Generic Name: Tobramycin Brand Name(s): Generics only. No brands available. Avability: Rx Pregnancy Category: N

Uses

What is Tobramycin used for?

Tobramycin is used to prevent or treat a wide variety of bacterial infections. Tobramycin belongs to a class of drugs known as aminoglycoside antibiotics. It works by stopping the growth of bacteria.

How should I take Tobramycin?

This medication is given by injection into a vein or muscle as directed by your doctor, usually every 8 hours. The dosage is based on your medical condition, weight, and response to treatment. Laboratory tests (such as kidney function, levels of drug in the blood) may be performed to help find the best dose for your condition.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

For the best effect, use this antibiotic at evenly spaced times. To help you remember, use this medication at the same time(s) every day.

Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may allow bacteria to continue to grow, which may result in a return of the infection.

Tell your doctor if your condition persists or worsens.

How do I store Tobramycin?

Tobramycin is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Tobramycin in the bathroom or the freezer. There may be different brands of Tobramycin that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Tobramycin down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Tobramycin?

Before using tobramycin, tell your doctor or pharmacist if you are allergic to it; or to other aminoglycoside antibiotics (such as gentamicin); or if you have any other allergies. This product may contain inactive ingredients (such as sulfites), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: cystic fibrosis, hearing problems (including deafness, decreased hearing), kidney problems, low blood minerals (including potassium, magnesium, calcium), myasthenia gravis, Parkinson’s disease.

Tobramycin may cause live bacterial vaccines (such as typhoid vaccine) to not work as well. Do not have any immunizations/vaccinations while using this medication unless your doctor tells you to.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the effects of this drug, especially kidney damage.

This medication is not recommended for use during pregnancy. Although there have been reports of harm in babies born to women using similar drugs, the risk for harm may not be the same with this drug. Discuss the risks and benefits with your doctor.

This drug passes into breast milk in very small amounts. However, many doctors consider breastfeeding safe while using this medication. Consult your doctor before breastfeeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Tobramycin during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Tobramycin. Tobramycin is pregnancy risk category N according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Tobramycin?

Nausea, vomiting, stomach upset, or loss of appetite may occur. Pain/irritation/redness at the injection site may rarely occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: numbness/tingling, muscle twitching or weakness, seizure.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor right away if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Tobramycin?

Other medications that may affect the kidneys or hearing may increase the risk of kidney damage or hearing loss if taken with tobramycin. Some affected drugs include: amikacin, amphotericin B, cidofovir, cisplatin, polymyxin B, cephalosporins such as cephaloridine, nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, among others.

Although most antibiotics are unlikely to affect hormonal birth control such as pills, patch, or ring, a few antibiotics (such as rifampin, rifabutin) can decrease their effectiveness. This could result in pregnancy. If you use hormonal birth control, ask your doctor or pharmacist for more details.

Tobramycin may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Tobramycin?

Tobramycin may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Tobramycin?

Tobramycin may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Tobramycin.

What is the dose of Tobramycin for an adult?

Usual Adult Dose for Bacteremia

Serious infections: 1 mg/kg IV or IM every 8 hours

Life-threatening infections: Up to 5 mg/kg/day may be administered IV or IM in 3 or 4 equal doses; however, the dosage should be reduced to 3 mg/kg/day as soon as clinically indicated.

Comments:

-To prevent increased toxicity due to excessive blood levels, dosage should not exceed 5 mg/kg/day unless serum levels are monitored.

-Limiting the duration of tobramycin therapy may help limit toxicity; once patient is stable for at least 48 hours, less toxic IV or oral antibiotic therapy may be considered according to microbiology sensitivity data.

Some experts recommend:

Extended-interval dosing: 4 to 7 mg/kg IV every 24 hours

Comments:

-A loading dose of 1.5 to 2 mg/kg has been recommended.

Usual Adult Dose for Intraabdominal Infection

Serious infections: 1 mg/kg IV or IM every 8 hours

Life-threatening infections: Up to 5 mg/kg/day may be administered IV or IM in 3 or 4 equal doses; however, the dosage should be reduced to 3 mg/kg/day as soon as clinically indicated.

