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standards of non-Merck sources.
ALERT: U.S. Boxed Warning
The FDA-approved labeling includes a boxed warning. See Warnings/Precautions section for a concise summary of this information. For verbatim wording of the boxed warning, consult the product labeling or www.fda.gov.
Pronunciation
(zye DOE vyoo deen)
Generic Available (U.S.)
Yes: Capsule, syrup, tablet
Index Terms
U.S. Brand Names
Canadian Brand Names
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Treatment of HIV infection in combination with at least two other antiretroviral agents; prevention of maternal/fetal HIV transmission as monotherapy
Use: Unlabeled/Investigational
Postexposure prophylaxis for HIV exposure as part of a multidrug regimen
Pregnancy Risk Factor
C
Pregnancy Considerations
Adverse events have been observed in some animal reproduction studies. Zidovudine crosses the placenta and the placenta also metabolizes zidovudine to the active metabolite. No increased risk of overall birth defects has been observed following first trimester exposure according to data collected by the antiretroviral pregnancy registry. The pharmacokinetics of zidovudine are not significantly altered in pregnancy and dosing adjustment is not needed. The Perinatal HIV Guidelines Working Group considers zidovudine the preferred NRTI for use in combination regimens during pregnancy. Zidovudine is part of the recommended first-line regimen in treatment-naive pregnant patients (with twice daily lopinavir/ritonavir and lamivudine or twice daily lopinavir/ritonavir and emtricitabine) (DHHS, 2011). The use of zidovudine reduces the maternal-fetal transmission of HIV by ~70% and should be used for antenatal therapy unless there is severe toxicity, concurrent stavudine use, documented resistance, or the mother is already on a fully suppressive regimen. In HIV-infected mothers not previously on antiretroviral therapy, and who do not need therapy for their own health, treatment may be delayed until after 10-12 weeks gestation (but no later than 28 weeks gestation). Intrapartum zidovudine is recommended for all women regardless of their antepartum regimen. Cases of lactic acidosis/hepatic steatosis syndrome related to mitochondrial toxicity have been reported in pregnant women receiving nucleoside analogues. It is not known if pregnancy itself potentiates this known side effect; however, women may be at increased risk of lactic acidosis and liver damage. In addition, these adverse events are similar to other rare but life-threatening syndromes which occur during pregnancy (eg HELLP syndrome). Hepatic enzymes and electrolytes should be monitored frequently during the third trimester of pregnancy in women receiving nucleoside analogues and clinicians should watch for early signs of the syndrome. Women in labor with an unknown HIV status should have a rapid HIV test. If the test is positive, begin I.V. zidovudine therapy. (If a postpartum confirmatory test is negative, zidovudine therapy in the infant can be stopped). Healthcare providers are encouraged to enroll pregnant women exposed to antiretroviral medications in the Antiretroviral Pregnancy Registry (1-800-258-4263 or www.APRegistry.com). Healthcare providers caring for HIV-infected women and their infants may contact the National Perinatal HIV Hotline (888-448-8765) for clinical consultation.
Lactation
Enters breast milk/contraindicated
Breast-Feeding Considerations
In infants born to mothers who are HIV positive, HAART while breast-feeding may decrease postnatal infection. Infant prophylaxis with zidovudine in combination with nevirapine or nevirapine alone may also decrease the risk of HIV transmission to the infant. However, maternal or infant antiretroviral therapy does not completely eliminate the risk of postnatal HIV transmission. In addition, multiclass resistant virus has been detected in breast-feeding infants despite maternal therapy.
In the United States where formula is accessible, affordable, safe, and sustainable, complete avoidance of breast-feeding by HIV-infected women is recommended to decrease potential transmission of HIV.
Contraindications
Life-threatening hypersensitivity to zidovudine or any component of the formulation
Warnings/Precautions
Boxed warnings:
• Hematologic toxicity: See “Concerns related to adverse effects” below.
• Lactic acidosis/hepatomegaly: See “Concerns related to adverse effects” below.
• Myopathy: See “Concerns related to adverse effects” below.
Special handling:
• Hazardous agent: Use appropriate precautions for handling and disposal.
Concerns related to adverse effects:
• Fat redistribution: May cause redistribution of fat (eg, buffalo hump, peripheral wasting with increased abdominal girth, cushingoid appearance).
• Hematologic toxicity: [U.S. Boxed Warning]: Often associated with hematologic toxicity including granulocytopenia, severe anemia requiring transfusions, or (rarely) pancytopenia. Use with caution in patients with bone marrow compromise (granulocytes <1000 cells/mm3 or hemoglobin <9.5 mg/dL); dosage adjustment may be required in patients who develop anemia or neutropenia.
• Immune reconstitution syndrome: Patients may develop immune reconstitution syndrome resulting in the occurrence of an inflammatory response to an indolent or residual opportunistic infection; further evaluation and treatment may be required.
• Lactic acidosis/hepatomegaly: [U.S Boxed Warning]: Lactic acidosis and severe hepatomegaly with steatosis have been reported with nucleoside analogues, including fatal cases; use with caution in patients with risk factors for liver disease (risk may be increased with female gender, obesity, pregnancy or prolonged exposure) and suspend treatment in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or hepatotoxicity (transaminase elevation may/may not accompany hepatomegaly and steatosis).
• Myopathy: [U.S. Boxed Warning]: Prolonged use has been associated with symptomatic myopathy and myositis.
Disease-related concerns:
• Renal impairment: Use with caution in patients with severe renal impairment; dosage adjustment recommended.
Concurrent drug therapy issues:
• Interferon alfa/ribavirin: Use with caution in combination with interferon alfa with or without ribavirin in HIV/HBV coinfected patients; monitor closely for hepatic decompensation, anemia, or neutropenia; dose reduction or discontinuation of interferon and/or ribavirin may be required if toxicity evident.
• Zidovudine-containing products: Do not administer with combination products that contain zidovudine as one of their components (eg, COMBIVIR® [lamivudine and zidovudine] or TRIZIVIR® [abacavir sulfate, lamivudine, and zidovudine]).
Adverse Reactions
As reported in adult patients with asymptomatic HIV infection. Frequency and severity may increase with advanced disease.
>10%:
Central nervous system: Headache (63%), malaise (53%)
Gastrointestinal: Nausea (51%), anorexia (20%), vomiting (17%)
1% to 10%:
Gastrointestinal: Constipation (6%)
Hematologic: Granulocytopenia (2%; onset 6-8 weeks), anemia (1%; onset 2-4 weeks)
Hepatic: Transaminases increased (1% to 3%)
Neuromuscular & skeletal: Weakness (9%)
Frequency not defined:
Cardiovascular: Cardiomyopathy, chest pain, syncope, vasculitis
Central nervous system: Anxiety, chills, confusion, depression, dizziness, fatigue, insomnia, loss of mental acuity, mania, seizure, somnolence, vertigo
Dermatologic: Pruritus, rash, skin/nail pigmentation changes, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria
Endocrine & metabolic: Body fat redistribution, diabetes, dyslipidemias, gynecomastia, insulin resistance
Gastrointestinal: Abdominal cramps, abdominal pain, dyspepsia, dysphagia, flatulence, mouth ulcer, oral mucosa pigmentation, pancreatitis, taste perversion
Genitourinary: Urinary frequency, urinary hesitancy
Hematologic: Aplastic anemia, hemolytic anemia, leukopenia, lymphadenopathy, pancytopenia with marrow hypoplasia, pure red cell aplasia
Hepatic: Hepatitis, hepatomegaly with steatosis, hyperbilirubinemia, jaundice, lactic acidosis
Neuromuscular & skeletal: Arthralgia, back pain, CPK increased, LDH increased, musculoskeletal pain, myalgia, neuropathy, muscle spasm, myopathy, myositis, paresthesia, rhabdomyolysis, tremor
Ocular: Amblyopia, macular edema, photophobia
Otic: Hearing loss
Respiratory: Cough, dyspnea, rhinitis, sinusitis
Miscellaneous: Allergic reactions, anaphylaxis, angioedema, diaphoresis, flu-like syndrome, immune reconstitution syndrome
Metabolism/Transport Effects
Substrate (minor) of CYP2A6, 2C9, 2C19, 3A4
Drug Interactions
Acyclovir-Valacyclovir: May enhance the CNS depressant effect of Zidovudine. Risk C: Monitor therapy
Clarithromycin: May enhance the myelosuppressive effect of Zidovudine. Clarithromycin may decrease the serum concentration of Zidovudine. Management: Monitor response to zidovudine closely when used with clarithromycin, and consider staggering zidovudine and clarithromycin doses when possible in order to minimize the potential for interaction. Risk D: Consider therapy modification
