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Retrovir

Generic Name: Zidovudine
Class: HIV Nucleoside and Nucleotide Reverse Transcriptase Inhibitors
VA Class: AM800
Chemical Name: 3′-Azido-3′-deoxythymidine
CAS Number: 30516-87-1
Brands: Retrovir

Zidovudine is also contained as an ingredient in the following combinations:
Abacavir Sulfate, Lamivudine, and Zidovudine
Lamivudine and Zidovudine

Medically reviewed on April 2, 2018

Warning

    Hematologic Toxicity
  • Hematologic toxicity (including neutropenia and severe anemia) reported, particularly in patients with advanced HIV-1 disease.1 227 229 231 (See Hematologic Effects under Cautions.)

    Myopathy
  • Symptomatic myopathy reported with prolonged use.1 227 229 231 (See Musculoskeletal Effects under Cautions.)

    Lactic Acidosis and Severe Hepatomegaly
  • Lactic acidosis and severe hepatomegaly with steatosis (including some fatalities) reported in patients receiving nucleoside analogs alone or in combination, including zidovudine and other antiretrovirals.1 227 229 231 (See Lactic Acidosis and Severe Hepatomegaly with Steatosis under Cautions.)

    Fixed Combinations
  • If using fixed combination of zidovudine and lamivudine (lamivudine/zidovudine; Combivir, generic) or fixed combination of abacavir, lamivudine, and zidovudine (abacavir/lamivudine/zidovudine; Trizivir, generic), consider that severe, acute exacerbations of HBV reported following discontinuance of lamivudine in HIV-infected patients coinfected with HBV.227 229 Closely monitor hepatic function for at least several months after lamivudine-containing preparation discontinued;227 229 if appropriate, initiation of HBV therapy may be warranted.227 229

  • If using abacavir/lamivudine/zidovudine, consider that abacavir has been associated with serious and sometimes fatal hypersensitivity reactions with multiple organ involvement.229 Individuals with human leukocyte antigen (HLA)-B*5701 allele are at higher risk for abacavir hypersensitivity reactions, although such reactions have occurred in patients without the HLA-B*5701 allele.229 Screen all patients for HLA-B*5701 allele prior to initiation or reinitiation of abacavir/lamivudine/zidovudine, unless patient has previously documented HLA-B*5701 allele assessment.229 Immediately discontinue abacavir/lamivudine/zidovudine if hypersensitivity reaction suspected, regardless of patient’s HLA-B*5701 status and even when other diagnoses are possible.229 Following a hypersensitivity reaction, never reinitiate abacavir-containing preparation because more severe symptoms, including death, can occur within hours.229 Similar severe reactions also reported rarely following reintroduction of abacavir-containing preparation in patients with no history of abacavir hypersensitivity.229

Introduction

Antiretroviral; HIV nucleoside reverse transcriptase inhibitor (NRTI).1 12 16 18 200 231 260 296

Uses for Retrovir

Treatment of HIV Infection

Treatment of HIV-1 infection in adults, adolescents, and pediatric patients;1 200 201 231 used in conjunction with other antiretrovirals.1 200 201 231

Used with another NRTI (dual NRTIs) in conjunction with an HIV integrase strand transfer inhibitor (INSTI), HIV nonnucleoside reverse transcriptase inhibitor (NNRTI), or HIV protease inhibitor (PI) in INSTI-, NNRTI-, or PI-based regimens.200 201

Dual NRTI option of zidovudine and lamivudine no longer recommended for initial treatment regimens in nonpregnant antiretroviral-naive HIV-infected adults and adolescents (greater toxicity than currently recommended dual NRTI options),200 but is recommended as an alternative (not a preferred) dual NRTI option for initial treatment regimens in antiretroviral-naive pregnant women.202

For initial treatment in antiretroviral-naive pediatric patients, experts state that zidovudine and lamivudine (or emtricitabine) is a preferred dual NRTI option for use in neonates, infants, and children <12 years of age and an alternative dual NRTI option in adolescents ≥12 years of age with sexual maturity rating (SMR) 3.201

Do not use dual NRTI option of zidovudine and stavudine at any time (in vitro and in vivo antagonistic antiretroviral effects reported).200 201

Lamivudine/zidovudine fixed combination can be used in adults, adolescents, and pediatric patients weighing ≥30 kg when dual NRTI option of zidovudine and lamivudine is indicated;227 used in conjunction with other antiretrovirals.227

Abacavir/lamivudine/zidovudine fixed combination can be used in adults, adolescents, and pediatric patients weighing ≥40 kg;229 used alone as a complete treatment regimen or in conjunction with other antiretrovirals.229 Data limited regarding use in patients with baseline viral loads >100,000 copies/mL.229

Triple NRTI regimen of abacavir, lamivudine, and zidovudine not recommended in antiretroviral-naive or antiretroviral experienced patients (inferior antiretroviral activity).200 201

Prevention of Perinatal HIV Transmission

Prevention of maternal-fetal transmission of HIV in certain pregnant HIV-infected women and in neonates born to HIV-infected women (HIV-exposed neonates).1 202 231

Prophylaxis in pregnant HIV-infected women (i.e., intrapartum IV zidovudine prophylaxis regimen);1 202 231 indicated based on degree of risk of perinatal HIV transmission near time of delivery.202

Prophylaxis in neonates born to HIV-infected women;202 zidovudine prophylaxis used alone in neonates at low risk of HIV acquisition or in conjunction with nevirapine prophylaxis in those at higher risk.202

Empiric HIV therapy in neonates born to HIV-infected women;202 used in 3-drug empiric regimen (zidovudine, lamivudine, and nevirapine) for prevention of perinatal HIV transmission in neonates at highest risk of HIV acquisition.202

Pregnant HIV-infected women: Multiple-drug antiretroviral regimens are standard of care in the US for treatment of HIV infection in pregnant women and for prevention of perinatal HIV transmission.202 In addition, to further decrease risk of perinatal HIV transmission, experts recommend that all pregnant HIV-infected women with plasma HIV-1 RNA levels >1000 copies/mL (or unknown HIV-1 RNA levels) near delivery receive an intrapartum IV zidovudine prophylaxis regimen initiated at onset of labor (or 3 hours before scheduled cesarean delivery) and continued until delivery.202 Intrapartum IV zidovudine prophylaxis regimen may be considered in pregnant HIV-infected women with plasma HIV-1 RNA levels of 50–999 copies/mL near time of delivery,202 but not necessary in those with plasma HIV-1 RNA levels ≤50 copies/mL during late pregnancy and near time of delivery if receiving antiretroviral treatment and there are no concerns related to maternal adherence to the treatment regimen.202

HIV-exposed neonates: Experts recommend that all neonates born to HIV-infected women (HIV-exposed neonates) receive an antiretroviral regimen (either prophylaxis or empiric HIV therapy) initiated as soon as possible after birth (within 6–12 hours) and continued through 4–6 weeks of age.202 Select antiretroviral prophylaxis regimen or empiric HIV treatment regimen based on likelihood of perinatal HIV transmission.202 HIV-exposed neonates at low risk of HIV acquisition (i.e., infants born to mothers who were receiving a recommended multiple-drug antiretroviral regimen during pregnancy with sustained viral suppression near delivery and no concerns related to maternal adherence to the treatment regimen) may receive a 4-week zidovudine prophylaxis regimen used alone.202 HIV-exposed neonates at higher risk of HIV acquisition (e.g., those born to HIV-infected women who did not receive antepartum or intrapartum antiretrovirals, received only intrapartum antiretrovirals, or received antepartum and intrapartum antiretrovirals with suboptimal viral suppression near delivery) should receive 2-drug prophylaxis regimen (6-week zidovudine prophylaxis and 3-dose nevirapine prophylaxis).202 Alternatively, those at highest risk can receive 3-drug empiric HIV therapy regimen (zidovudine, lamivudine, and nevirapine).202

Maternal and neonatal regimens recommended for prevention of perinatal HIV transmission in the US may differ from those used in other countries (e.g., resource-limited countries).202

Consult National Perinatal HIV Hotline at 888-448-8765 for information regarding antiretroviral treatment of pregnant HIV-infected women and their infants and prevention of perinatal HIV transmission.202

Postexposure Prophylaxis following Occupational Exposure to HIV (PEP)

Postexposure prophylaxis of HIV infection following occupational exposure (PEP) in health-care personnel and others exposed via percutaneous injury (e.g., needlestick, cut with sharp object) or mucous membrane or nonintact skin (e.g., chapped, abraded, dermatitis) contact with blood, tissue, or other body fluids that might contain HIV.96 97 98 149 194 199 337 338 339 340 341 342 343 344 418 465 531

