Tobramycin-injection

Tobramycin sulfate, a water-soluble antibiotic of the aminoglycoside group, is derived from the actinomycete Streptomyces tenebrarius. Sterile tobramycin sulfate is supplied as a sterile dry powder and is intended for reconstitution with 30 mL of Sterile Water for Injection, USP. Sulfuric acid and/or sodium hydroxide may have been added during manufacture to adjust the pH. † Each vial contains tobramycin sulfate equivalent to 1200 mg of tobramycin. After reconstitution, the solution will contain 40 mg of tobramycin per mL. The product contains no preservative or sodium bisulfite.

Tobramycin sulfate is 0-3-amino-3-deoxy-a-D-glucopyranosyl-(1→4)- 0-[2,6-diamino-2,3,6-trideoxy-a-D-ribo-hexopyranosyl-(1→6)]-2-deoxy- L-streptamine, sulfate (2:5)(salt) and has the chemical formula (C18H37N5O9)2•5H2SO4. The molecular weight is 1425.45. The structural formula for tobramycin is as follows:

The pharmacy bulk package of tobramycin for injection USP is a container of a sterile preparation for parenteral use that contains multiple single doses. It is intended for use in a pharmacy admixture program. Package use is restricted to the preparation of admixures for intravenous infusion or to the filling of empty sterile syringes for intravenous injections for patients with individualized dosing requirements.

† Each vial contains tobramycin sulfate equivalent to 1200 mg of tobramycin.

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, tobramycin 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 tobramycin as well as the risks.

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

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 tobramycin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to tobramycin 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, tobramycin 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

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 tobramycin, 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 tobramycin 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 tobramycin 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 tobramycin 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 tobramycin. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma or
• Sulfite allergy, history of—tobramycin 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.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Black, tarry stools
• bleeding gums
• blood in the urine or stools
• chills
• cloudy urine
• clumsiness
• continuing ringing or buzzing or other unexplained noise in the ears
• cough
• cracks in the skin
• decrease in the amount of urine
• dizziness or lightheadedness
• feeling of constant movement of self or surroundings
• feeling of fullness in the ears
• fever
• loss of balance
• loss of heat from the body
• loss or change in hearing
• nausea
• pale skin
• pinpoint red spots on the skin
• red, swollen skin
• scaly skin
• sensation of spinning
• shortness of breath
• sore throat
• trouble in hearing
• troubled breathing with exertion
• ulcers, sores, or white spots in the mouth
• unsteadiness
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting

Get emergency help immediately if any of the following symptoms of overdose occur:

• Inability to breath without assistance

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Confusion about identity, place, and time
• diarrhea
• headache
• hives or welts
• itching
• pain at the injection site
• redness of the skin
• skin rash
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.