tedizolid

(redirected from Sivextro)

tedizolid

(ted-eye-zoe-lid ),

Sivextro

(trade name)

Classification

Therapeutic: anti infectives
Pharmacologic: oxazolidinones
Pregnancy Category: C

Indications

Treatment of acute bacterial skin and skin structure infections (ABSSSI).

Action

Inhibits bacterial protein synthesis at the level of the 23S ribosome of the 50S subunit.

Therapeutic effects

Bacteriostatic action against enterococci, staphylococci and streptococci, resulting is resolution of infection.
Active against Staphylococcus aureus including methicillin-resistant strains (MRSA), Streptococcus pyogens, Streptococcus agalactiae, Streptococcus anginosus Group (including Streptococcus anginosus, Streptococcus intermedius, Streptococcus constellatus) and Enterococcus faecalis.

Pharmacokinetics

Absorption: IV administration results in complete bioavailability; well absorbed (91%) following oral administration, rapidly converted by phosphatases to its active form.
Distribution: Penetrates interstitial fluid space of adipose and skeletal muscle resulting in similar levels to plasma.
Metabolism and Excretion: Eliminated via liver with inactive metabolites excreted in feces (82%) and urine (18%); <3% excreted unchanged in urine or feces.
Half-life: 12 hr.

Time/action profile (blood levels)

ROUTEONSETPEAKDURATION
POunknown2.5 hr24 hr
IVrapidend of infusion24 hr

Contraindications/Precautions

Contraindicated in: Uncontrolled HTN, pheochromocytoma, thyrotoxicosis, or concurrent use of sympathomimetic agents, vasopressors, or dopaminergic agents (↑ risk of hypertensive response); Concurrent or recent (<2 wk) use of monoamine oxidase (MAO) inhibitors (↑ risk of hypertensive response); Carcinoid syndrome or concurrent use of SSRIs, TCAs, triptans, meperidine, or buspirone (↑ risk of serotonin syndrome).
Use Cautiously in: Neutropenia (safety and efficacy not established if WBC <1000 cells/mm3) Obstetric: Use in pregnancy only in potential maternal benefit justifies potential risk to fetus; Lactation: Use cautiously if breastfeeding; Pediatric: Safe and effective use in children <18 yr has not been established.

Adverse Reactions/Side Effects

Central nervous system

  • dizziness
  • headache

Gastrointestinal

  • pseudomembranous colitis (life-threatening)
  • nausea
  • diarrhea
  • vomiting

Interactions

Drug-Drug interaction

↑ risk of hypertensive response with MAO inhibitors, sympathomimetics (e.g., pseudoephedrine ), vasopressors (e.g., epinephrine, norepinephrine ), and dopaminergic agents (e.g., dopamine, dobutamine ); concurrent or recent use should be avoided. ↑ risk of serotonin syndrome with SSRIs, TCAs, triptans, meperidine, bupropion, or buspirone ; avoid concurrent use.

Route/Dosage

Oral Intravenous (Adults) 200 mg once daily for six days.

Availability

Tablets: 200 mg
Lyophilized powder for intravenous injection (requires reconstitution): 200 mg/vial

Nursing implications

Nursing assessment

  • Assess for infection (vital signs; appearance of wound, sputum, urine, and stool; WBC) at beginning of and during therapy.
  • Obtain specimens for culture and sensitivity prior to initiating therapy. First dose may be given before receiving.
  • Monitor bowel function. Diarrhea, abdominal cramping, fever, and bloody stools should be reported to health care professional promptly as a sign of pseudomembranous colitis. May begin up to several mo following cessation of therapy.
  • Lab Test Considerations: Consider alternate therapies in patients with neutrophil counts <1000 cells/mm3.
    • May cause anemia.

