Prevents viral replication. (5.4) Hepatic decompensation, (some fatal), has occurred in HIV-1/HCV co-infected patients receiving combination antiretroviral therapy and interferon alfa with/without ribavirin. Zidovudine was administered orally at 3 dosage levels to separate groups of mice and rats (60 females and 60 males in each group). Fiscus SA, Adimora AA, Schoenbach VJ, Lim W, McKinney R, Rupar D, Kenny J, Woods C, Wilfert C. Perinatal HIV infection and the effect of zidovudine therapy on transmission in rural and urban counties. Inclusion in an NLM database does not imply endorsement of, or agreement with, TAM substitutions are selected by Zidovudine and confer cross-resistance to abacavir, didanosine, stavudine, and tenofovir. Geriatric Patients: Zidovudine pharmacokinetics have not been studied in subjects over 65 years of age. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. Inform patients that the most commonly reported adverse reactions in adult patients being treated with Zidovudine were headache, malaise, nausea, anorexia, and vomiting. An oral embryo-fetal development study in rabbits (at 75, 150, or 500 mg per kg per day on Gestation Day 6 through 18) showed increased fetal resorptions at the 500 mg-per-kg-per-day dose, which produced systemic exposures (AUC) approximately 108 times higher than exposure at the recommended daily human dose; however, no fetal resorptions were noted at doses up to 150 mg per kg per day, which produced systemic exposure (AUC) approximately 23 times higher than exposures at the recommended daily human dose. official website and that any information you provide is encrypted This 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 a non-Zidovudine-containing regimen. Discontinuation of Zidovudine should be considered as medically appropriate. patients receiving ribavirin and zidovudine. There have been few reports of developmental delay, seizures, and other neurological disease. Before The doses in mice were reduced to 20, 30, and 40 mg per kg per day after Day 90 because of treatment-related anemia, whereas in rats only the high dose was reduced to 450 mg per kg per day on Day 91 and then to 300 mg per kg per day on Day 279. Infectious Diseases in Obstetrics and Gynecology, 10.1002/(SICI)1098-0997(1998)6:5<197::AID-IDOG2>3.0.CO;2-1. FOIA Nucleoside reverse transcriptase inhibitors (NRTIs), Drug class: nucleoside reverse transcriptase inhibitors (NRTIs), Reduction of Perinatal Transmission of HIV, 1.5 mg/kg infused over 30 minutes, every 6 hours. Matheson PB, Abrams EJ, Thomas PA, Hernn MA, Thea DM, Lambert G, Krasinski K, Bamji M, Rogers MF, Heagarty M. Efficacy of antenatal zidovudine in reducing perinatal transmission of human immunodeficiency virus type 1. Krauer B, Krauer F, Hytten FE. Inform patients that potentially life-threatening hypersensitivity reactions (e.g., anaphylaxis, Stevens-Johnson syndrome) can occur while receiving Zidovudine. Provided in collaboration with NIHs Office of AIDS Research. Prolonged use of Zidovudine has been associated with symptomatic myopathy [see Warnings and Precautions (5.3)]. Keep zidovudine in the container that it came in and keep the container tightly closed. Use an appropriate-sized syringe with 0.1 mL graduation to ensure accurate dosing of the oral solution formulation in neonates. Hematologic toxicity, including neutropenia and anemia, Lactic acidosis and severe hepatomegaly with steatosis, Hepatic decompensation in patients co-infected with HIV-1 and hepatitis C. in vitro . The rate of miscarriage is not reported in the APR. Zidovudine should be used with caution in patients who have bone marrow compromise evidenced by granulocyte count less than 1,000 cells per mm3 or hemoglobin less than 9.5 g per dL. However, no embryotoxicity was observed at doses that produced systemic exposure (AUC) approximately 23 times higher than exposures at the recommended clinical dose (see Data). Store zidovudine tablets at room temperature, 68F to 77F (20C to 25C). Sperling RS, Shapiro DE, McSherry GD, Britto P, Cunningham BE, Culnane M, Coombs RW, Scott G, Van Dyke RB, Shearer WT, et al. In addition to its utility as a component of a multidrug combination regimen for the treatment of adult and pediatric HIV-1 infection, it is the only agent approved by the FDA for the prevention of mother-to-child HIV-1 transmission. To treat HIV infection in adults,children, and infants. Where can I find more information about zidovudine? The effectiveness of ZDV for the prevention of mother-to-child HIV-1 transmission has been demonstrated in several studies. In patients maintained on hemodialysis or peritoneal dialysis or with creatinine clearance (CrCl) by Cockcroft-Gault less than 15 mL per min, the recommended oral dosage is 100 mg every 6 to 8 hours [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)]. See Table 2 for dosing recommendations. The .gov means its official. Effect of Food on Absorption 100 mg MS: back pain, myopathy. Metabolism and Elimination Carcinogenesis This Patient Version drug summary is based on the following FDA label(s): The American Hospital Formulary Service (AHFS) Patient Medication Information for, Zidovudine-related research studies,from. Take zidovudine tablets, capsules, or oral solution by mouth with or without food. In some cases the dose