Nebcin

Name: Nebcin

Nebcin Drug Class

Nebcin is part of the drug class:

  • Other aminoglycosides

Uses For Nebcin

Tobramycin injection is used to treat serious bacterial infections in many different parts of the body.

Tobramycin belongs to the class of medicines known as aminoglycoside antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

Tobramycin injection is usually used for serious bacterial infections for which other medicines may not work. However, it may also cause some serious side effects, including damage to your hearing, sense of balance, and kidneys. These side effects may be more likely to occur in elderly patients and newborn infants. You and your doctor should talk about the benefits of this medicine as well as the risks.

This medicine is to be administered only by or under the immediate supervision of your doctor.

Before Using Nebcin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of tobramycin injection in children. However, this medicine should be used with caution in premature and newborn infants.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tobramycin injection in the elderly. However, elderly patients are more likely to develop unwanted effects and to have kidney problems, which may require caution and an adjustment in the dose for patients receiving tobramycin injection.

Pregnancy

Pregnancy Category Explanation
All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Ataluren

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alcuronium
  • Atracurium
  • Cholera Vaccine, Live
  • Cidofovir
  • Cisatracurium
  • Colistimethate Sodium
  • Decamethonium
  • Doxacurium
  • Ethacrynic Acid
  • Fazadinium
  • Foscarnet
  • Furosemide
  • Gallamine
  • Hexafluorenium
  • Lysine
  • Mannitol
  • Metocurine
  • Mivacurium
  • Pancuronium
  • Pipecuronium
  • Rapacuronium
  • Rocuronium
  • Succinylcholine
  • Tubocurarine
  • Vancomycin
  • Vecuronium

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Cisplatin
  • Cyclosporine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Asthma or
  • Sulfite allergy, history of—This medicine contains sodium bisulfite which may cause an allergic reaction in patients with these conditions.
  • Burns, extensive or
  • Cystic fibrosis—Use with caution. Your doctor may need to change your dose if you have these conditions.
  • Kidney disease—Higher blood levels of tobramycin may result, which increases the risk of serious side effects.
  • Kidney disease, severe or
  • Muscle problems or
  • Myasthenia gravis (severe muscle weakness) or
  • Nerve problems or
  • Parkinson's disease—Use with caution. May make these conditions worse.

Precautions While Using Nebcin

Your doctor will check your progress closely while you or your child are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to receive it. Blood, urine, hearing, and nerve tests may be needed to check for unwanted effects. Electrolytes (e.g., calcium, magnesium, and potassium) in the blood should also be monitored by your doctor.

If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have blistering, peeling, or loosening of the skin; itching; hives; hoarseness; shortness of breath; sores, ulcers, or white spots in the mouth or on the lips; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you receive this medicine.

Stop using this medicine and check with your doctor right away if you or your child have sudden decrease in hearing or loss of hearing, which may be accompanied by dizziness and ringing in the ears. Tell your doctor if you or your child have dizziness or lightheadedness; feeling of constant movement of self or surroundings; or sensation of spinning. These may be symptoms of damage to your hearing or sense of balance.

Check with your doctor right away if you or your child have blood in the urine, change in frequency of urination or amount of urine, difficulty with breathing, drowsiness, increased thirst, loss of appetite, nausea or vomiting, swelling of feet or lower legs, or weakness. These may be symptoms of a serious kidney problem.

This medicine may cause nerve problems. Check with your doctor right away if you or your child have numbness, skin tingling, muscle twitching, or seizures.

Make sure your doctor knows that you or your child are using this medicine before having a surgery or other procedures that require you to receive a numbing medicine (e.g., anesthetics, neuromuscular blocking agents). Using tobramycin injection together with numbing medicines may increase your risk of having difficulty in breathing, drowsiness, inability to breathe without assistance, or unusual tiredness or weakness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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 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 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.

Precautions

NARROW THERAPEUTIC INDEX:
-This drug should be considered a narrow therapeutic index (NTI) drug as small differences in dose or blood concentrations may lead to serious therapeutic failures or adverse drug reactions.
Recommendations:
- Generic substitution should be done cautiously, if at all, as current bioequivalence standards are generally insufficient for NTI drugs.
-Additional and/or more frequent monitoring should be done to ensure receipt of an effective dose while avoiding unnecessary toxicities.

Consult WARNINGS section for dosing related precautions.

(web3)