USPHS recommends 3-drug regimen of raltegravir in conjunction with emtricitabine and tenofovir DF as the preferred regimen for PEP following occupational exposures to HIV.199 Several alternative regimens that include an INSTI, NNRTI, or PI and 2 NRTIs (dual NRTIs) also recommended.199 Preferred dual NRTI option for PEP regimens is emtricitabine and tenofovir DF (may be given as fixed combination emtricitabine/tenofovir DF); alternative dual NRTIs are tenofovir DF and lamivudine, lamivudine and zidovudine (may be given as lamivudine/zidovudine), or zidovudine and emtricitabine.199

Management of occupational exposures to HIV is complex and evolving; consult infectious disease specialist, clinician with expertise in administration of antiretroviral agents, and/or National Clinicians’ Postexposure Prophylaxis Hotline (PEPline at 888-448-4911) whenever possible.199 Do not delay initiation of PEP while waiting for expert consultation.199

Postexposure Prophylaxis following Nonoccupational Exposure to HIV (nPEP)

Postexposure prophylaxis of HIV infection following nonoccupational exposure (nPEP) in individuals exposed to blood, genital secretions, or other potentially infectious body fluids that might contain HIV when that exposure represents a substantial risk for HIV transmission.198

When nPEP indicated in adults and adolescents ≥13 years of age with normal renal function, CDC states preferred regimen is either raltegravir or dolutegravir used in conjunction with emtricitabine and tenofovir DF (given as emtricitabine/tenofovir DF).198 These experts state preferred nPEP regimen in adults and adolescents ≥13 years of age with impaired renal function (Clcr ≤59 mL/minute) is either raltegravir or dolutegravir used in conjunction with zidovudine and lamivudine.198

Consult infectious disease specialist, clinician with expertise in administration of antiretroviral agents, and/or the National Clinicians’ Postexposure Prophylaxis Hotline (PEPline at 888-448-4911) if nPEP indicated in certain exposed individuals (e.g., pregnant women, children, those with medical conditions such as renal impairment) or if considering a regimen not included in CDC guidelines, source virus is known or likely to be resistant to antiretrovirals, or healthcare provider is inexperienced in prescribing antiretrovirals.198 Do not delay initiation of nPEP while waiting for expert consultation.198

Retrovir Dosage and Administration

Administration

Administer orally1 231 or by intermittent or continuous IV infusion.1

Do not administer by rapid IV infusion or injection or by IM injection.1

When used for treatment of HIV infection, administer by IV infusion only until oral zidovudine can be substituted.1

Oral Administration

Administer capsules, tablets, or oral solution orally without regard to meals.1 231

Use oral solution in children who cannot reliably swallow intact capsules or tablets.1

Lamivudine/zidovudine: Administer orally twice daily without regard to meals.227 Do not use in pediatric patients weighing <30 kg, patients with renal impairment (i.e., Clcr <50 mL/minute), patients with hepatic impairment, or patients who experience dose-limiting adverse effects.227

Abacavir/lamivudine/zidovudine: Administer orally twice daily without regard to meals.229 Do not use in pediatric patients weighing <40 kg, patients with renal impairment (i.e., Clcr <50 mL/minute), or patients with hepatic impairment (contraindicated in those with moderate or severe hepatic impairment).229

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Dilution

Zidovudine concentrate for IV infusion containing 10 mg/mL must be diluted prior to administration.1 Withdraw appropriate dose from the vial and dilute in 5% dextrose injection to provide a solution containing ≤4 mg/mL.1

Rate of Administration

Intermittent IV infusions in adults: Infuse over 60 minutes.1

Intermittent IV infusions in neonates: Infuse over 30 minutes.1

Intrapartum IV prophylaxis regimen in pregnant HIV-infected women: Give initial dose by IV infusion over 60 minutes, then give by continuous IV infusion at a rate of 1 mg/kg per hour.1

Dosage

Pediatric Patients

Treatment of HIV Infection

Dosage in pediatric patients is based on weight or, alternatively, body surface area (BSA).1 201 202 231 To avoid medication errors, use extra care in calculating dose, transcribing medication order, dispensing prescription, and providing dosage instructions.1 231

Dosage in pediatric patients should not exceed adult dosage.1 231

Treatment of HIV Infection in Neonates
Oral

Premature neonates (gestational age <30 weeks): 2 mg/kg twice daily from birth to 4 weeks of age; 3 mg/kg twice daily from 4 weeks to 8–10 weeks of age; 12 mg/kg twice daily beginning at >8–10 weeks of age.201

Premature neonates (gestational age 30 to <35 weeks): 2 mg/kg twice daily from birth to 2 weeks of age; 3 mg/kg twice daily from 2 weeks to 6–8 weeks of age; 12 mg/kg twice daily beginning at >6–8 weeks of age.201

Full-term neonates (gestational age ≥35 weeks): 4 mg/kg twice daily from birth to 4 weeks of age and 12 mg/kg twice daily in those >4 weeks of age.201 Alternatively, when simplified weight-based dosage of oral solution containing 10 mg/mL used, experts recommend 10 mg (1 mL) twice daily in those weighing 2 to <3 kg, 15 mg (1.5 mL) twice daily in those weighing 3 to <4 kg, and 20 mg (2 mL) twice daily in those weighing 4 to <5 kg.201

IV

Premature neonates (gestational age <30 weeks): 1.5 mg/kg twice daily from birth to 4 weeks of age; 2.3 mg/kg twice daily from 4 weeks to 8–10 weeks of age; 9 mg/kg twice daily beginning at >8–10 weeks of age.201

Premature neonates (gestational age 30 to <35 weeks): 1.5 mg/kg twice daily from birth to 2 weeks of age; 2.3 mg/kg twice daily from 2 weeks to 6–8 weeks of age; 9 mg/kg twice daily beginning at >6–8 weeks of age.201

Full-term neonates (gestational age ≥35 weeks): 3 mg/kg twice daily from birth until 4 weeks of age; 9 mg/kg in those >4 weeks of age.201

Treatment of HIV Infection in Infants and Children
Oral

Infants and children ≥4 weeks of age weighing ≥4 kg: See Table 1.

Table 1. Oral Zidovudine Dosage Recommended in Pediatric Patients ≥4 Weeks of Age Weighing ≥4 kg 1201231

Body Weight (kg)

Twice-daily Dosage Regimen

Three-times-daily Dosage Regimen

4 to <9

12 mg/kg twice daily

8 mg/kg 3 times daily

9 to <30

9 mg/kg twice daily

6 mg/kg 3 times daily

≥30

300 mg twice daily

200 mg 3 times daily

Alternatively, if BSA used to calculate dosage for pediatric patients ≥4 weeks of age, manufacturer recommends 240 mg/m2 twice daily or 160 mg/m2 3 times daily.1 231 Some experts recommend 180–240 mg/m2 every 12 hours.201

Lamivudine/zidovudine in children and adolescents weighing ≥30 kg: 1 tablet (lamivudine 150 mg and zidovudine 300 mg) twice daily.227

Abacavir/lamivudine/zidovudine in children and adolescents weighing ≥40 kg: 1 tablet (abacavir 300 mg, lamivudine 150 mg, and zidovudine 300 mg) twice daily.229

Prevention of Perinatal HIV Transmission
Prophylaxis in Neonates Born to HIV-infected Women
Oral

Premature neonates (gestational age <30 weeks): 2 mg/kg twice daily initiated as soon as possible after birth (within 6–12 hours); increase to 3 mg/kg twice daily at 4 weeks of age and continue until 4–6 weeks of age.202

Premature neonates (gestational age 30 to <35 weeks): 2 mg/kg twice daily initiated as soon as possible after birth (within 6–12 hours); increase to 3 mg/kg twice daily at 2 weeks of age and continue until 4–6 weeks of age.202

Full-term neonates (gestational age ≥35 weeks): 4 mg/kg twice daily initiated as soon as possible after birth (within 6–12 hours); continue until 4–6 weeks of age.202 Alternatively, when simplified weight-based dosage of oral solution containing 10 mg/mL used, experts recommend 10 mg (1 mL) twice daily in those weighing 2 to <3 kg, 15 mg (1.5 mL) twice daily in those weighing 3 to <4 kg, and 20 mg (2 mL) twice daily in those weighing 4 to <5 kg.202

Neonates: Manufacturer recommends 2 mg/kg every 6 hours initiated within 12 hours of birth and continued through 6 weeks of age.1 231

Although 4-week zidovudine prophylaxis regimen may be used alone in HIV-exposed neonates at low risk of HIV acquisition (i.e., infants born to mothers who were receiving a recommended multiple-drug antiretroviral regimen during pregnancy with sustained viral suppression near delivery and no concerns related to maternal adherence to the treatment regimen), 6-week zidovudine prophylaxis regimen used in conjunction with a 3-dose nevirapine prophylaxis regimen (2-drug prophylaxis regimen) recommended for those at higher risk.202

Consult National Perinatal HIV Hotline at 888-448-8765 for information regarding selection of antiretrovirals, including dosage considerations, for prevention of perinatal HIV transmission.202

