Zyvox®(linezolid)

ZYVOX (linezolid) is a prescription antibiotic medicine used in adults and children to treat certain serious infections caused by Gram-positive bacteria, including:• pneumonia that develops in hospitalized patients (nosocomial pneumonia)• pneumonia that develops in the community (community-acquired pneumonia)• complicated skin and skin structure infections, including diabetic foot infections (without bone infection)• uncomplicated skin and skin structure infections• infections caused by Vancomycin-resistant Enterococcus faecium (VRE)• ZYVOX is not used to treat infections caused by Gram-negative bacteria.

• are allergic to linezolid or any of the ingredients in ZYVOX. See the end of this leaflet for a complete list of ingredients in ZYVOX.• take, or have taken within the last 2 weeks, a monoamine oxidase inhibitor (MAOI) medicine, such as phenelzine or isocarboxazid.

• have high blood pressure (hypertension)• have a tumor of the adrenal gland (pheochromocytoma)• have an overactive thyroid gland (thyrotoxicosis)• have diabetes and take insulin or oral diabetes medicines• have kidney problems• have liver problems• have bone marrow problems or low blood cell counts• have seizures or a history of seizures• are pregnant or plan to become pregnant. It is not known if ZYVOX will harm your unborn baby.• are breastfeeding or plan to breastfeed. ZYVOX may pass into your breast milk.• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.• ZYVOX may interact with other medicines. Especially tell your healthcare provider if you take: medicines for depression (SSRIs, tricyclic antidepressants, bupropion, buspirone), medicines for migraines (triptans), meperidine or other opioid pain medicines, medicines for colds or allergies that contain pseudoephedrine or phenylpropanolamine, dopamine, epinephrine, norepinephrine, or dobutamine

• Take ZYVOX exactly as your healthcare provider tells you to take it.• ZYVOX comes as tablets, an oral suspension (liquid), and as an injection given into a vein (intravenous or IV).• ZYVOX tablets and oral suspension may be taken with or without food.• If you are given ZYVOX oral suspension, shake it gently before each use. Do not shake vigorously.• Take ZYVOX for the full course of treatment, even if you feel better.• If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the next dose at your regular time. Do not take 2 doses at the same time.• If you take too much ZYVOX, call your healthcare provider or go to the nearest emergency room right away.

Avoid eating large amounts of foods or drinking beverages high in tyramine while taking ZYVOX. Tyramine is found in foods such as: aged cheeses, fermented or air-dried meats, sauerkraut, soy sauce, tap beers, red wines. Eating tyramine-rich foods while taking ZYVOX may cause your blood pressure to rise to dangerous levels.

ZYVOX may cause serious side effects, including:• Low blood cell counts (myelosuppression). ZYVOX can cause low platelet counts, low white blood cell counts, and anemia. Your healthcare provider should do blood tests weekly to check your blood cell counts, especially if you take ZYVOX for more than 2 weeks. Tell your healthcare provider right away if you have unusual bleeding or bruising, or signs of infection.• Nerve problems (peripheral and optic neuropathy). ZYVOX may cause nerve problems that can lead to numbness, tingling, or burning in your hands or feet, or vision changes including blurred vision, changes in color vision, or loss of vision.• Serotonin syndrome. A serious condition that can be life-threatening may happen when ZYVOX is taken with certain other medicines. Call your healthcare provider right away or go to the nearest emergency room if you develop: agitation, hallucinations, confusion, or other mental changes; fast heartbeat or changes in blood pressure; dizziness, sweating, flushing, or high body temperature; muscle twitching, stiffness, or loss of coordination; nausea, vomiting, or diarrhea.• Diarrhea (Clostridioides difficile-associated). Call your healthcare provider right away if you get watery diarrhea, diarrhea that does not go away, or bloody stools.• Lactic acidosis. Call your healthcare provider right away if you have repeated nausea and vomiting.• Seizures (convulsions)• Low blood sugar (hypoglycemia) — especially in people with diabetes• Low sodium levels in the blood (hyponatremia)• The most common side effects of ZYVOX include: diarrhea, vomiting, headache, nausea, anemia• These are not all the possible side effects of ZYVOX. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• Store ZYVOX tablets at room temperature at 77°F (25°C).• Store ZYVOX oral suspension at room temperature. Use within 21 days after mixing.• Protect from light.• Keep the bottle tightly closed.• Keep ZYVOX and all medicines out of the reach of children.

Active ingredient: linezolid• Inactive ingredients in ZYVOX tablets: microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide• Inactive ingredients in ZYVOX oral suspension: sucrose, citric acid, sodium citrate, microcrystalline cellulose and carboxymethylcellulose sodium, aspartame, sodium chloride, mannitol, sodium benzoate, colloidal silicon dioxide, xanthan gum, and strawberry flavor• Inactive ingredients in ZYVOX injection: dextrose monohydrate, sodium citrate dihydrate, and citric acid