Zidovudine Tablet 300 mg

Description

Antiretroviral Agent: Zidovudine, also known as azidothymidine (AZT), is a nucleoside reverse transcriptase inhibitor (NRTI) used in the treatment of HIV-1 infection.
First FDA-Approved HIV Drug: It was the first medication approved by the FDA for the treatment of HIV, a significant milestone in the management of the virus.
Adult Dosage: The 300 mg tablet is a standard oral dosage form for adults, typically administered twice daily as part of a combination antiretroviral therapy (ART) regimen.
Combination Therapy: Zidovudine is not used as a monotherapy. It is always prescribed in combination with at least two other antiretroviral agents to provide a complete and effective treatment plan and prevent the development of viral resistance.

Effective HIV Management: When used in combination, zidovudine effectively suppresses the replication of HIV, leading to a reduction in viral load and an increase in CD4+ T-cell counts.
Prevention of Mother-to-Child Transmission: It is a key medication used to prevent the transmission of HIV from a mother to her baby during pregnancy and childbirth.
Broad Antiviral Activity: Zidovudine is active against both HIV-1 and HIV-2, making it a versatile component in various treatment regimens.
Well-Studied Profile: Having been in use for several decades, its safety and efficacy profile is extensively documented, providing a wealth of clinical experience.

HIV-1 Infection: Indicated for the treatment of HIV-1 infection in adults and children, in combination with other antiretroviral agents.
Perinatal Transmission Prophylaxis: Used in HIV-positive pregnant women and in newborns to prevent the transmission of the virus from mother to child.
Post-Exposure Prophylaxis (PEP): It is a component of PEP regimens to prevent HIV infection after a potential exposure, such as an occupational injury.
Adult T-cell Leukemia-Lymphoma (ATL): Zidovudine is also used off-label in combination with interferon-alpha for the treatment of ATL, which is caused by the HTLV-1 retrovirus.

Nucleoside Reverse Transcriptase Inhibitor (NRTI): Zidovudine is a synthetic thymidine analog that belongs to the NRTI class of antiretroviral drugs.
Mechanism of Action: After being converted to its active triphosphate form inside the cell, it competitively inhibits the viral enzyme reverse transcriptase. This enzyme is essential for converting HIV’s RNA genome into DNA.
DNA Chain Termination: By being incorporated into the viral DNA chain, it acts as a chain terminator, effectively stopping the DNA from being built and preventing the virus from replicating.
Metabolism & Side Effects: Zidovudine is primarily metabolized in the liver and eliminated by the kidneys. It is known to cause bone marrow suppression, which can lead to anemia and neutropenia.

Temperature: Zidovudine tablets should be stored at a controlled room temperature, typically between 20∘C to 25∘C (68∘F to 77∘F).
Protection: Keep the tablets in their original, tightly closed container, protected from light and moisture.
Patient Compliance: Patients must be educated on the importance of taking every dose as prescribed to maintain a consistent therapeutic drug level and prevent the development of viral resistance.
Child Safety: Store the medication in a secure location, out of the reach of children and pets.

Pediatric Formulation: The oral liquid formulation of Zidovudine 50 mg/5 mL is specifically designed for pediatric patients and for adults who have difficulty swallowing tablets. The “(P)” indicates its primary use in this population.
Concentration: The solution provides a concentration of 50 mg of zidovudine per 5 mL, which is equivalent to 10 mg/mL, allowing for accurate and flexible dose calculation.
Flavored Solution: The oral solution is typically a pale yellow, flavored liquid, which helps improve palatability and adherence in children.
Prodrug: Similar to the tablet, this formulation contains the prodrug zidovudine, which is converted to its active form in the body.

Accurate Pediatric Dosing: The liquid formulation allows for precise dose calculation based on a child’s body weight, which is critical for achieving therapeutic drug levels without causing toxicity.
Simplified Administration: The oral liquid is easier for infants and young children to take compared to tablets, which improves compliance and reduces the risk of medication errors.
Prevention of Perinatal Transmission: It is the standard formulation for the prophylactic treatment of newborn infants exposed to HIV to prevent mother-to-child transmission.
Versatility: It can be used for various pediatric age groups, from newborns to children, until they are able to swallow tablets.

Pediatric HIV Treatment: Indicated for the treatment of HIV-1 infection in children from birth to 18 years of age, as part of a combination regimen.
Neonatal Prophylaxis: Used to prevent HIV infection in newborns who were exposed to the virus in utero, with dosing starting within 12 hours of birth and continuing for up to 6 weeks.
Patients with Dysphagia: The liquid formulation is also a viable option for adult patients who have difficulty swallowing pills.
Post-Exposure Prophylaxis (PEP): It is a key component of PEP regimens for children who have had a potential HIV exposure.

Nucleoside Reverse Transcriptase Inhibitor (NRTI): It belongs to the same NRTI class as the tablet formulation, acting as a synthetic thymidine analog.
Mechanism of Action: The mechanism remains identical to the tablet form: it is phosphorylated to its active triphosphate form, which then inhibits the viral enzyme reverse transcriptase by terminating the viral DNA chain.
Absorption and Metabolism: Zidovudine is rapidly absorbed from the gastrointestinal tract. A significant portion of the drug is metabolized in the liver, and the metabolites are eliminated by the kidneys.
Toxicity Profile: It carries the same risk of side effects as the tablet, most notably bone marrow suppression, which requires careful hematological monitoring in all patients, especially in newborns.

Temperature: Store the oral liquid at a controlled room temperature, typically between 20∘C to 25∘C (68∘F to 77∘F), unless otherwise specified by the manufacturer.
Protection: Keep the bottle tightly capped and protected from light and moisture.
Dosing Accuracy: Always use a calibrated oral syringe or measuring device provided with the medication to ensure accurate dosing. Do not use household spoons.
Administration: The medication can be taken with or without food. However, it is essential to follow the prescribed schedule to maintain consistent drug levels.