Pronunciation:

lin-AYZ-oh-lid

Brand Names:

• Zyvox

Dosage Forms:

• Tablet
• Powder for Suspension

Classifications:

Therapeutic—

Antibiotic

Chemical—

Oxazolidinone

Uses of This Medicine:

Linezolid is used to treat certain bacterial infections in many different parts of the body, including certain types of skin infections or pneumonia.

Linezolid belongs to the family of medicines called antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of linezolid in children.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of linezolid in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Almotriptan
• Amitriptyline
• Amoxapine
• Amphetamine
• Apraclonidine
• Atomoxetine
• Benzphetamine
• Brimonidine
• Bupropion
• Buspirone
• Carbamazepine
• Carbidopa
• Carbinoxamine
• Citalopram
• Clomipramine
• Clovoxamine
• Codeine
• Cyclobenzaprine
• Cyproheptadine
• Desipramine
• Desvenlafaxine
• Deutetrabenazine
• Dexmethylphenidate
• Dextroamphetamine
• Diethylpropion
• Dobutamine
• Dopamine
• Doxepin
• Doxylamine
• Duloxetine
• Eletriptan
• Entacapone
• Epinephrine
• Escitalopram
• Femoxetine
• Fenfluramine
• Flesinoxan
• Fluoxetine
• Fluvoxamine
• Frovatriptan
• Gepirone
• Guanadrel
• Guanethidine
• Hydroxytryptophan
• Imipramine
• Isocarboxazid
• Levodopa
• Levomethadyl
• Levomilnacipran
• Lisdexamfetamine
• Maprotiline
• Mazindol
• Meperidine
• Methamphetamine
• Methyldopa
• Methylene Blue
• Methylphenidate
• Milnacipran
• Mirtazapine
• Naratriptan
• Nefazodone
• Nefopam
• Nortriptyline
• Opipramol
• Ozanimod
• Paroxetine
• Phendimetrazine
• Phenelzine
• Phenmetrazine
• Phentermine
• Phenylalanine
• Phenylephrine
• Phenylpropanolamine
• Procarbazine
• Protriptyline
• Pseudoephedrine
• Rasagiline
• Reserpine
• Rizatriptan
• Safinamide
• Selegiline
• Serdexmethylphenidate
• Sertraline
• Sibutramine
• Solriamfetol
• Sumatriptan
• Tapentadol
• Tetrabenazine
• Tramadol
• Tranylcypromine
• Trazodone
• Trimipramine
• Tryptophan
• Venlafaxine
• Vilazodone
• Viloxazine
• Vortioxetine
• Zimeldine
• Zolmitriptan

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Albuterol
• Alfentanil
• Atropine
• Benzhydrocodone
• Buprenorphine
• Butalbital
• Butorphanol
• Cholera Vaccine, Live
• Dextromethorphan
• Difenoxin
• Dihydrocodeine
• Diphenhydramine
• Diphenoxylate
• Dolasetron
• Droperidol
• Ethchlorvynol
• Fentanyl
• Formoterol
• Granisetron
• Guarana
• Hydrocodone
• Hydromorphone
• Iobenguane I 123
• Iobenguane I 131
• Kava
• Lasmiditan
• Levorphanol
• Licorice
• Lithium
• Lorcaserin
• Ma Huang
• Mate
• Metaxalone
• Methadone
• Methotrexate
• Metoclopramide
• Midodrine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Norepinephrine
• Oliceridine
• Ondansetron
• Oxycodone
• Oxymetazoline
• Oxymorphone
• Palonosetron
• Pentazocine
• Reboxetine
• Remifentanil
• Risperidone
• St John's Wort
• Sufentanil
• Tolcapone
• Tyrosine
• Valbenazine
• Vilanterol
• Warfarin
• Ziprasidone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acarbose
• Chlorpropamide
• Clarithromycin
• Ginseng
• Glimepiride
• Glipizide
• Glyburide
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glargine, Recombinant
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Metformin
• Nateglinide
• Repaglinide
• Rifampin
• Tolazamide
• Tolbutamide

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Avocado
• Bitter Orange

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Tyramine Containing Food

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood problems or
• Bone marrow depression or
• Diabetes or
• Hypertension (high blood pressure), history of or
• Hypoglycemia (low blood sugar) or
• Seizures, history of—Use with caution. May make these conditions worse.

• Carcinoid syndrome or
• Hypertension (high blood pressure), uncontrolled or
• Pheochromocytoma or
• Thyroid problems—Should not be used in patients with these conditions unless they are closely monitored by their doctor for hypertension and serotonin syndrome.

• Infection at the catheter site—Should not be used in patients with this condition.

• Infection, Gram-negative—Use is not indicated in patients with this condition.

• Kidney disease, severe or
• Liver disease, moderate to severe—Use with caution. May cause thrombocytopenia (low platelet count in the blood) in patients with these conditions.

• Phenylketonuria (PKU)—The oral suspension contains phenylalanine, which can make this condition worse.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

To use the oral suspension:

• The liquid form of linezolid should be gently mixed by turning the bottle upside down 3 to 5 times before each dose. Do not shake this product.
• Measure the medicine with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.
• Do not use after the expiration date on the label. The medicine may not work properly after that date. If you have any questions about this, check with your pharmacist.

Keep using this medicine for the full time of treatment, even if you or your child begin to feel better after a few days. Also, it works best when there is a constant amount in the blood. To help keep the amount constant, linezolid must be given on a regular schedule.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (suspension or tablets):
  • For bacterial infections:
    • Adults and children 12 years of age and older—400 or 600 milligrams (mg) every 12 hours.
    • Children younger than 12 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 10 milligrams (mg) per kilogram (kg) of body weight every 8 or 12 hours as determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Keep out of the reach of children.

