The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy 1. Abacavir, lamivudine and zidovudine tablets, for oral use. If a child is unable to reliably swallow a retrovir capsule, the retrovir syrup formulation should be prescribed. Highlights of prescribing information these highlights do not include all the information needed to use humatep safely and effectively. Effect of coadministered drugs on lamivudine and zidovudine auc. Retrovir zidovudine gskpro for healthcare professionals. The national hiv curriculum is an aids education and training center aetc program supported by the health resources and services administration hrsa of the u. See full prescribing information for abacavir, lamivudine and zidovudine tablets. A more current version may be available on the manufacturers web site. Lactic acidosis associated with hepatomegaly and hepatic steatosis has been reported with zidovudine. Our retrovir zidovudine side effects drug center provides a comprehensive view of available drug information on the potential side effects when taking this medication. However, zidovudine levels remained within the therapeutic range during coadministration of rifabutin. See full prescribing information for complete boxed. Lamivudine and zidovudine act as nucleoside analogs, which are substrates for the human nucleoside kinases.
Highlights of prescribing information these highlights do not include all the information needed to use procrit safely and effectively. Zidovudine is a white to beige, odorless, crystalline solid with a molecular weight of. Full prescribing information 1 indications and usage fuzeonin combination with other antiretroviral agents is indicated for the treatment of hiv1 infection in treatmentexperienced patientswith evidence of hiv1 replication despite ongoing antiretroviral therapy. For information about retrovir iv infusion, consult the retrovir iv infusion full prescribing information. Highlights of prescribing information these highlights do not include all the information needed to use complera safely and effectively. It may be used to prevent mothertochild spread during birth or after a needlestick injury or other potential exposure. A safe and effective dose of kaletra oral solution in this. If a child is unable to reliably swallow a zidovudine tablet, the zidovudine syrup formulation should be prescribed. Zidovudine is indicated for the prevention of mothertochild transmission of hiv1 infection as part of a regimen that includes oral zidovudine beginning between 14 and 34 weeks gestation, continuous intravenous infusion of zidovudine during labor, and administration of zidovudine syrup to the neonate for the first 6 weeks of life. Consideration should be given to official treatment guidelines for hiv1 infection e. See full prescribing information for complete boxed warning.
Because of the potential for 1 hiv1 transmission in hivnegative infants, 2 developing viral resistance in hivpositive infants, and 3 adverse reactions in a breastfed infant instruct mothers not to breastfeed. Zidovudine usp is a white to beige, odorless, crystalline solid with a molecular weight of 267. The related drug information index provides comprehensive access to all drug information related to a specific drug types of content include full prescribing information, drug summaries, full prescribing information continuing medication education full pi cme, medication guides, risk evaluation and mitigation strategies rems summaries, rems continuing medication education rems cme, and. Risk of hematological toxicity, myopathy, lactic acidosis and severe hepatomegaly with steatosis retrovir zidovudine capsules, oral solution, and injection have been associated with. Risk of serious infections see full prescribing information for complete boxed warning. See full prescribing information for lamivudine and zidovudine tablets. See actual entry in rtecs for complete information. It is generally recommended for use with other antiretrovirals. Retrovir zidovudine tablets, capsules, and syrup label.
Several fdaapproved drug labels may be available for zidovudine. Patients with severe anemia andor neutropenia significant anemia hemoglobin 25% of baseline andor significant neutropenia granulocyte count 50% from baseline may require a dose. Do not use if printed safety seal under cap is broken or missing. Highlights of prescribing information these highlights do not include all the information needed to use retacritsafely and effectively. Zidovudine syrup fda prescribing information, side effects. Highlights of prescribing information these highlights do not include all the information needed to use zerit safely and effectively. The initial phosphorylation step is crucial for the drug. These highlights do not include all the information needed to use lamivudine and zidovudine tablets safely and effectively. This is not a complete list of side effects and others may occur. Highlights of prescribing information adult patients should. See prescribing information for dosage information.
