Tedizolid (oral/injection)

Tedizolid is an antibiotic used to treat skin infections in adults, including "MRSA" staph infections.

Tedizolid may also be used for other reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

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

Tedizolid 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.

Tedizolid 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 tedizolid 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 tedizolid 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 tedizolid injection dose only when you are ready to give an injection.

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

Each single-use vial (bottle) of tedizolid injection is for one use only. Throw it 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.

Follow all instructions on your medicine label and package. Inform all your healthcare providers about all your medical conditions, allergies, and all medicines you are taking.

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

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.

Tedizolid is not approved for use by anyone younger than 18 years old.

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

Tedizolid may cause serious side effects. Call your doctor right away if you have:

• severe stomach pain, diarrhea that is watery or bloody (even if it happens 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 side effects of tedizolid may include:

• nausea, vomiting, diarrhea;
• headache;
• dizziness; or
• pain, swelling, bruising, redness, or a hard lump where a tedizolid 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.

Usual Adult Dose for Skin and Structure Infection:

200 mg IV or orally once a day for 6 daysUse: 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 daysUse: 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

Use the medicine as soon as possible, but skip the missed dose if your next dose is due in less than 8 hours. Do not take two doses at the same time. Even if you miss a dose, continue taking the medicine daily until it is finished.

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

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

Tell your doctor about all the other medicines you are taking, especially:

• methotrexate;
• rosuvastatin (Crestor); or
• topotecan.

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