Names and pronunciation
(zye-doe′-vue-deen) Retrovir
Source page 1393
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Individual generic drug information
Extracted information for zidovudine only.
(zye-doe′-vue-deen) Retrovir
Source page 1393
Func. class.: Antiretroviral Func. class.: Trace element; nutritional supplement
Source pages 1393, 1395
Chem. class.: Nucleoside reverse transcriptase inhibitor (NRTI)
Source page 1393
Do not confuse: Retrovir/ritonavir
Source page 1393
ACTION: Inhibits replication of HIV-1 virus by incorporating into cellular DNA by viral reverse transcriptase, thereby terminating the cellular DNA chain ACTION: Needed for adequate healing, bone and joint development (23% zinc)
Source pages 1393, 1395
USES: Used in combination with at least 2 other antiretrovirals for HIV-1 infection, prevention of perinatal HIV USES: Prevention of zinc deficiency, adjunct to vit A therapy
Source pages 1393, 1395
Unlabeled uses: Wound healing Z Precautions: Pregnancy, parenteral; breastfeeding, neonates, hypocupremia, neonatal prematurity, renal disease
Source page 1395
Extracted information for zidovudine only.
CONTRAINDICATIONS: Hyper sensitivity Precautions: Pregnancy, breastfeeding, children, granulocyte count <1000/mm3 or HB <9.5 g/dL, severe renal disease, obesity
Source page 1393
Black Box Warning: Hepatotoxicity, ane- mia, lactic acidosis, myopathy, neutropenia Black Box Warning: Bone marrow sup- pression: monitor blood counts q2wk; watch for decreasing granulocytes, HB; if low, therapy may have to be discontinued and restarted after hematologic recovery; blood transfusions may be required; viral load, CD4 counts, LFTs, plasma HIV RNA, serum creatinine/BUN at baseline and throughout treatment Black Box Warning: Lactic acidosis, severe hepatomegaly with steatosis (rare): Obtain baseline LFTs; if elevated, discontinue; discontinue even if liver func- tion tests are normal but lactic acidosis, hepatomegaly are present; may be fatal; more common in females, may develop dyspnea, tachypnea Black Box Warning: Myopathy may oc- cur with long-term use, assess for myal- gia, arthralgia during long-term use • Lipoatrophy: May occur, another treat ment may be needed to prevent it • Hypersensitivity: Do not use if previous serious hypersensitivity to this product, Stevens-Johnson syndrome may occur • Immune reconstitution syndrome: As- sess for rash, fever, lymphadenopathy, ab- dominal pain due to opportunistic infections • Monitor lipid profile, blood glucose, hepatitis B serology, plasma hepatitis C RNA, serum cholesterol, pregnancy test, urinalysis, serum lipase, amylase • Pregnancy/breastfeeding: register pregnant patients at the Antiretroviral Pregnancy Registry, 1-800-258-4263; do not breastfeed, excreted in breast milk, max suppression of virus should be at- tained before pregnancy is considered; to be used near delivery even if HIV RNA status is unknown
Source pages 1393, 1394, 1395
SIDE EFFECTS CNS: Fever, headache, malaise, diaphore sis, dizziness, insomnia, paresthesia, som nolence, chills, tremors, twitching, anxiety, confusion, depression, lability, vertigo, loss of mental acuity, seizures, malaise EENT: Taste change, hearing loss, photophobia GI: Nausea, vomiting, diarrhea, anorexia, cramps, dyspepsia, constipation, dyspha gia, flatulence, rectal bleeding, mouth ulcer, abdominal pain, hepatomegaly GU: Dysuria, polyuria, urinary frequency, hesitancy HEMA: Granulocytopenia, anemia, severe bone marrow suppression INTEG: Rash, acne, pruritus, urticaria MS: Myalgia, arthralgia, muscle spasm RESP: Dyspnea, cough, wheezing SYST: Lactic acidosis, Stevens-Johnson syndrome SIDE EFFECTS GI: Nausea, vomiting, cramps, heartburn, ulcer formation OVERDOSE: Diarrhea, rash, dehydra tion, restlessness
Source pages 1394, 1396
INTERACTIONS Increase: bone marrow depression—anti neoplastics, radiation, ganciclovir, valGAN ciclovir, trimethoprim-sulfamethoxazole Increase: zidovudine level—methadone, atovaquone, fluconazole, probenecid, trimethoprim, valproic acid; may need to reduce zidovudine dose Increase: toxicity-fluconazole, probenecid Decrease: zidovudine levels—clarithro mycin, interferons, NRTIs, DOXOrubicin, ribavirin, stavudine; avoid concurrent use Drug/Lab Test Decrease: platelets, granulocytes Increase: LFTs, amylase, CPK INTERACTIONS Decrease: absorption of fluoroquino lones—tetracyclines Drug/Food Decrease: absorption of PO zinc—dairy products, caffeine
Source pages 1394, 1396
Extracted information for zidovudine only.