These highlights do not include all the information needed to use viramune safely and effectively. Retrovir zidovudine injection, for intravenous use. Zidovudine frequently causes gastrointestinal side effects, mitochondrial toxicity leading to lipodystrophy and lactic acidosis, and bone marrow suppression leading to anemia and neutropenia. Zidovudinelamivudine combivir treatment national hiv. Zidovudine is now rarely used in clinical practice. Retrovir prescribing information from the fda web site. It has a molecular formula of c10hn5o4 and a molecular weight of 267.
Antiretroviral therapy for hiv infection in infants and children. Zidovudine zdv, also known as azidothymidine azt, is an antiretroviral medication used to prevent and treat hivaids. Zidovudine did not affect the pharmacokinetics of rifabutin. Zidovudine lamivudine is a nucleoside reverse transcriptase inhibitor nrti combination tablet that was used as the backbone component of combination antiretroviral therapy for years, but now is rarely used due to shortterm and longterm toxicity from the zidovudine component. Hematologic toxicity, including neutropenia and anemia, has been associated with the use of zidovudine, a component of combivir. Jan 14, 2019 there is no information on the effects of zidovudine on the breastfed infant or the effects of the drug on milk production. In the early years of antiretroviral therapy, before threedrug antiretroviral therapy became the standard of care, zidovudinelamivudine was studied as dual therapy for treatment of hiv infection, and this strategy demonstrated immunologic benefit as compared to zidovudine or stavudine monotherapy, even in individuals with lamivudine resistance nuca 3001, actg 306, and actg 298. Highlights of prescribing information these highlights do not include all the information needed to use depakene safely and effectively. Prescribing information lamivudine 150 mgzidovudine 300.
For dose recommendations for neonates see dosage and administration 2. Retacrit epoetin alfaepbx highlights pfizer medical. Actemra subcutaneous formulation is not intended for. Zidovudine retrovir treatment national hiv curriculum.
Zidovudine was the first agent approved for treatment of hiv disease, and since its widespread availability in 1987, the pharmacokinetic disposition and clinical effects of zdv have been extensively evaluated. As pregnancy progressed, there was no evidence of drug accumulation. Zidovudine was the first antiretroviral medication shown to reduce mothertochild transmission of hiv. See full prescribing information for retrovir zidovudine tablets, capsules, and syrup initial u. Zidovudine zdv and lamivudine 3tc have long and distinguished histories among the 24 drugs now available to treat hivinfection. Lamivudine, zidovudine and nevirapine tablets 150300200mg. Due to the active ingredient zidovudine, retrovir azt is contraindicated in. A safe and effective dose of kaletra oral solution in. Highlights of prescribing information adult patients.
Zidovudine pharmacokinetics has been studied in a phase 1 study of 8 women during the last trimester of pregnancy. Zerit stavudine capsules, for oral use zerit stavudine for oral solution initial u. Lamivudine and zidovudine both competitively inhibit and reduce the activity of reverse transcriptase rt causing hiv infected cells to decrease the number of viruses in the body. Actemra subcutaneous formulation is not intended for intravenous. Only select registry of toxic effects of chemical substances rtecs data is presented here. The antiviral activity of zidovudine against hiv1 was assessed in a number of cell lines including monocytes and fresh human peripheral blood lymphocytes. A crixivan dose of 800mg every 8hours with zidovudine 200mg every 8hours and lamivudine 150mg twice a day has been studied in 16 hivinfected pregnant patients at 14 to 28 weeks of gestation at enrollment study pactg 358. Highlights of prescribing information adults pediatric.
Before prescribing retrovir capsules, children should be assessed for the ability to swallow capsules. Kaletra oral solution should not be used in preterm neonates in the immediate postnatal period because of possible toxicities. Lifethreatening including fatal hepatotoxicity and skin reactions 1 indications and usage 2 dosage and administration 2. Zidovudine syrup zidovudine oral solution, usp is for oral administration. These highlights do not include all the information needed to use retrovir safely and effectively. Hematologic toxicity including neutropenia and severe anemia have been associated with the use. Store at 20c to 25c 68 to 77f see usp controlled room temperature cipla limited.
