Sivextro (Intravenous)

Tedizolid injection is used to treat acute bacterial skin and skin structure infections (ABSSSI). It is an antibiotic that works by killing bacteria or stopping them from growing.

This medicine should only be given by your doctor or under their direct supervision.

It is very important that your doctor closely monitors you or your child's progress while receiving this medicine. This allows your doctor to determine if the medicine is working properly and to check for any unwanted effects.

This medicine may cause diarrhea, which can sometimes be severe. Diarrhea may also occur 2 months or more after you or your child stop taking 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 a medicine, you and your doctor need to consider the risks of taking the medicine compared to the benefits it may provide. Here are some important points to consider for this medicine:

Allergies

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

Pediatric

There have not been appropriate studies on the effects of tedizolid injection in children younger than 12 years. Safety and effectiveness have not been established for this age group.

Geriatric

Current studies have not shown any specific problems in elderly patients that would limit the usefulness of tedizolid injection.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while others can be used together even if an interaction might 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 you are receiving this medicine. The following interactions are based on their potential significance and may not include all possible interactions.

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

• Cholera Vaccine, Live

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used during meals or with certain foods because interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect the use of this medicine. Make sure to inform your doctor if you have any other medical issues, especially:

• Diarrhea—Use with caution. This may worsen the condition.

• Neutropenia (low white blood cell count)—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 or nurse immediately if any of the following side effects occur:

Less common

• Bluish color of the skin
• 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
• pain or tenderness of the skin
• 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, legs, 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

• Bleeding, blistering, burning, discoloration of the skin, infection, itching, lumps, numbness, pain, redness, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• 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:

• Powder for Solution

Therapeutic Class: Antibacterial

Chemical Class: Oxazolidinone

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. The medicine must be given slowly, so the needle will have to remain in place for at least 1 hour.

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