IV

Premature neonates (gestational age <30 weeks): 1.5 mg/kg twice daily initiated as soon as possible after birth (within 6–12 hours); increase to 2.3 mg/kg twice daily at 4 weeks of age and continue until 4–6 weeks of age.202

Premature neonates (gestational age 30 to <35 weeks): 1.5 mg/kg twice daily initiated as soon as possible after birth (within 6–12 hours); increase to 2.3 mg/kg twice daily at 2 weeks of age and continue until 4–6 weeks of age.202

Full-term neonates (gestational age ≥35 weeks): 3 mg/kg twice daily initiated as soon as possible after birth (within 6–12 hours); continue until 4–6 weeks of age.202

Neonates: Manufacturer recommends 1.5 mg/kg every 6 hours initiated within 12 hours of birth and continued through 6 weeks of age.1 231

Although 4-week zidovudine prophylaxis regimen may be used alone in HIV-exposed neonates at low risk of HIV acquisition (i.e., infants born to mothers who were receiving a recommended multiple-drug antiretroviral regimen during pregnancy with sustained viral suppression near delivery and no concerns related to maternal adherence to the treatment regimen), 6-week zidovudine prophylaxis regimen used in conjunction with a 3-dose nevirapine prophylaxis regimen recommended for those at higher risk.202

Consult National Perinatal HIV Hotline at 888-448-8765 for information regarding selection of antiretrovirals, including dosage considerations, for prevention of perinatal HIV transmission.202

Empiric HIV Therapy in Neonates Born to HIV-infected Women
Oral or IV

Recommended empiric HIV therapy regimen consists of zidovudine, lamivudine, and nevirapine initiated as soon as possible after birth (within 6–12 hours);202 used in HIV-exposed neonates considered at highest risk of HIV acquisition.202 (See Prevention of Perinatal HIV Transmission under Uses.)

Zidovudine dosage for empiric HIV therapy in neonates Born to HIV-infected women is the same as that recommended for prophylaxis in neonates born to HIV-infected women.202 (See Prophylaxis in Neonates Born to HIV-infected Women under Dosage and Administration.)

Optimal duration of empiric HIV therapy in HIV-exposed neonates unknown.202 Many experts recommend that 3-drug empiric regimen be continued for 6 weeks;202 others discontinue nevirapine and/or lamivudine if results of neonate's HIV nucleic acid amplification test (NAAT) are negative, but recommend continuing zidovudine for 6 weeks.202

Consult National Perinatal HIV Hotline at 888-448-8765 for information regarding selection of antiretrovirals, including dosage considerations, for prevention of perinatal HIV transmission.202

Adults

Treatment of HIV Infection
Oral

Zidovudine: 300 mg twice daily.1 231 Experts state usual dosage can be given as 300 mg twice daily or 200 mg 3 times daily.200

Lamivudine/zidovudine in adults weighing ≥30 kg: 1 tablet (lamivudine 150 mg and zidovudine 300 mg) twice daily.227

Abacavir/lamivudine/zidovudine in adults weighing ≥40 kg: 1 tablet (abacavir 300 mg, lamivudine 150 mg, and zidovudine 300 mg) twice daily.229

IV

Zidovudine: 1 mg/kg every 4 hours.1

Prevention of Perinatal HIV Transmission
HIV-infected Pregnant Women
IV

2 mg/kg given by IV infusion over 60 minutes (initiated at start of labor or 3 hours before scheduled cesarean delivery) followed by 1 mg/kg per hour given by continuous IV infusion until delivery.1 202 231

Indicated in pregnant HIV-infected women depending on plasma HIV-1 RNA levels near time of delivery.202 (See Prevention of Perinatal HIV Transmission under Uses.)

If oral zidovudine is part of current antiretroviral treatment regimen, substitute with IV zidovudine until after delivery;202 continue other antiretrovirals in the woman’s treatment regimen on schedule as much as possible during labor.202

Postexposure Prophylaxis following Occupational Exposure to HIV (PEP)
Oral

Zidovudine: 300 mg twice daily.199 Use in conjunction with other antiretrovirals (see Postexposure Prophylaxis following Occupational Exposure to HIV [PEP] under Uses).199

Lamivudine/zidovudine: 1 tablet (lamivudine 150 mg and zidovudine 300 mg) twice daily.199 Use in conjunction with a recommended INSTI, NNRTI, or PI (see Postexposure Prophylaxis following Occupational Exposure to HIV under Uses).199

Initiate PEP as soon as possible following occupational exposure to HIV (preferably within hours);199 continue for 4 weeks, if tolerated.199

Postexposure Prophylaxis following Nonoccupational Exposure to HIV (nPEP)
Oral

Zidovudine: Adjust dosage based on degree of renal impairment.198 Use in conjunction with other antiretrovirals (see Postexposure Prophylaxis following Nonoccupational Exposure to HIV [nPEP] under Uses).198

Initiate nPEP as soon as possible (within 72 hours) following nonoccupational exposure that represents a substantial risk for HIV transmission and continue for 28 days.198

nPEP not recommended if exposed individual seeks care >72 hours after exposure.198

Prescribing Limits

Pediatric Patients

Treatment of HIV Infection
Oral

Zidovudine in infants and children ≥4 weeks of age: Maximum 600 mg daily.1

Special Populations

Hepatic Impairment

Treatment of HIV Infection
Oral

Zidovudine: Data insufficient to recommend dosage adjustments for patients with hepatic impairment or liver cirrhosis.1 231

Lamivudine/zidovudine: Do not use in patients with hepatic impairment.227

Abacavir/lamivudine/zidovudine: Do not use in patients with hepatic impairment;229 contraindicated in those with moderate or severe hepatic impairment.229

IV

Zidovudine: Data insufficient to recommend dosage adjustments for patients with hepatic impairment or liver cirrhosis.1

Renal Impairment

Treatment of HIV Infection
Oral

Zidovudine in adults maintained on hemodialysis or peritoneal dialysis or with severe renal impairment (Clcr <15 mL/minute): 100 mg every 6–8 hours.1 231

Lamivudine/zidovudine: Do not use in patients with Clcr <50 mL/minute.227

Abacavir/lamivudine/zidovudine: Do not use in patients with Clcr <50 mL/minute.229

IV

Zidovudine in adults maintained on hemodialysis or peritoneal dialysis or with severe renal impairment (Clcr <15 mL/minute): 1 mg/kg every 6–8 hours.1

Geriatric Patients

Use with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.1 227 229 231

Cautions for Retrovir

Contraindications

  • Zidovudine: History of potentially life-threatening hypersensitivity reactions (e.g., anaphylaxis, Stevens-Johnson syndrome) to the drug or any ingredient in the formulation.1 231

  • Lamivudine/zidovudine: History of hypersensitivity to lamivudine or zidovudine.227

  • Abacavir/lamivudine/zidovudine: Positive for HLA-B*5701 allele; history of hypersensitivity to abacavir, lamivudine, or zidovudine; moderate or severe hepatic impairment.229

Warnings/Precautions

Warnings

Hematologic Effects

Hematologic toxicity (including neutropenia and severe anemia) reported, especially in patients with advanced HIV-1 disease.1 2 3 29 30 38 62 64 65 82 106 107 134 139 231 260 332 Pancytopenia reported; pancytopenia usually reversible following discontinuation of zidovudine.1 231

Determine CBCs and indices of anemia (e.g., hemoglobin, mean corpuscular volume) prior to and monitor frequently during zidovudine therapy, especially in patients with advanced HIV disease.1 50 64 181 227 229 231 332 Some experts recommend measuring CBCs with differentials 2–8 weeks after initiation of zidovudine treatment and every 3–6 months thereafter.200

Use with caution in patients who have bone marrow compromise evidenced by granulocyte count <1000 cells/mm3 or hemoglobin <9.5 g/dL.1 231

Substantial anemia (hemoglobin <7.5 g/dL or >25% reduction from baseline) and/or neutropenia (granulocyte count <750/mm3 or >50% reduction from baseline) may require dose interruption until there is evidence of bone marrow recovery.1 231 Dose interruption does not necessarily eliminate need for transfusion.1 231 If bone marrow recovery occurs following dose interruption, reinitiation may be appropriate using adjunctive measures (e.g., epoetin alfa), depending on hematologic indices and patient tolerance.1 231

Musculoskeletal Effects

Myopathy and myositis with pathologic changes, similar to that produced by HIV-1 disease, has been associated with long-term zidovudine use.1 227 229 231

Myalgia,1 231 musculoskeletal pain,1 231 arthralgia,1 231 back pain,1 231 generalized pain,1 231 muscle spasm,1 231 and tremor1 231 also reported.