DOSAGE AND ROUTES HIV with other antiretroviral agents • Adult/adolescents: PO 300 mg bid or 200 mg tid; IV INFUSION 1 mg/kg over 1 hr q4hr. Initiate oral therapy as soon as possible • Child 4 wk to <18 yr: PO max adult dose; ≥30 kg: 300 mg bid or 200 mg tid; 9-29 kg: PO 9 mg/kg bid or 6 mg/kg tid; 4-8 kg: PO 12 mg/kg bid or 8 mg/kg tid Perinatal (HIV) prophylaxis Z (intrapartum): • Pregnant females IV INFUSION 2 mg/kg over 1 hr, followed by 1 mg/kg/hr IV CONT INFUSION until clamping of the umbilical cord • Neonate ≥35 wk gestational age: IV 3 mg/kg q12hr beginning as soon as possible after birth, convert to PO as soon as possible Renal dose • Adult: PO CCr ≥15 mL/min: no change; CCr <15 mL/min, 100 mg q8hr or 300 mg/day • Pediatric patients: PO GFR ≥10 mL/ min/1.73 m2: no change; GFR <10 mL/ min/1.73 m2: reduce dose by 50% DOSAGE AND ROUTES Dietary supplement (elemental zinc) female: • Adult/adolescent/pregnant PO 11-13 mg/day • Adult/lactating female: PO 12-14 mg/ day × 12 mo • Adult/adolescent male ≥14 yr: PO 11 mg/day • Adult female ≥19 yr: PO 8 mg/day • Adolescent female ≥14 yr: PO 9 mg/day • Child 9-13 yr: PO 8 mg/day • Child 4-8 yr: PO 5 mg/day • Child 1-3 yr: PO 3 mg/day • Infant 7-12 mo: PO 3 mg/day • Infant birth to 6 mo: PO 2 mg/day (adequate intake) Nutritional supplement (IV) • Adult: 2.5-4 mg/day; may increase by 2 mg/day if needed • Child 1-5 yr: IV 50 mcg/kg/day Wound healing • Adult: PO 50 mg tid until healed (ele mental zinc)
Source pages 1393, 1394, 1395, 1396
Available forms: Caps 100; tabs 300 mg; inj 10 mg/mL; oral syrup 50 mg/5 mL Available forms: Tabs 66, 110, 220 mg; inj 1 mg/mL, 5 mg/mL; caps 25, 50 mg
Source pages 1394, 1396
Administer: • By mouth; capsules should be swal lowed whole • Trimethoprim-sulfamethoxazole, pyri methamine, or acyclovir as ordered to prevent opportunistic infections; if these products are given, watch for neurotoxicity • Store in cool environment; protect from light Intermittent IV INFUSION route • Latex is in vial stopper • After diluting in D5W to ≤4 mg/mL; give over 1 hr • Discard any unused portions • Protect unopened product from light; use diluted sol within 8 hr room tem perature, 24 hr refrigerated, do not use discolored solutions Y-site compatibilities: Acyclovir, alemtu zumab, allopurinol, amifostine, amikacin, amphotericin B, amphotericin B cholesteryl, anidulafungin, argatroban, aztreonam, cefepime, cefTAZidime, cefTRIAXone, cimeti dine, cisatracurium, clindamycin, dexametha sone, DOBUTamine, DOPamine, DOXOrubi cin liposome, erythromycin, filgrastim, fluconazole, fludarabine, gentamicin, granise tron, heparin, imipenem-cilastatin, LORaze pam, melphalan, metoclopramide, morphine, nafcillin, ondansetron, oxacillin, PACLitaxel, pentamidine, phenylephrine, piperacillin, piperacillin-tazobactam, potassium chloride, raNITIdine, remifentanil, sargramostim, tacrolimus, teniposide, thiotepa, tobramycin, trimethoprim-sulfamethoxazole, trimetrexate, vancomycin, vinorelbine, zoledronic acid Administer: • With meals to decrease gastric upset; avoid dairy products
Source pages 1394, 1396
Extracted information for zidovudine only.
