zidovudine (Rx)

Brand and Other Names:Retrovir, ZDV (formerly AZT)
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 100mg

tablet

  • 300mg

syrup

  • 50mg/5mL

injectable solution

  • 10mg/mL

HIV Infection Treatment

300 mg PO q12hr OR 200 mg PO q8hr (600 mg/day)

IV: 1 mg/kg/dose q4hr (6 times daily)

Prevention of Perinatal HIV Transmission

Indicated for prevention of maternal-fetal HIV-1 transmission

This indication is based on dosing regimens that includes antepartum and intrapartum therapy of HIV-1 infected mothers, and also postpartum therapy of HIV-1 exposed neonates

Instruct women to continue taking their antepartum combination PO antiretroviral agents (ART) on schedule as much as possible during labor and before scheduled cesarean delivery

Regardless of antepartum regimen or mode of delivery, administer by continuous IV infusion, near delivery in women with HIV RNA >1,000 copies/mL or unknown HIV RNA status; may also be considered in women with HIV RNA between 50 and 999 copies/mL

Discontinue intrapartum IV infusion if oral zidovudine was part of the antepartum regimen

Women receiving combination retroviral therapy with HIV RNA <50 copies/mL near delivery do not require zidovudine IV if there are no concerns related to adherence with oral ART regimen

IV administration (preferred)

  • During labor and delivery: 2 mg/kg loading dose followed by continuous IV infusion of 1 mg/kg/hr until umbilical cord clamped  
  • Scheduled cesarean delivery: Begin IV zidovudine 3 hr before surgery
  • Unscheduled cesarean delivery resulting from maternal or fetal complications: Consider administering loading dose then proceed to delivery

Oral administration (if IV not an option)

  • 600 mg loading dose followed by 400 mg orally every 3 hr

Dosage Modifications

Renal impairment (CrCl <15 mL/min; maintained on hemodialysis or peritoneal dialysis): 100 mg PO or 1 mg/kg IV q6-8 hr; alternatively 100 mg PO qDay or 300 mg/day PO

Renal impairment

  • CrCl ≥15 mL/min: Dose adjustment not necessary
  • CrCl <15 mL/min, hemodialysis, or peritoneal dialysis
    • Oral: 100 mg q6-8hr
    • IV: 1 mg/kg q6-8hr

Hepatic impairment

  • Primarily eliminated by hepatic metabolism and zidovudine concentrations appear to be increased in patients with impaired hepatic function
  • Frequent monitoring of hematologic toxicities advised
  • Data are insufficient to recommend dose adjustment

Dosing Considerations

Monitor: CBC with differential (monitor frequently in patients with poor bone marrow reserve), Hgb, serum creatinine, LFTs, HIV viral load and CD4

Anemia: (Hgb <7.5 g/dL or decline >25% from baseline) discontinue drug until recovery of marrow evident

Neutropenia: (granulocyte <750 cells/mm³ or decline >50% from baseline) discontinue drug until recovery of marrow evident

Dosage Forms & Strengths

capsule

  • 100mg

tablet

  • 300mg

syrup

  • 50mg/5mL

injectable solution

  • 10mg/mL

HIV Infection Treatment

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

Oral

  • GA ≥35 weeks
    • Birth to 4 weeks: 4 mg/kg PO BID
    • >4 weeks: 12 mg/kg PO BID
  • GA ≥30 to <35 weeks
    • Birth to 2 weeks: 2 mg/kg PO BID
    • 2 weeks: 3 mg/kg PO BID
    • >6-8 weeks: 12 mg/kg PO BID
  • GA <30 weeks
    • Birth to 4 weeks: 2 mg/kg PO BID
    • 4 to 8 weeks: 3 mg/kg PO BID
    • >8-10 weeks: 12 mg/kg PO BID
  • Infants born at or near term (GA ≥35 weeks)
    • 4 to <9 kg: 12 mg/kg PO BID
    • 9 to <30 kg: 9 mg/kg PO BID
    • ≥30 kg: 300 mg PO BID
  • Adolescents
    • 300 mg PO BID
  • Body surface area based dosing
    • 180-240 mg/m² PO BID