Lactic Acidosis and Severe Hepatomegaly with Steatosis

Lactic acidosis and severe hepatomegaly with steatosis (sometimes fatal) reported in patients receiving nucleoside analogs, including zidovudine.1 227 229 231 Reported most frequently in women; obesity also may be a risk factor.1 227 229 231 Has been reported in patients with no known risk factors.1 227 229

Use particular caution in patients with known risk factors for liver disease.1 227 229 231

Discontinue zidovudine if there are clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (e.g., hepatomegaly and steatosis even in the absence of markedly increased serum aminotransferase concentrations).1 227 229 231

HIV-infected Patients Coinfected with HCV

Exacerbation of anemia reported in patients coinfected with HIV and HCV receiving zidovudine, interferon alfa, and ribavirin concomitantly.1 231 (See Specific Drugs under Interactions.)

Hepatic decompensation, sometimes fatal, reported in patients coinfected with HIV and HCV receiving antiretroviral therapy concomitantly with interferon alfa with or without ribavirin.1 168 231 298 (See Specific Drugs under Interactions.)

Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis,1 231 angioedema,1 231 Stevens-Johnson syndrome,1 231 and toxic epidermal necrolysis,1 231 reported rarely.

A packaging component of zidovudine concentrate for IV infusion (i.e., vial stoppers) contains dry natural rubber (a latex derivative) which may cause allergic reactions in latex-sensitive individuals.1

Other Warnings and Precautions

Use of Fixed Combinations

Lamivudine/zidovudine, abacavir/lamivudine/zidovudine: Consider cautions, precautions, contraindications, and interactions associated with each drug in the fixed combination.227 229 Consider cautionary information applicable to specific populations (e.g., pregnant or nursing women, individuals with hepatic or renal impairment, pediatric patients, geriatric patients) for each drug.227 229

Lipodystrophy

Zidovudine has been associated with lipoatrophy (loss of subcutaneous fat);1 incidence and severity related to cumulative exposure to the drug.1 Fat loss, which is most evident in the face, limbs, and buttocks, may be only partially reversible and improvement may take months to years after switching to an antiretroviral regimen that does not contain zidovudine.1 Regularly assess patients for signs of lipoatrophy.1 If fat loss suspected, switch to an alternative antiretroviral regimen if feasible.1

Redistribution or accumulation of body fat, including central obesity, dorsocervical fat enlargement (“buffalo hump”), peripheral wasting, breast enlargement, and general cushingoid appearance, reported with antiretroviral agents.227 229 231 Mechanisms and long-term consequences of adipogenic effects unknown;227 229 231 causal relationship not established.227 229 231

Immune Reconstitution Syndrome

During initial treatment, patients who respond to antiretroviral therapy may develop an inflammatory response to indolent or residual opportunistic infections (e.g., Mycobacterium avium complex [MAC], M. tuberculosis, cytomegalovirus [CMV], Pneumocystis jirovecii [formerly P. carinii]); this may necessitate further evaluation and treatment.1 227 229 231

Autoimmune disorders (e.g., Graves' disease, polymyositis, Guillain-Barré syndrome) also reported in the setting of immune reconstitution; however, time to onset is more variable and can occur many months after initiation of antiretroviral therapy.1 227 229 231

Specific Populations

Pregnancy

Antiretroviral Pregnancy Registry at 800-258-4263 or [Web].1 202 227 229 231

Available data from the pregnancy registry indicate no difference in overall risk of birth defects among infants born to women who received zidovudine during pregnancy compared with US background rate for major birth defects.1 231

Experts state that zidovudine and lamivudine is an alternative dual NRTI option for initial treatment regimens in antiretroviral-naive pregnant women.202

Lactation

Zidovudine distributed into human milk.1 202 231

Instruct HIV-infected women not to breast-feed because of risk of HIV transmission and risk of adverse effects in the infant.1 202 227 229 231

Pediatric Use

Well tolerated in neonates and children.1 91 92 114 163 231 244 245 458 However, usual zidovudine dosage used in full-term neonates may be excessive in premature neonates.201 530 (See Pediatric Dosage under Dosage and Administration.)

Major adverse effects reported in children are similar to those reported in adults1 91 92 114 163 231 244 245 and include bone marrow toxicity resulting in anemia and/or neutropenia.1 91 92 114 155 231 244 245

Lamivudine/zidovudine: Do not use in pediatric patients weighing <30 kg.227

Abacavir/lamivudine/zidovudine: Do not use in pediatric patients weighing <40 kg.229

Geriatric Use

Insufficient experience in those ≥65 years of age to determine whether they respond differently than younger adults.1 227 229 231 No substantial differences in response relative to younger adults identified.1 231

Use with caution in geriatric patients because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.1 227 229 231

Hepatic Impairment

Zidovudine: Monitor frequently for hematologic toxicities since hepatic impairment increases plasma concentrations of zidovudine and may increase risk of adverse hematologic effects.1 231

Lamivudine/zidovudine: Do not use in patients with impaired hepatic function.227

Abacavir/lamivudine/zidovudine: Do not use in patients with impaired hepatic function;229 contraindicated in those with moderate or severe hepatic impairment.229

Renal Impairment

Zidovudine: Dosage adjustments recommended in patients maintained on hemodialysis or peritoneal dialysis or with severe renal impairment (Clcr <15 mL/minute).1 231 (See Renal Impairment under Dosage and Administration.)

Lamivudine/zidovudine: Do not use in patients with Clcr <50 mL/minute.227

Abacavir/lamivudine/zidovudine: Do not use in patients with Clcr <50 mL/minute.229

Common Adverse Effects

Headache, malaise, fever, cough, GI effects (anorexia, nausea, vomiting).1 231

Interactions for Retrovir

The following drug interactions are based on studies using zidovudine.1 When lamivudine/zidovudine or abacavir/lamivudine/zidovudine is used, consider interactions associated with each drug in the fixed combination.227 229

Specific Drugs

Drug

Interaction

Comments

Abacavir

No clinically important pharmacokinetic interactions216

No in vitro evidence of antagonistic antiretroviral effects216

Acetaminophen

Pharmacokinetic interactions unlikely156

Acyclovir

Increased toxicity reported;15 has been used concomitantly without increased toxicity61 181

Antifungals, azoles

Fluconazole: Increased zidovudine AUC and plasma concentrations1 231 457

Fluconazole: Monitor for zidovudine-associated adverse effects;457 routine zidovudine dosage adjustments not warranted1 231

Antimycobacterials, rifamycins

Rifabutin: Pharmacokinetic interactions unlikely409

Rifampin: Decreased zidovudine AUC1 150 231

Rifampin: Routine zidovudine dosage adjustments not warranted1 231

Atazanavir

No change in zidovudine AUC; possible decreased trough zidovudine concentrations200

No in vitro evidence of antagonistic antiretroviral effects203

Clinical importance of pharmacokinetic interaction unknown200

Atovaquone

Increased zidovudine AUC; no change in atovaquone pharmacokinetics1 231 242

Possible increased hematologic toxicity242

Routine zidovudine dosage adjustments not warranted;1 231 monitor for zidovudine-associated adverse effects200

Buprenorphine

No clinically important pharmacokinetic interactions200

Dosage adjustments not needed200

Cidofovir

No pharmacokinetic interaction with cidofovir; however, cidofovir must be given concomitantly with probenecid and probenecid can reduce zidovudine clearance243

Manufacturer of zidovudine states routine zidovudine dosage adjustments not warranted if zidovudine given with probenecid;1 231 manufacturer of cidofovir recommends zidovudine be temporarily discontinued or dosage reduced by 50% on days that cidofovir and probenecid are given243

Co-trimoxazole

Pharmacokinetic interactions unlikely333

Darunavir

Ritonavir-boosted darunavir: No clinically important pharmacokinetic interactions204

No in vitro evidence of antagonistic antiretroviral effects204

Delavirdine

No pharmacokinetic interactions212

In vitro evidence of additive or synergistic antiretroviral effects1 212

Didanosine

Decreased zidovudine concentrations and AUC;217 no effect on didanosine concentrations or AUC217

In vitro evidence of synergistic antiretroviral effects281

Doxorubicin

In vitro evidence of antagonism1 231 534

Avoid concomitant use1 231

Efavirenz

No effect on zidovudine peak concentrations or AUC213

In vitro evidence of additive or synergistic antiretroviral effects213

Dosage adjustment not needed213

Emtricitabine

Increased zidovudine peak concentration and AUC;218 no effect on emtricitabine peak concentrations or AUC218

In vitro evidence of additive to synergistic antiretroviral effects218

Pharmacokinetic interaction not considered clinically important218

Enfuvirtide

In vitro evidence of additive to synergistic antiretroviral effects223

Etravirine

No in vitro evidence of antagonistic antiretroviral effects214

Fosamprenavir

Increased amprenavir AUC;205 increased zidovudine concentrations and AUC205

In vitro evidence of synergistic antiretroviral effects205

Ganciclovir or valganciclovir

No clinically important pharmacokinetic interactions200

Potential increased risk of hematologic toxicity196 197 200 278 524

Concomitant use not recommended;196 278 524 advise patients that concomitant use may not be tolerated by some individuals and may result in severe granulocytopenia (neutropenia)1 165 197 233 521