Comments:

-To prevent increased toxicity due to excessive blood levels, dosage should not exceed 5 mg/kg/day unless serum levels are monitored.

-Limiting the duration of tobramycin therapy may help limit toxicity; once patient is stable for at least 48 hours, less toxic IV or oral antibiotic therapy may be considered according to microbiology sensitivity data.

Some experts recommend:

Extended-interval dosing: 4 to 7 mg/kg IV every 24 hours

Comments:

-A loading dose of 1.5 to 2 mg/kg has been recommended.

Usual Adult Dose for Osteomyelitis

Serious infections: 1 mg/kg IV or IM every 8 hours

Life-threatening infections: Up to 5 mg/kg/day may be administered IV or IM in 3 or 4 equal doses; however, the dosage should be reduced to 3 mg/kg/day as soon as clinically indicated.

Comments:

-To prevent increased toxicity due to excessive blood levels, dosage should not exceed 5 mg/kg/day unless serum levels are monitored.

-Limiting the duration of tobramycin therapy may help limit toxicity; once patient is stable for at least 48 hours, less toxic IV or oral antibiotic therapy may be considered according to microbiology sensitivity data.

Some experts recommend:

Extended-interval dosing: 4 to 7 mg/kg IV every 24 hours

Comments:

-A loading dose of 1.5 to 2 mg/kg has been recommended.

Usual Adult Dose for Pneumonia

Serious infections: 1 mg/kg IV or IM every 8 hours

Life-threatening infections: Up to 5 mg/kg/day may be administered IV or IM in 3 or 4 equal doses; however, the dosage should be reduced to 3 mg/kg/day as soon as clinically indicated.

Comments:

-To prevent increased toxicity due to excessive blood levels, dosage should not exceed 5 mg/kg/day unless serum levels are monitored.

-Limiting the duration of tobramycin therapy may help limit toxicity; once patient is stable for at least 48 hours, less toxic IV or oral antibiotic therapy may be considered according to microbiology sensitivity data.

Some experts recommend:

Extended-interval dosing: 4 to 7 mg/kg IV every 24 hours

Comments:

-A loading dose of 1.5 to 2 mg/kg has been recommended.

Usual Adult Dose for Pyelonephritis

Serious infections: 1 mg/kg IV or IM every 8 hours

Life-threatening infections: Up to 5 mg/kg/day may be administered IV or IM in 3 or 4 equal doses; however, the dosage should be reduced to 3 mg/kg/day as soon as clinically indicated.

Comments:

-To prevent increased toxicity due to excessive blood levels, dosage should not exceed 5 mg/kg/day unless serum levels are monitored.

-Limiting the duration of tobramycin therapy may help limit toxicity; once patient is stable for at least 48 hours, less toxic IV or oral antibiotic therapy may be considered according to microbiology sensitivity data.

Some experts recommend:

Extended-interval dosing: 4 to 7 mg/kg IV every 24 hours

Comments:

-A loading dose of 1.5 to 2 mg/kg has been recommended.

Usual Adult Dose for Skin or Soft Tissue Infection

Serious infections: 1 mg/kg IV or IM every 8 hours

Life-threatening infections: Up to 5 mg/kg/day may be administered IV or IM in 3 or 4 equal doses; however, the dosage should be reduced to 3 mg/kg/day as soon as clinically indicated.

Comments:

-To prevent increased toxicity due to excessive blood levels, dosage should not exceed 5 mg/kg/day unless serum levels are monitored.

-Limiting the duration of tobramycin therapy may help limit toxicity; once patient is stable for at least 48 hours, less toxic IV or oral antibiotic therapy may be considered according to microbiology sensitivity data.

Some experts recommend:

Extended-interval dosing: 4 to 7 mg/kg IV every 24 hours

Comments:

-A loading dose of 1.5 to 2 mg/kg has been recommended.

Usual Adult Dose for Bacterial Infection

Serious infections: 1 mg/kg IV or IM every 8 hours

Life-threatening infections: Up to 5 mg/kg/day may be administered IV or IM in 3 or 4 equal doses; however, the dosage should be reduced to 3 mg/kg/day as soon as clinically indicated.

Comments:

-To prevent increased toxicity due to excessive blood levels, dosage should not exceed 5 mg/kg/day unless serum levels are monitored.

-Limiting the duration of tobramycin therapy may help limit toxicity; once patient is stable for at least 48 hours, less toxic IV or oral antibiotic therapy may be considered according to microbiology sensitivity data.

Some experts recommend:

Extended-interval dosing: 4 to 7 mg/kg IV every 24 hours

Comments:

-A loading dose of 1.5 to 2 mg/kg has been recommended.

Usual Adult Dose for Sepsis

Serious infections: 1 mg/kg IV or IM every 8 hours

Life-threatening infections: Up to 5 mg/kg/day may be administered IV or IM in 3 or 4 equal doses; however, the dosage should be reduced to 3 mg/kg/day as soon as clinically indicated.

Comments:

-To prevent increased toxicity due to excessive blood levels, dosage should not exceed 5 mg/kg/day unless serum levels are monitored.

-Limiting the duration of tobramycin therapy may help limit toxicity; once patient is stable for at least 48 hours, less toxic IV or oral antibiotic therapy may be considered according to microbiology sensitivity data.

Some experts recommend:

Extended-interval dosing: 4 to 7 mg/kg IV every 24 hours

Comments:

-A loading dose of 1.5 to 2 mg/kg has been recommended.

Usual Adult Dose for Burns – External

Serious infections: 1 mg/kg IV or IM every 8 hours

Life-threatening infections: Up to 5 mg/kg/day may be administered IV or IM in 3 or 4 equal doses; however, the dosage should be reduced to 3 mg/kg/day as soon as clinically indicated.

Comments:

-To prevent increased toxicity due to excessive blood levels, dosage should not exceed 5 mg/kg/day unless serum levels are monitored.

-Limiting the duration of tobramycin therapy may help limit toxicity; once patient is stable for at least 48 hours, less toxic IV or oral antibiotic therapy may be considered according to microbiology sensitivity data.

-In patients with extensive burns, altered pharmacokinetics may result in reduced serum levels of aminoglycosides; measurement of tobramycin serum levels is recommended as basis for dose adjustment.

Some experts recommend: 2 to 2.5 mg/kg loading dose, followed by 1.7 to 2 mg/kg IV every 8 hours

Usual Adult Dose for Cystic Fibrosis

Parenteral:

IV: 5 to 10 mg/kg/day IV in 2 to 4 divided doses or 10 to 15 mg/kg/day IV in 3 to 4 divided doses; alternatively, 7 to 15 mg/kg IV every 24 hours has been used

Comments:

-In patients with cystic fibrosis, altered pharmacokinetics may result in reduced serum levels of aminoglycosides; measurement of tobramycin serum levels is recommended as basis for dose adjustment.

-In patients with severe cystic fibrosis, an initial dosing regimen of 10 mg/kg/day in 4 equally divided doses is suggested only as a guide by the manufacturer.

-The serum levels of tobramycin should be measured directly during therapy due to wide interpatient variability.

Inhalation:

Inhalation Solution: 300 mg via nebulizer over approximately 15 minutes twice a day

Inhalation Powder: Using the Podhaler(TM) device, inhale the contents of four 28 mg capsules twice a day

Duration of therapy: 28 days

Comments:

-Doses should be inhaled as close to 12 hours apart as possible and not less than 6 hours apart.

-Administer in alternating cycles of 28 days on and 28 days off.

-If patient is on multiple therapies, the following order of administration has been recommended: bronchodilator, chest physiotherapy, other inhaled medications, and lastly, inhaled tobramycin.

-Safety and efficacy have not been established in patients colonized with Burkholderia cepacia.

