Sivextro (Oral)

Tedizolid is used to treat acute bacterial skin and skin structure infections (ABSSSI). It is part of a group of medications known as antibiotics. Tedizolid kills bacteria or stops them from growing. However, this medicine will not work for colds, flu, or other viral infections.

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 using this medicine. This will help your doctor see if the medicine is working correctly and check for any unwanted effects.

If your or your child's symptoms do not improve or get worse, contact your doctor.

This medicine may cause diarrhea, and in some cases, it can be severe. Diarrhea 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 worsens, consult your doctor. Do not take any medicine to treat diarrhea without first checking with your doctor.

Do not take other medicines unless your doctor has discussed them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use this medicine, you and your doctor must consider the risks against the benefits. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies done on how tedizolid affects children younger than 12 years old. Safety and effectiveness have not been established for this age group.

Geriatric

Studies conducted so far have not shown any specific problems in older adults that would limit the usefulness of tedizolid.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction could happen. In these cases, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below while using this medicine. The following interactions are based on their potential significance and are not all-inclusive.

Using this medicine with any of the following is usually not recommended, but it may be necessary in some cases. If both are prescribed together, your doctor may change the dose or frequency of one or both medicines.

• Cholera Vaccine, Live
• Methotrexate

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may impact the use of this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

• Diarrhea—Use with caution. This condition may worsen with the use of this medicine.

• Neutropenia (low white blood cell count)—Use with caution. Tedizolid may not be as effective in patients with this condition.

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.

In the U.S.

• Sivextro

Available Dosage Forms:

• Tablet

Therapeutic Class: Antibacterial

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.

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.