Loading…
3TC 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: 3TC (lamivudine) in combination with other antiretroviral agents is indicated for the treatment of HIV infection. 1.1 Pediatrics Pediatrics (< 18 years of age): 3TC is indicated in pediatric patients aged 3 months and older in combination with other antiretroviral agents. 1.2 Geriatrics Geriatrics (≥ 65 years of age):…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment 01/2022 7 WARNINGS AND PRECAUTIONS, General 01/2022 7 WARNINGS AND PRECAUTIONS, General [Removed] 05/2023 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
4 1 INDICATIONS ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 4 4 DOSAGE AND ADMINISTRATION ................................................................................. 6 5 OVERDOSAGE..............................................................................................................
6
). • Important Differences among Lamivudine-Containing Products Lamivudine tablets and oral solution 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 3TC can be taken with or without food Adults, Adolescents and Children weighing at least 25 kg The recommended oral dose of 3TC 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).
3 Pediatrics, Lower Virologic Suppression with Oral Solutions in Pediatrics). Scored Tablets 3TC 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 3TC Tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow 3TC Tablets, the oral solution formulation should be prescribed. The recommended oral dosage of 3TC Tablets for HIV-1-infected pediatric patients is presented in Table 1.
Patients changing between lamivudine oral solution and lamivudine tablets should follow the dosing recommendations that are specific for the formulation. 3 Pharmacokinetics, Special Populations and Conditions, Pediatrics ). The safety and efficacy have not been established for pediatrics less than 3 month of age.
Health Canada has not authorized an indication for pediatric patients less than 3 month of age. Hepatic Impairment No dose adjustment is necessary in patients with moderate or severe hepatic impairment unless accompanied by renal impairment.
, General 01/2022 7 WARNINGS AND PRECAUTIONS, General [Removed] 05/2023 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES ............................................................................................ 2 TABLE OF CONTENTS ..............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ...................................................................... 4 1 INDICATIONS ...............................................................................................................
4 2 CONTRAINDICATIONS ................................................................................................. 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 4 4 DOSAGE AND ADMINISTRATION .................................................................................
6 5 OVERDOSAGE.............................................................................................................. 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 8 7 WARNINGS AND PRECAUTIONS ..................................................................................
12 8 ADVERSE REACTIONS ................................................................................................ 20 9 DRUG INTERACTIONS ................................................................................................
23 10 CLINICAL PHARMACOLOGY ....................................................................................... 23 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 27 12 SPECIAL HANDLING INSTRUCTIONS ...........................................................................
27 PART II: SCIENTIFIC INFORMATION ....................................................................................... 28 13 PHARMACEUTICAL INFORMATION ............................................................................
3TC 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.
Know a brand we are missing in Canada? Suggest a brand →
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.
3TC May 3, 2023 Page 6 of 46 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 3TC should be adjusted, as shown in Table 2 and Table 3 in accordance with creatinine clearance. Table 2 Adjustment of Dosage of 3TC in Accordance With Creatinine Clearance in Adults, Adolescents and Children weighing ≥25 kg Creatinine clearance (mL/min) Recommended Dosage of 3TC ≥ 50 150 mg twice daily or 300 mg once daily 30 - 50 150 mg once daily 15 - 29 150 mg first dose, then 100 mg once daily 5 - 14 150 mg first dose, then 50 mg once daily < 5 50 mg first dose, then 25 mg once daily There are no data available on the use of lamivudine in children with renal impairment.
A reduction in the dose and/or an increase in the dosing interval should be considered in children aged at least three months and weighing less than 25 kg with a creatinine clearance of less than 50 mL/min. The same percentage reduction in the adult dose is recommended for pediatric patients with renal impairment.
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. 3TC May 3, 2023 Page 7 of 46 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. 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. 3TC May 3, 2023 Page 8 of 46 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 4 –Dosage Forms, Strengths, Composition and Packaging Dosage Forms Tablets 3TC tablets 150 mg are white, modified diamond-shaped, scored, film-coated tablets and imprinted with "GX CJ7" on both faces.
3TC tablets 300 mg are grey, modified diamond-shaped, film-coated tablets and imprinted with "GX EJ7" on one face. Oral Solution 3TC oral solution is a colourless to pale yellow, strawberry-banana flavour, clear liquid.
Packaging Tablets 150 mg:
Supplied in bottles of 60 tablets 300 mg: Supplied in bottles of 30 tablets. Oral Solution Supplied in 240 mL plastic bottles. Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Tablets/ 150 mg Tablets/ 300 mg Oral Solution/ 10 mg/mL hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide black iron oxide, hydroxypropyl […]
28 14 CLINICAL TRIALS ........................................................................................................ 29 15 MICROBIOLOGY ........................................................................................................
35 16 NON-CLINICAL TOXICOLOGY ..................................................................................... 38 PATIENT MEDICATION INFORMATION ..................................................................................
40 3TC May 3, 2023 Page 4 of 46 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS 3TC (lamivudine) in combination with other antiretroviral agents is indicated for the treatment of HIV infection. 1 Pediatrics Pediatrics (< 18 years of age): 3TC is indicated in pediatric patients aged 3 months and older in combination with other antiretroviral agents.
2 Geriatrics Geriatrics (≥ 65 years of age): Clinical studies of 3TC did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater […]