SIVEXTRO 200 mg/1
tedizolid phosphate · TABLET, FILM COATED · Merck Sharp & Dohme LLC
SIVEXTRO is a tablet, film coated containing tedizolid phosphate at 200 mg/1, taken oral. Manufactured by Merck Sharp & Dohme LLC.
Key Facts
- Brand Name
- SIVEXTRO
- Generic Name
- tedizolid phosphate
- NDC Code (Product)
67919-041- Manufacturer
- Merck Sharp & Dohme LLC
- Strength
- 200 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA205435
- Marketing Start
- 06/20/2014
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE SIVEXTRO is an oxazolidinone antibacterial indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible microorganisms in adult and pediatric patients (at least 26 weeks gestational age and weighing at least 1 kg) ( 1.1 ) Usage to Reduce Development of Drug-Resistant Bacteria 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 bacteria. 1.1 Acute Bacterial Skin and Skin Structure Infections SIVEXTRO ® is indicated 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 , in adult and pediatric patient…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Do not administer SIVEXTRO Tablets to pediatric patients weighing less than 35 kg. ( 2.1 ) Adult Patients Intravenous and Oral Dosage : 200 mg administered once daily orally or as an intravenous (IV) infusion over 1 hour for 6 days as specified in Table 1 in the full prescribing information. ( 2.2 ) Pediatric Patients Intravenous Dosage (at least 26 weeks gestational age and weighing at least 1 kg): Weight-based dosing as an intravenous infusion as specified in Table 2 in the full prescribing information. ( 2.3 ) Pediatric Patients Oral Dosage (weighing greater than or equal to 35 kg): Weight-based dosing as an oral tablet administered once daily as specified in Table 3 in the full prescribing information. ( 2.3 ) 2.1 Important Administration Instructions for Pediatric Patients Weighing Less than 35 kg Do not administer SIVEXTRO Tablets to pediatric patients weighing less than 35 kg [see Dosage and Administration 2.3 ]. 2.2 Recommended Dosage for Adult Patients The recommended dosage of SIVEXTRO is 200 mg administered once daily for six (6) days either as an oral tablet (with or without food) or as an intravenous (IV) infusion in adult patients. The reco…
Contraindications
4 CONTRAINDICATIONS None. None ( 4 )
Drug Interactions
7 DRUG INTERACTIONS SIVEXTRO (when administered orally) can increase the plasma concentrations of orally administered Breast Cancer Resistance Protein (BCRP) substrates. Monitor for adverse reactions related to the concomitant BCRP substrates if coadministration cannot be avoided. ( 7 , 12.3 ) SIVEXTRO has the potential for interaction with serotonergic agents. ( 5.1 , 7 ) 7.1 Membrane Transporters 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 possible, an interruption in the treatment of the co-administered BCRP substrate medicinal product should be considered during treatment with SIVEXTRO, especially for BCRP substrates with a narrow therapeutic index (e.g., methotrexate or topotecan). If coadministration cannot be avoided, monitor for adverse reactions related to the concomitantly administered BCRP substrates, including rosuvastatin [see Clinical Pharmacology (12.3) ]. 7.2 Serotonergic Agents In postmarketing experience, there have been reports of serotonin syndrome in patients taking SIVEXTRO with ser…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Serotonin Syndrome [see Warnings and Precautions (5.1) ] Clostridioides difficile -Associated Diarrhea [see Warnings and Precautions (5.3) ] The most common adverse reactions (≥2%) in adult patients are nausea, headache, diarrhea, infusion- or injection-related adverse reactions, vomiting, and dizziness. ( 6.1 ) The most common adverse reactions (>2%) in pediatric patients (12 years to less than 18 years of age) are phlebitis and increased hepatic transaminases. ( 6.1 ) The most common adverse reactions (>2%) in pediatric patients (less than 12 years of age) are infusion- or injection-related adverse reactions and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be compared directly to rates from clinical trials of another drug and may not reflect rates observed in practice. Clinical Trials Exp…
Frequently Asked Questions
What is SIVEXTRO used for?
SIVEXTRO contains tedizolid phosphate. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is SIVEXTRO a controlled substance?
SIVEXTRO is not classified as a controlled substance by the DEA.
What is the generic name for SIVEXTRO?
The generic name for SIVEXTRO is tedizolid phosphate. There are no other listed brand versions of tedizolid phosphate.
What is the NDC code for SIVEXTRO 200 mg/1?
The NDC (National Drug Code) for SIVEXTRO 200 mg/1 is 67919-041, listed by Merck Sharp & Dohme LLC.
Other SIVEXTRO Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)