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Zyvox (linezolid) is an oxazolidinone antibiotic that fights bacteria in the body. Linezolid is also an MAO (monoamine oxidase) inhibitor.
Zyvox is used to treat different types of bacterial infections, such as pneumonia, skin infections, and infections that are resistant to other antibiotics.
Zyvox may also be used for purposes not listed in this medication guide.
Some medicines can cause unwanted or dangerous effects when used with Zyvox. Tell your doctor about all other medicines you use.
Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.
Many drugs can interact with linezolid. Before using this medicine, tell your doctor about all other medications you use. You may need to stop using certain medicines before using Zyvox (in some cases for up to 5 weeks before starting treatment).
During your treatment with Zyvox, do not start or stop using any other medications unless your doctor tells you to. You should not use this medicine at is resistant to medication if you have untreated or uncontrolled high blood pressure, a carcinoid tumor, adrenal gland tumor, or a severely overactive thyroid. If you take an antidepressant or psychiatric medication, call your doctor right away if you have signs of a serious drug interaction, including: confusion, memory problems, feeling hyperactive (mentally or physically), loss of coordination, muscle twitching, shivering, sweating, diarrhea, and/or fever.
You should not use Zyvox if you are allergic to linezolid.
Do not use linezolid if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, methylene blue injection, phenelzine, rasagiline, selegiline, and tranylcypromine.
Tell your doctor if you have ever had:
high blood pressure;
a thyroid disorder;
a carcinoid tumor;
bone marrow suppression or a weak immune system;
kidney or liver disease;
pheochromocytoma (adrenal gland tumor);
diabetes;
seizures; or
if you use a catheter.
It is not known whether linezolid will harm an unborn baby. Tell your doctor if you are pregnant.
It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks.
Zyvox liquid (oral suspension) contains phenylalanine. Tell your doctor if you have phenylketonuria (PKU).
Use Zyvox exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.
Zyvox tablets or oral suspension can be taken with or without food.
Zyvox 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.
Prepare your injection only when you are ready to give it. Do not use if the medicine has particles in it. Call your pharmacist for new medicine.
Read and carefully follow any Instructions for Use provided with your medicine. Do not use Zyvox if you don't understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.
Gently mix the oral suspension (liquid) by turning the bottle upside down 3 to 5 times. Do not shake. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).
You will need frequent medical tests. Your vision and blood pressure may also need to be checked often.
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. Linezolid will not treat a viral infection such as the flu or a common cold.
Store all forms of Zyvox at room temperature away from moisture, heat, and light. Do not freeze. Throw away any liquid not used within 21 days.
Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.
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.
Eating tyramine while you are using linezolid can raise your blood pressure to dangerous levels. Avoid foods that have a high level of tyramine, such as:
aged cheeses or meats;
pickled or fermented meats, smoked or air-dried meats;
sauerkraut;
soy sauce;
tap beer (alcoholic and nonalcoholic);
red wine; or
any meat, cheese, or other protein-based food that has been improperly stored.
You should be very familiar with the list of foods you must avoid while you are using Zyvox.
Get emergency medical help if you have signs of an allergic reaction to Zyvox (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Call your doctor at once if you have:
vision problems, changes in color vision;
severe stomach pain, diarrhea that is watery or bloody;
a seizure;
sweating, feeling anxious or shaky (may be signs of low blood sugar);
high levels of serotonin in the body - agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea;
lactic acidosis - unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired; or
low blood cell counts - fever, chills, tiredness, weakness, confusion, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
Common Zyvox side effects may include:
nausea, vomiting, diarrhea;
mild skin rash;
anemia (low red blood cells); or
headache, dizziness.
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.
Some medicines can interact with linezolid and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.
Many drugs can interact with linezolid, and some drugs should not be used together. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all your current medicines and any medicine you start or stop using.
Further informationRemember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Zyvox only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Zyvox (www.drugs.com/zyvox.html).
Note: This document contains side effect information about linezolid. Some of the dosage forms listed on this page may not apply to the brand name Zyvox.
In SummaryMore frequent side effects include: anemia, decreased hemoglobin, and thrombocytopenia. See below for a comprehensive list of adverse effects.
For the ConsumerApplies to linezolid: oral powder for suspension, oral tablet
Other dosage forms:
Along with its needed effects, linezolid (the active ingredient contained in Zyvox) 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 linezolid:
More common
Less common
Incidence not known
Some side effects of linezolid 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:
Less common
Incidence not known
For Healthcare Professionals
Applies to linezolid: intravenous solution, oral powder for reconstitution, oral tablet
GeneralThis drug was discontinued due to side effects in up to 3.5% of patients. The most common side effects leading to discontinuation were diarrhea, headache, nausea, and vomiting.
