Zidovudine (1 brand name, 1 dosage form, 1 route)
Available dosage forms: TABLET, FOR SUSPENSION.
Routes of administration: ORAL.
Brand Names
- LAMIVUDINE/NEVIRAPINE/ZIDOVUDINE TABLETS
Boxed Warning
Zidovudine, a component of lamivudine and zidovudine tablets, has been associated with hematologic toxicity including neutropenia and severe anemia, particularly in patients with advanced Human Immunodeficiency Virus (HIV-1) disease [see Warnings and Precautions ( 5.1)]. Prolonged use of zidovudine has been associated with symptomatic myopathy [see Warnings and Precautions ( 5.2)]. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues, including lamivudine and zidovudine (components of lamivudine and zidovudine tablets). Discontinue lamivudine and zidovudine tablets if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur [see Warnings and Precautions ( 5.3)]. Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and HIV-1 and have discontinued lamivudine, which is one component of lamivudine and zidovudine tablets. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue lamivudine and zidovudine tablet and are co-infected with HIV-1 and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted [see Warnings and Precautions ( 5.4)].
Indications and Usage
Lamivudine and zidovudine tablets a combination of 2 nucleoside analogues, are indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.
Contraindications
Lamivudine and zidovudine tablets are contraindicated in patients with a previous hypersensitivity reaction to lamivudine or zidovudine.
Adverse Reactions
The following adverse reactions are discussed 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 ( 5.2)]. • Lactic acidosis and severe hepatomegaly with steatosis [see Boxed Warning, Warnings and Precautions ( 5.3)]. • Exacerbations of hepatitis B [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)]. • Exacerbation of anemia in HIV-1/HCV co-infected patients receiving ribavirin and zidovudine [see Warnings and Precautions ( 5.5)]. • Pancreatitis [see Warnings and Precautions ( 5.6)]. • Immune reconstitution syndrome [see Warnings and Precautions ( 5.7)]. • Lipoatrophy [see Warnings and Precautions ( 5.8)].
Mechanism of Action
Lamivudine and zidovudine tablet is an antiretroviral agent [see Microbiology ( 12.4)].
Overdosage
There is no known specific treatment for overdose with lamivudine and zidovudine tablet. If overdose occurs, the patient should be monitored and standard supportive treatment applied as required. Lamivudine Because a negligible amount of lamivudine was removed via (4-hour) hemodialysis, continuous ambulatory peritoneal dialysis, and automated peritoneal dialysis, it is not known if continuous hemodialysis would provide clinical benefit in a lamivudine overdose event. Zidovudine Acute overdoses of zidovudine have been reported in pediatric patients and adults. These involved exposures up to 50 grams. No specific symptoms or signs have been identified following acute overdosage with zidovudine apart from those listed as adverse events such as fatigue, headache, vomiting, and occasional reports of hematological disturbances. Patients recovered without permanent sequelae. Hemodialysis and peritoneal dialysis appear to have a negligible effect on the removal of zidovudine, while elimination of its primary metabolite, 3’-azido-3’-deoxy-5’-O-β-D-glucopyranuronosylthymidine (GZDV), is enhanced.