IV

  • GA ≥35 weeks
    • Birth to 4 weeks: 3 mg/kg IV BID
    • >4 weeks: 9 mg/kg IV BID
  • GA ≥30 to <35 weeks
    • Birth to 2 weeks: 1.5 mg/kg IV BID
    • 2-6 weeks: 2.3 mg/kg IV BID
    • >6-8 weeks: 9 mg/kg IV BID
  • GA <30 weeks
    • Birth to 4 weeks: 1.5 mg/kg IV BID
    • 4-8 weeks: 2.3 mg/kg IV BID
    • >8-10 weeks: 9 mg/kg IV BID
  • Infants ≥3 months
    • 120 mg/m²/dose IV q6h; not to exceed 160 mg/dose
  • Adolescents ≥30 kg
    • 1-2 mg/kg IV q4hr

HIV Perinatal Transmission Prevention

Indicated to prevent mother-to-child HIV transmission in all HIV-exposed infants

2 mg/kg PO q6hr or 1.5 mg/kg IV q6hr for 4-6 weeks as determined by risk  

Consultation is available from the National Perinatal HIV Hotline (888-448-8765)

Low risk of perinatal HIV transmission

  • Mother who received ART during pregnancy with sustained viral suppression near delivery and no concerns related to adherence
  • Give zidovudine for 4 weeks

Higher risk of perinatal HIV transmission

  • High risk includes
    • Mothers who received neither antepartum nor intrapartum ARV drugs
    • Mothers who received only intrapartum ARV drugs
    • Mothers who received antepartum and intrapartum ARV drugs, but who have detectable viral load near delivery, particularly if delivery was vaginal
    • Mothers with acute or primary HIV infection during pregnancy or breastfeeding (in which case, the mother should discontinue breastfeeding)
  • Neonatal ARV
    • 2-drug ARV prophylaxis with zidovudine for 6 weeks and 3 doses of nevirapine (prophylactic dosage given within 48 hr of birth, 48 hr after first dose, and 96 hr after second dose) OR
    • Empiric HIV therapy using either zidovudine, lamivudine, and nevirapine (treatment dosage) OR zidovudine, lamivudine, and raltegravir from birth to age 6 weeks

Presumed newborn HIV exposure

  • Mothers with unknown HIV status who test HIV positive at delivery or postpartum or whose newborns have a positive HIV antibody test
  • Neonatal ARV
    • ARV management as above (for higher risk of perinatal HIV transmission)
    • Discontinue neonate ARV treatment immediately if supplemental testing confirms that the mother does not have HIV

Newborn with HIV

  • Positive newborn HIV virologic test
  • Give 3-drug ARV regimen using treatment doses

Oral dosage as determined by gestational (GA in weeks) and birth age

  • GA <30 weeks
    • Birth to 4 weeks: 2 mg/kg PO BID  
    • >4 weeks: 3 mg/kg PO BID
  • GA ≥30 to <35 weeks
    • Birth to 2 weeks: 2 mg/kg PO BID  
    • >2 weeks: 3 mg/kg PO BID
  • GA ≥35 weeks
    • 4 mg/kg/dose PO BID  
  • Infants <6 weeks (GA≥35 weeks)
    • Mother received standard antiretroviral therapy during pregnancy, viral suppression was sustained, maternal adherence not a concern: 4-week course recommended
    • Intravenous weight based dosing: 2 mg/kg/dose q12hr

IV dosage as determined by gestational (GA in weeks) and birth age

  • GA <30 weeks
    • Birth to 4 weeks: 1.5 mg/kg IV BID
    • >4 weeks: 2.3 mg/kg IV BID
  • GA ≥30 to <35 weeks
    • Birth to 2 weeks: 1.5 mg/kg IV BID
    • >2 weeks: 2.3 mg/kg IV BID
  • GA ≥35 weeks
    • 3 mg/kg/dose IV BID
  • Infants born prematurely (GA<35 weeks)
    • Use neonate dosing; standard infant dosing may be excessive in infants who were born prematurely
  • Infants <6 weeks (GA≥35 weeks)
    • Mother received standard antiretroviral therapy during pregnancy, viral suppression was sustained, maternal adherence not a concern: 4-week course recommended
    • IV weight based dosing: 2 mg/kg/dose q12hr

