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APO-LAMIVUDINE is a brand name for Lamivudine, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: APO-LAMIVUDINE (lamivudine) in combination with other antiretroviral agents is indicated for the treatment of HIV infection. 1.1 Pediatrics Pediatrics (< 18 years of age): APO-LAMIVUDINE is indicated in pediatric patients weighing greater than or equal to 14 kg in combination with other antiretroviral agents. • Before…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment 06/2023 7 WARNINGS AND PRECAUTIONS 06/2023 7 WARNINGS AND PRECAUTIONS, General [Removed] 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 .................................................................... 4 1 INDICATIONS ...........................................................................................................
1 Pediatrics ............................................................................................................... 2 Geriatrics ...............................................................................................................
4 2 CONTRAINDICATIONS.............................................................................................. 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ......................................................... 4 4 DOSAGE AND ADMINISTRATION ................................................................................
2 Recommended Dose and Dosage Adjustment........................................................ 5 Missed Dose .......................................................................................................... 6 5 OVERDOSAGE..........................................................................................................
6
). APO-LAMIVUDINE (Lamivudine Tablets) Page 5 of 46 • Important Differences among Lamivudine-Containing Products Lamivudine tablets used to treat HIV-1 infection contain a higher dose of the active ingredient (lamivudine) than lamivudine tablets and oral solution used to treat chronic HBV infection.
Patients with HIV-1 infection should receive only dosage forms appropriate for treatment of HIV-1. 2 Recommended Dose and Dosage Adjustment APO-LAMIVUDINE can be taken with or without food. Adults, Adolescents and Children weighing at least 25 kg The recommended oral dose of APO-LAMIVUDINE for adults and adolescents weighing at least 25 kg is 300 mg daily, administered as either 150 mg twice daily or 300 mg once daily (see 7 WARNINGS AND PRECAUTIONS, 10 CLINICAL PHARMACOLOGY and 14 CLINICAL TRIALS).
Scored Tablets APO-LAMIVUDINE is also available as a scored tablet for HIV-1-infected pediatric patients weighing greater than or equal to 14 kg for whom a solid dosage form is appropriate. Before prescribing APO-LAMIVUDINE Tablets, children should be assessed for the ability to swallow tablets.
If a child is unable to reliably swallow APO-LAMIVUDINE Tablets, the oral solution formulation should be prescribed. The recommended oral dosage of APO-LAMIVUDINE Tablets for HIV-1-infected pediatric patients is presented in Table 1.
Table 1 - Dosing Recommendations for APO-LAMIVUDINE Scored (150 mg) Tablets in Pediatric Patients Weight (kg) Once-Daily Dosing Regimen Twice-Daily Dosing Total Daily DoseAM Dose PM Dose 14 to <20 1 tablet (150 mg) ½ tablet (75 mg) ½ tablet (75 mg) 150 mg ≥20 to <25 1 ½ tablets (225 mg) ½ tablet (75 mg) 1 tablet (150 mg) 225 mg ≥25 2 tablets (300 mg) 1 tablet (150 mg) 1 tablet (150 mg) 300 mg Pediatric patients weighing less than 14 kg APO-LAMIVUDINE is not recommended for pediatric patients weighing less than 14 kg because appropriate dose adjustment is not possible in these patients.
06/2023 7 WARNINGS AND PRECAUTIONS, General [Removed] 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 ....................................................................
4 1 INDICATIONS ........................................................................................................... 1 Pediatrics ...............................................................................................................
2 Geriatrics ............................................................................................................... 4 2 CONTRAINDICATIONS..............................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ......................................................... 4 4 DOSAGE AND ADMINISTRATION ................................................................................ 2 Recommended Dose and Dosage Adjustment........................................................
5 Missed Dose .......................................................................................................... 6 5 OVERDOSAGE..........................................................................................................
6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .............................. 7 7 WARNINGS AND PRECAUTIONS ............................................................................... 1 Special Populations ................................................................................................
APO-LAMIVUDINE is contraindicated in patients with previously demonstrated clinically significant hypersensitivity to any of the components of the products (see section 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Lamivudine 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.
