stavudine (Rx)

Brand and Other Names:Zerit, d4T
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 15mg
  • 20mg
  • 30mg
  • 40mg

powder for oral solution

  • 1mg/mL (200mL)

HIV Infection

<60 kg: 30 mg PO q12hr

≥60 kg: 40 mg PO q12hr

Renal Impairment

≥60 kg

  • CrCl >50 mL/min: 40 mg PO q12hr
  • CrCl 26-50 mL/min: 20 mg PO q12hr
  • CrCl 10-25 mL/min: 20 mg PO qDay

<60 kg

  • CrCl >50 mL/min: 30 mg PO q12hr
  • CrCl 26-50 mL/min: 15 mg PO q12hr
  • CrCl 10-25 mL/min: 15 mg PO qDay

Dosage Forms & Strengths

capsule

  • 15mg
  • 20mg
  • 30mg
  • 40mg

powder for oral solution

  • 1mg/mL (200mL)

HIV Infection

Indicated for treatment of HIV infection in combination with other antiretroviral agents

Birth-13 days: 0.5 mg/kg PO q12hr  

<30 kg, ≥14 days: 1 mg/kg PO q12hr

30-60 kg: As adults; 30 mg PO q12hr

>60 kg: As adults; 40 mg PO q12hr

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Interactions

Interaction Checker

and stavudine

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
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            Adverse Effects

            >10%

            Headache

            Chills/fever

            Malaise

            Insomnia

            Anxiety

            Depression

            Pain

            Rash

            Nausea

            Vomiting

            Diarrhea

            Pancreatitis

            Abdominal pain

            Peripheral neuropathy

            1-10%

            Neutropenia

            Thrombocytopenia

            Incr hepatic transaminases

            Incr bilirubin

            Myalgia

            Back pain

            Weakness

            Postmarketing Reports

            Metabolic disorders: lipoatrophy, lipodystrophy

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            Warnings

            Black Box Warnings

            Fatal and nonfatal pancreatitis reported; suspend if pancreatitis suspected and discontinue if confirmed

            Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) reported with use of nucleoside analogues alone or in combination

            Fatal lactic acidosis reported in pregnant women who have received didanosine and stavudine with other antiretroviral agents. Combination is contraindicated in pregnant women

            Contraindications

            Hypersensitivity

            Coadministration with didanosine

            Cautions

            Risk of potentially fatal lactic acidosis & severe hepatomegaly with steatosis, with use alone & especially with didanosine

            Risk of potentially fatal pancreatitis when used with didanosine

            Decrease dose in renal impairment

            Severe motor weakness reported

            Risk of immune reconstitution syndrome if used in combination w/ other antiretroviral drugs

            Randomized controlled trials found lipoatrophy or lipodystrophy developed in a higher proportion of patients treated with stavudine compared to other nucleosides (tenofovir or abacavir)

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            Pregnancy & Lactation

            Pregnancy

            There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to drug during pregnancy; healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263

            Fatal lactic acidosis reported in pregnant individuals who received combination of stavudine and didanosine with other antiretroviral agents; unclear if pregnancy augments risk of lactic acidosis/hepatic steatosis syndrome reported in non-pregnant individuals receiving nucleoside analogues; combination of with didanosine is contraindicated

            Prospective pregnancy data from APR not sufficient to adequately assess risk of major birth defects, miscarriage or adverse developmental outcomes

            Animal data

            • In animal reproduction studies, no adverse developmental effects observed with oral administration of stavudine at clinically relevant exposures; no developmental toxicities observed in rats and rabbits at systemic exposures 112 (AUC) and 183 (Cmax) times, respectively, exposures in humans at recommended human dose

            Lactation

            The Centers for Disease Control and Prevention recommend that HIV-infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV; based on limited data, the drug has been detected in human milk; no data are available regarding effects of stavudine on breastfed infant, or effects on milk production

            Because of potential for HIV transmission (in HIV-negative infants), developing viral resistance (in HIV-positive infants) and adverse reactions in breastfed infants similar to those seen in adults, instruct mothers not to breastfeed if they are receiving therapy

            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

            Nucleoside Reverse Transcriptase Inhibitor (NRTI); thymidine analog that interferes with HIV viral DNA dependent DNA polymerase and inhibits viral replication

            Pharmacokinetics

            Half-Life: 1-1.6 hr

            Peak Plasma Time: 1 hr; 3 hr (XR)

            Peak Plasma Concentration: (conventional) 228±62 ng/mL; (XR) 536±146 ng/mL

            AUC: (conventional) 1966±629 ng.hr/mL; (XR) 2568±454 ng.hr/mL

            Bioavailability: 86.4% (adults); 76.9% (children)

            Vd: 46 L

            Clearance: 594±165 mL/min (total body); 237±98 mL/min (renal)

            Excretion: Urine (95%); feces (3%)

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            Images

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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.
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            • 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.