Vials
NDC 36000-244-25 40 mg/mL, 2 mL vial; Open blister Pack of 25 Vials