Brand Names:

• Tobi

Dosage Forms:

• Solution

Uses of This Medicine:

Aminoglycosides are used to treat serious bacterial infections. They work by killing bacteria or preventing their growth.

Aminoglycosides are given by injection to treat serious bacterial infections in many different parts of the body. In addition, some aminoglycosides may be given by irrigation (applying a solution of the medicine to the skin or mucous membranes or washing out a body cavity) or by inhalation into the lungs. Streptomycin may also be given for tuberculosis (TB). These medicines may be given with 1 or more other medicines for bacterial infections, or they may be given alone. Aminoglycosides may also be used for other conditions as determined by your doctor. However, aminoglycosides will not work for colds, flu, or other virus infections.

Aminoglycosides given by injection are usually used for serious bacterial infections for which other medicines may not work. However, aminoglycosides 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 good these medicines may do as well as the risks of receiving them.

Aminoglycosides are to be administered only by or under the immediate supervision of your doctor.

Before Using This Medicine:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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.

Children

Children are especially sensitive to the effects of aminoglycosides. Damage to hearing, sense of balance, and kidneys is more likely to occur in premature infants and neonates.

Older adults

Elderly people are especially sensitive to the effects of aminoglycosides. Serious side effects, such as damage to hearing, sense of balance, and kidneys may occur in elderly patients.

Pregnancy

Studies on most of the aminoglycosides have not been done in pregnant women. Some reports have shown that aminoglycosides, especially streptomycin and tobramycin, may cause damage to the infant's hearing, sense of balance, and kidneys if the mother was receiving the medicine during pregnancy. However, this medicine may be needed in serious diseases or other situations that threaten the mother's life. Be sure you have discussed this with your doctor.

Breast-feeding

Aminoglycosides pass into breast milk in small amounts. However, they are not absorbed very much when taken by mouth. To date, aminoglycosides have not been reported to cause problems in nursing babies.

Other medicines

Using medicines in this class 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
• Cidofovir
• Cisatracurium
• Decamethonium
• Doxacurium
• Ethacrynic Acid
• Fazadinium
• Furosemide
• Gallamine
• Hexafluorenium
• Lysine
• Metocurine
• Mivacurium
• Pancuronium
• Pipecuronium
• Rapacuronium
• Rocuronium
• Succinylcholine
• Tacrolimus
• Tubocurarine
• Vancomycin
• Vecuronium

Other interactions

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 medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney disease Patients with kidney disease may have increased aminoglycoside blood levels and increased chance of side effects.

• Loss of hearing and/or balance (eighth-cranial-nerve disease) High aminoglycoside blood levels may cause hearing loss or balance disturbances.

• Myasthenia gravis or
• Parkinson's disease Aminoglycosides may cause muscular problems, resulting in further muscle weakness.

Proper Use of This Medicine:

To help clear up your infection completely, aminoglycosides must be given for the full time of treatment, even if you begin to feel better after a few days. Also, this medicine works best when there is a certain amount in the blood or urine. To help keep the correct level, aminoglycosides must be given on a regular schedule.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

The dose of most aminoglycosides is based on body weight and must be determined by your doctor. The medicine is injected into a muscle or vein. Depending on the aminoglycoside prescribed, doses are given at different times and for different lengths of time. These times are as follows:

• For all dosage forms:
  • Adults and children: The dose is given every eight or twelve hours for seven to ten days.
  • Newborn babies: The dose is given every twelve hours for seven to ten days.
  • Premature babies: The dose is given every eighteen to twenty-four hours for seven to ten days.

• For all dosage forms:
  • Adults and children: The dose is given every eight hours for seven to ten days or more.
  • Infants: The dose is given every eight to sixteen hours for seven to ten days or more.
  • Premature and full-term newborn babies: The dose is given every twelve to twenty-four hours for seven to ten days or more.

• For all dosage forms:
  • Adults and children: The dose is given every eight or twelve hours for seven to ten days.

• For all dosage forms:
  • Adults and children: The dose is given every eight or twelve hours for seven to fourteen days.

• For all dosage forms:
  • The dose of streptomycin is often not based on body weight and the amount given depends on the disease being treated.
    • Treatment of tuberculosis (TB):
      • Adults: Dose is based on body weight and must be determined by your doctor. This dose is injected into a muscle. The dosing schedule will also be determined by your doctor, usually once daily or twice weekly or three times-a-week. This medicine must be given with other medicines for tuberculosis (TB).
      • Children and adolescents: Dose is based on body weight and must be determined by your doctor. This dose is injected into a muscle. The dosing schedule will also be determined by your doctor, usually once daily or twice weekly or three times-a-week. This medicine must be given with other medicines for tuberculosis (TB).
    • Treatment of bacterial infections:
      • Adults: 250 to 500 milligrams of streptomycin is injected into a muscle every six hours; or 500 milligrams to 1 gram of streptomycin is injected into a muscle every twelve hours.
      • Children and adolescents: Dose is based on body weight and must be determined by your doctor. This dose is injected into a muscle every six to twelve hours.

• For all dosage forms:
  • Adults and adolescents: The dose is given every six to eight hours for seven to ten days or more.
  • Older infants and children: The dose is given every six to sixteen hours.
  • Premature and full-term newborn babies: The dose is given every twelve to twenty-four hours.

Side Effects of This Medicine:

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 immediately if any of the following side effects occur:

More common

Any loss of hearing

clumsiness or unsteadiness

dizziness

greatly increased or decreased frequency of urination or amount of urine

increased thirst

loss of appetite

muscle twitching, or convulsions (seizures

nausea or vomiting

numbness, tingling, or burning of face or mouth (streptomycin only)

ringing or buzzing or a feeling of fullness in the ears

Less common

Any loss of vision (streptomycin only)

skin rash, itching, redness, or swelling

Rare

(Once-daily or high dose gentamicin only-)

Chills

fever

shaking

Rare

(All aminoglycosides-)

Difficulty in breathing

drowsiness

weakness

In addition, leg cramps, skin rash, fever, and convulsions (seizures) may occur when gentamicin is given by injection into the muscle or a vein, and into the spinal fluid.

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

Any loss of hearing

clumsiness or unsteadiness

dizziness

greatly increased or decreased frequency of urination or amount of urine

increased thirst

loss of appetite

nausea or vomiting

ringing or buzzing or a feeling of fullness in the ears

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.