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APO-ZIDOVUDINE is a brand name for Zidovudine, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: , 1.2 Geriatrics 06/2023 3 SERIOUS WARNINGS AND PRECAUTIONS BOX 06/2023 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations 06/2023 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 06/2023 7 WARNINGS AND PRECAUTIONS, General 06/2023 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment 06/2023 7 WARNINGS AND PRECAUTIONS, General 06/2023 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic 06/2023 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 ....................................................................... 5 1 INDICATIONS ....................................................................................................................
1 Pediatrics ........................................................................................................................ 2 Geriatrics .........................................................................................................................
5 2 CONTRAINDICATIONS ....................................................................................................... 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ..................................................................
6 4 DOSAGE AND ADMINISTRATION ...................................................................................... 1 Dosing Considerations.....................................................................................................
2 Recommended Dose and Dosage Adjustment ................................................................ 7 5 OVERDOSAGE ...................................................................................................................
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). 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 APO-ZIDOVUDINE is 600 mg per day in divided doses in combination with other antiretroviral agents.
Suggested dosing regimens are listed in the following Table 1. 5 g/dL or reduction of > 25% of baseline) and/or significant granulocytopenia (granulocyte count of < 750 cells/mm3 or reduction of > 50% from baseline) may require a dose interruption until evidence of marrow recovery is observed (see 8 ADVERSE REACTIONS).
In patients who develop significant anemia, dose modification does not necessarily eliminate the need for transfusion. For less severe anemia or granulocytopenia, a reduction in daily dose may be adequate. If marrow recovery occurs following dose modification, gradual increases in dose may be appropriate depending on hematologic indices and patient tolerance.
3 Pharmacokinetics and 10 CLINICAL PHARMACOLOGY). There are insufficient data to recommend dose adjustment of zidovudine in patients with impaired hepatic function. Careful monitoring for hematologic toxicities is advised (see 7 WARNINGS AND PRECAUTIONS- Hepatic/Biliary/Pancreatic).
5 OVERDOSAGE No specific symptoms or signs have been identified following acute overdose with zidovudine, APO-ZIDOVUDINE (Zidovudine Capsules) Page 8 of 52 apart from those listed as adverse reactions (see 8 ADVERSE REACTIONS). Activated charcoal should be administered to aid in the removal of unabsorbed drug.
, General 06/2023 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic 06/2023 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 .......................................................................
5 1 INDICATIONS .................................................................................................................... 1 Pediatrics ........................................................................................................................
2 Geriatrics ......................................................................................................................... 5 2 CONTRAINDICATIONS .......................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX .................................................................. 6 4 DOSAGE AND ADMINISTRATION ...................................................................................... 1 Dosing Considerations.....................................................................................................
2 Recommended Dose and Dosage Adjustment ................................................................ 7 5 OVERDOSAGE ...................................................................................................................
7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ...................................... 8 7 WARNINGS AND PRECAUTIONS ........................................................................................ 1 Special Populations .......................................................................................................
• APO-ZIDOVUDINE 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.
General supportive measures are recommended. Patients should be observed closely for evidence of toxicity (see 8 ADVERSE REACTIONS) and given the necessary supportive therapy. Hemodialysis and peritoneal dialysis appear to have a limited effect on elimination of zidovudine but enhance the elimination of the glucuronide metabolite.
For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 2 Dosage Forms, Strengths, Composition and Packaging. Route of Administration Dosage Form / Strength / Composition Non-medicinal Ingredients Oral Capsules, 100 mg Colloidal silicon dioxide, corn starch microcrystalline cellulose, stearic acid and talc.
The capsule, imprinted with edible black ink, contains gelatin and titanium dioxide. The edible black ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. APO-ZIDOVUDINE capsules 100 mg are hard gelatin capsules with a white opaque body, and a white opaque cap imprinted "APO Z100", with white to off-white powder fill, containing 100 mg of zidovudine.
Available in bottles of 100, 500 and 1000, and in unit dose packages of 100. 7 WARNINGS AND PRECAUTIONS General While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded.
Precautions to prevent transmission should be taken in accordance with national guidelines. Anemia (usually not observed before six weeks of zidovudine therapy but occasionally occurring APO-ZIDOVUDINE (Zidovudine Capsules) Page 9 of 52 earlier), neutropenia (usually not observed before four weeks therapy but sometimes occurring earlier) and leucopenia (usually secondary to neutropenia) can be expected to occur in patients with advanced symptomatic HIV disease receiving zidovudine.
These occurred more frequently at higher dosages (1200 to 1500 mg/day) and in patients with poor bone marrow reserve prior to treatment, particularly with advanced HIV disease. Hematological parameters should be carefully monitored.
For patients with advanced symptomatic HIV disease it is generally recommended that blood tests are performed at least every two weeks for the first three months of therapy and at least monthly thereafter. 0 x 109/L. Serious Adverse Reactions Several serious adverse events have been reported with use of zidovudine in clinical practice.
Reports of pancreatitis, sensitization reactions (including anaphylaxis in one patient), vasculitis, and seizures have been rare. These adverse events, except for sensitization, have also been associated with HIV disease. Changes in skin and nail pigmentation have been associated with the use of zidovudine.
Before combination therapy with APO-ZIDOVUDINE is initiated, consult the complete prescribing information for each drug. The safety profile of APO-ZIDOVUDINE plus other antiretroviral agents reflects the individual safety profiles of each component.
The incidence of adverse reactions appears to increase with disease progression, and patients should be monitored carefully, especially as disease progression occurs. Endocrine and Metabolism • Lipoatrophy Treatment with zidovudine has been associated with loss of subcutaneous fat.
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1 Pregnant Women ........................................................................................................ 2 Breast-feeding ............................................................................................................
3 Pediatrics .................................................................................................................... 4 Geriatrics ....................................................................................................................
14 8 ADVERSE REACTIONS ...................................................................................................... 1 Adverse Reaction Overview ..........................................................................................
2 Clinical Trial Adverse Reactions ..................................................................................... 1 Clinical Trial Adverse Reactions - Pediatrics ................................................................
3 Less Common Clinical Trial Adverse Reactions .............................................................. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ..........................................................................................................
5 Post-Market Adverse Reactions .................................................................................... 23 9 DRUG INTERACTIONS .....................................................................................................
2 Drug Interactions Overview .......................................................................................... 4 Drug-Drug Interactions..................................................................................................
5 Drug-Food Interactions ................................................................................................. 6 Drug-Herb Interactions .................................................................................................
7 Drug-Laboratory Test Interactions ................................................................................ 30 10 CLINICAL PHARMACOLOGY .............................................................................................
1 Mechanism of Action .................................................................................................. 3 Pharmacokinetics........................................................................................................
30 11 STORAGE, STABILITY AND DISPOSAL............................................................................... 32 12 SPECIAL HANDLING INSTRUCTIONS ................................................................................
32 PART II: SCIENTIFIC INFORMATION ........................................................................................ 33 13 PHARMACEUTICAL INFORMATION .................................................................................
33 14 CLINICAL TRIALS ............................................................................................................. 1 Clinical Trials by Indication..........................................................................................
2 Comparative Bioavailability Studies ............................................................................ 34 15 MICROBIOLOGY ..............................................................................................................
35 16 NON-CLINICAL TOXICOLOGY ........................................................................................... 39 APO-ZIDOVUDINE (Zidovudine Capsules) Page 4 of 52 17 SUPPORTING PRODUCT MONOGRAPHS .........................................................................
44 PATIENT MEDICATION INFORMATION […]