tedizolid (Rx)

Brand and Other Names:Sivextro
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 200mg

injection, lyophilized powder for reconstitution

  • 200mg/vial

Skin & Skin Structure Infections

Indicated for acute bacterial skin and skin structure infections

200 mg PO/IV qDay for 6 days

Susceptible isolates of 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)
  • Enterococcus faecalis

Dosage Modifications

Hepatic impairment: No dosage adjustment required

Renal impairment or hemodialysis: No dosage adjustment required

Dosage Forms & Strengths

tablet

  • 200mg

injection, lyophilized powder for reconstitution

  • 200mg/vial

Skin & Skin Structure Infections

Indicated for acute bacterial skin and skin structure infections in patients aged ≥12 years

<12 years: Safety and efficacy not established

12-18 years: 200 mg PO/IV qDay for 6 days

Susceptible isolates of 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)
  • Enterococcus faecalis

Dosage Modifications

Hepatic impairment: No dosage adjustment required

Renal impairment or hemodialysis: No dosage adjustment required

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Interactions

Interaction Checker

and tedizolid

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Contraindicated (1)

            • cyproheptadine

              tedizolid, cyproheptadine. Other (see comment). Contraindicated. Comment: MAO inhibitors may prolong and intensify the anticholinergic effects of antihistamines. Cyproheptadine may diminish the serotonergic effect of MAO inhibitors.

            Serious - Use Alternative (56)

            • almotriptan

              tedizolid, almotriptan. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • amitriptyline

              tedizolid, amitriptyline. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • amoxapine

              tedizolid, amoxapine. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • bupropion

              tedizolid, bupropion. Either increases levels of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • cholera vaccine

              tedizolid, cholera vaccine. pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid coadministration of cholera vaccine with systemic antibiotics since these agents may be active against the vaccine strain. Do not administer cholera vaccine to patients who have received oral or parenteral antibiotics within 14 days prior to vaccination.

            • citalopram

              tedizolid, citalopram. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • clomipramine

              tedizolid, clomipramine. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • cyclobenzaprine

              tedizolid, cyclobenzaprine. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • deferiprone

              deferiprone, tedizolid. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid use of deferiprone with other drugs known to be associated with neutropenia or agranulocytosis; if an alternative is not possible, monitor absolute neutrophil count more frequently.

            • desipramine

              tedizolid, desipramine. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • desvenlafaxine

              tedizolid, desvenlafaxine. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • dextroamphetamine

              tedizolid, dextroamphetamine. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • dolasetron

              tedizolid, dolasetron. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • doxepin

              tedizolid, doxepin. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • duloxetine

              tedizolid, duloxetine. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • eletriptan

              tedizolid, eletriptan. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • escitalopram

              tedizolid, escitalopram. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • fentanyl

              tedizolid, fentanyl. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • fluoxetine

              tedizolid, fluoxetine. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • fluvoxamine

              fluvoxamine and tedizolid both increase serotonin levels. Avoid or Use Alternate Drug.

            • frovatriptan

              tedizolid, frovatriptan. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • granisetron

              tedizolid, granisetron. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • imipramine

              tedizolid, imipramine. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • isocarboxazid

              tedizolid, isocarboxazid. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Interaction with MAOIs were not studied in clinical trials; drugs within the same class(eg linezolid) are contraindicated with MAOIs.

            • levomilnacipran

              tedizolid, levomilnacipran. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • lisdexamfetamine

              tedizolid, lisdexamfetamine. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • meperidine

              tedizolid, meperidine. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • metformin

              tedizolid will increase the level or effect of metformin by unspecified interaction mechanism. Avoid or Use Alternate Drug.

            • methamphetamine

              tedizolid, methamphetamine. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • methylene blue

              tedizolid, methylene blue. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase levels of serotonin; increased risk of serotonin syndrome.

            • mirtazapine

              tedizolid, mirtazapine. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • naratriptan

              tedizolid, naratriptan. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • nefazodone

              tedizolid, nefazodone. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • nortriptyline

              tedizolid, nortriptyline. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • ondansetron

              tedizolid, ondansetron. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • palonosetron

              tedizolid, palonosetron. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • paroxetine

              tedizolid, paroxetine. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • phenelzine

              tedizolid, phenelzine. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Interaction with MAOIs were not studied in clinical trials; drugs within the same class(eg linezolid) are contraindicated with MAOIs.