Nervous systemCommon (1% to 10%): Headache, dizziness, taste alteration/perversion (metallic taste)
Uncommon (0.1% to 1%): Convulsions, hypoesthesia, paresthesia, tinnitus
Frequency not reported: Drowsiness, seizure, Bell's palsy, sensory loss
Postmarketing reports: Serotonin syndrome (with concomitant serotonergic agents), peripheral neuropathy
Several cases of peripheral and/or optic neuropathy have been reported, mainly when the duration of therapy was longer than 28 days. For example, irreversible sensory loss and peripheral neuropathy were reported in a patient after using this drug for 6 months for actinomycosis. The time from the onset of therapy to the first sign of peripheral neuropathy averaged 4 months (range: 10 days to 6 months) in 10 patients with only peripheral neuropathy. In all patients with peripheral neuropathy (n=16), complete recovery was not observed after this drug was stopped.
At least 15 instances of serotonin syndrome have been reported in patients using this drug with citalopram, sertraline, venlafaxine, fluoxetine, or paroxetine; other concurrent drugs and/or comorbidities may have contributed to the development of serotonin syndrome. The time from the onset of therapy to the first sign of serotonin syndrome averaged 4 days (range: 1 to 20 days) and from the first sign to stopping this drug ranged from 1 to 16 days. Symptoms resolved within 1 to 9 days in 14 patients while 1 patient died suddenly. Three patients died. The first patient developed symptoms 3 weeks after concurrent use of this drug and citalopram. Severe lactic acidosis developed followed by myocardial infarction, and after 3 further episodes of cardiac arrest, the patient died. The second patient stopped sertraline on day 1 and developed symptoms on day 9 of linezolid therapy. The patient had cardiopulmonary arrest, then anoxic brain injury, hypertension, tachycardia, and diarrhea, and died in 2 weeks; a similar incident occurred 6 weeks earlier when this drug and sertraline were used. The third patient, who was using citalopram, developed symptoms on day 2 of linezolid therapy and died with cerebral hemorrhage 1 month after the start of serotonin syndrome despite stopping this drug.
A 49-year-old male with multiple comorbidities developed symptoms on day 21 of therapy and was diagnosed with Bell's palsy; symptoms included strange sensation in mouth (no pain, sores, blisters), excessive tearing of left eye, inability to drink properly, left facial frowning, and left-sided facial weakness (involving upper and lower facial muscles). This drug was discontinued and the Bell's palsy completely resolved by day 90. The patient restarted linezolid 5 months later and again showed symptoms on day 21 of therapy. This drug was discontinued and by day 35, the Bell's palsy had practically resolved. The patient had no remaining symptoms 4 months after his second episode.
Convulsions have also been reported during postmarketing experience.
GastrointestinalIn cases with known outcome, tooth discoloration was removable with professional dental cleaning (manual descaling).
A 60-year-old man with spondylodiscitis developed a fatal case of C difficile colitis after a long-term course of this drug.
Superficial tooth discoloration and tongue discoloration have also been reported during postmarketing experience.
Common (1% to 10%): Diarrhea, nausea, vomiting, elevated lipase, elevated amylase, tongue discoloration, oral candidiasis, localized abdominal pain, generalized abdominal pain, constipation, dyspepsia
Uncommon (0.1% to 1%): Pancreatitis, gastritis, abdominal distention, dry mouth, glossitis, loose stools, stomatitis, tongue disorder
Rare (0.01% to 0.1%): Antibiotic-associated colitis (including pseudomembranous colitis), superficial tooth discoloration
Frequency not reported: Clostridium difficile-associated diarrhea, lingua villosa nigra, C difficile colitis
HematologicCommon (1% to 10%): Decreased hemoglobin, decreased platelet count, decreased WBC count, anemia, decreased neutrophils, thrombocytopenia/low platelet count (some requiring platelet transfusions), decreased leukocytes, increased neutrophils, increased eosinophils, decreased hematocrit, decreased RBC count, increased platelet count, increased WBC count
Uncommon (0.1% to 1%): Leukopenia, neutropenia, eosinophilia, increased reticulocyte count
Rare (0.01% to 0.1%): Pancytopenia
Frequency not reported: Red cell hypoplasia, myelotoxicity, bleeding events
Postmarketing reports: Myelosuppression (including anemia, leukopenia, pancytopenia, thrombocytopenia), sideroblastic anemia
Thrombocytopenia (platelets less than 100,000/mm3) has been reported in 32% of patients (n=19) using this drug for more than 10 days. In another study (n=295), thrombocytopenia (platelets less than 150 x 10[9]/L) occurred in 6.4% of patients and severe thrombocytopenia (platelets less than 50 x 10[9]/L) occurred in 0.3% using this drug for more than 5 days. It has been suggested that the mechanism of linezolid-associated thrombocytopenia was immune-mediated.
