Tedizolid

2-10%

Nausea (8%)

Headache (6%)

Diarrhea (4%)

Hemoglobin <10.1 g/dL (3.1%)

Vomiting (3%)

Platelets <112 x 10³/mm³ (2.3%)

Dizziness (2%)

<2%

Blood and lymphatic system disorders: Anemia

Cardiovascular: Palpitations, tachycardia

Eye disorders: Asthenopia, vision blurred, visual impairment, vitreous floaters

General disorders and administration site conditions: Infusion-related reactions

Immune system disorders: Drug hypersensitivity

Infections and infestations: Clostridium difficile colitis, oral candidiasis, vulvovaginal mycotic infection

Investigations: Hepatic transaminases increased, decreased WBCs

Nervous system disorders: Hypoesthesia, paresthesia, seventh nerve paralysis

Psychiatric disorders: Insomnia

Skin and subcutaneous tissue disorders: Pruritus, urticaria, dermatitis

Vascular disorders: Flushing, hypertension

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.

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.

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

To make sure tedizolid is safe for you, tell your doctor if you have recently been sick with a fever, cold or flu symptoms, cough, or sore throat.

FDA pregnancy category C. It is not known whether tedizolid will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

Tedizolid can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medicine to anyone under 18 years old without medical advice.

Tedizolid is a prescription medication used to treat infections of the skin.

Tedizolid is used to treat acute bacterial skin and skin structure infections caused by certain susceptible bacteria, including Staphylococcus aureus (including methicillin-resistant strains (MRSA) and methicillin-susceptible strains), various Streptococcus species, and Enterococcus faecalis.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Tedizolid is part of the drug class:

• OTHER ANTIBACTERIALS

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Tedizolid falls into category C.  In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose of tedizolid (Sivextro) is 200 mg administered once daily for six (6) days.

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous, as phosphate [preservative free]:

Sivextro: 200 mg (1 ea)

Tablet, Oral, as phosphate:

Sivextro: 200 mg

Oral: Administer with or without food.

Intravenous: Administer as an IV infusion over 1 hour; do not administer as an IV push or bolus. Not for intra-arterial, IM, intrathecal, intraperitoneal, or subcutaneous administration. If the same IV line is to be used for sequential infusion of other drugs or solutions, the line should be flushed with NS before and after tedizolid infusion.

Concerns related to adverse effects:

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

Disease-related concerns:

• Neutropenia: Not recommended for use in patients with neutrophil counts <1000 cells/mm3. Alternative therapies should be considered when treating patients with neutropenia and acute bacterial skin and skin structure infections (ABSSI).