Dosing Considerations

Monitor CBC, Hgb

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Interactions

Interaction Checker

and zidovudine

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      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (1)

            • elvitegravir/cobicistat/emtricitabine/tenofovir DF

              zidovudine, elvitegravir/cobicistat/emtricitabine/tenofovir DF. Other (see comment). Contraindicated. Comment: Elvitegravir/cobicistat/emtricitabine/tenofovir is a complete regimen for HIV and should not be administered with other antiretrovirals.

            Serious - Use Alternative (9)

            • cabotegravir

              zidovudine, cabotegravir. Other (see comment). Avoid or Use Alternate Drug. Comment: Cabotegravir plus rilpivirine is a complete regimen. Coadministration with other antiretroviral medications for treating HIV-1 infection is not recommended.

            • cidofovir

              cidofovir, zidovudine. Either increases levels of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: When cidofovir is administered concurrently with probenecid, zidovudine clearance may be decreased. Reduce dose of zidovudine by 50% on days of cidofovir/probenecid administration. .

            • clozapine

              clozapine, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased risk of myelosuppression.

            • deferiprone

              deferiprone, zidovudine. 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.

            • ganciclovir

              ganciclovir increases toxicity of zidovudine by pharmacodynamic synergism. Contraindicated.

            • pretomanid

              pretomanid will increase the level or effect of zidovudine by Other (see comment). Avoid or Use Alternate Drug. In vitro studies demonstrated that pretomanid significantly inhibits OAT3; monitor for increased adverse effects and consider dosage reduction for OAT3 substrates.

            • ribavirin

              ribavirin decreases effects of zidovudine by Other (see comment). Avoid or Use Alternate Drug. Comment: Mechanism: Competition for thymidine kinase for conversion to active form.

            • stavudine

              zidovudine decreases effects of stavudine by Other (see comment). Contraindicated. Comment: Mechanism: Competition for thymidine kinase for conversion to active form.

            • valganciclovir

              valganciclovir increases toxicity of zidovudine by pharmacodynamic synergism. Contraindicated.

            Monitor Closely (51)

            • abacavir

              abacavir and zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • acalabrutinib

              acalabrutinib, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration may increase risk of myelosuppressive effects.

            • atazanavir

              atazanavir and zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • azathioprine

              azathioprine, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.

            • carboplatin

              carboplatin, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.

            • cidofovir

              cidofovir, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.

            • cisplatin

              cisplatin, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.

            • clarithromycin

              clarithromycin increases toxicity of zidovudine by unknown mechanism. Use Caution/Monitor. Increased risk of myelosuppression.

              clarithromycin, zidovudine. Mechanism: unknown. Use Caution/Monitor. Clarithromycin may increase or decrease levels of zidovudine. Literature describes conflicting reports. Separate administration by minimum 2 to 4 hours. .

            • clofarabine

              clofarabine, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.

            • conivaptan

              conivaptan increases levels of zidovudine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • dasatinib

              dasatinib, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.

            • dexrazoxane

              dexrazoxane, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.

            • doxorubicin

              zidovudine increases toxicity of doxorubicin by pharmacodynamic synergism. Use Caution/Monitor. Inreased risk of myelosuppression.

              doxorubicin decreases effects of zidovudine by Other (see comment). Use Caution/Monitor.

            • doxorubicin liposomal

              zidovudine increases toxicity of doxorubicin liposomal by pharmacodynamic synergism. Use Caution/Monitor. Inreased risk of myelosuppression.

              doxorubicin liposomal decreases effects of zidovudine by Other (see comment). Use Caution/Monitor. Comment: Concomitant administration of zidovudine and doxorubicin should be avoided since an antagonistic relationship has been demonstrated in vitro.

            • efavirenz

              efavirenz and zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • emtricitabine

              emtricitabine and zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • enfuvirtide

              enfuvirtide and zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • fosamprenavir

              fosamprenavir and zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • hydroxyurea

              hydroxyurea, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.

              zidovudine, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.

