Zidovudine
Generic Name: zidovudine
Brand Names:
Zidovudine
11 DESCRIPTION Zidovudine (formerly called azidothymidine [AZT]), a pyrimidine nucleoside analogue active against HIV-1. The chemical name of zidovudine is 3'- azido-3'-deoxythymidine; it has the following structural formula: Zidovudine USP is a white to beige, odorless, crystalline solid with a molecular weight of 267.24 and a solubility of 20.1 mg per mL in water at 25°C. The molecular formula is C 10 H 13 N 5 O 4 . Zidovudine tablets, USP are for oral administration.
Overview
11 DESCRIPTION Zidovudine (formerly called azidothymidine [AZT]), a pyrimidine nucleoside analogue active against HIV-1. The chemical name of zidovudine is 3'- azido-3'-deoxythymidine; it has the following structural formula: Zidovudine USP is a white to beige, odorless, crystalline solid with a molecular weight of 267.24 and a solubility of 20.1 mg per mL in water at 25°C. The molecular formula is C 10 H 13 N 5 O 4 . Zidovudine tablets, USP are for oral administration.
Uses
1 INDICATIONS & USAGE Zidovudine tablets are a nucleoside analogue reverse transcriptase inhibitor indicated for: •Treatment of Human Immunodeficiency Virus (HIV-1) infection in combination with other antiretroviral agents. ( 1.1 ) • Prevention of maternal-fetal HIV-1 transmission. ( 1.2 ) 1.1 Treatment of HIV-1 Zidovudine tablets, a nucleoside reverse transcriptase inhibitor, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. 1.2 Prevention of Maternal-Fetal HIV-1 Transmission Zidovudine tablets are indicated for the prevention of maternal-fetal HIV-1 transmission [see Dosage and Administration ( 2.3 )]. The indication is based on a dosing regimen that included 3 components: 1. antepartum therapy of HIV-1-infected mothers 2.
Dosage
2 DOSAGE & ADMINISTRATION • Treatment of HIV-1 infection: Adults: Recommended oral dosage is 300 mg twice a day with other antiretroviral agents. ( 2.1 ) Pediatric patients (aged 4 weeks to less than 18 years): Dosage should be calculated based on body weight not to exceed adult dose. ( 2.2 ) • Prevention of maternal-fetal HIV-1 transmission: Specific dosage instructions for mother and infant. ( 2.3 ) • Patients with severe anemia and/or neutropenia: Dosage interruption may be necessary. ( 2.4 ) • Renal impairment: Recommended oral dosage in hemodialysis or peritoneal dialysis or in patients with creatinine clearance (CrCl) less than mL per minute is 100 mg every 6 to 8 hours.
Side Effects
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • Hematologic toxicity, including neutropenia and anemia [see Boxed Warning, Warnings and Precautions ( 5.1 )]. • Symptomatic myopathy [see Boxed Warning, Warnings and Precautions ( 5.3 )]. • Lactic acidosis and severe hepatomegaly with steatosis [see Boxed Warning, Warnings and Precautions ( 5.4 )]. • Hepatic decompensation in patients co-infected with HIV-1 and hepatitis C [see Warnings and Precautions ( 5.5 )]. The following adverse reactions are discussed in greater detail in other sections of the labeling: • Hematologic toxicity, including neutropenia and anemia [see Boxed Warning, Warnings and Precautions ( 5.1 )].
Interactions
7 DRUG INTERACTIONS • Avoid use with stavudine. ( 7.1 ) • Avoid use with doxorubicin. ( 7.2 ) • Bone marrow suppressive/cytotoxic agents: May increase the hematologic toxicity of zidovudine. ( 7.3 ) 7.1 Antiretroviral Agents Stavudine Concomitant use of zidovudine with stavudine should be avoided since an antagonistic relationship has been demonstrated in vitro. Nucleoside Analogues Affecting DNA Replication Some nucleoside analogues affecting DNA replication, such as ribavirin, antagonize the in vitro antiviral activity of zidovudine against HIV-1; concomitant use of such drugs should be avoided. 7.2 Doxorubicin Concomitant use of zidovudine with doxorubicin should be avoided since an antagonistic relationship has been demonstrated in vitro.