Conivaptan: May increase the serum concentration of CYP3A4 Substrates. Management: Upon completion/discontinuation of conivaptan, allow at least 7 days before initiating therapy with drugs that are CYP3A4 substrates. Risk D: Consider therapy modification
Divalproex: May decrease the metabolism of Zidovudine. Risk C: Monitor therapy
DOXOrubicin: May enhance the adverse/toxic effect of Zidovudine. DOXOrubicin may diminish the therapeutic effect of Zidovudine. Risk D: Consider therapy modification
DOXOrubicin (Liposomal): May enhance the adverse/toxic effect of Zidovudine. DOXOrubicin (Liposomal) may diminish the therapeutic effect of Zidovudine. Risk D: Consider therapy modification
Fluconazole: May decrease the metabolism of Zidovudine. Risk C: Monitor therapy
Ganciclovir-Valganciclovir: May enhance the adverse/toxic effect of Reverse Transcriptase Inhibitors (Nucleoside). Hematologic toxicity is of specific concern. Risk D: Consider therapy modification
Interferons: May enhance the adverse/toxic effect of Zidovudine. Interferons may decrease the metabolism of Zidovudine. Risk C: Monitor therapy
Methadone: May increase the serum concentration of Zidovudine. Risk C: Monitor therapy
Probenecid: May decrease the metabolism of Zidovudine. Risk C: Monitor therapy
Protease Inhibitors: May decrease the serum concentration of Zidovudine. Risk C: Monitor therapy
Ribavirin: May enhance the hepatotoxic effect of Reverse Transcriptase Inhibitors (Nucleoside). Lactic acidosis may occur. Risk D: Consider therapy modification
Ribavirin: Zidovudine may enhance the adverse/toxic effect of Ribavirin. Specifically, the risk/severity of anemia may be increased. Management: Due to significantly increased risk of anemia, consider even closer monitoring for anemia than routinely recommended for ribavirin. Alternative therapies should be considered when clinically possible, particularly for patients with other risk factors. Risk D: Consider therapy modification
Rifamycin Derivatives: May decrease the serum concentration of Zidovudine. Exceptions: Rifabutin. Risk C: Monitor therapy
Stavudine: Zidovudine may diminish the therapeutic effect of Stavudine. Risk X: Avoid combination
Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy
Valproic Acid: May decrease the metabolism of Zidovudine. Risk C: Monitor therapy
Storage
I.V.: Store undiluted vials at 15°C to 25°C (59°F to 77°F). Protect from light. When diluted, solution is physically and chemically stable for 24 hours at room temperature and 48 hours if refrigerated.
Tablets, capsules, syrup: Store at 15°C to 25°C (59°F to 77°F). Protect capsules from moisture.
Reconstitution
Solution for injection should be diluted with D5W to a concentration ≤4 mg/mL. Attempt to administer diluted solution within 8 hours if stored at room temperature or 24 hours if refrigerated to minimize potential for microbial-contaminated solutions ≥≥(vials are single-use and do not contain preservative).
Compatibility
Stable in D5W, NS.
Incompatible with blood products and protein solutions.
Y-site administration: Compatible: Acyclovir, allopurinol, amifostine, amikacin, amphotericin B, amphotericin B cholesteryl sulfate complex, anindulafungin, aztreonam, cefepime, ceftazidime, ceftriaxone, cimetidine, cisatracurium, clindamycin, dexamethasone sodium phosphate, dobutamine, docetaxel, dopamine, doxorubicin liposome, erythromycin lactobionate, etoposide, filgrastim, fluconazole, fludarabine, gatifloxacin, gemcitabine, gentamicin, granisetron, heparin, imipenem/cilastatin, linezolid, lorazepam, melphalan, metoclopramide, morphine, nafcillin, ondansetron, oxacillin, paclitaxel, pantoprazole, pemetrexed, pentamidine, phenylephrine, piperacillin, piperacillin/tazobactam, potassium chloride, ranitidine, remifentanil, sargramostim, teniposide, thiotepa, tobramycin, trimethoprim/sulfamethoxazole, vancomycin, vinorelbine. Variable (consult detailed reference): Meropenem, TPN.
