Tobi

DRUG DESCRIPTION

TOBI® is a tobramycin solution for inhalation. It is a sterile, clear, slightly yellow, non-pyrogenic, aqueous solution with the pH and salinity adjusted specifically for administration by a compressed air driven reusable nebulizer. The chemical formula for tobramycin is C18H37N5O9 and the molecular weight is 467.52. Tobramycin is O-3-amino-3-deoxy-?-D-glucopyranosyl-(1?4)-O-[2,6-diamino-2,3,6-trideoxy-?-D-ribo-hexopyranosyl-(1?6)]-2-deoxy-L-streptamine. The structural formula for tobramycin is:

TOBI (Tobramycin) Structural Formula Illustration

Each single-use 5 mL ampule contains 300 mg tobramycin and 11.25 mg sodium chloride in sterile water for injection. Sulfuric acid and sodium hydroxide are added to adjust the pH to 6.0. Nitrogen is used for sparging. All ingredients meet USP requirements. The formulation contains no preservatives.

What are the possible side effects of tobramycin (Tobi)?

If you experience any of the following serious side effects, stop using tobramycin and seek emergency medical attention or notify your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • ringing in the ears or changes in hearing;
  • dizziness;
  • new or worsening respiratory problems or difficulty breathing;
  • muscle weakness; or
  • a rash.

If you experience any of the following less serious...

Read All Potential Side Effects and See Pictures of Tobi »

What are the precautions when taking tobramycin (Tobi)?

Before using tobramycin inhalation solution, 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, 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: hearing problems (including deafness, decreased hearing), kidney problems, myasthenia gravis, Parkinson's disease.

Tobramycin may cause live bacterial vaccines (such as typhoid vaccine) not to work as well. Therefore, do not have any immunizations/vaccinations while using this medication without the consent of your doctor.

Before...

Read All Potential Precautions of Tobi »


Tobi Consumer (continued)

SIDE EFFECTS: Hoarseness and changes in voice may 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 immediately if any of these unlikely but serious side effects occur: signs of hearing damage (such as ringing/roaring sounds in the ears, hearing loss, dizziness), unusual decrease in the amount of urine.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, wheezing/unusual trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using tobramycin inhalation solution, 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, 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: hearing problems (including deafness, decreased hearing), kidney problems, myasthenia gravis, Parkinson's disease.

Tobramycin may cause live bacterial vaccines (such as typhoid vaccine) not to work as well. Therefore, do not have any immunizations/vaccinations while using this medication without the consent of your doctor.

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

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.

It is unknown if inhaled tobramycin passes into breast milk. However, other forms of this drug pass into breast milk in very small amounts, and many doctors consider breastfeeding safe while using this drug. Consult your doctor before breastfeeding.


Tobi Patient Information Including Side Effects

Brand Names: Tobi

Generic Name: tobramycin (inhalation) (Pronunciation: toe bra MY sin)

  • What is tobramycin (Tobi)?
  • What are the possible side effects of tobramycin (Tobi)?
  • What is the most important information I should know about tobramycin (Tobi)?
  • What should I discuss with my healthcare provider before using tobramycin (Tobi)?
  • How should I use tobramycin (Tobi)?
  • What happens if I miss a dose (Tobi)?
  • What happens if I overdose (Tobi)?
  • What should I avoid while using tobramycin (Tobi)?
  • What other drugs will affect tobramycin (Tobi)?
  • Where can I get more information?

What is tobramycin (Tobi)?

Tobramycin is an antibiotic. It fights bacteria in the body.

Tobramycin inhalation is inhaled into the lungs using a nebulizer. Tobramycin inhalation is used to treat lung infections in patients with cystic fibrosis.

Tobramycin may also be used for purposes other than those listed here.

What are the possible side effects of tobramycin (Tobi)?

If you experience any of the following serious side effects, stop using tobramycin and seek emergency medical attention or notify your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • ringing in the ears or changes in hearing;
  • dizziness;
  • new or worsening respiratory problems or difficulty breathing;
  • muscle weakness; or
  • a rash.

If you experience any of the following less serious side effects, continue using tobramycin and talk to your doctor:

  • changes in voice; or
  • unpleasant taste or odor of the medication.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about tobramycin (Tobi)?

Notify your doctor immediately if you develop ringing in the ears, dizziness, or changes in hearing during treatment with tobramycin.

To reduce the risk of illness, infection, or injury from contamination, you must thoroughly clean all parts of the nebulizer as directed after each treatment.

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