-Bethkis(R): Safety and efficacy have not been established in patients with forced expiratory volume in 1 second (FEV1) less than 40% or greater than 80% predicted.

-TOBI(R): Safety and efficacy have not been established in patients with FEV1 less than 25% or greater than 75% predicted.

-TOBI(R) Podhaler(TM): Safety and efficacy have not been established in patients with FEV1 less than 25% or greater than 80% predicted.

Approved indication: The management of cystic fibrosis patients with Pseudomonas aeruginosa

Usual Adult Dose for Endocarditis

Serious infections: 1 mg/kg IV or IM every 8 hours

Life-threatening infections: Up to 5 mg/kg/day may be administered IV or IM in 3 or 4 equal doses; however, the dosage should be reduced to 3 mg/kg/day as soon as clinically indicated.

Comments:

-To prevent increased toxicity due to excessive blood levels, dosage should not exceed 5 mg/kg/day unless serum levels are monitored.

-Some experts recommend a loading dose of 1.5 to 2 mg/kg.

American Heart Association, Infectious Diseases Society of America (IDSA) recommendations:

Preferred regimen for infective endocarditis due to Pseudomonas aeruginosa: 8 mg/kg IV or IM once a day

Comments:

-Maintenance of peak levels of 15 to 20 mcg/mL and trough levels of 2 mcg/mL or less is recommended.

-Tobramycin should be administered in combination with either an extended-spectrum penicillin (e.g., ticarcillin, piperacillin) or ceftazidime or cefepime in full doses.

-The toxicity associated with this regimen has been reported as low; combination therapy should be given for at least 6 weeks.

Usual Adult Dose for Meningitis

Serious infections: 1 mg/kg IV or IM every 8 hours

Life-threatening infections: Up to 5 mg/kg/day may be administered IV or IM in 3 or 4 equal doses; however, the dosage should be reduced to 3 mg/kg/day as soon as clinically indicated.

Comments:

-To prevent increased toxicity due to excessive blood levels, dosage should not exceed 5 mg/kg/day unless serum levels are monitored.

-Some experts recommend a loading dose of 2 mg/kg.

-Parenteral therapy should be continued for at least 1 week after the patient becomes afebrile and cerebrospinal fluid (CSF) normalizes.

IDSA recommendations:

Parenteral: 5 mg/kg/day IV or IM in 3 divided doses

Intraventricular: 5 to 20 mg intraventricularly (preservative-free formulation) per day; subsequent doses should be based on the CSF concentration

Duration of therapy:

Neisseria meningitidis: 7 days

Haemophilus influenzae: 7 days

Streptococcus pneumoniae: 10 to 14 days

Streptococcus agalactiae: 14 to 21 days

Aerobic gram-negative bacilli: 21 days

Listeria monocytogenes: 21 days or longer

Comments:

-These guidelines are not standardized and the duration of therapy should be individualized based on the patient’s clinical response.

-IV antimicrobial therapy is recommended for the duration of therapy to ensure that adequate CSF levels are attained.

Usual Adult Dose for Peritonitis

Serious infections: 1 mg/kg IV or IM every 8 hours

Life-threatening infections: Up to 5 mg/kg/day may be administered IV or IM in 3 or 4 equal doses; however, the dosage should be reduced to 3 mg/kg/day as soon as clinically indicated.

Comments:

-To prevent increased toxicity due to excessive blood levels, dosage should not exceed 5 mg/kg/day unless serum levels are monitored.

-Limiting the duration of tobramycin therapy may help limit toxicity; once patient is stable for at least 48 hours, less toxic IV or oral antibiotic therapy may be considered according to microbiology sensitivity data.

Some experts recommend:

IV: 2 mg/kg loading dose, followed by 1.7 mg/kg IV every 8 hours or 5 mg/kg IV every 24 hours

Intraperitoneal in CAPD patients: 0.6 to 0.75 mg/kg intraperitoneally once a day or 16 to 20 mg per every 2 L dialysate

Usual Adult Dose for Shunt Infection

(Not approved by FDA)

IDSA recommendations: 5 to 20 mg intraventricularly (preservative-free formulation) up to every 24 hours, in addition to parenteral antibiotic therapy

Comments:

-Subsequent doses should be based on the CSF concentration.

