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RETROVIR (AZT) is a brand name for Zidovudine, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: , 1.1 Pediatrics 06/2021 1 INDICATIONS, 1.2 Geriatrics 06/2021 3 SERIOUS WARNINGS AND PRECAUTIONS BOX 06/2021 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations 06/2021 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 06/2021 7 WARNINGS AND PRECAUTIONS, General 06/2021 7 WARNINGS AND…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment 06/2021 7 WARNINGS AND PRECAUTIONS, General 06/2021 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic 06/2021 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed.
RECENT MAJOR LABEL CHANGES ............................................................................................ 2 TABLE OF CONTENTS ..............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ...................................................................... 4 1 INDICATIONS ...............................................................................................................
5 2 CONTRAINDICATIONS ................................................................................................. 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION .................................................................................
9 5 OVERDOSAGE.............................................................................................................. 9
). With regards to the treatment of HIV-1 infection, the safety and efficacy of orally-dosed RETROVIR (AZT) in pediatric patients weighing less than 4 kg has not been established. In addition, the safety and efficacy of RETROVIR (AZT) administered via infusion for treatment of HIV-1 infection in pediatric patients less than 3 months old has not been established.
2 Geriatrics Geriatrics (>65 years of age): Zidovudine pharmacokinetics have not been studied in patients over 65 years of age and no specific data are available. However, since special care is advised in this age group due to age-associated changes such as the decrease in renal function and alterations in hematological parameters, appropriate monitoring of patients before and during use of zidovudine is advised.
2 CONTRAINDICATIONS • RETROVIR (AZT) is contraindicated for patients who have potentially life-threatening allergic reactions to any of the components of the formulations (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ).
65 mmol/L). 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions WARNING: RISK OF HEMATOLOGICAL TOXICITY, MYOPATHY, LACTIC ACIDOSIS Hematologic Toxicity RETROVIR (zidovudine) syrup, and injection have been associated with hematologic toxicity including neutropenia and severe anemia, particularly in patients with advanced HIV-1 disease (see 7 WARNINGS AND PRECAUTIONS).
Myopathy Prolonged use of RETROVIR has been associated with symptomatic myopathy (see 7 WARNINGS AND PRECAUTIONS). Lactic Acidosis and Severe Hepatomegaly Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including RETROVIR and other antiretrovirals.
Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur (see 7 WARNINGS AND PRECAUTIONS). 1 Dosing Considerations Monitoring of Patients Hematologic toxicities appear to be related to pre-treatment bone marrow reserve and to dose and duration of therapy.
, General 06/2021 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic 06/2021 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
4 1 INDICATIONS ............................................................................................................... 5 2 CONTRAINDICATIONS .................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION ................................................................................. 9 5 OVERDOSAGE..............................................................................................................
9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 9 7 WARNINGS AND PRECAUTIONS ................................................................................ 15 8 ADVERSE REACTIONS ................................................................................................
26 9 DRUG INTERACTIONS ................................................................................................ 32 10 CLINICAL PHARMACOLOGY .......................................................................................
33 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 36 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 36 PART II: SCIENTIFIC INFORMATION .......................................................................................
• RETROVIR (AZT) is contraindicated for patients who have potentially life-threatening allergic reactions to any of the components of the formulations (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ). 65 mmol/L).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Zidovudine in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
In patients with poor bone marrow reserve, particularly in patients with advanced RETROVIR (AZT) (Zidovudine Syrup and Solution for Infusion) Page 6 of 55 symptomatic HIV disease, frequent monitoring of hematologic indices is recommended to detect serious anemia or granulocytopenia (see 8 ADVERSE REACTIONS).
In patients who experience hematologic toxicity, reduction in hemoglobin may occur as early as 2 to 4 weeks, and granulocytopenia usually occurs after 6 to 8 weeks. Patients treated with zidovudine should be under close clinical observation to manage potential opportunistic infections associated with HIV disease.
Prompt recognition of infection or toxicities and appropriate management is required. 2 Recommended Dose and Dosage Adjustment Treatment of HIV-1 Infection Oral Administration Adults and Adolescents weighing at least 30 kg The recommended total oral daily dose of RETROVIR (AZT) is 600 mg per day in divided doses in combination with other antiretroviral agents.
Suggested dosing regimens are listed in the following Table 1. Table 1 Suggested Dosing Regimens for Adults and Adolescents (weighing at least 30 kg) Formulation Dosing Regimen Twice daily (every 12 hours) Three times daily (every 8 hours) Syrup 6 teaspoonfuls (30 mL) RETROVIR (AZT) Syrup 4 teaspoonfuls (20 mL) RETROVIR (AZT) Syrup Children weighing at least 4 kg The recommended oral dose in children weighing 4 kg, in combination with other antiretroviral agents, is provided in Table 2 below.
The appropriate dose of RETROVIR (AZT) for each child should be calculated based on body weight (kg) and should not exceed the recommended adult dose. 6 mL/kg) ≥ 30 600 mg/day 300 mg (30 mL) 200 mg (20 mL) Alternatively, dosing for RETROVIR (AZT) can be based on body surface area (BSA) for each child.
The recommended oral dose of RETROVIR (AZT) is 480 mg/m2/day in divided doses (240 mg/m2 twice daily or 160 mg/m2 three times daily). In some cases the dose calculated by mg/kg will not be the same as that calculated by BSA. Children weighing less than 4 kg Available data are insufficient to propose specific dosing recommendations for children weighing < 4 kg.
With regards to the treatment of HIV-1 infection, the safety and efficacy of orally-dosed RETROVIR (AZT) in pediatric patients weighing less than 4 kg has not been established. In addition, the safety and efficacy of RETROVIR (AZT) administered via infusion for treatment of HIV-1 infection in pediatric patients less than 3 months old has not been established.
Solution for Infusion Adults and Adolescents weighing at least 30 kg The recommended dose is 1 to 2 mg/kg administered as a 1-hour infusion every 4 hours around the clock (6 times daily). Patients should receive intravenous RETROVIR (AZT) only until oral therapy can be administered.
The intravenous dosing regimen equivalent to the oral administration of 100 mg every 4 hours is approximately 1 mg/kg intravenously every 4 hours. RETROVIR (AZT) solution for infusion is administered intravenously at a constant rate over 1 hour.
Rapid infusion or bolus injection should be avoided. RETROVIR (AZT) solution for infusion should not be given intramuscularly. Children at least 3 months of […]
37 13 PHARMACEUTICAL INFORMATION ............................................................................ 37 14 CLINICAL TRIALS ........................................................................................................
37 15 MICROBIOLOGY ........................................................................................................ 38 16 NON-CLINICAL TOXICOLOGY .....................................................................................
42 PATIENT MEDICATION INFORMATION .................................................................................. 47 RETROVIR (AZT) (Zidovudine Syrup and Solution for Infusion) Page 4 of 55 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS RETROVIR (AZT) (zidovudine syrup, and solution for infusion) is indicated for the treatment of HIV infection when antiretroviral therapy is warranted.
Therapy with RETROVIR (AZT) has been shown to prolong survival and decrease the incidence of opportunistic […]