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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 and/or refer to product labeling for additional detail.
Medication Safety Issues
Sound-alike/look-alike issues:
Azidothymidine may be confused with azathioprine, aztreonam
Retrovir® may be confused with ritonavir
AZT is an error-prone abbreviation (mistaken as azathioprine, aztreonam)
Pronunciation
(zye DOE vyoo deen)
U.S. Brand Names
Index Terms
Generic Available
Yes: Tablet
Canadian Brand Names
Pharmacologic Category
Pharmacologic Category Synonyms
Use
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 Implications
Zidovudine crosses the placenta. No increased risk of overall birth defects has been observed following 1st trimester exposure according to data collected by the antiretroviral pregnancy registry. The use of zidovudine reduces the maternal-fetal transmission of HIV by ?70% and should be considered for antenatal and intrapartum therapy whenever possible. The Perinatal HIV Guidelines Working Group considers zidovudine the preferred NRTI for use in combination regimens during pregnancy. In HIV-infected mothers not previously on antiretroviral therapy, treatment may be delayed until after 10-12 weeks gestation. Cases of lactic acidosis/hepatic steatosis syndrome have been reported in pregnant women receiving nucleoside analogues. It is not known if pregnancy itself potentiates this known side effect; however, pregnant women may be at increased risk of lactic acidosis and liver damage. Hepatic enzymes and electrolytes should be monitored frequently during the 3rd trimester of pregnancy in women receiving nucleoside analogues. 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). Health professionals are encouraged to contact the antiretroviral pregnancy registry to monitor outcomes of pregnant women exposed to antiretroviral medications (1-800-258-4263 or www.APRegistry.com).
Lactation
Enters breast milk/contraindicated
Breast-Feeding Considerations
HIV-infected mothers are discouraged from breast-feeding 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.
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: 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.
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, gynecomastia
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
Drug Interactions
Substrate (minor) of CYP2A6, 2C9, 2C19, 3A4
Acyclovir, valacyclovir: May increase CNS depression of zidovudine; monitor.
Bone marrow suppressants/cytotoxic agents: Concomitant use may increase risk of hematologic toxicity. (May be seen with dapsone, doxorubicin, flucytosine, vincristine, vinblastine.)
Doxorubicin: May reduce phosphorylation of zidovudine (based on in vitro data); manufacturer recommends not to use concomitantly.
Fluconazole: Fluconazole may increase levels/effects of zidovudine.
Ganciclovir, valganciclovir: Concomitant use may increase risk of hematologic toxicities; monitor hemoglobin, hematocrit, and white blood cell count with differential frequently; dose reduction or interruption of either agent may be needed.
Interferon-alfa: Concomitant use may increase risk of hepatic decompensation or hematologic toxicities; monitor hemoglobin, hematocrit, and white blood cell count with differential frequently; dose reduction or interruption of either agent may be needed.
Methadone: May increase serum levels/effects of zidovudine; monitor.
Nelfinavir: May decrease levels/effects of zidovudine; monitor.
Probenecid: Probenecid may increase zidovudine levels/effects. Myalgia, malaise, and/or fever and maculopapular rash have been reported with concomitant use.
Ribavirin: Concomitant use of ribavirin and nucleoside analogues may increase the risk of developing hepatic decompensation or other signs of mitochondrial toxicity, including pancreatitis or lactic acidosis. May decrease the antiviral activity of zidovudine (based on in vitro data); monitor closely.
Rifampin: May decrease levels of zidovudine; monitor.
Stavudine: Zidovudine may decrease the antiviral activity of stavudine (based on in vitro data); avoid concurrent use.
Valproic acid: Valproic acid may increase plasma levels of zidovudine; monitor for possible increase in side effects (AUC increased by 80%).
Storage
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.
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 microbially-contaminated solutions.
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, 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, 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; crosses placenta
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:
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
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 (per AIDSinfo guidelines): 100 mg 5 times/day or 200 mg 3 times/day or 300 mg twice daily. Begin at 14-34 weeks gestation and continue until start of 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
Treatment of HIV infection:
Children 6 weeks to 12 years:
Oral: 160 mg/m2/dose every 8 hours (maximum: 200 mg every 8 hours); some Working Group members use a dose of 180 mg/m2 to 240 mg/m2 every 12 hours when using in drug combinations with other antiretroviral compounds, but data on this dosing in children is limited
I.V. continuous infusion: 20 mg/m2/hour
I.V. intermittent infusion: 120 mg/m2/dose every 6 hours
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: 100 mg (oral) or 1 mg/kg (I.V.) every 6-8 hours
Continuous arteriovenous or venovenous hemodiafiltration effects: Administer 100 mg every 8 hours
Dosing adjustment in hepatic impairment: Insufficient data to make dosing recommendation. AIDSinfo guidelines do not support dosing adjustment at this time.
Administration: Oral
Administer around-the-clock to promote less variation in peak and trough serum levels. Oral zidovudine may be administered without regard to food.
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 food.
Patient Education
Do not take any new prescription or over-the-counter medications or herbal products during therapy without consulting prescriber. 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 (2-3 L/day of fluids) unless advised by prescriber to restrict fluids. Avoid alcohol to decrease risk of hypersensitivity reaction. You may be susceptible to infection (avoid crowds and exposure to known infections and do not have any vaccinations without consulting prescriber). Frequent blood tests may be required with prolonged therapy. May cause body changes due to redistribution of body fat, facial atrophy, or breast enlargement (normal effects of drug). May cause headache, dizziness, or weakness (use caution when driving or engaging in tasks requiring alertness until response to drug is known); nausea or vomiting; mouth sores (small, frequent meals, frequent mouth care, chewing gum, or sucking lozenges may help); constipation (increased dietary fluid and fibers may help); CNS changes (anxiety, chills, confusion, depression, loss of mental acuity, or seizures - contact prescriber); or back or muscle pain (if persistent contact prescriber for appropriate analgesic). 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. Note: 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. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Do not breast-feed.
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, risk factors for liver disease, or renal impairment; dose reduction may be necessary. Assess other pharmacological or herbal products patient may be taking (eg, increased risk of nephrotoxicity, hepatotoxicity, lactic acidosis), especially those that increase risk of peripheral neuropathy. Assess results of laboratory tests (CD4 count and viral load, CBC and platelet count, LFTs), therapeutic response, and adverse reactions on a regular basis throughout therapy (eg, lactic acidosis [elevated transaminases], anemia, neutropenia, hepatic decompensation, gastrointestinal disturbance [nausea, vomiting, diarrhea], myalgia, peripheral neuropathy). Teach patient proper use (eg, timing of multiple medications and drugs that should not be used concurrently), possible side effects/appropriate interventions, and adverse symptoms to report.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule:
Retrovir®: 100 mg
Injection, solution [preservative free]:
Retrovir®: 10 mg/mL (20 mL)
Syrup:
Retrovir®: 50 mg/5 mL (240 mL) [contains sodium benzoate; strawberry flavor]
Tablet: 300 mg
Retrovir®: 300 mg
Pricing: U.S. (www.drugstore.com)
Capsules (Retrovir)
100 mg (180): $394.04
Syrup (Retrovir)
50 mg/5 mL (240): $56.09
Tablets (Retrovir)
300 mg (60): $396.58
Tablets (Zidovudine)
300 mg (60): $170.00
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International Brand Names
Lexi-Comp.com
Last full review/revision April 2008
Content last modified April 2008
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