-Shunt removal is usually necessary to achieve a cure.

Renal Dose Adjustments

Parenteral:

Adults:

Dosage should be adjusted in renal insufficiency. Various nomograms and methods have been proposed for determining the dosage in renally impaired adult patients – reduced doses at fixed intervals or normal doses at prolonged intervals. Regimens are ideally based on individualized pharmacokinetic dosing.

Manufacturer recommendations for patients with impaired renal function: Following a loading dose of 1 mg/kg, subsequent doses should be adjusted, either with reduced doses administered at 8-hour intervals or with normal doses given at prolonged intervals. Both methods are suggested as guides to be used when tobramycin serum levels cannot be measured directly. They are based on either the CrCl or the serum creatinine of the patient (these values correlate with the half-life of tobramycin). The regimens derived from either method should be used in conjunction with careful clinical and laboratory monitoring and should be modified as necessary.

The following adjustments have been suggested:

CrCl 40 to 60 mL/min: Normal dose administered IV or IM every 12 hours

CrCl 20 to 40 mL/min: Normal dose administered IV or IM every 24 hours

CrCl 10 to 20 mL/min: Normal dose administered IV or IM every 48 hours

CrCl less than 10 mL/min: Normal dose administered IV or IM every 72 hours

The following adjustments to the maintenance dose have been suggested (modified from Sarubbi and Hull, 1978):

CrCl 70 to 80 mL/min: 76% to 91% of the loading dose every 8 to 12 hours

CrCl 60 to 70 mL/min: 71% to 88% of the loading dose every 8 to 12 hours

CrCl 50 to 60 mL/min: 65% to 84% of the loading dose every 8 to 12 hours

CrCl 40 to 50 mL/min: 72% to 92% of the loading dose every 12 to 24 hours

CrCl 30 to 40 mL/min: 63% to 92% of the loading dose every 12 to 24 hours

CrCl 20 to 30 mL/min: 50% to 81% of the loading dose every 12 to 24 hours

CrCl 10 to 20 mL/min: 34% to 75% of the loading dose every 12 to 24 hours

CrCl less than 10 mL/min: 21% to 47% of the loading dose every 24 hours or a one-time loading dose with subsequent doses based on serum concentrations, estimated clearance and the patient’s condition

Extended-interval dosing (dose and interval adjustment):

CrCl 80 mL/min or more: 5 to 7 mg/kg every 24 hours

CrCl 60 to 79 mL/min: 4 to 5.5 mg/kg every 24 hours

CrCl 50 to 59 mL/min: 3.5 to 5 mg/kg every 24 hours

CrCl 40 to 49 mL/min: 2.5 to 3.5 mg/kg every 24 hours

CrCl 30 mL/min: 2 to 2.8 mg/kg every 24 hours

CrCl 20 mL/min: 4 to 5 mg/kg every 48 hours

CrCl 10 mL/min: 3 to 4 mg/kg every 48 hours

Extended-interval dosing (constant dose with interval adjustment):

CrCl 61 mL/min or more: 7 mg/kg every 24 hours

CrCl 40 to 60 mL/min: 7 mg/kg every 36 hours

CrCl 20 to 40 mL/min: 7 mg/kg every 48 hours; monitor serum levels

CrCl less than 20 mL/min: 7 mg/kg once; repeat when trough level is less than 1 mcg/mL

Inhalation:

If nephrotoxicity is suspected, therapy should be discontinued until tobramycin serum concentrations fall below 2 mcg/mL.

Liver Dose Adjustments

No adjustment recommended.

Dose Adjustments

Parenteral: In obese patients, the appropriate parenteral dose may be calculated by using the estimated lean body weight plus 40% of the excess as the basic weight on which to figure mg/kg.

Inhalation: No dosage adjustments are made.

