Lamivudine Zidovudine
Product Images NDC 61919-061

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Lamivudine Zidovudine (NDC 61919-061). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Direct Rx, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Image Description (Label)

Packaging label for Lamivudine Zidovudine 150/300 mg, featuring 2 tablets. The product is generic for COMBIVIR and each film-coated tablet contains 150 mg lamivudine USP and 300 mg zidovudine USP. Packaged and distributed by Direct Rx, Alpharetta, GA. The label includes dosing warnings, storage instructions, and lot and expiration date information.*

FDA Label Image

Image Description (Molecule)

Chemical structures of the active ingredients lamivudine and zidovudine are shown. Lamivudine's structure includes a nitrogenous base and a sugar component. Zidovudine's structure includes an azido group on a deoxythymidine base. Both have associated solubility and physical description details in water at specified temperatures.*

FDA Label Image

Image Description (Table1 1)

A data table presenting percentages of various signs and symptoms, including nasal signs and symptoms at 20%, cough at 18%, skin rashes at 9%, musculoskeletal pain at 12%, myalgia at 8%, and arthralgia at 5%. The symptoms are categorized under headings like Skin and Musculoskeletal.*

FDA Label Image

Image Description (Table1)

Table presenting selected clinical adverse reactions with at least 5% frequency in four controlled clinical trials of EPIVIR 300 mg/day plus RETROVIR 600 mg/day for a sample size of 251. Adverse reactions are categorized by body system including body as a whole, digestive, nervous system, and respiratory, listing specific symptoms and their respective percentages.*

FDA Label Image

Image Description (Table2)

A data table titled 'Frequencies of Selected Laboratory Abnormalities Among Adults in 4 Controlled Clinical Trials of EPIVIR 300 mg/day plus RETROVIR 600 mg/day'. It lists abnormal laboratory test levels (Neutropenia, Anemia, Thrombocytopenia, ALT, AST, Bilirubin, Amylase) alongside the percentage and number of patients experiencing these abnormalities in the EPIVIR plus RETROVIR group. Additional notes define terms such as ULN (Upper Limit of Normal) and ANC (Absolute Neutrophil Count).*

FDA Label Image

Image Description (Table3)

A table presenting pharmacokinetic parameters for Lamivudine and Zidovudine in adults. Parameters include oral bioavailability, volume of distribution, plasma protein binding, CSF:plasma ratio, systemic and renal clearance, and elimination half-life, with data values, sample sizes, and notes on statistical presentation.*

FDA Label Image

Image Description (Table4 1)

A data table listing various drugs including Methadone, Nelfinavir, Probenecid, Rifampin, Ritonavir, and Valproic acid. It details their dosages, frequency, treatment duration, and observed effects on the area under the concentration versus time curve (AUC), indicating increases, decreases, or no significant changes along with confidence intervals and notes about assessment status.*

FDA Label Image

Image Description (Table4)

Table showing the effect of coadministered drugs on Lamivudine and Zidovudine AUC (Area Under the Curve). It lists drugs that may alter Lamivudine and Zidovudine blood concentrations, specifying coadministered drug doses, Lamivudine or Zidovudine doses, number of subjects (n), changes in drug concentrations (AUC and variability), and concentrations of coadministered drugs where applicable.*

FDA Label Image

Image Description (Table5)

A data table titled 'Table 5. Number of Patients (%) With At Least 1 HIV-1 Disease-Progression Event or Death' showing patient counts and percentages for three treatment groups: Current Therapy (n=460), EPIVIR plus Current Therapy (n=896), and EPIVIR plus a NNRTI plus Current Therapy (n=460). The endpoints are 'HIV-1 progression or death' and 'Death' with corresponding patient numbers and percentages detailed for each group.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.