calculated by mg per kg will not be the same as that calculated by BSA. GZDV AUC is about 3-fold greater than the Zidovudine AUC. sharing sensitive information, make sure youre on a federal In addition to the adverse reactions listed in Table 3, adverse reactions observed at an incidence of greater than or equal to 5% in any treatment arm in clinical trials (NUCA3001, NUCA3002, NUCB3001, and NUCB3002) were abdominal cramps, abdominal pain, arthralgia, chills, dyspepsia, fatigue, insomnia, musculoskeletal pain, myalgia, and neuropathy. Proportional increases in plasma Zidovudine concentrations were observed following administration of oral solution from 90 to 240 mg per m2 every 6 hours. Data sources include IBM Watson Micromedex (updated 5 June 2023), Cerner Multum (updated 5 June 2023), ASHP (updated 10 Apr 2023) and others. Manufactured by: Concomitant use of Zidovudine with stavudine should be avoided since an antagonistic relationship has been demonstrated in vitro. Patients Aged 3 Months to 12 Years: Overall, Zidovudine pharmacokinetics in pediatric patients older than 3 months are similar to those in adult patients. Advise patients that loss of subcutaneous fat may occur in patients receiving Zidovudine and that they will be regularly assessed during therapy [see Warnings and Precautions (5.7)]. The MACDP evaluates women and infants from a limited geographic area and does not include outcomes for births that occurred at less than 20 weeks' gestation. For more information on the use of zidovudine in children and infants with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection. FDA Label: Capsule, oral solution, injection (solution), capsule, oral solution, injection [solution], zidovudine capsules, oral solution, and injectable solution, immune reconstitution inflammatory syndrome, Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV, Swelling of yourface,lips, mouth, tongue, or throat, Yellowing of your skin or the whites of your eyes (, Loss of appetite for several days or longer, Pain, aching, or tenderness onthe right sideof your stomach/abdominal area. There have been few reports of developmental delay, seizures, and other neurological disease. Changes in skin and nail pigmentation, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis, sweating, urticaria. Instruct women with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in the breast milk [see Use in Specific Populations (8.2)]. If youhave ever had any blood disorders, such as. Start neonatal dosing within 12 hours after birth and continue through 6 weeks of age. The estimated background rate of miscarriage in clinically recognized pregnancies in the U.S. general population is 15% to 20%. Document the number, duration, and severity of seizures, and report these findings immediately to the physician. You can report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online. Pediatrics A transplacental carcinogenicity bioassay in CD-1 mice with zidovudine. Pharmacokinetics of Zidovudine were dose independent at oral dosing regimens ranging from 2 mg per kg every 8 hours to 10 mg per kg every 4 hours. The apparent volume of distribution of Zidovudine is 1.6 0.6 L per kg (Table 7) and binding to plasma protein is low (less than 38%). Impairment of Fertility Before using zidovudine, tell your health care provider: Zidovudine comes in the following forms and strengths: Use zidovudine according to your health care providers instructions. The APR uses the MACDP as the U.S. reference population for birth defects in the general population. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur. 600 mg/day. Drug Interactions Guidance for the design of bioequivalence studies. There are insufficient data to recommend dose adjustment of Zidovudine capsules in patients with impaired hepatic function or liver cirrhosis. When zidovudine is used to treat HIV infection, the medicine is always used in combination with other HIV medicines. If you have taken or used too much zidovudine, contact your health care provider or local poison control center (1-800-222-1222) right away, or go to the nearest hospital emergency room. There have been reports of mild, transient elevations in serum lactate levels, which may be due to mitochondrial dysfunction, in neonates and infants exposed in utero or peri-partum to Zidovudine-containing products. Neuro: tremor. WARNING: RISK OF HEMATOLOGICAL TOXICITY, MYOPATHY, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, Zidovudine capsules have been associated with hematologic toxicity including neutropenia and severe anemia, particularly in patients with advanced HIV-1 disease, Zidovudine has been associated with symptomatic myopathy, Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including Zidovudine and other antiretrovirals. These oral embryo-fetal development studies in the rat and rabbit revealed no evidence of fetal malformations with Zidovudine. At doses that produced tumors in mice and rats, the estimated drug exposure (as measured by AUC) was approximately 3 times (mouse) and 24 times (rat) the estimated human exposure at the recommended therapeutic dose of 100 mg every 4 hours. A survival benefit for monotherapy with Zidovudine was not demonstrated in the latter 2 trials. If overdose occurs, the patient should be monitored for evidence of toxicity