            • ibritumomab tiuxetan

              ibritumomab tiuxetan, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.

            • ifosfamide

              ifosfamide, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Ifosfamide may enhance the toxicities of myelosuppressive agents. Monitor for increased risk of myelosuppression.

            • imatinib

              imatinib, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.

            • indinavir

              indinavir and zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • interferon alfa 2b

              interferon alfa 2b increases levels of zidovudine by decreasing metabolism. Use Caution/Monitor.

            • interferon alfa n3

              interferon alfa n3 increases levels of zidovudine by decreasing metabolism. Use Caution/Monitor. Interferons may enhance potential for adverse effects. Patients should be monitored for signs and symptoms of increased myelosuppression and liver decompensation.

            • interferon beta 1a

              interferon beta 1a increases levels of zidovudine by decreasing renal clearance. Use Caution/Monitor. Interferons may enhance potential for adverse effects. Patients should be monitored for signs and symptoms of increased myelosuppression and liver decompensation.

            • interferon beta 1b

              interferon beta 1b increases levels of zidovudine by decreasing renal clearance. Use Caution/Monitor. Interferons may enhance potential for adverse effects. Patients should be monitored for signs and symptoms of increased myelosuppression and liver decompensation.

            • ketoconazole

              ketoconazole increases levels of zidovudine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • lamivudine

              lamivudine and zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • lenalidomide

              lenalidomide, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.

            • methotrexate

              methotrexate, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.

            • mitomycin

              mitomycin, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.

            • nelfinavir

              nelfinavir and zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • nevirapine

              nevirapine and zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • orlistat

              orlistat will decrease the level or effect of zidovudine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Loss of virological control reported in HIV-infected patients taking orlistat concomitantly. Exact mechanism is unclear, but may include a drug-drug interaction that inhibits systemic absorption of the antiretroviral drug. Monitor HIV RNA levels frequently and if increased HIV viral load confirmed, discontinue orlistat.

            • oxaliplatin

              oxaliplatin, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.

            • peginterferon alfa 2b

              peginterferon alfa 2b will increase the level or effect of zidovudine by Other (see comment). Use Caution/Monitor. Interferons may enhance adverse effects of zidovudine including increased myelosuppression.

            • primaquine

              primaquine, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.

            • probenecid

              probenecid increases levels of zidovudine by decreasing metabolism. Use Caution/Monitor.

            • rifabutin

              rifabutin will decrease the level or effect of zidovudine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • rifampin

              rifampin decreases levels of zidovudine by increasing metabolism. Use Caution/Monitor.

            • ritonavir

              ritonavir and zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • saquinavir

              saquinavir and zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • stavudine

              stavudine and zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • tenofovir DF

              tenofovir DF and zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • thiotepa

              thiotepa, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.

            • tipranavir

              tipranavir and zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

              tipranavir decreases levels of zidovudine by unspecified interaction mechanism. Use Caution/Monitor.

            • tobramycin inhaled

              tobramycin inhaled and zidovudine both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity

            • tocilizumab

              tocilizumab decreases levels of zidovudine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Interaction applies to inflammatory conditions, such as rheumatoid arthritis, associated with increased levels of IL-6.

            • trimethoprim

              trimethoprim increases levels of zidovudine by decreasing renal clearance. Use Caution/Monitor. Potential for increased toxicity. .

            • valproic acid

              valproic acid increases levels of zidovudine by decreasing metabolism. Use Caution/Monitor. Potential for increased toxicity. .

            Minor (18)

            • amphotericin B deoxycholate

              zidovudine increases toxicity of amphotericin B deoxycholate by pharmacodynamic synergism. Minor/Significance Unknown.

            • black cohosh

              black cohosh increases toxicity of zidovudine by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of hepatoxicity.

            • cyanocobalamin

              zidovudine decreases levels of cyanocobalamin by unspecified interaction mechanism. Minor/Significance Unknown.

            • dapsone

              zidovudine, dapsone. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Increased bone marrow toxicity.

            • didanosine

              zidovudine increases levels of didanosine by decreasing renal clearance. Minor/Significance Unknown.