Compatibility when admixed: Variable (consult detailed reference): Meropenem.
Mechanism of Action
Zidovudine is a thymidine analog which interferes with the HIV viral RNA-dependent DNA polymerase resulting in inhibition of viral replication; nucleoside reverse transcriptase inhibitor
Pharmacodynamics/Kinetics
Distribution: Significant penetration into the CSF
Vd: 1-2.2 L/kg
Relative diffusion from blood into CSF: Adequate with or without inflammation (exceeds usual MICs)
CSF:blood level ratio: Normal meninges: ~60%
Protein binding: 25% to 38%
Metabolism: Hepatic via glucuronidation to inactive metabolites; extensive first-pass effect
Bioavailability: 54% to 74%
Half-life elimination: Terminal: 0.5-3 hours
Time to peak, serum: 30-90 minutes
Excretion:
Oral: Urine (72% to 74% as metabolites, 14% to 18% as unchanged drug)
I.V.: Urine (45% to 60% as metabolites, 18% to 29% as unchanged drug)
Dosage
Prevention of maternal-fetal HIV transmission: Note: Consider use of zidovudine in combination with nevirapine (and possibly lamivudine) in select situations (eg, infants born to mothers with suboptimal viral suppression at delivery, infants born to mothers with only intrapartum therapy or no therapy, or infants born to mothers with known antiretroviral drug-resistant virus) (DHHS [perinatal], 2010).
Neonatal: Note: Dosing should begin 6-12 hours after birth and continue for the first 6 weeks of life.
Oral:
Full-term infants: 2 mg/kg/dose every 6 hours
Infants ≥30 weeks and <35 weeks gestation at birth: 2 mg/kg/dose every 12 hours; at 2 weeks of age, advance to 2 mg/kg/dose every 8 hours
Infants <30 weeks gestation at birth: 2 mg/kg/dose every 12 hours; at 4 weeks of age, advance to 2 mg/kg/dose every 8 hours
Alternate dosing for infants >35 weeks gestation (for use in low resource settings; may also be considered for use in higher resource settings if simplicity in dosing/administration is important):
Infants <2.5 kg at birth: 10 mg twice daily
Infants >2.5 kg at birth: 15 mg twice daily
I.V.: Infants unable to receive oral dosing:
Full term: 1.5 mg/kg/dose every 6 hours
Infants ≥30 weeks and <35 weeks gestation at birth: 1.5 mg/kg/dose every 12 hours; at 2 weeks of age, advance to 1.5 mg/kg/dose every 8 hours
Infants <30 weeks gestation at birth: 1.5 mg/kg/dose every 12 hours; at 4 weeks of age, advance to 1.5 mg/kg/dose every 8 hours
Maternal: Oral (DHHS [perinatal], 2010): Begin oral therapy with usual recommended dose as soon as possible in women who require treatment for their own health (including use during the first trimester); may delay therapy until after 10-12 weeks gestation (but no later than 28 weeks gestation) in women who are using antiretroviral medications solely for the prevention of perinatal transmission. Dose adjustment is not required for pregnant women. Change to I.V. dosing during labor.
During labor and delivery, administer zidovudine I.V. at 2 mg/kg as loading dose followed by a continuous I.V. infusion of 1 mg/kg/hour until the umbilical cord is clamped. For scheduled cesarean delivery, begin I.V. zidovudine 3 hours before surgery.
Treatment of HIV infection:
Children 4 weeks to <18 years:
Oral: Dose should be calculated by body weight (in kg) or body surface area and should not exceed the recommended adult dose. Note: Doses calculated by body weight may not be the same as those calculated by body surface area.
