tedizolid (Rx)

Brand and Other Names:Sivextro
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 200mg

lyophilized powder for reconstitution

  • 200mg/vial
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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

<18 years: Safety and efficacy not established

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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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            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

            Serotonin syndrome: Avoid coadministration with serotonergic psychiatric drugs (eg, SSRIs, SNRIs, TCAs, MAOIs) unless indicated for life-threatening or urgent infections (eg, vancomycin-resistant enterococcal infections, nosocomial pneumonia, complicated skin and skin structure infections such as methicillin-resistant S aureus), due to increased risk of serotonin syndrome; tedizolid may increase serotonin CNS levels by MAO-A inhibition

            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

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: Unknown if distributed in human breast milk

            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 the upright 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

            Administer as IV infusion 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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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            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
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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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.