Pronunciation:

te-DIZ-oh-lid FOS-fate

Brand Names:

• Sivextro

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antibacterial

Chemical—

Oxazolidinone

Uses of This Medicine:

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.

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 have not been performed on the relationship of age to the effects of tedizolid in children younger than 12 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tedizolid in the elderly.

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 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 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.

This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

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 12 years of age and older—200 milligrams (mg) once a day for 6 days.
    • Children younger than 12 years of age—Use and dose must be 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.

If your next dose is less than 8 hours away, 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 While Using This Medicine:

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 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:

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.