Inclusion or absence of a drug label on the aidsinfo site does not imply endorsement or lack thereof by aidsinfo. Viread tenofovir disoproxil fumarate tablets, for oral use viread tenofovir disoproxil fumarate powder, for oral use initial u. Zidovudine investigated as a drug, mutagen, reproductive effector, and tumorigen. Retrovir zidovudine toxicity, myopathy, and lactic acidosis and sinjection, for intravenous use. Aug 01, 2019 in mothers with hiv receiving lamivudine monotherapy 300 mg twice daily 6 times the recommended daily dosage for hbv or combination therapy 150 mg lamivudine twice daily 3 times the recommended daily dosage for hbv with 300 mg zidovudine twice daily, the median breast milk to plasma lamivudine concentration ratio was 0. Lamivudinenevirapinezidovudine whopar part 4 april 2016. Highlights of prescribing information provide adequate. In these cases, the physician should refer to the individual prescribing information for these medicinal products. Highlights of prescribing information prescribing information. Full prescribing information 1 indications and usage mytesi is indicated for symptomatic relief of noninfectious diarrhea in adult patients with hivaids on antiretroviral therapy. See full prescribing information for lamivudine, zidovudine and nevirapine tablets 150300200mg.
Videx ec didanosine, usp delayedrelease capsules entericcoated beadlets initial u. Physicians should refer to the individual prescribing information for these me dicinal products. Highlights of prescribing information these highlights do not include all the information needed to use lamivudine, zidovudine and nevirapine tablets 150300200mg safely and effectively. Highlights of prescribing information these highlights do not. Zidovudine syrup fda prescribing information, side. Treatment with combivir should be suspended in any patient who. In 16 hivinfected patients on zidovudine 100 or 200 mg q 4h, rifabutin 300 or 450 mgday lowered the cmax and auc of zidovudine by about 48% and 32%, respectively. Coadministration of zerit with zidovudine should be avoided. In 16 hivinfected patients on zidovudine 100 or 200 mg q 4h, rifabutin. Abacavir, lamivudine and zidovudine tablets safely and effectively.
Reduction of allogeneic rbc transfusions in patients undergoing elective, noncardiac, nonvascular surgery 1. Alternatively, dosing for zidovudine oral solution can be based on body surface area bsa for each child. These highlights do not include all the information needed to use actemra safely and effectively. Hematologictoxicity, impairment of fertility, fetal toxicity, mutagenesis and carcinogenesis 8 1 8indications and usage fem 1. Aidsinfo provides the following drug label solely as an example of the labels available for zidovudine. Call your doctor for medical advice about side effects. Side effects of retrovir zidovudine, warnings, uses. In neonates less than or equal to 14 days old, bioavailability was greater, total body clearance was slower, and halflife was longer than in pediatric subjects older than 14 days. Each tablet contains 150 mg of lamivudine and 300 mg of zidovudine. Retrovir iv prescribing information from the fda web site. Highlights of prescribing information these highlights do not include all the information needed to use abacavir, lamivudine and zidovudine tablets safely and effectively.
Highlights of prescribing information these highlights do not include all the information needed to use viread safely and effectively. Actemra tocilizumab injection, for intravenous or subcutaneous use initial u. Highlights of prescribing information procrit epoetin alfa. Zidovudine oral solution fda prescribing information. The effects of concomitant myelosuppressive chemotherapy and upon initiation, there is a minimum of two. There is no information on the effects of zidovudine on the breastfed infant or the effects of the drug on milk production. See boxed warning for information about the following. Lamivudine fda prescribing information, side effects and uses. The recommended oral dose of zidovudine oral solution is 480 mg per m 2 per day in divided doses 240 mg per m 2 twice daily or 160 mg per m 2 three times daily. Highlights of prescribing information these highlights do not include all the information needed to use retrovir safely and effectively. The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
Highlights of prescribing information these highlights do not include all the information needed to use videx ec safely and effectively. However, as dosage adjustments for zidovudine may be necessary, it is recommended that separate preparations of lamivudine and zidovudine be administered to patients with severe hepatic impairment. Limited data in patients with cirrhosis suggest that. Use with caution in patients with hepatomegaly, hepatitis, or other risk factors for liver disease and hepatic steatosis including obesity and alcohol abuse. Retrovir azt is contraindicated for patients who have potentially lifethreatening allergic reactions to any of the components of the formulations see dosage forms, composition and packaging section. Esas increase the risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access and tumor progression or recurrence 1 indications and usage 1.