In a study of patients with linezolid-associated thrombocytopenia, the use of vitamin B6 helped reverse the incidence of thrombocytopenia. Vitamin B6 was most effective when used after this drug was held. Once hematologic levels returned to baseline, coadministration of this drug with vitamin B6 resulted in stable hemoglobin levels for the remainder of therapy.
Another study compared this drug plus 50 mg vitamin B6 per day (n=31) with this drug alone (n=62) administered to patients with cancer. This study concluded vitamin B6 was not beneficial in the prevention of leukopenia or thrombocytopenia, but found a possible trend towards the prevention of anemia.
HepaticCommon (1% to 10%): Elevated ALT, elevated AST, abnormal liver function tests
Uncommon (0.1% to 1%): Elevated total bilirubin
MetabolicCommon (1% to 10%): Elevated alkaline phosphatase, elevated LDH, elevated nonfasting glucose
Uncommon (0.1% to 1%): Hyponatremia, decreased nonfasting glucose
Frequency not reported: Hyperlactatemia, metabolic acidosis, hypokalemia
Postmarketing reports: Lactic acidosis, hypoglycemia (including symptomatic episodes)
At least 7 instances of lactic acidosis have been reported after use of this drug. The time from the onset of therapy to the first sign of lactic acidosis ranged from 1 to 16 weeks. This drug was stopped within 4 days of identifying lactic acidosis. Two of the 7 patients died despite stopping therapy. The lactate levels normalized in the 5 surviving patients after stopping this drug, but 1 of the patients had sequelae of blindness and disorientation.
RenalCommon (1% to 10%): Elevated BUN
Uncommon (0.1% to 1%): Elevated creatinine, renal failure
Frequency not reported: Exacerbation of renal failure, abnormal renal function, acute interstitial nephritis
DermatologicCommon (1% to 10%): Rash, pruritus
Uncommon (0.1% to 1%): Urticaria, dermatitis, diaphoresis
Postmarketing reports: Bullous skin disorders (including severe cutaneous adverse reactions [SCAR] such as Stevens-Johnson syndrome and toxic epidermal necrolysis), angioedema, alopecia
GenitourinaryCommon (1% to 10%): Vaginal candidiasis
Uncommon (0.1% to 1%): Vaginitis, polyuria, vulvovaginal disorder
OtherCommon (1% to 10%): Fungal infection, candidiasis, fever, localized pain, decreased total protein, decreased albumin, decreased sodium, decreased calcium, increased/decreased potassium, increased/decreased bicarbonate
Uncommon (0.1% to 1%): Chills, fatigue, increased thirst, increased sodium, increased calcium, increased/decreased chloride
Frequency not reported: Generalized edema
OcularPartially irreversible bilateral optic neuritis has been reported after 41 weeks of therapy.
Several cases of peripheral and/or optic neuropathy have been reported. The time from the onset of therapy to the first sign of optic neuropathy averaged 10 months (range: 1 to 48 months) in 6 patients with only optic neuropathy. The time to discontinuation of this drug due to optic neuropathy averaged 11 months (range: 1 to 56 months) after therapy initiation. This drug was stopped in 12 cases after the development of optic neuropathy; improvement or complete recovery was observed in all cases.
Uncommon (0.1% to 1%): Blurred vision
Rare (0.01% to 0.1%): Changes in visual field defect
Frequency not reported: Partially irreversible bilateral optic neuritis
Postmarketing reports: Optic neuropathy (sometimes progressing to loss of vision), optic neuritis, loss of vision, changes in visual acuity, changes in color vision
CardiovascularCommon (1% to 10%): Hypertension
Uncommon (0.1% to 1%): Arrhythmia (tachycardia), transient ischemic attacks, phlebitis, thrombophlebitis
Frequency not reported: Increased and decreased blood pressure, supraventricular tachycardia
PsychiatricCommon (1% to 10%): Insomnia
Frequency not reported: Confusion
MusculoskeletalCommon (1% to 10%): Elevated creatine phosphokinase
LocalUncommon (0.1% to 1%): Injection site pain
HypersensitivityPostmarketing reports: Anaphylaxis
RespiratoryFrequency not reported: Interstitial pneumonia
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Zyvox (www.drugs.com/zyvox.html).
August 5, 2020
December 16, 2020
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