Dosing based on body surface area: 240 mg/m2 every 12 hours (maximum: 300 mg every 12 hours) or 160 mg/m2/dose every 8 hours (maximum: 200 mg every 8 hours)
Dosing based on weight (Note: 3 times daily dose is approved but rarely used in clinical practice):
4 to <9 kg: 12 mg/kg/dose twice daily or 8 mg/kg/dose 3 times/day
≥9 to <30 kg: 9 mg/kg/dose twice daily or 6 mg/kg/dose 3 times/day
≥30 kg: 300 mg twice daily or 200 mg 3 times/day
Children 6 weeks to <12 years (per AIDSinfo guidelines):
I.V. continuous infusion: 20 mg/m2/hour
I.V. intermittent infusion: 120 mg/m2/dose every 6 hours
Children ≥12 years: I.V. intermittent infusion: 1 mg/kg/dose every 4 hours around-the-clock (5-6 doses/day)
Adults:
Oral: 300 mg twice daily or 200 mg 3 times/day
I.V.: 1 mg/kg/dose administered every 4 hours around-the-clock (5-6 doses/day)
Prevention of HIV following needlesticks (unlabeled use): Oral: Adults: 200 mg 3 times/day plus lamivudine 150 mg twice daily; a protease inhibitor (eg, indinavir) may be added for high risk exposures; begin therapy within 2 hours of exposure if possible
Patients should receive I.V. therapy only until oral therapy can be administered
Dosing adjustment for hematologic toxicity: Consider dose interruption for significant anemia (hemoglobin <7.5 g/dL or >25% reduction from baseline) and/or neutropenia (granulocyte count <750 cells/mm3 or >50% reduction from baseline) until evidence of recovery. Anemia associated with chronic zidovudine may warrant dose reduction.
Dosing adjustment in renal impairment: Clcr <15 mL/minute including hemo-/peritoneal dialysis:
Oral: 100 mg every 6-8 hours or 300 mg once daily (DHHS, 2011)
I.V.: 1 mg/kg every 6-8 hours
Continuous renal replacement therapy (CRRT): No adjustment needed (Aronoff, 2007)
Dosing adjustment in hepatic impairment: Insufficient data to make dosing recommendation
Administration: Oral
Administer around-the-clock to promote less variation in peak and trough serum levels. Oral zidovudine may be administered without regard to meals.
Administration: I.M.
Do not give I.M.
Administration: I.V.
Avoid rapid infusion or bolus injection
Neonates: Infuse over 30 minutes
Adults: Infuse loading dose over 1 hour, followed by continuous infusion
Administration: I.V. Detail
pH: 5.5
Monitoring Parameters
Monitor CBC and platelet count at least every 2 weeks, liver function tests, MCV, serum creatinine kinase, viral load, and CD4 count; observe for appearance of opportunistic infections
Dietary Considerations
May be taken without regard to meals.
Patient Education
This drug will not cure HIV, nor has it been found to reduce transmission of HIV; use appropriate precautions to prevent spread to other persons. This drug is prescribed as one part of a multidrug combination; take exactly as directed for full course of therapy. Maintain adequate hydration unless advised by prescriber to restrict fluids. Avoid alcohol. Frequent blood tests may be required. May cause body changes due to redistribution of body fat, facial atrophy, or breast enlargement (normal effects of drug). May cause headache, dizziness, weakness, nausea, vomiting, mouth sores, constipation, CNS changes (anxiety, chills, confusion, depression, loss of mental acuity, or seizures - contact prescriber), or back or muscle pain. Report excessive fatigue, easy bruising or bleeding, change in urinary pattern, dark urine or light stool, chest pain or palpitations, rash or skin sores, muscle or bone pain, or tremor. Stop drug and report immediately symptoms of hypersensitivity/allergic reaction (eg, swelling of lips, face, mouth, or throat; rash; difficulty breathing or chest tightness; excessive sweating; numbness or loss of sensation). Do not restart without specific instruction by your prescriber.
Additional Information
Potential compliance problems, frequency of administration, and adverse effects should be discussed with patients before initiating therapy to help prevent the emergence of resistance.
Anesthesia and Critical Care Concerns/Other Considerations
Does not reduce risk of transmitting HIV infections. Potential compliance problems, frequency of administration, and adverse effects should be discussed with patients before initiating therapy to help prevent the emergence of resistance.
Dental Health: Effects on Dental Treatment
Key adverse event(s) related to dental treatment: Taste perversion, oral mucosa pigmentation, dysphagia, and mouth ulcer.
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
May cause anxiety, confusion, depression, dizziness, drowsiness, insomnia, or mania
Mental Health: Effects on Psychiatric Treatment
Granulocytopenia is common; avoid clozapine and carbamazepine. Valproic acid may decrease the clearance of zidovudine. GI side effects are common; concurrent use with SSRIs may produce additive effects.