Indinavir

Slightly increased indinavir concentrations and AUC; slightly increased zidovudine AUC, decreased zidovudine peak concentrations206

In vitro evidence of synergistic antiretroviral effects206

Interferon (interferon alfa, peginterferon alfa)

Possible increased risk of potentially fatal hepatic decompensation in patients coinfected with HIV and HCV receiving antiretroviral agents and interferon alfa (or peginterferon alfa) with or without ribavirin1 231 298

Increased risk of hematologic toxicity (e.g., neutropenia, thrombocytopenia) and hepatic toxicity in patients receiving interferon alfa (or peginterferon alfa), ribavirin, and zidovudine1 231 298 395 399

In vitro evidence of synergistic antiretroviral effects34 57 351 395 396 397 398 399

Monitor for adverse effects1 231 298 395 399

If zidovudine used in patients receiving interferon alfa (or peginterferon alfa) with or without ribavirin, closely monitor for toxicities (e.g., hepatic decompensation, neutropenia, anemia); consider discontinuing zidovudine as medically appropriate; consider discontinuing or reducing dosage of interferon alfa (or peginterferon alfa) and/or ribavirin if worsening toxicities, including hepatic decompensation (Child-Pugh >6) occur1 231 298

Lamivudine

No clinically important pharmacokinetic interactions1 219 231

In vitro evidence of synergistic antiretroviral effects219

Dosage adjustments not needed1

Lopinavir and ritonavir

Lopinavir: Possible decreased zidovudine concentrations207

Clinical importance unknown207

Macrolides (clarithromycin)

Decreased zidovudine AUC1

Routine zidovudine dosage adjustments not warranted1

Maraviroc

No effect on zidovudine pharmacokinetics224

No in vitro evidence of antagonistic antiretroviral effects224

Megestrol acetate

Slight decrease in zidovudine AUC102

Not considered clinically important102

Methadone

Increased zidovudine AUC; no change in methadone pharmacokinetics350

Routine zidovudine dosage adjustments not warranted;1 231 monitor for zidovudine-associated adverse effects200

Myelosuppressive or cytotoxic agents

Increased risk of hematologic toxicity1 29 176 231 332

Use with caution29 176 332

Nelfinavir

Decreased zidovudine peak concentrations and AUC;1 208 231 no effect on nelfinavir concentrations1 231

In vitro evidence of synergistic antiretroviral effects208

Routine zidovudine dosage adjustments not warranted1 231

Nevirapine

Decreased zidovudine concentrations and AUC215

No in vitro evidence of antagonistic antiretroviral effects215

Oxazepam

Pharmacokinetic interactions unlikely353

Phenytoin

Pharmacokinetic interactions; alteration in pharmacokinetics of both drugs reported1 231

Use caution; monitor closely1 231

Probenecid

Increased zidovudine peak plasma concentrations and AUC1 231

Routine zidovudine dosage adjustments not warranted1 231

Raltegravir

No in vitro evidence of antagonistic antiretroviral effects225

Ribavirin

In vitro evidence that ribavirin can reduce phosphorylation of zidovudine;37 60 200 no evidence of pharmacokinetic or pharmacodynamic interaction (e.g., loss of virologic suppression of HIV or HCV) in patients coinfected with HIV and HCV receiving zidovudine and ribavirin1

Exacerbation of anemia reported in patients coinfected with HIV and HCV receiving ribavirin and zidovudine concomitantly1

Possible increased risk of potentially fatal hepatic decompensation in patients coinfected with HIV and HCV receiving antiretroviral agents and interferon alfa (or peginterferon alfa) with or without ribavirin1 298

Concomitant use not recommended; if used concomitantly, use caution and monitor for virologic response and toxicities (e.g., hepatic decompensation, neutropenia, anemia)1 200 227 229 231

Rilpivirine

Pharmacokinetic interactions not expected226

No in vitro evidence of antagonistic antiretroviral effects226

Ritonavir

Decreased zidovudine concentrations and AUC; no effect on ritonavir concentrations or AUC1 209 231

In vitro evidence of additive antiretroviral effects209

Dosage adjustments not needed1 231

Saquinavir

In vitro evidence of additive or synergistic antiretroviral effects210

Simeprevir

Clinically important interactions not expected187

Stavudine

In vitro and in vivo evidence of antagonism1 8 200 220 231

Do not use concomitantly1 200 201 220 231

Tenofovir

In vitro evidence of additive to synergistic antiretroviral effects221

Tipranavir

Ritonavir-boosted tipranavir: Decreased zidovudine AUC; may also decrease tipranavir concentrations and AUC211

In vitro evidence of additive antiretroviral effects211

Clinical importance unknown211

Appropriate dosages for concomitant use with ritonavir-boosted tipranavir not established200

Valproic acid

Increased zidovudine AUC;1 231 effect on valproic acid concentrations not studied1 231

Routine zidovudine dosage adjustments not warranted1 231

Retrovir Pharmacokinetics

Absorption

Bioavailability

Well absorbed following oral administration; peak plasma concentrations achieved within 0.5–1.5 hours.1 2 4 110 111 115 116 117 119 231 Mean oral bioavailability is 64%.1 231

AUC following administration of zidovudine tablets or oral solution is equivalent to that following administration of zidovudine capsules.1 231

Fixed-combination tablet containing lamivudine 150 mg and zidovudine 300 (lamivudine/zidovudine) is bioequivalent to one 150-mg lamivudine tablet and one 300-mg zidovudine tablet given simultaneously.227

Fixed-combination tablet containing abacavir 300 mg, lamivudine 150 mg, and zidovudine 300 mg (abacavir/lamivudine/zidovudine) is bioequivalent to one 300-mg abacavir tablet, one 150-mg lamivudine tablet, and one 300-mg zidovudine tablet given simultaneously.20 229

Food

Extent of absorption (AUC) not affected by food.1

Special Populations

Zidovudine AUC increased in patients with renal impairment.1 177 231

Zidovudine pharmacokinetics in pediatric patients >3 months of age similar to that in adults; bioavailability is 61% in infants 14 days to 3 months of age and 65% in pediatric patients 3 months to 12 years of age.1 Bioavailability is greater in neonates ≤14 days of age and is reported to be 89%.1

Pharmacokinetics of zidovudine in pregnant women similar to that reported in nonpregnant adults.1 231

Distribution

Extent

Widely distributed.1 32 231

Distributed into CSF; 1 32 67 114 148 177 231 ratio of CSF/plasma concentrations reported in adults or children with HIV infection is 0.15–2.1.1 32 67 114 115 148 177 231

Distributed into semen.110 145 159 160

Crosses human placenta and is distributed into amniotic fluid, cord blood, and fetal blood120 185 261 262 528 and fetal liver, muscle, and CNS tissue.185

Distributed into milk.1 177 231

Plasma Protein Binding

<38%.1 177 231

Elimination

Metabolism

Rapidly metabolized via glucuronidation in the liver.4 22

Intracellularly, zidovudine is phosphorylated and converted by cellular enzymes to the active 5′-triphosphate metabolite.1 4 7 18 25 46 177 231

Elimination Route

Eliminated principally in urine via both glomerular filtration and tubular secretion.1 22 32 110 115 116 231

Zidovudine not removed by hemodialysis or peritoneal dialysis1 231

Half-life

Adults: 0.5–3 hours.1 2 32 30 119 177 231

Neonates and infants: 3.1 hours in neonates ≤14 days of age, 1.9 hours in infants 14 days to 3 months of age, or 1.5 hours in pediatric patients 3 months to 12 years of age.1 231

Special Populations

Patients with hepatic impairment: Zidovudine clearance decreased.1 231 Mean half-life 1.8 hours.103

Patients with severe renal impairment: Mean half-life 1.4 hours.1 113

Stability

Storage

Oral

Capsules

15–25°C;1 protect from moisture, light, and heat.164

Solution

15–25°C.1

Tablets

Zidovudine: 20–25°C.231

Lamivudine/zidovudine: 2–30°C.227

Abacavir/lamivudine/zidovudine: 25°C (may be exposed to 15–30°C).229

Parenteral

Concentrate for IV Infusion

15–25°C;1 protect from light.1

After dilution in 5% dextrose, physically and chemically stable for 24 hours when stored at room temperature and for 48 hours when refrigerated at 2–8°C.1

To minimize risk of microbial contamination, administer diluted solutions within 8 hours if stored at room temperature or within 24 hours if refrigerated.1