Keep out of the reach of children.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the mixed suspension at room temperature. Throw away any unused medicine 21 days after it has been prepared. If you have any questions about this, check with your pharmacist.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress while you are taking this medicine, to see if the medicine is working properly. Blood and urine tests may be needed to check for any unwanted effects.

If your or your child's symptoms do not improve within 28 days or if they become worse, check with your doctor.

You should not use this medicine if you or your child have used an MAO inhibitor (MAOI), including isocarboxazid, phenelzine, Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days. Also, do not use this medicine if you or your child are also using the following medicines: buspirone (Buspar®), dobutamine (Dobutrex®), dopamine (Intropin®), epinephrine (Adrenalin®), norepinephrine (Levophed®), cold medicines or decongestants (eg, phenylpropanolamine, pseudoephedrine, or Sudafed®), medicine to treat depression (eg, amitriptyline, bupropion, doxepin, fluoxetine, nortriptyline, paroxetine, Celexa®, Effexor®, Elavil®, Lexapro®, Paxil®, or Zoloft®), medicine to treat migraine headaches (eg, sumatriptan, zolmitriptan, Axert®, Imitrex®, or Zomig®), or narcotic pain medicines (eg, meperidine, Demerol®).

Linezolid can lower the number of white blood cells in your blood temporarily, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions your doctor may ask you to take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you or your child are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.

This medicine may cause infertility to men. Talk with your doctor before using this medicine if you plan to have children.

This medicine may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop taking this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. If you have any questions or if mild diarrhea continues or gets worse, check with your doctor.

You may develop low blood sugar while you or your child are taking this medicine. You may feel weak, drowsy, confused, anxious, or very hungry. You may have trouble seeing or have a headache that won't go away. Ask your doctor what you should do if this happens. Some things that can lead to low blood sugar are exercising more than normal or waiting too long to eat.

This medicine may cause a serious reaction called lactic acidosis (build-up of acid in the blood). Call your doctor right away if you or your child feel very tired, weak, or nauseated, if you vomit or have trouble breathing, or if you feel lightheaded or fainting.

This medicine may cause serious condition called serotonin syndrome when taken with certain medicines, including medicines to treat depression (SSRIs) or narcotic pain medicines. Check with your doctor first before taking any other medicines. Contact your doctor right away if you or your child experience agitation, confusion, diarrhea, fever, overactive reflexes, poor coordination, restlessness, shivering, sweating, or trembling or shaking.

Check with your doctor right away if blurred vision, difficulty in reading, or any other change in vision occurs during treatment with this medicine. Your eyes may need to be checked by an ophthalmologist (eye doctor).

When taken with certain foods or drinks, linezolid can cause an increase in blood pressure. To avoid this, do not eat large amounts of foods or drink beverages that have a high tyramine content (most common in foods that are aged, fermented, pickled, or smoked to increase their flavor, including aged cheeses, air-dried, fermented, or smoked fish, meat, or poultry, sauerkraut, soy sauce, red wine, or tap beer). If a list of these foods and beverages is not given to you, ask your doctor to provide one.

Check with your doctor right away if you have agitation, coma, confusion, decreased urine output, depression, dizziness, headache, hostility, increased thirst, irritability, lethargy, muscle pain or cramps, muscle twitching, nausea or vomiting, rapid weight gain, seizures, stupor, swelling of the face, ankles, or hands, or unusual tiredness or weakness. These may be symptoms of hyponatremia (low sodium levels in the blood) or syndrome of inappropriate antidiuretic hormone (SIADH).

Do not take other medicines unless thy have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine 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:

More common

Chills

confusion

diarrhea

dizziness

fainting

fast heartbeat

fever

lightheadedness

pale skin

rapid, shallow breathing

rash

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

Less common

Black, tarry stools

bleeding gums

blood in the urine or stools

bluish lips or skin

body aches or pain

chest pain or tightness

constipation

cough

decreased urine

dry mouth

dryness or soreness of the throat

ear congestion

headache

hoarseness

increased thirst

irregular heartbeat

loss of appetite

loss of voice

mood changes

muscle pain or cramps

nausea or vomiting

numbness or tingling in the hands, feet, or lips

painful or difficult urination

pinpoint red spots on the skin

runny or stuffy nose

seizures

severe stomach pain

sneezing

sores, ulcers, or white spots on the lips or in the mouth

swollen glands

trouble with swallowing

voice changes

vomiting of blood or material that looks like coffee grounds

Incidence not known

Agitation

blindness

blistering, peeling, or loosening of the skin

blurred vision

burning, numbness, tingling, or painful sensations

coma

decreased vision

depression

eye pain

general feeling of discomfort

hives, itching

hostility

irritability

joint pain

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

lethargy

muscle pain, cramping, or twitching

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

rapid weight gain

red skin lesions, often with a purple center

red, irritated eyes

sleepiness or unusual drowsiness

stomach discomfort

stupor

swelling of the face, ankles, or hands

swollen glands

unexplained bleeding or bruising

unsteadiness or awkwardness

weakness in the arms, hands, legs, or feet

Some side effects 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

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

change in taste

discoloration of the tongue

itching of the vagina or outside genitals

pain during sexual intercourse

pain in the arms or legs

sore mouth or tongue

thick, white curd-like vaginal discharge without odor or with mild odor

trouble sleeping

Incidence not known

Discoloration of the tooth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.