Nursing: Physical Assessment/Monitoring
Assess closely for any previous allergy history prior to beginning treatment. Use caution in presence of bone marrow compromise or renal impairment; dose reduction may be necessary. Assess CD4 count and viral load, CBC and platelet count, and LFTs. Monitor for lactic acidosis (elevated transaminases), anemia, neutropenia, hepatic decompensation, gastrointestinal disturbance (nausea, vomiting, diarrhea), myalgia, and peripheral neuropathy. Teach patient proper timing of multiple medications.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Capsule, oral: 100 mg
Retrovir®: 100 mg
Injection, solution [preservative free]:
Retrovir®: 10 mg/mL (20 mL)
Syrup, oral: 50 mg/5 mL (240 mL)
Retrovir®: 50 mg/5 mL (240 mL [DSC], 240s) [contains sodium benzoate; strawberry flavor]
Tablet, oral: 300 mg
Retrovir®: 300 mg
Pricing: U.S. (www.drugstore.com)
Capsules (Retrovir)
100 mg (180): $477.01
Syrup (Retrovir)
50 mg/5 mL (240): $71.99
Tablets (Retrovir)
300 mg (60): $479.97
Tablets (Zidovudine)
300 mg (60): $169.98
References
Aronoff GR, Bennett WM, Berns JS, et al, Drug Prescribing in Renal Failure: Dosing Guidelines for Adults and Children, 5th ed. Philadelphia, PA: American College of Physicians; 2007, p 82.
Bendayan R, Georgis W, and Rafi-Tari S, “Interaction of 3′-Azido-3′-Deoxythymidine With the Organic Base Transporter in a Cultured Renal Epithelium,” Pharmacotherapy, 1995, 15(3):338-44.
Carpenter CC, Fischel MA, Hammer SM, et al, “Antiretroviral Therapy for HIV Infection in 1997. Updated Recommendations of the International AIDS Society - USA Panel,” JAMA, 1997, 277(24):1962-9.
CDC and the National Foundation for Infectious Disease, “Public Health Service Guidelines for the Management of Health-Care Worker Exposures to HIV and Recommendations for Postexposure Prophylaxis,” MMWR Recomm Rep, May 15, 1998/47 (RR-7):29-30.
CDC and the National Foundation for Infectious Disease, “Update: Provisional Public Health Service Recommendations for Chemoprophylaxis After Occupational Exposure to HIV,” MMWR, 1996, 45(22):468-80.
Collins JM and Unadkat JD, “Clinical Pharmacokinetics of Zidovudine: An Overview of Current Data,” Clin Pharmacokinet, 1989, 17(1):1-9.
D'Silva M, Leibowitz D, and Flaherty JP, “Seizure Associated With Zidovudine,” Lancet, 1995, 346(8972):452.
“Drugs for AIDS and Associated Infections,” Med Lett Drugs Ther, 1993, 35(904):79-86.
Fischl MA, Richman DD, Hansen N, et al, “The Safety and Efficacy of Zidovudine (AZT) in the Treatment of Subjects With Mildly Symptomatic Human Immunodeficiency Virus Type 1 (HIV) Infection. A Double-Blind, Placebo-Controlled Trial. The AIDS Clinical Trials Group,” Ann Intern Med, 1990, 112(10):727-37.
Gill PS, Harrington W, Kaplan MH, et al, “Treatment of Adult T-Cell Leukemia-Lymphoma With a Combination of Interferon Alfa and Zidovudine,” N Engl J Med, 1995, 332(26):1744-8.
Gorman SE, Dela Cruz F, and Paloucek F, “Ketoconazole and Zidovudine Overdose,” Am J Emerg Med, 1995, 13(1):115-6.
Hagler DN and Frame PT, “Azidothymidine Neurotoxicity,” Lancet, 1986, 2(8520):1392-3.
Hargreaves M, Fuller G, Costello C, et al, “Zidovudine Overdose,” Lancet, 1988, 2(8609):509.
Hermine O, Bouscary D, Gessain A, et al, “Brief Report: Treatment of Adult T-Cell Leukemia-Lymphoma With Zidovudine and Interferon Alfa,” N Engl J Med, 1995, 332(26):1749-51.