Dialysis

Parenteral:

In patients undergoing dialysis, 25% to 70% of the administered dose may be removed, depending on the duration and type of dialysis.

The following adjustments have been suggested:

Adults:

Intermittent hemodialysis (3 times/week, complete sessions): 2 to 3 mg/kg IV once as a loading dose, with subsequent doses based on serum concentrations, estimated clearance, and the patient’s condition; doses should be administered following dialysis

Peritoneal dialysis: Normal dose administered IV or IM every 72 hours; concentrations should be monitored

Pediatric hemodialysis patients:

1 month or older: 1.25 to 1.75 mg/kg/dose IV or IM after dialysis

What is the dose of Tobramycin for a child?

Usual Pediatric Dose for Bacterial Infection

Manufacturer recommendations:

Premature or full-term neonates 1 week of age or less: Up to 4 mg/kg/day may be administered IV or IM in 2 equal doses every 12 hours.

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

American Academy of Pediatrics (AAP) recommendations:

7 days or less, 2000 g or less: 5 mg/kg IV or IM every 48 hours

7 days or less, greater than 2000 g: 4 mg/kg IV or IM every 24 hours

8 to 28 days, 2000 g or less: 4 to 5 mg/kg IV or IM every 24 to 48 hours

8 to 28 days, greater than 2000 g: 4 mg/kg IV or IM every 12 to 24 hours

1 month or older: 1 to 2.5 mg/kg IV or IM every 8 hours for severe infections

Comments (AAP):

-The longer dosing interval may be used in extremely low birth weight (less than 1000 g) neonates until 2 weeks of life.

-Tobramycin is not appropriate for the treatment of mild to moderate infections in patients 1 month or older.

-Measurement of serum levels is recommended in order to individualize and optimize dosing.

Usual Pediatric Dose for Cystic Fibrosis

Parenteral:

IV or IM: 2.5 mg/kg IV or IM every 6 hours or 3.3 mg/kg IV or IM every 8 hours

Comments:

-In patients with severe cystic fibrosis, an initial dosing regimen of 10 mg/kg/day in 4 equally divided doses is suggested only as a guide by the manufacturer.

-The AAP states that higher doses (8 to 10 mg/kg/day) are appropriate for pulmonary exacerbations in patients with cystic fibrosis.

-In patients with cystic fibrosis, altered pharmacokinetics may result in reduced serum levels of aminoglycosides; measurement of tobramycin serum levels is recommended as basis for dose adjustment.

-The serum levels of tobramycin should be measured directly during therapy due to wide interpatient variability.

Inhalation:

6 years or older:

Inhalation Solution: 300 mg via nebulizer over approximately 15 minutes twice a day

Inhalation Powder: Using the Podhaler(TM) device, inhale the contents of four 28 mg capsules twice a day

Duration of therapy: 28 days

Comments:

-Doses should be inhaled as close to 12 hours apart as possible and not less than 6 hours apart.

-Administer in alternating cycles of 28 days on and 28 days off.

-If patient is on multiple therapies, the following order of administration has been recommended: bronchodilator, chest physiotherapy, other inhaled medications, and lastly, inhaled tobramycin.

-Safety and efficacy have not been established in patients colonized with B cepacia.

-TOBI(R): Safety and efficacy have not been established in patients with FEV1 less than 25% or greater than 75% predicted.

-Bethkis(R): Safety and efficacy have not been established in patients with FEV1 less than 40% or greater than 80% predicted.

-TOBI(R) Podhaler(TM): Safety and efficacy have not been established in patients with FEV1 less than 25% or greater than 80% predicted.

Approved indication: The management of cystic fibrosis patients with P aeruginosa

How is Tobramycin available?

Tobramycin is available in the following dosage forms and strengths:

  • Injectable solution,
  • Injectable powder for injection,
  • Intravenous solution,
  • Inhalation solution,
  • Inhalation capsule,
  • Compounding powder

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Tobramycin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

 

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: August 9, 2018 | Last Modified: August 9, 2018

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