Sivextro oral / injection

Tedizolid is an antibiotic that fights bacteria.

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

Tedizolid may also be used for purposes not listed in this medication guide.

Take or use the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 8 hours away. Do not use extra medicine to make up the missed dose.

Tell your doctor about all your current medicines and any you start or stop using, 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 interactions are listed in this medication guide.

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.

Usual Adult Dose for Bacterial Infection:

Oral: 200 mg orally once daily for 6 days
Parenteral: 200 mg IV infusion once daily for 6 days

Comments: No dose adjustment is needed when switching from IV to oral.

Uses: Acute bacterial skin and skin structure infections caused by susceptible isolates of S. aureus (including methicillin-resistant (MRSA) and methicillin-susceptible (MSSA ) isolates), S. pyogenes, S. agalactiae, S. anginosus, and E faecalis.

Applies to tedizolid: oral tablet

Other dosage forms:

• intravenous powder for solution

Along with its needed effects, tedizolid (the active ingredient contained in Sivextro) 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 while taking tedizolid:

• Abdominal or stomach tenderness
• back pain
• blurred vision
• chest tightness
• chills
• dizziness
• fast, pounding, or irregular heartbeat or pulse
• fever
• headache
• hives or welts, itching, or skin rash
• hoarseness
• joint pain, stiffness, or swelling
• nausea and vomiting
• nervousness
• pale skin
• pounding in the ears
• redness of the skin
• severe abdominal or stomach cramps and pain
• slow or fast heartbeat
• swelling of the eyelids, face, lips, hands, or feet
• tightness in the chest
• troubled breathing or swallowing
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• watery or severe diarrhea, which may also be bloody

Some side effects of tedizolid 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:

• Burning, numbness, tingling, or painful sensations
• diarrhea
• unsteadiness or awkwardness
• weakness in the arms, hands, legs, or feet

• Blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in vision
• feeling of warmth
• redness of the face, neck, arms, and occasionally, upper chest
• seeing floating spots before the eyes
• sore mouth or tongue
• trouble sleeping
• white patches in the mouth or on the tongue

Applies to tedizolid: intravenous powder for injection, oral tablet

General

The most common adverse reactions were nausea, headache, diarrhea, vomiting, and dizziness. Median time to onset was 5 days.[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, diarrhea, vomiting[Ref]

Cardiovascular

Frequency not reported: palpitations, tachycardia, hypertension[Ref]

Palpitations, tachycardia, and hypertension were reported at a rate of less than 2%.[Ref]

Dermatologic

Frequency not reported: Dermatitis, flushing, pruritus, urticaria[Ref]

Dermatitis, flushing, pruritus, and urticaria were reported at a rate of less than 2%.[Ref]

Hematologic

Anemia and decreased WBC count were reported at a rate of less than 2%. Decreases in hemoglobin (less than 10 g/dL in males and less than 9 g/dL in females) platelet count (less than 112 x 10(3)/mm(3)) and absolute neutrophil count (less than 0.8 x 10(3)/mm(3)) were reported in 3.1%, 2.3%, and 0.5%, respectively.[Ref]

Frequency not reported: Anemia, decreased WBC count[Ref]

Hepatic

Frequency not reported: Hepatic transaminase elevations[Ref]

Hepatic transaminase elevations were reported at a rate of less than 2%.[Ref]

Immunologic

Drug hypersensitivity, Clostridium difficile colitis, oral candidiasis, and vulvovaginal mycotic infection were reported at a rate of less than 2%.[Ref]

Frequency not reported: Drug hypersensitivity, Clostridium difficile colitis, oral candidiasis, vulvovaginal mycotic infection[Ref]

Local

Frequency not reported: Infusion-related reactions[Ref]

Infusion-related reactions were reported at a rate of less than 2%.[Ref]

Nervous system

Frequency not reported: Hypoesthesia, paresthesia, VIIth nerve paralysis[Ref]

Hypoesthesia, paresthesia, and VIIth nerve paralysis were reported at a rate of less than 2%.[Ref]

Ocular

Frequency not reported: Asthenopia, blurred vision, visual impairment, vitreous floaters[Ref]

Asthenopia, blurred vision, visual impairment, and vitreous floaters were reported at a rate of less than 2%.[Ref]

Psychiatric

Insomnia was reported at a rate of less than 2%.[Ref]

Frequency not reported: Insomnia[Ref]

Some side effects of Sivextro may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Yes