Zyvox Intravenous

Linezolid injection 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 to be given only by or under the direct supervision of a doctor.

A nurse or other trained health professional will give you or your child this medicine in a hospital. This medicine is given through a needle placed in one of your veins for 30 to 120 minutes.

Your doctor will give you or your child a few doses of this medicine until your condition improves, and then switch you to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

It is very important that your doctor check you or your child closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.

If your or your child's symptoms do not improve within a few 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) such as 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®), meperidine (Demerol®), norepinephrine (Levophed®), cold medicines or decongestants (such as phenylpropanolamine, pseudoephedrine, or Sudafed®), medicine to treat depression (such as amitriptyline, doxepin, fluoxetine, nortriptyline, paroxetine, Celexa®, Effexor®, Elavil®, Lexapro™, Paxil®, or Zoloft®), or medicine to treat migraine headaches (such as sumatriptan, zolmitriptan, Axert®, Imitrex®, or Zomig®).

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 diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop using 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 using 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 vomits 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. Check with your doctor first before taking any other medicines. 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.

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 (e.g., 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.

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.

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 or nurse immediately if any of the following side effects occur:

• Chills
• confusion
• dizziness
• fainting
• fast heartbeat
• fever
• lightheadedness
• pale skin
• rapid, shallow breathing
• rash
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness

• Black, tarry stools
• bleeding gums
• blood in the urine or stools
• bluish lips or skin
• body aches or pain
• chest pain
• congestion
• constipation
• convulsions
• cough
• decreased urine
• difficult or labored breathing
• 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
• nasal congestion
• nausea or vomiting
• not breathing
• numbness or tingling in the hands, feet, or lips
• painful or difficult urination
• pinpoint red spots on the skin
• runny nose
• severe stomach pain
• shortness of breath
• sneezing
• sores, ulcers, or white spots on the lips or in the mouth
• swollen glands
• tender, swollen glands in the neck
• tightness in the chest
• trouble with swallowing
• voice changes
• vomiting of blood or material that looks like coffee grounds
• wheezing

• Abdominal or stomach discomfort
• blindness
• blistering, peeling, or loosening of the skin
• blurred vision
• burning, numbness, tingling, or painful sensations
• decreased appetite
• decreased vision
• diarrhea
• eye pain
• general feeling of discomfort
• high fever
• hives
• itching
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• muscle pain or cramping
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• sleepiness
• 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:

• Abdominal or stomach pain
• bad, unusual, or unpleasant (after) taste
• change in taste
• discoloration of the tongue
• itching of the vagina or outside genitals
• loose stools
• pain during sexual intercourse
• pain in the arms or legs
• sleeplessness
• sore mouth or tongue
• thick, white curd-like vaginal discharge without odor or with mild odor
• trouble sleeping
• unable to sleep

• 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.

Before using linezolid, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, blood/bone marrow problems (such as low red/white blood cells and platelets), certain tumor conditions (such as pheochromocytoma, carcinoid syndrome), overactive thyroid, seizures.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

If you have diabetes, linezolid may lower your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of low blood sugar such as sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Linezolid may cause live bacterial vaccines (such as typhoid vaccine) to not work as well. Do not have any immunizations/vaccinations while using this medication unless your doctor tells you to.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.