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution CompatibilityHID

Compatible

Dextrose 5% in water

Sodium chloride 0.9%

Drug Compatibility
Admixture CompatibilityHID

Compatible

Dobutamine HCl

Ranitidine HCl

Variable

Meropenem

Y-Site CompatibilityHID

Compatible

Acyclovir sodium

Allopurinol sodium

Amifostine

Amikacin sulfate

Amphotericin B

Amphotericin B cholesteryl sulfate complex

Anidulafungin

Aztreonam

Ceftazidime

Ceftriaxone sodium

Cisatracurium besylate

Clindamycin phosphate

Co-trimoxazole

Dexamethasone sodium phosphate

Dobutamine HCl

Docetaxel

Dopamine HCl

Doripenem

Doxorubicin HCl liposomal

Erythromycin lactobionate

Etoposide phosphate

Filgrastim

Fluconazole

Fludarabine phosphate

Gemcitabine HCl

Gentamicin sulfate

Granisetron HCl

Heparin sodium

Imipenem–cilastatin sodium

Linezolid

Lorazepam

Melphalan HCl

Metoclopramide HCl

Morphine sulfate

Nafcillin sodium

Ondansetron HCl

Oxacillin sodium

Oxytocin

Paclitaxel

Pemetrexed disodium

Pentamidine isethionate

Phenylephrine HCl

Piperacillin sodium–tazobactam sodium

Potassium chloride

Ranitidine HCl

Remifentanil HCl

Sargramostim

Teniposide

Thiotepa

Tobramycin sulfate

Vancomycin HCl

Vinorelbine tartrate

Variable

Meropenem

Actions and Spectrum

  • Zidovudine is an analog of thymidine.2 4 12 18 29 39

  • Pharmacologically related to, but structurally different from, other NRTIs (e.g., abacavir, didanosine, emtricitabine, lamivudine, stavudine); also differs pharmacologically and structurally from other currently available antiretrovirals.1 2

  • A prodrug that is inactive until converted intracellularly to zidovudine triphosphate.1 16 25

  • Active in vitro against HIV-11 4 5 7 18 25 30 231 and HIV-2.189 260 382

  • Inhibits replication of HIV by interfering with viral RNA-directed DNA polymerase (reverse transcriptase).1 2 4 16 18 19 25 30 79 231

  • HIV-1 with reduced susceptibility to zidovudine have been produced in vitro and have emerged during therapy with the drug.1 141 142 151 189 190 231 260 264 265 296 305 358 359 360 361 362 363 364 365 366 367 402 446 448 525 Genotypic analyses of isolates selected in cell culture and recovered from zidovudine-treated patients showed thymidine analog mutations (TAMs) in the HIV-1 reverse transcriptase that include M41L, D67N, K70R, L210W, T215Y or F, and K219E/R/H/Q/N/Q.1 231 260 265 359 360 361 365 366 402 419

  • Strains of HIV resistant to zidovudine may be cross-resistant to some other NRTIs (e.g., abacavir, didanosine, lamivudine, stavudine, tenofovir).219 220 290 303 362 366 446 450

Advice to Patients

  • Critical nature of compliance with HIV therapy and importance of remaining under the care of a clinician.1 200

  • Advise patients that effective antiretroviral regimens can decrease HIV concentrations in blood and genital secretions and strict adherence to such regimens in conjunction with risk-reduction measures may decrease, but cannot absolutely eliminate, the risk of secondary transmission of HIV to others.200 Importance of continuing to practice safer sex (e.g., consistent use of condoms).200

  • Inform patients that neutropenia and/or anemia are the major toxicities reported with zidovudine and that the frequency and severity are greater in patients with more advanced disease and in those who initiate therapy later in the course of their infection.1 231 Importance of CBC monitoring, especially in patients with advanced symptomatic HIV-1 disease.1 231 Advise patients that if hematologic toxicity develops, transfusions or discontinuance of the drug may be required.1 231

  • Inform patients that potentially life-threatening hypersensitivity reactions (e.g., anaphylaxis, Stevens-Johnson syndrome) have been reported in patients receiving zidovudine.1 231 Importance of immediately contacting a clinician if rash develops since this may be a sign of a more serious reaction.1 231

  • Advise latex-sensitive patients that vial stoppers of zidovudine concentrate for IV infusion contain dry natural rubber (a latex derivative) which may cause allergic reactions in individuals sensitive to latex.1

  • Advise patients that lactic acidosis and severe hepatomegaly with steatosis have been reported with use of nucleoside analogs and other antiretrovirals.1 231 Importance of discontinuing zidovudine and notifying a clinician if symptoms suggestive of lactic acidosis or pronounced hepatotoxicity develop.1 231

  • Inform HIV-infected patients coinfected with HCV that hepatic decompensation (sometimes fatal) has been reported when antiretrovirals were used for treatment of HIV infection in patients receiving interferon alfa with or without ribavirin.1 231 (See Interactions.)

  • Inform patients that myopathy and myositis with pathologic changes (similar to that produced by HIV-1 disease) have been reported in individuals who received long-term zidovudine therapy.1 231

  • Advise patients to immediately contact a clinician if they have any signs or symptoms of infection since inflammation from previous infections may occur soon after antiretroviral therapy is initiated.1 231

  • Inform patients that loss of subcutaneous fat may occur during zidovudine therapy and that they will be regularly assessed for this effect.1 Also inform patients that redistribution/accumulation of body fat has occurred in patients receiving antiretrovirals and that the cause and long-term health effects are unknown.231

  • Inform patients that the most commonly reported adverse effects of zidovudine are headache, malaise, nausea, anorexia, and vomiting.1 231 Advise patients to contact a clinician if they experience muscle weakness, shortness of breath, symptoms of hepatitis or pancreatitis, or any other unexpected adverse events.1 231

  • Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal products, and any concomitant illnesses.1 231

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 231 Advise HIV-infected women not to breast-feed.1 231

  • Importance of advising patients of other important precautionary information.1 231 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Zidovudine

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules

100 mg*

Retrovir

ViiV

Zidovudine Capsules

Solution

10 mg/mL*

Retrovir Syrup

ViiV

Zidovudine Oral Solution

Tablets, film-coated

300 mg*

Zidovudine Tablets

Parenteral

For injection concentrate, for IV infusion only

10 mg/mL*

Retrovir Injection

ViiV

Zidovudine for Injection Concentrate

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Zidovudine Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, film-coated

300 mg with Abacavir Sulfate 300 mg (of abacavir) and Lamivudine 150 mg*

Abacavir Sulfate, Lamivudine, and Zidovudine Tablets

Trizivir

ViiV

300 mg with Lamivudine 150 mg*

Combivir

ViiV

Lamivudine and Zidovudine Tablets

AHFS DI Essentials. © Copyright 2018, Selected Revisions April 2, 2018. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. ViiV Healthcare. Retrovir (zidovudine) capsules, and syrup for oral use, and injection for IV use prescribing information. Research Triangle Park, NC; 2017 Nov.

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49. Saez-Lorens X, Nelson RP, Emmanuel P et al. A randomized, double-blind study of triple nucleoside therpay of abacavir, lamivudine, and zidovudine versus lamivudine and zidovudine in previously treated human immunodeficiency virus type 1-infected children. Pediatrics. 2001; 107:e4. http://www.ncbi.nlm.nih.gov/pubmed/11134468?dopt=AbstractPlus

50. Reviewers’ comments (personal observations).

51. Kirk E (Burroughs Wellcome Co, Research Triangle Park, NC): Personal communication; 1987 Jun 18.

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56. Davtyan DG, Vinters HV. Wernicke’s encephalopathy in AIDS patient treated with zidovudine. Lancet. 1987; 1:919-20. http://www.ncbi.nlm.nih.gov/pubmed/2882316?dopt=AbstractPlus

57. Ruprecht RM, Chou TC, Chipty F et al. Interferon-alpha and 3′-azido-3′-deoxythymidine are highly synergistic in mice and prevent viremia after acute retrovirus exposure. J Acquir Immune Defic Syndr. 1990; 3:591-600. http://www.ncbi.nlm.nih.gov/pubmed/2159992?dopt=AbstractPlus

58. Lin JC, Zhang ZX, Chou TC et al. Syndergistic inhibition of Epstein-Barr virus: transformation of B lymphocytes by alpha and gamma interferon and by 3′-azido-3′-deoxythymidine. J Infect Dis. 1989; 159:248-54. http://www.ncbi.nlm.nih.gov/pubmed/2536780?dopt=AbstractPlus

59. Jacobson MA, Mills J. Serious cytomegalovirus disease in the acquired immunodeficiency syndrome (AIDS). Ann Intern Med. 1988; 108:585-94. http://www.ncbi.nlm.nih.gov/pubmed/2831765?dopt=AbstractPlus

60. Hirsch MS, Kaplan JC. Treatment of immunodeficiency virus infections. Antimicrob Agents Chemother. 1987; 31:839-43. http://www.ncbi.nlm.nih.gov/pubmed/3304154?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=284196&blobtype=pdf

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62. Richman DD, Fischl MA, Grieco MH et al. The toxicity of azidothymidine (AZT) in the treatment of patients with AIDS and AIDS-related complex. N Engl J Med. 1987; 317:192-7. http://www.ncbi.nlm.nih.gov/pubmed/3299090?dopt=AbstractPlus

63. Furth PA, Kazakis AM. Nail pigmentation changes associated with azidothymidine (zidovudine). Ann Intern Med. 1987; 107:350. http://www.ncbi.nlm.nih.gov/pubmed/3497596?dopt=AbstractPlus

64. Forester G. Profound cytopenia secondary to azidothymidine. N Engl J Med. 1987; 31:772.

65. Gill PS, Rarick M, Brynes RK et al. Azidothymidine associated with bone marrow failure in the acquired immunodeficiency syndrome (AIDS). Ann Intern Med. 1987; 107:502-5. http://www.ncbi.nlm.nih.gov/pubmed/3477107?dopt=AbstractPlus

66. Sandstrom EG, Kaplan JC. Antiviral therapy in AIDS: clinical pharmacological properties and therapeutic experience to date. Drugs. 1987; 34:372-90. http://www.ncbi.nlm.nih.gov/pubmed/2824170?dopt=AbstractPlus

67. Rolinski B, Bogner JR, Sadri I et al. Absorption and elimination kinetics of zidovudine in the cerebrospinal fluid in HIV-1-infected patients. J Acquir Immune Defic Syndr. 1997; 15:192-7.