Potential Nursing Diagnoses

Risk for infection (Indications)
Diarrhea (Adverse Reactions)

Implementation

  • Dose adjustment is not necessary when switching from IV to oral dose.
  • Oral: May be administered with or without food.
  • Intravenous Administration
  • Intermittent Infusion: Reconstitute each vial with 4 mL of Sterile Water for Injection. Gently swirl and let vial stand until completely dissolved; avoid shaking. Diluent: Dilute further with 250 mL of 0.9% NaCl by slowing injecting reconstituted solution into 250 mL bag. Gently invert bag to mix; avoid shaking to minimize foaming. Solution is clear and colorless to pale yellow; do not administer solutions that are discolored or contain particulate material. Must be used within 24 hrs of reconstitution at room temperature or under refrigeration.
  • Rate: Infuse over 1 hr.
  • Y-Site Incompatibility: solutions containing calcium or magnesium, Lactated Ringer's, Hartmann's solution

Patient/Family Teaching

  • Advise patients taking oral tedizolid to take as directed, for full course of therapy, even if feeling better. Take missed doses as soon as remembered up to 8 hrs before next dose; if less than 8 hrs before next dose, wait until next scheduled dose. Do not double dose.
  • Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
  • Instruct patient to notify health care professional if changes in vision occur or immediately if diarrhea, abdominal cramping, fever, or bloody stools occur and not to treat with antidiarrheals without consulting health care professionals.
  • Advise female patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
  • Advise patient to notify health care professional if no improvement is seen in a few days.

Evaluation/Desired Outcomes

  • Resolution of signs and symptoms of infection. Length of time for complete resolution depends on organism and site of infection.
References in periodicals archive ?
These new antibiotics include Orbactiv (oritavancin), Sivextro (tedizolid phosphate) and Xydalba (dalbavancin), which have indicated to treat acute bacterial skin and skin structure infections (ABSSSIs).
The Medicines Company UK Ltd will market Orbactiv while Cubist (UK) Ltd will market Sivextro.
Not surprisingly, surveyed ID specialists reported being more likely to prescribe oral formulations of both Cubist's Sivextro (tedizolid) and Tetraphase's emerging drug eravacycline when discharging patients than OPAT with either drug, suggesting oral formulations of these agents will see greater use as discharge therapy.
The agency approved Dalvance (dalbavancin) in May, Sivextro (tedizolid) in June and Orbactiv (oritavancin) in August.
Three-quarters of surveyed ID specialists indicated they would prescribe Cubist's second-generation oxazolidinone, Sivextro, over Pfizer's Zyvox for the treatment of skin infections due to MRSA.
The agency approved Dalvance (dalbavancin) in May 2014 and Sivextro (tedizolid) in June 2014.
Later this week, the FDA will decide whether it should approve Cubist's experimental anti-infective drug - Sivextro.
Impact of generic linezolid on uptake of Cubist's Sivextro (tedizolid): Among the majority of hospital pharmacy directors who indicated they would include tedizolid on formulary, only 15 percent indicated they would not include it if generic linezolid (priced at a 25 percent discount to branded Zyvox) were available, suggesting that pharmacy directors consider tedizolid sufficiently differentiated from linezolid to merit formulary inclusion of both agents.
FDA Panel in Favor of Cubist (Nasdaq: CBST -Free Report ) Drug: Cubist investors had a good start to the week with the company receiving a favorable recommendation from an FDA advisory panel for its experimental anti-infective drug - Sivextro (tedizolid).
Cubist (Nasdaq: CBST-Free Report )Drug Closer to FDA Approval: Cubist investors had a good start to the week with the company receiving a favorable recommendation from an FDA advisory panel for its experimental anti-infective drug - Sivextro (tedizolid).
April 3, 2014 /PRNewswire/ -- Decision Resources Group finds that following its launch, Cubist's second generation oxazolidinone Sivextro will be highly differentiated from other anti-MRSA (methicillin-resistant Staphylococcus aureus) agents for the treatment of complicated skin and skin structure infections (cSSSIs) due to MRSA.