            • fluconazole

              fluconazole increases levels of zidovudine by decreasing metabolism. Minor/Significance Unknown.

            • flucytosine

              zidovudine increases toxicity of flucytosine by pharmacodynamic synergism. Minor/Significance Unknown.

            • food

              food decreases levels of zidovudine by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

            • kava

              kava increases toxicity of zidovudine by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of hepatoxicity.

            • lamivudine

              lamivudine increases effects of zidovudine by pharmacodynamic synergism. Minor/Significance Unknown. Beneficial synergism.

            • methadone

              methadone increases levels of zidovudine by decreasing renal clearance. Minor/Significance Unknown.

            • pentamidine

              zidovudine increases toxicity of pentamidine by pharmacodynamic synergism. Minor/Significance Unknown.

            • pyrimethamine

              zidovudine, pyrimethamine. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Increased bone marrow toxicity.

            • sulfamethoxazole

              zidovudine increases toxicity of sulfamethoxazole by pharmacodynamic synergism. Minor/Significance Unknown.

              sulfamethoxazole increases levels of zidovudine by decreasing renal clearance. Minor/Significance Unknown.

            • valacyclovir

              valacyclovir increases effects of zidovudine by unknown mechanism. Minor/Significance Unknown. Monitor for lethargy and fatigue.

            • vinblastine

              zidovudine increases toxicity of vinblastine by pharmacodynamic synergism. Minor/Significance Unknown.

            • vincristine

              zidovudine increases toxicity of vincristine by pharmacodynamic synergism. Minor/Significance Unknown.

            • vincristine liposomal

              zidovudine increases toxicity of vincristine liposomal by pharmacodynamic synergism. Minor/Significance Unknown.

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            Adverse Effects

            >10%

            Anemia (23% in children)

            Anorexia (11%)

            Diarrhea (17%)

            Fever (16%)

            Granulocytopenia (39% in children)

            Headache, severe (42%)

            Leukopenia (39%)

            Nausea (46-61%)

            Pain (20%)

            Rash (17%)

            Vomiting (6-25%)

            Weakness (19%)

            1-10%

            Malaise (8%)

            Dizziness (6%)

            Insomnia (5%)

            Somnolence (8%)

            Hyperpigmentation of nails (bluish-brown)

            Dyspepsia (5%)

            Changes in platelet count

            Paresthesia (6%)

            Postmarketing Reports

            Reproductive System and Breast: Gynecomastia

            Skin and Subcutaneous Tissue: Changes in skin and nail pigmentation, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis, sweating, urticaria

            Renal and Urinary: Urinary frequency, urinary hesitancy

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            Warnings

            Black Box Warnings

            Neutropenia and severe anemia reported, particularly in patients with advanced HIV disease

            Myopathy associated with prolonged use

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

            Contraindications

            Hypersensitivity

            Cautions

            Risk of severe anemia and bone marrow depression; use with caution in patients with bone marrow compromise; hemoglobin reduction may occur 2-4 weeks and neutropenia may occur 6-8 weeks after initiating therapy; monitor blood counts; dose interruption may be required in patients who develop anemia or neutropenia

            Female sex and obesity may be risk factors for development of lactic acidosis and severe hepatomegaly with steatosis in patients treated with antiretroviral nucleoside analogues

            Monitor CBC with differentials (patients with poor bone marrow reserve require more frequent monitoring); perform CD4 count every 3-6 months; liver function tests recommended every 6-12 months

            (All NRTIs): Risk of potentially fatal lactic acidosis and severe hepatomegaly with steatosis when used alone or in combination with other antiretrovirals; suspend treatment in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or hepatotoxicity (elevation of transaminase with or without hepatomegaly and steatosis may occur)

            Risk of immune reconstitution syndrome if used in combination with other antiretroviral drugs; further evaluation and treatment may be required; autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barré syndrome) reported to occur in setting of immune reconstitution; time to onset is more variable, and can occur many months after initiation of treatment

            Lipoatrophy, causing loss of subcutaneous fat, especially in the face and buttocks may occur; incidence and severity associated with cumulative exposure; may be only partially reversible improvement may take months or years after switching to regimen that does not contain zidovudine; monitor for signs of lipoatrophy and consider switching to non-zidovudine-containing regimen if lipoatrophy occurs