            • protriptyline

              tedizolid, protriptyline. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • rasagiline

              tedizolid, rasagiline. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Interaction with MAOIs were not studied in clinical trials; drugs within the same class(eg linezolid) are contraindicated with MAOIs.

            • rizatriptan

              tedizolid, rizatriptan. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • selegiline

              tedizolid, selegiline. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Interaction with MAOIs were not studied in clinical trials; drugs within the same class(eg linezolid) are contraindicated with MAOIs.

            • selegiline transdermal

              tedizolid, selegiline transdermal. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Interaction with MAOIs were not studied in clinical trials; drugs within the same class(eg linezolid) are contraindicated with MAOIs.

            • sertraline

              tedizolid, sertraline. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • sumatriptan

              tedizolid, sumatriptan. Either increases levels of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • sumatriptan intranasal

              tedizolid, sumatriptan intranasal. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • tapentadol

              tedizolid, tapentadol. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • tramadol

              tedizolid, tramadol. Either increases levels of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • tranylcypromine

              tedizolid, tranylcypromine. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Interaction with MAOIs were not studied in clinical trials; drugs within the same class(eg linezolid) are contraindicated with MAOIs.

            • trazodone

              tedizolid, trazodone. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • trimipramine

              tedizolid, trimipramine. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • tyramine

              tedizolid, tyramine. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • venlafaxine

              tedizolid, venlafaxine. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • vilazodone

              tedizolid, vilazodone. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • vortioxetine

              tedizolid, vortioxetine. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • zolmitriptan

              tedizolid, zolmitriptan. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            Monitor Closely (1)

            • levodopa inhaled

              levodopa inhaled increases effects of tedizolid by dopaminergic effects. Use Caution/Monitor. Coadministration of selective MAO-B inhibitors with levodopa may be associated with orthostatic hypotension.

            Minor (0)

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              Adverse Effects

              2-10%

              Nausea (8%)

              Headache (6%)

              Diarrhea (4%)

              Hemoglobin <10.1 g/dL (3.1%)

              Vomiting (3%)

              Platelets <112 x 10³/mm³ (2.3%)

              Dizziness (2%)

              <2%

              Blood and lymphatic system disorders: Anemia

              Cardiovascular: Palpitations, tachycardia

              Eye disorders: Asthenopia, vision blurred, visual impairment, vitreous floaters

              General disorders and administration site conditions: Infusion-related reactions

              Immune system disorders: Drug hypersensitivity

              Infections and infestations: Clostridium difficile colitis, oral candidiasis, vulvovaginal mycotic infection

              Investigations: Hepatic transaminases increased, decreased WBCs

              Nervous system disorders: Hypoesthesia, paresthesia, seventh nerve paralysis

              Psychiatric disorders: Insomnia

              Skin and subcutaneous tissue disorders: Pruritus, urticaria, dermatitis

              Vascular disorders: Flushing, hypertension

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              Warnings

              Contraindications

              None

              Cautions

              Safety and efficacy in patients with neutropenia (<1000 cells/mm³) is uncertain; in animal models of infection, tedizolid antibacterial activity was reduced in animal models with neutropenia

              Clostridium difficile-associated diarrhea (CDAD) reported with nearly all systemic antibacterial agents, including tedizolid; evaluate if diarrhea occur

              Prescribing antibiotics in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit and increases the risk of the development of drug-resistant bacteria

              Drug interactions overview

              • Clinical trials of tedizolid to date have excluded patients receiving MAOIs, SSRIs, and SNRIs and TCAs; however, the risk of serotonin syndrome may be a class effect and appropriate caution should be taken to avoid coadministration of these agents with tedizolid
              • Oral tedizolid inhibits breast cancer resistance protein (BCRP) in the intestine, which may increase plasma concentrations and/or adverse reactions of orally administered BCRP substrates; consider avoiding BCRP substrates during oral tedizolid treatment especially for BCRP substrates with a narrow therapeutic index (eg, methotrexate or topotecan); if coadministration cannot be avoided, monitor for adverse reactions related to the concomitantly administered BCRP substrates
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              Pregnancy & Lactation