Hepatic Impairment APO-LAMIVUDINE (Lamivudine Tablets) Page 6 of 46 No dose adjustment is necessary in patients with moderate or severe hepatic impairment unless accompanied by renal impairment. Renal Impairment Patients with impaired renal function have increases in Cmax and half-life of lamivudine with diminishing creatinine clearance.
In addition, apparent total oral clearance of lamivudine decreases as creatinine clearance decreases. Doses of APO-LAMIVUDINE should be adjusted, as shown in Table 2 in accordance with creatinine clearance. APO-LAMIVUDINE is not recommended in adult and pediatric patients weighing equal or greater than 25 kg with creatinine clearance less than 30 mL/min because appropriate dose adjustment is not possible in these patients.
APO-LAMIVUDINE is not recommended in pediatric patients with renal impairment weighing less than 25 kg because appropriate dose adjustment is not possible in these patients. 5 Missed Dose If you forget to take your medicine, take it as soon as you remember.
Then continue as before. 5 OVERDOSAGE If overdosage occurs the patient should be monitored, and standard supportive treatment applied as required. Administration of activated charcoal may be used to aid in the removal of unabsorbed active substance.
General supportive measures are recommended. Since lamivudine is dialyzable, continuous hemodialysis could be used in the treatment of overdose, although this has not been studied. APO-LAMIVUDINE (Lamivudine Tablets) Page 7 of 46 No specific signs or symptoms have been identified following acute overdose with lamivudine, apart from those listed as adverse reactions.
For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 3 – Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength / Composition Non-medicinal Ingredients Oral Tablets / 150 mg and 300 mg Colloidal silicon dioxide, crospovidone, ferric- ferrous oxide (300 mg tablet), hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose anhydrous, magnesium stearate, polyethylene glycol and titanium dioxide.
APO-LAMIVUDINE 150 mg Tablets:
Each white to off-white, diamond shaped, biconvex film- coated tablet contains 150 mg of lamivudine. Engraved “APO” on one side, “LMV” score “150” on the other side. Available in bottles of 100 and 60 tablets.
APO-LAMIVUDINE 300 mg Tablets:
Each grey, diamond shaped, biconvex film-coated tablet contains 300 mg of lamivudine. Engraved “APO” on one side, “LMV 300” on the other side. Available in bottles of 100 and 30 tablets. 7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX at the beginning of Part I: Health Professional Information.
General APO-LAMIVUDINE (lamivudine) should not be administered concomitantly with other products containing lamivudine including lamivudine tablets and oral solution, lamivudine and zidovudine tablets, abacavir and lamivudine tablets, dolutegravir, abacavir, and lamivudine tablets, or dolutegravir and lamivudine tablets.
APO-LAMIVUDINE should also not be administered concomitantly with emtricitabine containing products, including efavirenz/emtricitabine/tenofovir disoproxil fumarate tablets, emtricitabine capsules, emtricitabine/tenofovir disoproxil fumarate tablets, emtricitabine/rilpivirine/ tenofovir disoproxil fumarate tablets, elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate tablets, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide tablets, APO-LAMIVUDINE (Lamivudine Tablets) Page 8 of […]
11 8 ADVERSE REACTIONS ............................................................................................ 19 9 DRUG INTERACTIONS ............................................................................................ 22 10 CLINICAL PHARMACOLOGY ....................................................................................
22 11 STORAGE, STABILITY AND DISPOSAL ...................................................................... 26 12 SPECIAL HANDLING INSTRUCTIONS........................................................................ 26 PART II: SCIENTIFIC INFORMATION .....................................................................................
27 13 PHARMACEUTICAL INFORMATION ........................................................................ 27 14 CLINICAL TRIALS .................................................................................................... 33 15 MICROBIOLOGY ....................................................................................................
34 16 NON-CLINICAL TOXICOLOGY .................................................................................. 37 17 SUPPORTING PRODUCT MONOGRAPHS ................................................................. 39 PATIENT MEDICATION INFORMATION ................................................................................
40 APO-LAMIVUDINE (Lamivudine Tablets) Page 4 of 46 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS APO-LAMIVUDINE (lamivudine) in combination with other antiretroviral agents is indicated for the treatment of HIV infection. 1 Pediatrics Pediatrics (< […]