            Myopathy associated with prolonged use exhibit pathological changes similar to that produced by HIV-1 disease

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            Pregnancy & Lactation

            Pregnancy

            Available data from the APR show no difference in the overall risk of birth defects for lamivudine or zidovudine compared with background rate for birth defects of 2.7% in the Metropolitan Atlanta Congenital Defects Program (MACDP) reference population; APR uses the MACDP as the U.S. reference population for birth defects in the general population; MACDP evaluates women and infants from a limited geographic area and does not include outcomes for births that occurred at less than 20 weeks gestation; rate of miscarriage is not reported in the APR

            Hyperlactatemia, which may be due to mitochondrial dysfunction, reported in infants with in utero exposure to zidovudine-containing products; events were transient and asymptomatic in most cases; developmental delay, seizures, and other neurological disease also reported; a causal relationship between these events and exposure to zidovudine-containing products in utero or peri-partum not established

            Drug has been shown to cross placenta and concentrations in neonatal plasma at birth were essentially equal to those in maternal plasma at delivery; mild, transient elevations in serum lactate levels reported, which may be due to mitochondrial dysfunction, in neonates and infants exposed in utero or peri-partum to zidovudine-containing products; clinical relevance of transient elevations in serum lactate is unknown

            Lactation

            The Centers for Disease Control and Prevention recommend that HIV-1-infected mothers in the United States not breastfeed infants to avoid risking postnatal transmission of HIV-1 infection; lamivudine is present in human milk; there is no information on effects of lamivudine or zidovudine on breastfed infant or effects of drugs on milk production; because of potential for (1) HIV-1 transmission (in HIV-negative infants), (2)developing viral resistance (in HIV-positive infants), and (3) serious adverse reactions in a breastfed infant, 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

            Inhibits thymidine kinase

            Nucleoside Reverse Transcriptase Inhibitor (NRTI)

            Use with 3TC inhibits resistance

            Distribution

            Penetrates CNS well

            Protein binding: 25-38%

            Vd: 1-2.2 L/kg

            Metabolism

            Liver

            Elimination

            Half-life: 1 hr

            Excretion: Urine

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            Administration

            IV Preparation

            Dilute to not to exceed 4 mg/mL with D5W

            IV Administration

            Infuse over 1 hr

            Also given continuous infusion

            Do NOT give IVP or IM

            IV Incompatibilities

            Additive: Meropenem (may be dependent on meropenem concentration)

            Y-Site: Meropenem (may be dependent on meropenem concentration)

            IV Compatibilities

            Solution: D5W, NS

            Y-site (partial list): acyclovir, allopurinol, cefepime, clindamycin, dopamine, erythromycin, fluconazole, heparin, imipenem-cilastatin, linezolid, lorazepam, morphine, KCl, TMP-SMX, vancomycin

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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            Retrovir intravenous
            -
            10 mg/mL vial
            Retrovir intravenous
            -
            10 mg/mL vial
            Retrovir oral
            -
            10 mg/mL syrup
            Retrovir oral
            -
            100 mg capsule
            zidovudine oral
            -
            300 mg tablet
            zidovudine oral
            -
            300 mg tablet
            zidovudine oral
            -
            100 mg capsule
            zidovudine oral
            -
            300 mg tablet
            zidovudine oral
            -
            300 mg tablet
            zidovudine oral
            -
            10 mg/mL syrup

            Copyright © 2010 First DataBank, Inc.

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            Patient Education
            zidovudine intravenous

            NO MONOGRAPH AVAILABLE AT THIS TIME

            USES: Consult your pharmacist.

            HOW TO USE: Consult your pharmacist.

            SIDE EFFECTS: Consult your pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Consult your pharmacist.

            DRUG INTERACTIONS: Consult your pharmacist.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

            NOTES: No monograph available at this time.

            MISSED DOSE: Consult your pharmacist.

            STORAGE: Consult your pharmacist.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

            Information last revised July 2016. Copyright(c) 2021 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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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.
            Additional Offers
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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.