Zidovudine (Monograph)

Brand name: Retrovir
Drug class: HIV Nucleoside and Nucleotide Reverse Transcriptase Inhibitors
- Reverse Transcriptase Inhibitors
VA class: AM800
Chemical name: 3′-Azido-3′-deoxythymidine
CAS number: 30516-87-1

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

Medically reviewed by Drugs.com on Mar 25, 2024. Written by ASHP.

Warning

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.)

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

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.)

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 Zidovudine

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^{† [off-label]} 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^{† [off-label]} (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^{† [off-label]} (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 (Cl_cr ≤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

Zidovudine 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., Cl_cr <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., Cl_cr <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† [off-label]

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

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

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

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† [off-label]

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

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 (Cl_cr <15 mL/minute): 100 mg every 6–8 hours.¹ ²³¹

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

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

IV

Zidovudine in adults maintained on hemodialysis or peritoneal dialysis or with severe renal impairment (Cl_cr <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 Zidovudine

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 (Cl_cr <15 mL/minute).¹ ²³¹ (See Renal Impairment under Dosage and Administration.)

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

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

Common Adverse Effects

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

Drug Interactions

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

Zidovudine 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

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

† Off-label: 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.

2. Yarchoan R, Klecker RW, Weinhold KJ et al. Administration of 3′-azido-3′-deoxythymidine, an inhibitor of HTLV-III/LAV replication, to patients with AIDS or AIDS-related complex. Lancet. 1986; 1:575-80. http://www.ncbi.nlm.nih.gov/pubmed/2869302?dopt=AbstractPlus

3. Yarchoan R, Berg G, Brouwers P et al. Response of human-immunodeficiency-virus-associated neurological disease to 3′-azido-3′-deoxythymidine. Lancet. 1987; 1:132-5. http://www.ncbi.nlm.nih.gov/pubmed/2879972?dopt=AbstractPlus

4. Yarchoan R, Broder S. Development of antiretroviral therapy for the acquired immunodeficiency syndrome and related disorders. N Engl J Med. 1987; 316:557-64. http://www.ncbi.nlm.nih.gov/pubmed/3543683?dopt=AbstractPlus

5. Vogt M, Hirsch MS. Prospects for the prevention and therapy of infections with the human immunodeficiency virus. Rev Infect Dis. 1986; 8:991-1000. http://www.ncbi.nlm.nih.gov/pubmed/3541131?dopt=AbstractPlus

6. Kaplan LD, Wofsy CB, Volberding PA. Treatment of patients with acquired immunodeficiency syndrome and associated manifestations. JAMA. 1987; 257:1367-74. http://www.ncbi.nlm.nih.gov/pubmed/3546745?dopt=AbstractPlus

7. Mitsuya H, Broder S. Strategies for antiviral therapy in AIDS. Nature. 1978; 325:773-8.

8. Havlir DV, Tierney C, Friedland GH et al. In vivo antagonism with zidovudine plus stavudine combination therapy. J Infect Dis. 2000; 182:321-5. http://www.ncbi.nlm.nih.gov/pubmed/10882616?dopt=AbstractPlus

11. Gallo RC. The AIDS virus. Sci Am. 1987; 46-56.

12. Lin TS, Gao YS, Mancini WR. Synthesis and biological activity of various 3′-azido and 3′-amino analogs of 5-substituted pyrimidine deoxyribonucleosides. J Med Chem. 1983; 26:1691-6. http://www.ncbi.nlm.nih.gov/pubmed/6644738?dopt=AbstractPlus

13. Hagler DN, Frame PT. Azidothymidine neurotoxicity. Lancet. 1986; 2:1392-3. http://www.ncbi.nlm.nih.gov/pubmed/2878246?dopt=AbstractPlus

14. Chaisson RE, Allain JP, Leuther M et al. Significant changes in HIV antigen level in the serum of patients treated with azidothymidine. N Engl J Med. 1986; 315:1610-1. http://www.ncbi.nlm.nih.gov/pubmed/3466034?dopt=AbstractPlus

15. Bach MC. Possible drug interaction during therapy with azidothymidine and acyclovir for AIDS. N Engl J Med. 1987; 316:547. http://www.ncbi.nlm.nih.gov/pubmed/3468354?dopt=AbstractPlus

16. Nakashima H, Matsui T, Harada S et al. Inhibition of replication and cytopathic effect of human T cell lymphotropic virus type III/lymphadenopathy-associated virus by 3′-azido-3′-deoxythymidine in vitro. Antimicrob Agents Chemother. 1986; 30:933-7. http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=180622&blobtype=pdf http://www.ncbi.nlm.nih.gov/pubmed/2434024?dopt=AbstractPlus

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35. Burroughs Wellcome Co. Information for patients enrolled in the Retrovir (zidovudine) program. Research Triangle Park, NC; 1987 Apr.

