Tedizolid phosphate

What is Tedizolid phosphate?

• Tedizolid phosphate (SIVEXTRO) is an oxazolidinone-class antibacterial drug used for people 12 years of age and older who have a skin infection or an infection in the tissue below the skin. SIVEXTRO is an antibiotic that works by stopping the growth of certain bacteria.

What are the uses of this medicine?

• This medicine is used in adult and pediatric patients 12 years of age and older for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus Group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus), and Enterococcus faecalis.
• To reduce the development of drug-resistant bacteria and maintain the effectiveness of SIVEXTRO and other antibacterial drugs, SIVEXTRO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

How does this medicine work?

• Tedizolid (te diz' oh lid) is a synthetic, second generation oxazolidinone antibiotic, similar to linezolid, that has broad bactericidal activity against gram positive organisms such as enterococci and staphylococci and most streptococci.
• Importantly, tedizolid has potent activity against Methicillin resistant strains of Staphyloccocus aureus (MRSA).
• Tedizolid acts by binding to the 50S subunit of bacterial ribosome, preventing the formation of the functional ribosomal 70S subunit and thereby blocking bacterial protein synthesis.
• In several randomized controlled trials, tedizolid was found to be similar in efficacy (“non-inferior”) to linezolid as therapy of acute bacterial skin and skin-structure infections.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Orally administered SIVEXTRO inhibits Breast Cancer Resistance Protein (BCRP) in the intestine, which can increase the plasma concentrations of orally administered BCRP substrates, and the potential for adverse reactions.
• If coadministration cannot be avoided, monitor for adverse reactions related to the concomitantly administered BCRP substrates, including rosuvastatin.

Is this medicine FDA approved?

• This medicine is approved in the year 2014.

How should this medicine be used?

Recommended Dosage:

• 200 mg administered once daily orally or as an intravenous (IV) infusion over 1 hour for six (6) days in adult and pediatric patients 12 years of age and older.

Administration

• Take SIVEXTRO exactly how your doctor tells you to take it.
• Take 1 SIVEXTRO tablet 1 time each day.
• Take SIVEXTRO for 6 days, at the same time every day.
• Take SIVEXTRO by mouth, with or without food.
• Administer as an intravenous infusion only.
• Do not administer as an intravenous push or bolus. Do not mix SIVEXTRO with other drugs when administering. It is not intended for intra-arterial, intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.
• The intravenous bag containing the reconstituted and diluted intravenous solution should be inspected visually for particulate matter prior to administration. Discard if visible particles are observed. The resulting solution is clear and colorless to pale-yellow in color.
• After reconstitution and dilution, SIVEXTRO is to be administered via intravenous infusion using a total time of 1 hour.
• The total time from reconstitution to administration should not exceed 24 hours at room temperature or under refrigeration at 2°C to 8°C (36°F to 46°F).
• Discard unused portion.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As injection: 200 mg, sterile, lyophilized powder in single-dose vial for reconstitution for intravenous infusion;
• Tablet: 200 mg

This medicine is available in fallowing brand namesː

• SIVEXTRO

What side effects can this medication cause?

The most common side effects of this medicine include:

• nausea
• headache
• dizziness
• vomiting
• diarrhea
• increased liver enzymes

Some less common side effects are:

• Problems with your skin
• itching, red or itchy rash, hives, acne
• hot flushes or feeling like you are blushing or your face, neck or chest is red
• not able to feel something as well
• a tingling or prickling sensation
• Problems with your sleep
• hard time sleeping
• Problems with your body
• numbness
• Problems with infections
• vagina that is infected, inflamed or itchy
• fungal infections of skin, mouth
• Problems with your eyes
• eye strain
• blurred or impaired vision
• seeing dots or spots in your eyes
• Problems with your heart
• Your heartbeat does not feel normal. It could feel like your heart is beating too fast or pumping harder than usual.
• Problems with your vascular system
• high blood pressure
• Problems with your blood work

Your doctor may tell you that you have the following while taking Sivextro:

• a low white blood cell count
• anemia (low red blood cells)
• bleeding or bruising easily

• SIVEXTRO may cause serious side effects, including diarrhea from C-diff (Clostridioides difficile) infection.

What special precautions should I follow?

• The safety and efficacy of SIVEXTRO in patients with neutropenia (neutrophil counts <1000 cells/mm3) have not been adequately evaluated. In an animal model of infection, the antibacterial activity of SIVEXTRO was reduced in the absence of granulocytes. Consider alternative therapies in neutropenic patients.
• Clostridioides difficile-associated diarrhea (CDAD) has been reported for nearly all systemic antibacterial agents including SIVEXTRO. Evaluate if diarrhea occurs.

What to do in case of emergency/overdose?

Management of overdosage:

• In the event of overdosage, SIVEXTRO should be discontinued and general supportive treatment given.
• Hemodialysis does not result in meaningful removal of tedizolid from systemic circulation.

Can this medicine be used in pregnancy?

• Based on animal reproduction studies, SIVEXTRO may cause fetal harm when administered to pregnant women.
• The available data on the use of SIVEXTRO in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Can this medicine be used in children?

• The safety and effectiveness of SIVEXTRO for the treatment of ABSSSI have been established in pediatric patients aged 12 years and older.
• Safety and effectiveness of SIVEXTRO in pediatric patients below the age of 12 years have not been established.

What are the active and inactive ingredients in this medicine?

• The active ingredient: tedizolid phosphate.
• The inactive ingredients: crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, and povidone.
• Film coating: polyethylene glycol/macrogol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide.

Who manufactures and distributes this medicine?

• Sivextro tablets Manufactured by: Patheon Inc., Whitby, Ontario, L1N 5Z5 Canada
• Sivextro for injection Manufactured by: Patheon Italia S.p.A., 03013, Ferentino, FR Italy

What should I know about storage and disposal of this medication?

• Store SIVEXTRO at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep SIVEXTRO and all medicines out of the reach of children.

• Dailymed label info on Tedizolid phosphate
• FDA Tedizolid phosphate

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