Linezolid (Oral route)
- Powder for Suspension
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:
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.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of linezolid in children.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of linezolid in the elderly.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
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.
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.
- Methylene Blue
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.
- Bitter Orange
- Iobenguane I 123
- Ma Huang
- Morphine Sulfate Liposome
- St John's Wort
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.
- Guar Gum
- Insulin Aspart, Recombinant
- Insulin Degludec
- Insulin Detemir
- Insulin Glargine, Recombinant
- Insulin Glulisine
- Insulin Human Regular
- Insulin Lispro, Recombinant
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 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:
- 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.
- 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.
- Infection at the catheter site—Should not be used in patients with this condition.
- 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.
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.
- For bacterial infections:
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.
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. 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 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. 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, 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, such as 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.
Side Effects of This Medicine:
- More common
- fast heartbeat
- pale skin
- rapid, shallow breathing
- troubled breathing with exertion
- 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
- decreased urine
- difficult or labored breathing
- dry mouth
- dryness or soreness of the throat
- ear congestion
- 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
- 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
- Incidence not known
- Abdominal or stomach discomfort
- blistering, peeling, or loosening of the skin
- blurred vision
- burning, numbness, tingling, or painful sensations
- decreased appetite
- decreased vision
- eye pain
- fast, shallow breathing
- general feeling of discomfort
- high fever
- joint 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
- swollen glands
- unexplained bleeding or bruising
- unsteadiness or awkwardness
- weakness in the arms, hands, legs, or feet
- Less common
- bad, unusual, or unpleasant (after) taste
- 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
- loose stools
- 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
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:
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:
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.
Last Updated: 11/4/2014