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JAMP 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: , 1.1_Pediatrics 02/2024 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 11/2022 7 WARNINGS AND PRECAUTIONS, General 11/2022 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES ............................................................................................ 2 TABLE OF…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment 11/2022 7 WARNINGS AND PRECAUTIONS, General 11/2022 TABLE OF CONTENTS 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 ..............................................................................................................
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). • Important Differences among Lamivudine-Containing Products JAMP Lamivudine Page 5 of 46 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 JAMP Lamivudine can be taken with or without food. Adults, Adolescents and Children weighing at least 25 kg The recommended oral dose of JAMP 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 JAMP 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 JAMP Lamivudine Tablets, children should be assessed for the ability to swallow tablets.
If a child is unable to reliably swallow JAMP Lamivudine Tablets, the oral solution formulation should be prescribed. The recommended oral dosage of JAMP Lamivudine Tablets for HIV-1-infected pediatric patients is presented in Table 1.
Table 1 Dosing Recommendations for JAMP 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: JAMP Lamivudine is not recommended for pediatric patients weighing less than 14 kg because appropriate dose adjustment is not possible in these patients.
, General 11/2022 TABLE OF CONTENTS 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 ................................. 8 7 WARNINGS AND PRECAUTIONS ................................................................................... 1 Special Populations ...............................................................................................
1 Pregnant Women............................................................................................ 2 Breast-feeding................................................................................................. 3 Pediatrics ........................................................................................................
JAMP
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.
JAMP Lamivudine Page 6 of 46 Hepatic Impairment 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 JAMP Lamivudine should be adjusted, as shown in Table 2 in accordance with creatinine clearance. Table 2 Adjustment of Dosage of JAMP Lamivudine in Accordance With Creatinine Clearance in Adults, Adolescents and Children weighing ≥25 kg Creatinine clearance (mL/min) Recommended Dosage of JAMP Lamivudine ≥ 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 JAMP 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.
JAMP 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. JAMP Lamivudine Page 7 of 46 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.
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 Tablets/ 300 mg hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide black iron oxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide Dosage Forms Tablets JAMP Lamivudine tablets 150 mg are white, modified diamond-shaped, scored on both sides, film-coated tablets containing 150 mg of lamivudine and engraved with "LMV" on one side and "150” on the other side.
Available in plastic bottles of 60 tablets and 100 tablets. JAMP Lamivudine tablets 300 mg are grey, modified diamond-shaped, film-coated tablets containing 300 mg of lamivudine and engraved with “LMV” on one side and “300” on the other side.
Available in plastic bottles of 30 tablets and 100 tablets. 7 WARNINGS AND PRECAUTIONS Please see 3 Serious Warnings and Precautions Box at the beginning of Part I: Health Professional Information. For management of a suspected drug overdose, contact your regional poison control centre.
JAMP Lamivudine Page 8 of 46 General JAMP Lamivudine should not be administered concomitantly with other products containing lamivudine including HEPTOVIR Tablets (lamivudine) and Oral solution, COMBIVIR Tablets (lamivudine/zidovudine), KIVEXA Tablets (abacavir/lamivudine), TRIUMEQ Tablets (dolutegravir/abacavir/lamivudine), or DOVATO Tablets (dolutegravir/lamivudine).
JAMP Lamivudine should also not be administered concomitantly with emtricitabine containing products, including ATRIPLA tablets (efavirenz/emtricitabine/tenofovir disoproxil fumarate), EMTRIVA capsules (emtricitabine), TRUVADA tablets (emtricitabine/tenofovir disoproxil fumarate), COMPLERA tablets (emtricitabine/rilpivirine/ […]
4 Geriatrics......................................................................................................... 12 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...................................................... 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 ............................................................................ 28 14 CLINICAL TRIALS ........................................................................................................
33 15 MICROBIOLOGY ......................................................................................................... 35 16 NON-CLINICAL TOXICOLOGY ......................................................................................
38 17 SUPPORTING PRODUCT MONOGRAPHS .................................................................... 38 PATIENT MEDICATION INFORMATION .................................................................................. 40 JAMP Lamivudine Page 4 of 46 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS JAMP Lamivudine (lamivudine) in combination with other antiretroviral agents is indicated for the treatment of HIV infection.
1 Pediatrics Pediatrics (< 18 years of age): JAMP Lamivudine is indicated in pediatric patients weighing greater than or equal to 14 kg in combination with other antiretroviral agents. • Before prescribing JAMP Lamivudine tablets, children should be assessed […]