Warnings
BOXED WARNING WARNING: RISK OF HEMATOLOGICAL TOXICITY, MYOPATHY, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS Zidovudine tablets have been associated with hematologic toxicity including neutropenia and severe anemia, particularly in patients with advanced HIV-1 disease [see Warnings and Precautions ( 5.1 )]. Prolonged use of zidovudine has been associated with symptomatic myopathy [see Warnings and Precautions ( 5.3 )]. 5 WARNINGS AND PRECAUTIONS • See boxed warning for information about the following: hematologic toxicity, myopathy, and lactic acidosis and severe hepatomegaly ( 5.1 , 5.3 , 5.4 ) • Exacerbation of anemia has been reported in HIV-1/HCV co-infected patients receiving ribavirin and zidovudine. Coadministration of ribavirin and zidovudine is not advised. ( 5.5 ) • Hepatic decompensation, (some fatal), has occurred in HIV-1/HCV co-infected patients receiving combination antiretroviral therapy and interferon alfa with/without ribavirin. Discontinue zidovudine as medically appropriate and consider dose reduction or discontinuation of interferon alfa, ribavirin, or both. 4 CONTRAINDICATIONS Zidovudine tablets are contraindicated in patients who have had a potentially life-threatening hypersensitivity reaction (e.g., anaphylaxis, Stevens-Johnson syndrome) to any of the components of the formulations. Hypersensitivity to zidovudine or any of the components (e.g., anaphylaxis, Stevens-Johnson syndrome). ( 4 )
Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to zidovudine during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Available data from the APR show no difference in the overall risk of birth defects for zidovudine compared with the background rate for birth defects of 2.7% in the Metropolitan Atlanta Congenital Defects Program (MACDP) reference population (see Data). The APR uses the MACDP as the U.S.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Zidovudine Tablets USP, 300 mg are white to off white colored, biconvex, round film coated tablets debossed with 'H' on one side and '1' on other side. Bottle of 60 (NDC 31722-509-60). Store at 20° to 25° C (68° to 77°F) [see USP Controlled Room Temperature].
Frequently Asked Questions
What is Zidovudine used for?▼
1 INDICATIONS & USAGE Zidovudine tablets are a nucleoside analogue reverse transcriptase inhibitor indicated for: •Treatment of Human Immunodeficiency Virus (HIV-1) infection in combination with other antiretroviral agents. ( 1.1 ) • Prevention of maternal-fetal HIV-1 transmission. ( 1.2 ) 1.1 Treatment of HIV-1 Zidovudine tablets, a nucleoside reverse transcriptase inhibitor, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. 1.2 Prevention of Maternal-Fetal HIV-1 Transmission Zidovudine tablets are indicated for the prevention of maternal-fetal HIV-1 transmission [see Dosage and Administration ( 2.3 )]. The indication is based on a dosing regimen that included 3 components: 1. antepartum therapy of HIV-1-infected mothers 2.
What are the side effects of Zidovudine?▼
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • Hematologic toxicity, including neutropenia and anemia [see Boxed Warning, Warnings and Precautions ( 5.1 )]. • Symptomatic myopathy [see Boxed Warning, Warnings and Precautions ( 5.3 )]. • Lactic acidosis and severe hepatomegaly with steatosis [see Boxed Warning, Warnings and Precautions ( 5.4 )]. • Hepatic decompensation in patients co-infected with HIV-1 and hepatitis C [see Warnings and Precautions ( 5.5 )]. The following adverse reactions are discussed in greater detail in other sections of the labeling: • Hematologic toxicity, including neutropenia and anemia [see Boxed Warning, Warnings and Precautions ( 5.1 )].
Can I take Zidovudine during pregnancy?▼
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to zidovudine during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Available data from the APR show no difference in the overall risk of birth defects for zidovudine compared with the background rate for birth defects of 2.7% in the Metropolitan Atlanta Congenital Defects Program (MACDP) reference population (see Data). The APR uses the MACDP as the U.S.
What are the important warnings for Zidovudine?▼
BOXED WARNING WARNING: RISK OF HEMATOLOGICAL TOXICITY, MYOPATHY, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS Zidovudine tablets have been associated with hematologic toxicity including neutropenia and severe anemia, particularly in patients with advanced HIV-1 disease [see Warnings and Precautions ( 5.1 )]. Prolonged use of zidovudine has been associated with symptomatic myopathy [see Warnings and Precautions ( 5.3 )]. 5 WARNINGS AND PRECAUTIONS • See boxed warning for information about the following: hematologic toxicity, myopathy, and lactic acidosis and severe hepatomegaly ( 5.1 , 5.3 , 5.4 ) • Exacerbation of anemia has been reported in HIV-1/HCV co-infected patients receiving ribavirin and zidovudine. Coadministration of ribavirin and zidovudine is not advised. ( 5.5 ) • Hepatic decompensation, (some fatal), has occurred in HIV-1/HCV co-infected patients receiving combination antiretroviral therapy and interferon alfa with/without ribavirin. Discontinue zidovudine as medically appropriate and consider dose reduction or discontinuation of interferon alfa, ribavirin, or both. 4 CONTRAINDICATIONS Zidovudine tablets are contraindicated in patients who have had a potentially life-threatening hypersensitivity reaction (e.g., anaphylaxis, Stevens-Johnson syndrome) to any of the components of the formulations. Hypersensitivity to zidovudine or any of the components (e.g., anaphylaxis, Stevens-Johnson syndrome). ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.