Description
Tedizolid is used to treat acute bacterial skin and skin structure infections (ABSSSI). It belongs to the class of drugs called antibiotics. Tedizolid 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.
This product is available in the following dosage forms:
- Tablet
Before Using
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.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of tedizolid in children younger than 26 weeks gestational age and weighing less than 1 kilogram (kg). Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tedizolid in the elderly.
Breastfeeding
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.
Drug Interactions
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 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.
- Cholera Vaccine, Live
- Methotrexate
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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
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:
- Diarrhea—Use with caution. May make this condition worse.
- Neutropenia (low white blood cell count)—Use with caution. Tedizolid may not work as well in patients with this condition.
Proper Use
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.
This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.
You may take this medicine with or without food.
Keep using this medicine for the full time of treatment, even if you begin to feel better after the first few doses. Your infection may not clear up if you stop using this medicine too soon.
This medicine works best when there is a constant amount in the blood. To help keep the amount constant, tedizolid 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 form (tablets):
- For treatment of skin infections:
- Adults and children weighing 35 kilograms (kg) or more—200 milligrams (mg) once a day for 6 days.
- Children weighing less than 35 kg—Use of injection dosage form is recommended.
- Children younger than 26 weeks gestational age and weighing less than 1 kg—Use and dose must be determined by your doctor.
- For treatment of skin infections:
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.
If you miss a dose and it is less than 8 hours until your next dose, skip the missed dose and go back to your regular schedule.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your or your child's progress while using 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 or if they become worse, check with your doctor.
This medicine may cause diarrhea, and in some cases it can be severe. It may also occur 2 months or more after you or your child stop using this medicine. If you or your child have diarrhea that continues or gets worse, check with your doctor. Do not take any medicine to treat diarrhea without checking first with your doctor.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
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:
Less common
- Blurred vision
- chest tightness
- diarrhea
- dizziness
- fast, slow, pounding, or irregular heartbeat or pulse
- fever
- headache
- hives or welts, itching, or skin rash
- hoarseness
- irritation
- itching of the vagina or genitals
- joint pain, stiffness, or swelling
- nervousness
- pale skin
- pounding in the ears
- redness of the skin
- severe stomach cramps and pain
- sore mouth or tongue
- stomach tenderness
- swelling of the eyelids, face, lips, hands, or feet
- thick, white vaginal discharge with mild or no odor
- trouble breathing or swallowing
- unusual bleeding or bruising
- unusual tiredness or weakness
- watery or severe diarrhea, which may also be bloody
- white patches in the mouth or on the tongue
Incidence not known
- Black, tarry stools
- blood in the urine or stools
- chills
- cough
- lower back or side pain
- painful or difficult urination
- pinpoint red spots on the skin
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:
More common
- Nausea
Less common
- Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- double vision
- feeling of warmth
- feeling that you cannot keep your eyes open
- increased sensitivity of the eyes to light
- redness of the face, neck, arms, and occasionally, upper chest
- seeing floating spots before the eyes
- sore neck, shoulders, or back
- sore, tired, burning, or itching eyes
- trouble concentrating
- trouble sleeping
- vomiting
- watery or dry eyes
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.
DRG-20110249
