Sivextro is an antibiotic that fights bacteria.

Sivextro is used to treat skin infections in people 12 years of age and older, including "MRSA" staph infections.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Sivextro and other antibacterial drugs, this medicine should only be used to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.

Sivextro should only be used to treat bacterial infections. Tedizolid does not treat viral infections (e.g., the common cold).

While it is common to feel better early in the course of therapy, Sivextro should be taken exactly as directed. Skipping doses or not completing the full course of therapy may decrease the effectiveness of the immediate treatment and increase the likelihood that bacteria will develop resistance and will not be treatable in the future.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You should not use Sivextro if you are allergic to tedizolid.

Tell your doctor if you have recently been sick with diarrhea, a fever, cold or flu symptoms, cough, or sore throat.

Tell your doctor if you have ever had diarrhea while taking antibiotics.

Tedizolid may harm an unborn baby. Tell your doctor if you are pregnant.

It may not be safe to breastfeed while using tedizolid. Ask your doctor about any risk.

Sivextro is not approved for use by anyone younger than 12 years old.

Use Sivextro exactly as prescribed by your doctor. Follow Follow all directions on your prescription label and read all medication guides or instruction sheets.

Sivextro oral is taken by mouth. Take this medicine at the same time each day, with or without food.

Sivextro injection is given as an infusion into a vein. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself. The injection must be given slowly, and the infusion can take at least 1 hour to complete.

Sivextro injection must be mixed with a liquid (diluent) before using it. When using injections by yourself, be sure you understand how to properly mix and store the medicine. Use only the diluent provided with your medicine.

Gently swirl but do not shake the mixed medicine. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication. Tedizolid will not treat a viral infection such as the flu or a common cold.

Store Sivextro tablets at room temperature away from moisture and heat.

Keep each tablet in its blister pack until you are ready to take it. Prepare your injection dose only when you are ready to give an injection.

After mixing Sivextro injection, you may store the mixture for up to 24 hours at room temperature or in a refrigerator.

Each single-use injection vial (bottle) is for one use only. Throw the vial away after one use, even if there is still medicine left inside.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Usual Adult Dose for Skin and Structure Infection:

200 mg IV or orally once a day for 6 days

Use: For the treatment of acute bacterial skin and skin structure infections due to susceptible isolates of Staphylococcus aureus (including methicillin-resistant and methicillin-susceptible isolates), Streptococcus pyogenes, S agalactiae, S anginosus group (including S anginosus, S intermedius, and S constellatus), Enterococcus faecalis

Usual Pediatric Dose for Skin and Structure Infection:

12 years or older: 200 mg IV or orally once a day for 6 days

Use: For the treatment of acute bacterial skin and skin structure infections due to susceptible isolates of S aureus (including methicillin-resistant and methicillin-susceptible isolates), S pyogenes, S agalactiae, S anginosus group (including S anginosus, S intermedius, and S constellatus), E faecalis.

You should not use Sivextro if you are allergic to tedizolid.

Tell your doctor if you have recently been sick with diarrhea, a fever, cold or flu symptoms, cough, or sore throat.

Tell your doctor if you have ever had diarrhea while taking antibiotics.

Tedizolid may harm an unborn baby. Tell your doctor if you are pregnant.

It may not be safe to breastfeed while using tedizolid. Ask your doctor about any risk.

Sivextro is not approved for use by anyone younger than 12 years old.

Use the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 8 hours. Do not use two doses at one time. Even if you skip a dose, keep taking the medicine each day until it is gone.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.

Get emergency medical help if you have signs of an allergic reaction to Sivextro: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody (even if it occurs months after your last dose);

• numbness or tingling;

• vision problems, severe headache or pain behind your eyes;

• sores or white patches in your mouth or on your skin;

• vaginal itching or discharge;

• fast or pounding heartbeats; or

• low blood cell counts - fever, chills, tiredness, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Common Sivextro side effects may include:

• nausea, vomiting, diarrhea;

• headache;

• dizziness; or

• pain, swelling, bruising, redness, or a hard lump where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• methotrexate;

• rosuvastatin (Crestor); or

• topotecan.

This list is not complete. Other drugs may interact with tedizolid, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.