37. Vogt MW, Hartshorn KL, Furman PA et al. Ribavirin antagonizes the effect of azidothymidine on HIV replication. Science. 1987; 235:1376-9. http://www.ncbi.nlm.nih.gov/pubmed/2435003?dopt=AbstractPlus

38. Barnes DM. Promising results halt trial of anti-AIDS drug. Science. 1986; 234:15-6. http://www.ncbi.nlm.nih.gov/pubmed/3529393?dopt=AbstractPlus

39. Horwitz JP, Chua J, Noel M. Nucleosides. V. The monomesylates of 1-(2′-deoxy-β-d-lyxofuranosyl)thymine. J Org Chem. 1964; 29:2076-8.

40. Hahn BH, Shaw GM, Taylor ME et al. Genetic variation in HTLV-III/LAV over time in patients with AIDS or at risk for AIDS. Science. 1986; 232:1548-53. http://www.ncbi.nlm.nih.gov/pubmed/3012778?dopt=AbstractPlus

41. Kakuda TN. Pharmacology of nucleoside and nucleotide reverse transcriptase inhibitor-induced mitochondrial toxicity. Clin Ther. 2000; 22:685-708. http://www.ncbi.nlm.nih.gov/pubmed/10929917?dopt=AbstractPlus

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43. Morris AAM, Carr A. HIV nucleoside analogues: new adverse effects on mitochondria? Lancet. 1999; 354:1046-7.

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46. Burroughs Wellcome Co. Retrovir (zidovudine) investigators/clinicians forum summary report. Research Triangle Park, NC; 1987 Apr.

47. Yarchoan R, Broder S. Strategies for the pharmacological intervention against HTLV-III/LAV. In: Broder S, ed. AIDS: modern concepts and therapeutic challenges. New York: Marcel Dekker Inc; 1987:335-60.

48. De Miranda P, Good SS, Yarchoan R et al. Alteration of zidovudine pharmacokinetics by probenecid in patients with AIDS or AIDS-related complex. Clin Pharmacol Ther. 1989; 46:494-500. http://www.ncbi.nlm.nih.gov/pubmed/2582706?dopt=AbstractPlus

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.

52. Elwell LP, Ferone R, Freeman GA et al. Antibacterial activity and mechanism of action of 3′-azido-3′-deoxythymidine (BS A509U). Antimicrob Agents Chemother. 1987; 31:274-80. http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=174705&blobtype=pdf http://www.ncbi.nlm.nih.gov/pubmed/3551832?dopt=AbstractPlus

53. Sommadossi JP, Carlisle R. Toxicity of 3′-azido-3′-deoxythymidine and 9-(1,3-dihydroxy-2-propoxymethyl)guanine for normal human hematopoietic progenitor cells in vitro. Antimicrob Agents Chemother. 1987; 31:452-4. http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=174750&blobtype=pdf http://www.ncbi.nlm.nih.gov/pubmed/3495235?dopt=AbstractPlus

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55. Anon. Zidovudine (AZT). Lancet. 1987; 1:957-8. http://www.ncbi.nlm.nih.gov/pubmed/2882345?dopt=AbstractPlus

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.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=284196&blobtype=pdf http://www.ncbi.nlm.nih.gov/pubmed/3304154?dopt=AbstractPlus

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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.

69. Mueller BU, Pizzo PA, Farley M et al. Pharmacokinetic evaluation of the combination of zidovudine and didanosine in children with human immunodeficiency virus infection. J Pediatr. 1994; 125:142-6. http://www.ncbi.nlm.nih.gov/pubmed/8021765?dopt=AbstractPlus

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

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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

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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.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=164148&blobtype=pdf http://www.ncbi.nlm.nih.gov/pubmed/9371353?dopt=AbstractPlus

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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

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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

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

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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.

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