Linezolid (Oral)

Linezolid is used to treat specific bacterial infections in various parts of the body, including some skin infections and pneumonia.

Linezolid is part of a group of medicines called antibiotics. It works by killing bacteria or stopping their growth. However, this medicine will not work for colds, flu, or any other infections caused by viruses.

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

It is very important for your doctor to monitor your or your child's progress while taking this medicine to ensure it is working properly. Blood and urine tests may be required to check for any unwanted effects.

If your or your child's symptoms do not improve within 28 days or if they worsen, contact your doctor.

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

Linezolid can temporarily reduce the number of white blood cells in your blood, increasing the risk of infection. It can also lower the number of platelets, which are important for blood clotting. If this happens, your doctor may recommend certain precautions, especially if your blood count is low, to help reduce the risk of infection or bleeding:

• If possible, avoid contact with people who have infections. Contact your doctor immediately if you think you or your child may have an infection or if you experience fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Contact your doctor right away if you notice any unusual bleeding or bruising, black, tarry stools, blood in your urine or stools, or small red spots on your skin.

This medicine may affect fertility in men. Discuss with your doctor if you plan to have children before using this medicine.

This medicine may cause diarrhea, which can sometimes be severe. It may occur 2 months or more after stopping this medicine. Do not take any medicine to treat diarrhea without first consulting your doctor. If you have any questions or if mild diarrhea continues or worsens, contact your doctor.

You may experience low blood sugar while taking this medicine. Symptoms can include weakness, drowsiness, confusion, anxiety, or extreme hunger. You might have trouble seeing or have a persistent headache. Ask your doctor what to do if this occurs. Some factors that can lead to low blood sugar include excessive exercise or delaying meals.

This medicine may cause a serious condition called lactic acidosis (a build-up of acid in the blood). Contact your doctor immediately if you or your child feel very tired, weak, or nauseated, if you vomit or have difficulty breathing, or if you feel lightheaded or faint.

This medicine may cause a serious condition called serotonin syndrome when taken with certain medicines, including some antidepressants (SSRIs) or narcotic pain medicines. Consult your doctor 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.

Contact your doctor immediately if you experience blurred vision, difficulty reading, or any other changes in vision while taking this medicine. Your eyes may need to be examined by an ophthalmologist (eye doctor).

When taken with certain foods or drinks, linezolid can raise blood pressure. To prevent this, avoid eating large amounts of foods or drinking beverages high in tyramine (often found in aged, fermented, pickled, or smoked foods, including aged cheeses, air-dried, fermented, or smoked fish, meat, or poultry, sauerkraut, soy sauce, red wine, or tap beer). If you do not receive a list of these foods and drinks, ask your doctor to provide one.

Contact your doctor immediately 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 you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you need to consider the risks of taking it against the benefits it will provide. This is a decision to be made with your doctor. For this medicine, keep the following in mind:

Allergies

Notify your doctor if you have ever experienced any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare professional if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies have not shown any specific problems in children that would limit the usefulness of linezolid.

Geriatric

Studies have not demonstrated specific problems in elderly patients that would limit the usefulness of linezolid. However, older adults may be more sensitive to the effects of this medicine than younger adults.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these cases, your doctor may need to adjust the dose, or other precautions may be necessary. It is particularly important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are based on their potential significance and are not necessarily a complete list.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or adjust your other medicines.

• 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 necessary in some situations. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both 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
• 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 increase the risk of certain side effects, but using both drugs may be the best option for you. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both 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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used at or around the time of eating food or certain types of food, as interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions are based on their potential significance and are not necessarily a complete list.

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

• Avocado
• Bitter Orange

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

• Tyramine Containing Food

Other Medical Problems

Other medical issues may affect the use of this medicine. Make sure to inform your doctor about any other medical problems you have, 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. This may worsen these conditions.

• Carcinoid syndrome or
• Hypertension (high blood pressure), uncontrolled or
• Pheochromocytoma or
• Thyroid problems—Should not be used in patients with these conditions unless monitored closely 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. This may cause thrombocytopenia (low platelet count in the blood) in patients with these conditions.

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

Along with its beneficial effects, a medicine may cause some unwanted effects. Not all of these side effects will happen, but if they do, you may need medical help.

Check with your doctor right away 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 happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Additionally, your health care professional may be able to tell you how 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 can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Zyvox

Available Dosage Forms:

• Tablet
• Powder for Suspension

Therapeutic Class: Antibiotic

Chemical Class: Oxazolidinone

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.

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