68. Melamed AJ, Muller RJ, Gold JWM et al. Possible zidovudine-induced hepatotoxicity. JAMA. 1987; 258:2063.

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70. Bach MC. Zidovudine for lymphocytic interstitial pneumonia associated with AIDS. Lancet. 1987; 2:796. http://www.ncbi.nlm.nih.gov/pubmed/2889008?dopt=AbstractPlus

71. Panwalker AP. Nail pigmentation in the acquired immunodeficiency syndrome (AIDS). Ann Intern Med. 1987; 107:943-4. http://www.ncbi.nlm.nih.gov/pubmed/3479923?dopt=AbstractPlus

72. Fischl MA, Finkelstein DM, He W et al. A phase II study of recombinant human interferon-alpha 2a and zidovudine in patients with AIDS-related Kaposi’s sarcoma. AIDS Clinical Trials Group. J Acquir Immune Defic Syndr Hum Retrovirol. 1996; 11:379-84. http://www.ncbi.nlm.nih.gov/pubmed/8601224?dopt=AbstractPlus

73. Hargraves M, Fuller G, Costello C et al. Zidovudine overdose. Lancet. 1988; 2:509. http://www.ncbi.nlm.nih.gov/pubmed/2900428?dopt=AbstractPlus

74. Pickus OB. Overdose of zidovudine. N Engl J Med. 1988; 318:1206. http://www.ncbi.nlm.nih.gov/pubmed/3163102?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=2814222&blobtype=pdf

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76. Hymes KB, Greene JB, Karpatkin S. The effect of azidothymidine on HIV-related thrombocytopenia. N Engl J Med. 1988; 318:516-7. http://www.ncbi.nlm.nih.gov/pubmed/3422338?dopt=AbstractPlus

77. Gorard DA, Henry K, Guiloff RJ. Necrotising myopathy and zidovudine. Lancet. 1988; 1:1050. http://www.ncbi.nlm.nih.gov/pubmed/2896888?dopt=AbstractPlus

78. Panegyres PK, Tan N, Kakulas BA et al. Necrotising myopathy and zidovudine. Lancet. 1988; 1:1050-1. http://www.ncbi.nlm.nih.gov/pubmed/2896888?dopt=AbstractPlus

79. St Clair MH, Richards CA, Spector T et al 3′-azido-3′-deoxythymidine triphosphate as an inhibitor and substrate of purified human immunodeficiency virus reverse transcriptase. Antimicrob Agents Chemother. 1987; 31:1972-7.

80. Terasaki T, Pardridge WM. Restricted transport of 3′-azido-3′deoxythymidine and dideoxynucleosides through the blood-brain barrier. J Infect Dis. 1988; 158:630-2. http://www.ncbi.nlm.nih.gov/pubmed/2842410?dopt=AbstractPlus

81. Hirsch MS. Azidothymidine. J Infect Dis. 1988; 157:427-31. http://www.ncbi.nlm.nih.gov/pubmed/3278063?dopt=AbstractPlus

82. Richman DD, Andrews J, AZT Collaborative Working Group. Results of continued monitoring of participants in the placebo-controlled trial of zidovudine for serious human immunodeficiency virus infection. Am J Med. 1988; 85(Suppl 2A):208-13. http://www.ncbi.nlm.nih.gov/pubmed/3044087?dopt=AbstractPlus

83. Helbert M, Robinson D, Peddle B et al. Acute meningo-encephalitis on dose reduction of zidovudine. Lancet. 1988; 1:1249-52. http://www.ncbi.nlm.nih.gov/pubmed/2897518?dopt=AbstractPlus

84. Harris PJ, Caceres CA. Azidothymidine in the treatment of AIDS. N Engl J Med. 1988; 318:250. http://www.ncbi.nlm.nih.gov/pubmed/3422108?dopt=AbstractPlus

85. Richman DD, Fischl MA, Nusinoff-Lehrman S et al. Azidothymidine in the treatment of AIDS. N Engl J Med. 1988; 318:251.

86. Creigh-Kirk T, Doi P, Andrews E et al. Survival experience among patients with AIDS receiving zidovudine: follow-up of patients in a compassionate plea program. JAMA. 1988; 260:3009-15. http://www.ncbi.nlm.nih.gov/pubmed/3263514?dopt=AbstractPlus

87. Bartlett JA. HIV therapeutics: an emerging science. JAMA. 1988; 260:3051-2. http://www.ncbi.nlm.nih.gov/pubmed/3054186?dopt=AbstractPlus

88. The Swiss Group for Clinical Studies on the Acquired Immunodeficiency Syndrome (AIDS). Zidovudine for the treatment of thrombocytopenia associated with human immunodeficiency virus (HIV): a prospective study. Ann Intern Med. 1988; 109:718-21. http://www.ncbi.nlm.nih.gov/pubmed/3190058?dopt=AbstractPlus

89. Helbert M, Fletcher T, Peddle B et al. Zidovudine-associated myopathy. Lancet. 1988; 2:689-90. http://www.ncbi.nlm.nih.gov/pubmed/2901551?dopt=AbstractPlus

90. Schmitt FA, Bigley JW, McKinnis R et al. Neuropsychological outcome of zidovudine (AZT) treatment of patients with AIDS and AIDS-related complex. N Engl J Med. 1988; 319:1573-8. http://www.ncbi.nlm.nih.gov/pubmed/3059187?dopt=AbstractPlus

91. Blanche S, Caniglia M, Fischer A et al. Zidovudine therapy in children with acquired immunodeficiency syndrome. Am J Med. 1988; 85(Suppl 2A):203-7. http://www.ncbi.nlm.nih.gov/pubmed/3165604?dopt=AbstractPlus

92. Pizzo PA, Eddy J, Falloon J et al. Effect of continuous intravenous infusion of zidovudine (AZT) in children with symptomatic HIV infection. N Engl J Med. 1988; 319:889-96. http://www.ncbi.nlm.nih.gov/pubmed/3166511?dopt=AbstractPlus

93. O’Dowd MA, McKegney FP. Manic syndrome associated with zidovudine. JAMA. 1988; 260:3587. http://www.ncbi.nlm.nih.gov/pubmed/3193583?dopt=AbstractPlus

94. Schaerf FW, Miller R, Pe et al. Manic syndrome associated with zidovudine. JAMA. 1988; 260:3587-8. http://www.ncbi.nlm.nih.gov/pubmed/3193583?dopt=AbstractPlus

95. Chaisson RE, Leuther MD, Allain JP et al. Effect of zidovudine on serum human immunodeficiency virus core antigen levels: results from a placebo-controlled trial. Arch Intern Med. 1988; 148:2151-3. http://www.ncbi.nlm.nih.gov/pubmed/3263098?dopt=AbstractPlus

96. LaFon SW, Lehrman SN, Barry DW. Prophylactically administered Retrovir in health care workers potentially exposed to human immunodeficiency virus. J Infect Dis. 1988; 158:503. http://www.ncbi.nlm.nih.gov/pubmed/3042884?dopt=AbstractPlus

97. Burroughs Wellcome Co. Study to examine prophylactic use of Retrovir in health care workers. Research Triangle Park, NC; 1988 May 4. Press release.

98. Burroughs Wellcome Co. Protocol 27,433-20, project P53: a placebo-controlled trial to evaluate Retrovir in preventing infection with the human immunodeficiency virus (HIV) in health care workers after accidental exposure. Research Triangle Park, NC; 1988 Apr 21.