and given standard supportive treatment as required. Sperling RS, Shapiro DE, Coombs RW, Todd JA, Herman SA, McSherry GD, O'Sullivan MJ, Van Dyke RB, Jimenez E, Rouzioux C, et al. The recommended oral dose of Zidovudine capsules is 300 mg twice daily in combination with other antiretroviral agents. Significant anemia (hemoglobin less than 7.5 g per dL or reduction greater than 25% of baseline) and/or significant neutropenia (granulocyte count less than 750 cells per mm3 or reduction greater than 50% from baseline) may require a dose interruption until evidence of marrow recovery is observed [see Warnings and Precautions (5.1)]. In a randomized, double-blind, placebo-controlled trial in HIV-1-infected women and their neonates conducted to determine the utility of Zidovudine for the prevention of maternal-fetal HIV-1 transmission, Zidovudine oral solution at 2 mg per kg was administered every 6 hours for 6 weeks to neonates beginning within 12 hours following birth. Eastman PS, Shapiro DE, Coombs RW, Frenkel LM, McSherry GD, Britto P, Herman SA, Sperling RS. These events were transient and asymptomatic in most cases. A majority of these cases have been in women. CNS: SEIZURES, headache, weakness, anxiety, confusion, mental acuity, dizziness, insomnia, mental depression, restlessness, syncope. A dosage adjustment is recommended for patients undergoing hemodialysis or peritoneal dialysis [see Dosage and Administration (2.5)]. Liebes L, Mendoza S, Wilson D, Dancis J. To learn more about possible side effects of zidovudine, read the drug labels or package inserts for zidovudine tablets and zidovudine capsules, oral solution, and injectable solution or talk to your health care provider or pharmacist. Slowed progression and sequelae of HIV infection. Two transplacental carcinogenicity studies were conducted in mice. Zidovudine ( ZDV ), also known as azidothymidine ( AZT ), is an antiretroviral medication used to prevent and treat HIV/AIDS. What are the most important things to know about zidovudine? The optimal time during gestation to initiate ZDV therapy and the relative importance of the intrapartum and newborn components is the focus of both current interventional and observational studies. However, a causal relationship between these events and exposure to Zidovudine-containing products in utero or peri-partum has not been established (see Data). Zidovudine tablets are indicated for the prevention of maternal-fetal HIV-1 transmission [see Dosage and Administration ( 2.3)]. GI: abdominal pain, diarrhea, nausea, anorexia, drug-induced hepatitis, dyspepsia, oral mucosa pigmentation, vomiting. Implications for HIV screening. 10 x 10 Unit-dose Capsules NDC 65862-107-10 The observed abnormalities included problems in embryogenesis (prior to 14 weeks) or were recognized on ultrasound before or immediately after initiation of study drug. Please refer to the FDA drug labels (capsule, oral solution, injection [solution]; tablet) for additional information regarding the use of zidovudine in people with HIV. For people with HIV in the United States, the, 200-mg/20-mL single-use vials of injectable solution. Apparent Zidovudine oral clearance was approximately 50% of that reported in subjects with normal renal function. Antiretroviral therapy for HIV infection in 1998: updated recommendations of the International AIDS Society-USA Panel. For more information on the use of zidovudine to prevent mother-to-child transmission of HIV, please refer to the Recommendations for the Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States. Zidovudine in combination with other antiretroviral agents has been shown to be superior to monotherapy for one or more of the following endpoints: delaying death, delaying development of AIDS, increasing CD4+ cell counts, and decreasing plasma HIV-1 RNA. Please consult the latest official manual style if you have any questions regarding the format accuracy. An official website of the United States government. Risk adapted transmission prophylaxis to prevent vertical HIV-1 transmission: Effectiveness and safety of an abbreviated regimen of postnatal oral Zidovudine.pdf Available via license: CC BY 2.0 . Zidovudine can cause serious, life-threatening side effects. Each dose of Zidovudine Tablets USP 300 mg should be taken approximately 12 hours apart. This trial was a multi-center, randomized, double-blind, placebo-controlled trial that compared Zidovudine 600 mg per day plus EPIVIR 300 mg per day with Zidovudine plus EPIVIR plus indinavir 800 mg three times daily. Zidovudine has also been studied in neonates perinatally exposed to HIV-1 [see Dosage and Administration (2.2), Adverse Reactions (6.1), Clinical Pharmacology (12.3), Clinical Studies (14.2, 14.3)]. Zidovudine can cause blood disorders such as very low number of red blood cells (severe anemia) or lower than normal number of white blood cells (neutropenia). Assess dizziness or syncope that might affect gait, balance, and other functional activities (See Appendix C). Antagonistic relationship has been demonstrated in vitro recognized pregnancies in the APR the physician with antiretroviral. The prevention of mother-to-child HIV-1 transmission has been demonstrated in vitro AIDS Society-USA Panel, anaphylaxis Stevens-Johnson! 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