Hilts AE and Fish DN, “Dosage Adjustment of Antiretroviral Agents in Patients With Organ Dysfunction,” Am J Health Syst Pharm, 1998, 55:2528-33.
Hirsch MS and D'Aquila RT, “Therapy for Human Immunodeficiency Virus Infection,” N Engl J Med, 1993, 328(23):1686-95.
Hoggard PG, Veal GJ, Wild MJ, et al, “Drug Interactions With Zidovudine Phosphorylation in vitro,” Antimicrob Agents Chemother, 1995, 39(6):1376-8.
Ioannidis JP, Cappelleri JC, Lau J, et al, “Early or Deferred Zidovudine Therapy in HIV-Infected Patients Without an AIDS-Defining Illness,” Ann Intern Med, 1995, 122(11):856-66.
Kinloch-De Loes S, Hirschel BJ, Hoen B, et al, “A Controlled Trial of Zidovudine in Primary Human Immunodeficiency Virus Infection,” N Engl J Med, 1995, 333(7):408-13.
Marchbanks K, Dudley MN, Posner MR, et al, “Pharmacokinetics and Pharmacodynamics of High-Dose Zidovudine Administered as a Continuous Infusion in Patients With Cancer,” Pharmacotherapy, 1995, 15(4):451-7.
McLeod GX and Hammer SM, “Zidovudine: Five Years Later,” Ann Intern Med, 1992, 117(6):487-501.
Morris DJ, “Adverse Effects and Drug Interactions of Clinical Importance With Antiviral Drugs,” Drug Saf, 1994, 10(4):281-91.
Mueller BU, Jacobsen F, Butler KM, et al, “Combination Treatment With Azidothymidine and Granulocyte Colony-Stimulating Factor in Children With Human Immunodeficiency Virus Infection,” J Pediatr, 1992, 121(5 Pt 1):797-802.
Newell ML and Gibb DM, “A Risk-Benefit Assessment of Zidovudine in the Prevention of Perinatal HIV Transmission,” Drug Saf, 1995, 12(4):274-82.
Panel on Antiretroviral Guidelines for Adults and Adolescents, “Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents, Department of Health and Human Services,” January 10, 2011; 1-166. Available at http://www.aidsinfo.nih.gov
“Perinatal HIV Guidelines Working Group. Public Health Service Task Force Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States,” May 24, 2010. Available at http://aidsinfo.nih.gov/ContentFiles/PerinatalGL.pdf
Rachlis A and Fanning MM, “Zidovudine Toxicity: Clinical Features and Management,” Drug Saf, 1993, 8(4):312-20.
Skowron G, Bozzette SA, Lim L, et al, “Alternating and Intermittent Regimens of Zidovudine and Dideoxycytidine in Patients With AIDS or AIDS-Related Complex,” Ann Intern Med, 1993, 118(5):321-30.
Taburet AM, Naveau S, Zorza G, et al, “Pharmacokinetics of Zidovudine in Patients With Liver Cirrhosis,” Clin Pharmacol Ther, 1990, 47(6):731-9.
Volberding PA, Lagakos SW, Grimes JM, et al, “A Comparison of Immediate With Deferred Zidovudine Therapy for Asymptomatic HIV-Infected Adults With CD4 Cell Counts of 500 or More Per Cubic Millimeter. AIDS Clinical Trials Group,” N Engl J Med, 1995, 333(7):401-7.
Volberding PA, Lagakos SW, Koch MA, et al, “Zidovudine in Asymptomatic Human Immunodeficiency Virus Infection. A Controlled Trial in Persons With Fewer Than 500 CD4-Positive Cells Per Cubic Millimeter. The AIDS Clinical Trials Group of the National Institute of Allergy and Infectious Diseases,” N Engl J Med, 1990, 322(14):941-9.
Wyles DL and Gerber JG, “Antiretroviral Drug Pharmacokinetics in Hepatitis with Hepatic Dysfunction,” Clin Infect Dis, 2005, 40(1):174-81.
Working Group on Antiretroviral Therapy and Medical Management of HIV-Infected Children, “Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection,” August 16, 2010. Available at http://www.aidsinfo.nih.gov
International Brand Names
Lexi-Comp.com
Last full review/revision May 2011
Content last modified May 2011
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