              Pregnancy

              Based on animal reproduction studies, may cause fetal harm when administered to pregnant females; there are no adequate and well-controlled studies in pregnant women

              Only use during pregnancy only if the potential benefit justifies the potential risk to the fetus

              Animal data

              • In embryo-fetal studies in mice and rats, drug was shown to produce fetal developmental toxicities in mice and maternal toxicity and fetal developmental toxicities in rats
              • Drug administered orally during organogenesis to pregnant animals was associated with reduced fetal weights and an increased incidence of costal cartilage anomalies in the absence of maternal toxicity in mice; and maternal toxicity, decreased fetal weights, and increased skeletal variations in rats at plasma exposures approximately 4- and 6-times respectively, the human plasma exposure at the maximum recommended human dose (MRHD) of 200 mg/day
              • In female rats, drug administered during organogenesis through lactation, did not show evidence of fetal toxicity, developmental delays, or impaired reproduction in offspring at plasma exposures approximately equivalent to the human plasma exposure at the MRHD

              Lactation

              Tedizolid is excreted in the breast milk of rats; when drug is present in animal milk, it is likely that the drug will be present in human milk

              Unknown whether tedizolid is excreted in human milk

              Exercise caution when administering to a nursing woman; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from drug or from underlying maternal condition

              Pregnancy Categories

              A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

              B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

              C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

              D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

              X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

              NA: Information not available.

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              Pharmacology

              Mechanism of Action

              Tedizolid phosphate is the prodrug of tedizolid

              Oxazolidione antibiotic; action is mediated by binding to the 50S subunit of the bacterial ribosome, resulting in inhibition of protein synthesis

              Absorption

              Bioavailability: 91% (PO and IV); no dosage adjustment is needed between IV and PO dose

              Peak plasma concentration, steady-state: 2.2 mcg/mL (PO); 3 mcg/mL (IV)

              Peak plasma time: 3 hr (PO fasting); at end of 1 hr infusion (IV)

              AUC, steady-state: 8.4 mcg•hr/mL (PO); 5.9 mcg•hr/mL (IV)

              Distribution

              Protein bound: 70-90%

              Vd: 67-80 L

              Metabolism

              There was no degradation of tedizolid in human liver microsomes, indicating tedizolid is unlikely to be a substrate for hepatic CYP450 enzymes

              Elimination

              Half-life: 12 hr

              Excretion: 82% feces; 18% urine

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              Administration

              Oral Administration

              May take with or without food

              IV Compatibilities

              0.9% NaCl

              IV Incompatibilities

              Any solution containing divalent cations (eg, Ca2+, Mg2+), including lactated Ringer injection and Hartmann solution

              IV Preparation

              Reconstitute 200 mg vial with 4 mL sterile water for injection

              Gently swirl the contents and let the vial stand until the lyophilized powder cake has completely dissolved and any foam disperses

              Inspect vial for particulate matter

              Reconstituted solution should be clear and colorless to pale-yellow

              Tilt vial and insert a syringe with appropriately sized needle into the bottom corner of the vial and remove 4 mL of the reconstituted solution; do not invert the vial during extraction

              Must be further diluted with 250 mL of 0.9% NaCl; slowly inject the 4 mL of reconstituted solution into the 250 mL bag, invert IV bag gently to mix

              Do NOT shake IV bag (may cause foaming)

              IV Administration

              Infuse over 1 hr

              Do NOT give as IV push or bolus

              Not for intra-arterial, IM, IT, intraperitoneal, or SC administration

              Missed Dose

              • Take missed dose as soon as possible anytime up to 8 hr prior to the next scheduled dose
              • If <8 hr remain before the next dose, wait until the next scheduled dose

              Storage

              Unreconstituted vial: Store at controlled room temperature (20-25°C [68-77°F]); excursions permitted to 15-30°C (59-86°F)

              Reconstituted vial or diluted IV bag: Do not exceed 24 hr at either room temperature or refrigerated (2-8°C [36-46°F])

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              Patient Handout

              A Patient Handout is not currently available for this monograph.
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              Formulary

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              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
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              ST Step Therapy
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.