Assess: • HIV: monitor for symptoms of HIV, baseline and throughout treatment Assess: • Zinc deficiency: poor wound healing, absence of taste, smell, slowing growth • Alkaline phosphatase, HDL monthly in long-term therapy • Zinc levels during treatment, CBC • Pregnancy/breastfeeding: use only if benefits outweigh fetal risk (IV); consid ered safe in breastfeeding
Source pages 1394, 1396
Evaluate: • Therapeutic response: decreased viral load, increased CD4 counts, decreased symptoms of HIV Evaluate: • Therapeutic response: absence of zinc deficiency
Source pages 1395, 1396
CLINICAL CONSIDERATIONS CLINICAL CONSIDERATIONS
Source pages 1394, 1396
Patient and caregiver information: • That GI complaints and insomnia re solve after 3-4 wk of treatment • HIV: That repeat testing in 4-6 wk is needed due to risk of false positive if used in newborn • That product is not a cure for AIDS but will control symptoms; that compliance with treatment is required • To notify prescriber of sore throat, swollen lymph nodes, malaise, fever, shortness of breath because other infec tions may occur; to avoid crowds or people with known infections • That patient is still infective, may pass AIDS virus on to others • That follow-up visits must be contin ued because serious toxicity may occur; that blood counts must be done q2wk; that blood transfusions may be needed for severe anemia • That product must be taken bid or tid around the clock to prevent variations in blood levels • To notify prescriber of rash, nausea, vomiting, weakness • That serious product interactions may occur if OTC products are ingested; to check with prescriber before taking aspi- rin, acetaminophen, indomethacin • That other products may be necessary to prevent other infections • To take without regard to meals • Not to take other antiretrovirals except those prescribed • That product may cause fainting or dizziness; to avoid driving or other haz ardous tasks until response is known • That redistribution of body fat may occur • Not to breastfeed during treatment, that use during pregnancy reduces trans- mission to neonate Galzin Patient and caregiver information: • That element must be taken for 2-3 mo to be effective • To immediately report nausea, diar- rhea, rash, severe vomiting, restlessness, abdominal pain, tarry stools
Source pages 1395, 1396
Extracted information for zidovudine only.
PHARMACOKINETICS PO: Rapidly absorbed from GI tract, peak 1⁄2-11⁄2 hr; IV peak infusions end; metabolized in liver (inactive metabo lites), excreted by kidneys, protein binding 38%, half-life 1⁄2-3 hr
Source page 1394
Filter the extracted dose blocks for this individual drug.
HIV with other antiretroviral agents
• Adult/adolescents: PO 300 mg bid or 200 mg tid; IV INFUSION 1 mg/kg over 1 hr q4hr. Initiate oral therapy as soon as possible
Candidate age grouping · source pages 1393, 1394, 1395, 1396
HIV with other antiretroviral agents
• Adult/adolescent male ≥14 yr: PO 11 mg/day
Candidate age grouping · source pages 1393, 1394, 1395, 1396
HIV with other antiretroviral agents
• Adolescent female ≥14 yr: PO 9 mg/day
Candidate age grouping · source pages 1393, 1394, 1395, 1396