99. Furman PA, Barry DW. Spectrum of antiviral activity and mechanism of action of zidovudine: an overview. Am J Med. 1988; 85(Suppl 2A):176-81. http://www.ncbi.nlm.nih.gov/pubmed/3044082?dopt=AbstractPlus

100. Ayers KM. Preclinical toxicology of zidovudine: an overview. Am J Med. 1988; 85(Suppl 2A):186-8. http://www.ncbi.nlm.nih.gov/pubmed/3044084?dopt=AbstractPlus

101. Nightingale SL. Update on zidovudine. JAMA. 1988; 260:898. http://www.ncbi.nlm.nih.gov/pubmed/3165139?dopt=AbstractPlus

102. Van Harken DR, Pei JC, Wagner J et al. Pharmacokinetic interaction of megestrol acetate with zidovudine in human immunodeficiency virus-infected patients. Antimicrob Agents Chemother. 1997; 41:2480-3. http://www.ncbi.nlm.nih.gov/pubmed/9371353?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=164148&blobtype=pdf

103. Bareggi SR, Cinque P, Mazzei M et al. Pharmacokinetics of zidovudine in HIV-positive patients with liver disease. J Clin Pharmacol. 1994; 34:782-6. http://www.ncbi.nlm.nih.gov/pubmed/7929874?dopt=AbstractPlus

104. Dubin G, Braffman MN. Zidovudine-induced hepatotoxicity. Ann Intern Med. 1989; 110:85-6. http://www.ncbi.nlm.nih.gov/pubmed/2908831?dopt=AbstractPlus

105. Maxwell S, Scheftner WA, Kessler HA et al. Manic syndrome associated with zidovudine treatment. JAMA. 1988; 259:3406-7. http://www.ncbi.nlm.nih.gov/pubmed/3163740?dopt=AbstractPlus

106. Roberts DE, Berman SM, Sharlene N et al Effect of lithium carbonate on zidovudine-associated neutropenia in the acquired immunodeficiency syndrome. Am J Med. 1988; 85:428-31.

107. Herbert V, Hirschman S, Jacobson J. Lithium for zidovudine-induced neutropenia in AIDS. JAMA. 1988; 260:3588. http://www.ncbi.nlm.nih.gov/pubmed/3193584?dopt=AbstractPlus

109. Kornhauser DM, Petty BG, Hendrix CW et al. Probenecid and zidovudine metabolism. Lancet. 1989; 2:473-5. http://www.ncbi.nlm.nih.gov/pubmed/2570186?dopt=AbstractPlus

110. Langtry HD, Campoli-Richards DM. Zidovudine: a review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy. Drugs. 1989; 37:408-50. http://www.ncbi.nlm.nih.gov/pubmed/2661194?dopt=AbstractPlus

111. Balis FM, Pizzo PA, Eddy J et al. Pharmacokinetics of zidovudine administered intravenously and orally in children with human immunodeficiency virus infection. J Pediatr. 1989; 114:880-4. http://www.ncbi.nlm.nih.gov/pubmed/2715903?dopt=AbstractPlus

112. Nachman SA, Stanley K, Yogev R et al. Nucleoside analogs plus ritonavir in stable antiretroviral therapy-experienced HIV-infected children. JAMA. 2000; 283:492-8. http://www.ncbi.nlm.nih.gov/pubmed/10659875?dopt=AbstractPlus

113. Singlas E, Pioger JC, Taburet AM et al. Zidovudine disposition in patients with severe renal impairment: influence of hemodialysis. Clin Pharmacol Ther. 1989; 46:190-7. http://www.ncbi.nlm.nih.gov/pubmed/2758728?dopt=AbstractPlus

114. Balis FM, Pizzo PA, Murphy RF et al. The pharmacokinetics of zidovudine administered by continuous infusion in children. Ann Intern Med. 1989; 110:279-85. http://www.ncbi.nlm.nih.gov/pubmed/2643914?dopt=AbstractPlus

115. Collins JMN, Unadkat JD. Clinical pharmacokinetics of zidovudine: a overview of current data. Clin Pharmacokinet. 1989; 17:1-9. http://www.ncbi.nlm.nih.gov/pubmed/2663302?dopt=AbstractPlus

116. Laskin OL, de Miranda P, Blum MR. Azidothymidine steady-state pharmacokinetics in patients with AIDS and AID-related complex. J Infect Dis. 1989; 159:745-7. http://www.ncbi.nlm.nih.gov/pubmed/2926164?dopt=AbstractPlus

117. Morse GD, Olson J, Portmore A et al. Pharmacokinetics of orally administered zidovudine among patients with hemophilia and asymptomatic human immunodeficiency virus (HIV) infection. Antiviral Res. 1989; 11:57-66. http://www.ncbi.nlm.nih.gov/pubmed/2729955?dopt=AbstractPlus

118. van Rossum AM, Niesters HGM, Geelen SPM et al. Clinical and virologic response to combination treatment with indinavir, zidovudine, and lamivudine in children with human immunodeficiency virus-1 infection: a multicenter study in the Netherlands. J Pediatr. 2000; 136:780-8. http://www.ncbi.nlm.nih.gov/pubmed/10839877?dopt=AbstractPlus

119. Drew RH, Weller S, Gallis HA et al. Bioequivalence assessment of zidovudine (Retrovir) syrup, solution, and capsule formulations in patients infected with human immunodeficiency virus. Antimicrob Agents Chemother. 1989; 33:1801-3. http://www.ncbi.nlm.nih.gov/pubmed/2589846?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=172758&blobtype=pdf

120. Gillet JY, Garraffo R, Abrar D et al. Fetoplacental passage of zidovudine. Lancet. 1989; 2:269-70. http://www.ncbi.nlm.nih.gov/pubmed/2569069?dopt=AbstractPlus

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124. Herbert V, Jacobson J, Fong W et al. Lithium for zidovudine-induced neutropenia in AIDS. JAMA. 1989; 262:776.

125. Staszewski S, Rehmet S, Odewald J et al Overdosage of zidovudine. Lancet. 1989; 1:385. Letter.

126. Curtis M, Gill MJ, Brownell AK. Polymyositis like syndrome in the acquired immunodeficiency syndrome. Arch Neurol. 1989; 46:841. http://www.ncbi.nlm.nih.gov/pubmed/2757521?dopt=AbstractPlus

127. Bessen LJ, Greene JB, Louie E et al. Severe polymyositis-like syndrome associated with zidovudine therapy of AIDS and ARC. N Engl J Med. 1988; 318:708. http://www.ncbi.nlm.nih.gov/pubmed/3422706?dopt=AbstractPlus

128. Gertner E, Thurn JR, Williams DN et al. Zidovudine-associated myopathy. Am J Med. 1989; 86:814-8. http://www.ncbi.nlm.nih.gov/pubmed/2729341?dopt=AbstractPlus

129. Saracchini S, Vaccher E, Covezzi E et al. Lethal neurotoxicity associated with azidothymidine therapy. J Neurol, Neurosurg, and Psychiat. 1989; 52:539-47.

130. Vaiopoulos G, Mangakis J, Karabinis A et al. Nail pigmentation and azidothymidine. Ann Intern Med. 1988; 108:777. http://www.ncbi.nlm.nih.gov/pubmed/3162791?dopt=AbstractPlus

131. Fisher CA, McPoland PR. Azidothymidine-induced nail pigmentation. Cutis. 1989; 43:552-4. http://www.ncbi.nlm.nih.gov/pubmed/2743809?dopt=AbstractPlus

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133. Merenich JA, Hannon RN, Gentry RH et al Azidothymidine-induced hyperpigmentation mimicking primary adrenal insufficiency. Am J Med. 1989; 86:469-70.

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137. Goldsmith JC, Irvine W. Reversible agranulocytosis related to azidothymidine therapy. Am J Hematol. 1989; 30:263-4. http://www.ncbi.nlm.nih.gov/pubmed/2929589?dopt=AbstractPlus

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140. Jacobson MA, McGrath MS, Joseph P et al Zidovudine-induced fever. J Acquir Immune Defic Syndr. 1989; 2:382-8.

141. Jeffries DJ. Zidovudine resistant HIV. BMJ. 1989; 298:1132-3. http://www.ncbi.nlm.nih.gov/pubmed/2500164?dopt=AbstractPlus

142. Rooke R, Tremblay M, Soudeyns H et al. Isolation of drug-resistant variants of HIV-1 from patients on long-term zidovudine therapy. AIDS. 1989; 3:411-5. http://www.ncbi.nlm.nih.gov/pubmed/2504243?dopt=AbstractPlus

143. Routy JP, Prajs E, Blanc AP et al. Seizure after zidovudine overdose. Lancet. 1989; 1:384-5. http://www.ncbi.nlm.nih.gov/pubmed/2563536?dopt=AbstractPlus

144. Kavesh NG, Holzman RS, Seidlin M. The combined toxicity of azidothymidine and antimycobacterial agents: a retrospective study. Am Rev Respir Dis. 1989; 139:1094-7. http://www.ncbi.nlm.nih.gov/pubmed/2712436?dopt=AbstractPlus

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