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JAMP LAMIVUDINE / ZIDOVUDINE 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: 11/2023 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 11/2023 7 WARNINGS AND PRECAUTIONS, General 11/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment 11/2023 7 WARNINGS AND PRECAUTIONS, General 11/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 1 Pediatrics ...............................................................................................................
2 Geriatrics ............................................................................................................... 1 Dosing Considerations ...........................................................................................
2 Recommended Dose and Dosage Adjustment ....................................................... 5 Missed Dose........................................................................................................... 6
section). 1 Dosing Considerations JAMP Lamivudine / Zidovudine may be administered with or without food. Because JAMP Lamivudine / Zidovudine is a fixed dose tablet, it should not be prescribed for patients requiring dosage adjustments, such as pediatric patients who weigh less than 40 kg with renal impairment (creatinine clearance <50 mL/min).
2 Recommended Dose and Dosage Adjustment Adults and Adolescents (> 12 years of age) weighing at least 30 kg The recommended oral dose of JAMP Lamivudine / Zidovudine for adults and adolescents weighing at least 30 kg is one tablet (containing 150 mg of lamivudine and 300 mg zidovudine) twice daily.
Dose Adjustment It is recommended that separate doses of lamivudine and zidovudine be administered to: pediatric patients weighing less than 30 kg or patients requiring dosing adjustments due to adverse events. See complete prescribing information for lamivudine and zidovudine for dosage adjustments.
Geriatrics No specific data are available, however special care is advised in this age group due to age JAMP Lamivudine / Zidovudine (lamivudine and zidovudine tablets) Page 6 of 51 associated changes such as the decrease in renal function and alteration of hematological parameters.
Hepatic Insufficiency It is recommended that JAMP Lamivudine / Zidovudine not be used in patients with hepatic impairment. For these patients, it is recommended that lamivudine and zidovudine be administered as separate tablets. Renal Insufficiency It is recommended that JAMP Lamivudine / Zidovudine not be used in patients with reduced renal function (creatinine clearance less than 30 mL/min).
For these patients, it is recommended that lamivudine and zidovudine be administered as separate tablets. The individual Product Monographs for lamivudine and zidovudine should be consulted for appropriate dosage adjustments. 3-fold higher lamivudine exposure (AUC) than patients with a creatinine clearance ≥50 mL per min.
, General 11/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 1 Pediatrics ...............................................................................................................
2 Geriatrics ............................................................................................................... 1 Dosing Considerations ...........................................................................................
2 Recommended Dose and Dosage Adjustment ....................................................... 5 Missed Dose........................................................................................................... 1 Special Populations ..............................................................................................
1 Pregnant Women ................................................................................................. 2 Breast-feeding .....................................................................................................
3 Pediatrics ............................................................................................................. 4 Geriatrics .............................................................................................................
13 8 ADVERSE REACTIONS ................................................................................................. 2 Clinical Trial Adverse Reactions............................................................................ 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ................................................................................................
5 Post-Market Adverse Reactions ........................................................................... 16 9 DRUG INTERACTIONS ................................................................................................ 2 Drug Interactions Overview .................................................................................
• JAMP Lamivudine / Zidovudine (lamivudine and zidovudine) is contraindicated in patients with previously demonstrated clinically significant hypersensitivity to any of the components of the product. For a complete listing see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section.
65 mmol/L)
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.
In the original lamivudine registrational trials in combination with zidovudine, higher lamivudine exposures were associated with higher rates of hematologic toxicities (neutropenia and anemia), although discontinuations due to neutropenia or anemia each occurred in <1% of subjects.
Patients with a sustained creatinine clearance between 30 and 49 mL per min who receive Lamivudine and Zidovudine Tablets should be monitored for hematologic toxicities. If new or worsening neutropenia or anemia develop, dose adjustment of lamivudine, per lamivudine prescribing information, is recommended.
If lamivudine dose adjustment is indicated, JAMP Lamivudine / Zidovudine should be discontinued and the individual components should be used to construct the treatment regimen. 5 Missed Dose If you forget to take your medicine, take it as soon as you remember.
Then continue as before. 5 OVERDOSAGE There is no known antidote for JAMP Lamivudine / Zidovudine. If overdosage occurs the patient should be monitored, and standard supportive treatment applied as required. Although no data is available, administration of activated charcoal may be used to aid in removal of unabsorbed drug.
Because a negligible amount of lamivudine was removed via (4-hour) hemodialysis, continuous ambulatory peritoneal dialysis, and automated peritoneal dialysis, it is not known if continuous hemodialysis would provide clinical benefit in a lamivudine overdose event.
Hemodialysis and peritoneal dialysis appear to have a negligible effect on the removal of JAMP Lamivudine / Zidovudine (lamivudine and zidovudine tablets) Page 7 of 51 zidovudine while elimination of its primary metabolite, GZDV is enhanced.
No specific signs or symptoms have been identified following acute overdose with lamivudine or zidovudine 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 1 Dosage Form, Strength, Composition and Packaging Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Tablets/ 150 mg lamivudine and 300 mg zidovudine colloidal silicon dioxide, hydroxypropyl methyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide.
JAMP Lamivudine / Zidovudine tablets are white coloured, biconvex modified capsule shaped, film coated tablet having score on one side and ‘ML 6’ debossed on the other side of the tablet. Available in HDPE bottles of 60 tablets. 7 WARNINGS AND PRECAUTIONS Please see the Serious Warnings and Precautions Box at the beginning of Part I: Health Professional Information.
General Patients should be cautioned about the concomitant use of self-administered medications. JAMP Lamivudine / Zidovudine is a fixed-dose combination of lamivudine and zidovudine. JAMP Lamivudine / Zidovudine should not be administered concomitantly with other products containing either lamivudine or zidovudine including 3TC Tablets and oral solution; RETROVIR Syrup and Solution for infusion (zidovudine syrup and solution for infusion), KIVEXA Tablets (abacavir sulfate and lamivudine), DELSTRIGO Tablets (doravirine / lamivudine / tenofovir disoproxil fumarate tablets), DOVATO Tablets (dolutegravir sodium and lamivudine tablets), or TRIUMEQ Tablets (dolutegravir sodium / abacavir sulfate / lamivudine tablets).
JAMP Lamivudine / Zidovudine should also not be administered concomitantly with emtricitabine containing products, including ATRIPLA Tablets (efavirenz / emtricitabine / tenofovir disoproxil fumarate tablets), EMTRIVA Capsules (emtricitabine capsules), TRUVADA Tablets (emtricitabine / tenofovir disoproxil fumarate tablets), COMPLERA […]
4 Drug-Drug Interactions ........................................................................................ 19 10 CLINICAL PHARMACOLOGY ........................................................................................ 1 Mechanism of Action ...........................................................................................
3 Pharmacokinetics ................................................................................................. 24 11 STORAGE, STABILITY AND DISPOSAL.......................................................................... 31 12 SPECIAL HANDLING INSTRUCTIONS ...........................................................................
31 PART II: SCIENTIFIC INFORMATION ....................................................................................... 32 13 PHARMACEUTICAL INFORMATION ............................................................................
32 14 CLINICAL TRIALS......................................................................................................... 2 Comparative Bioavailability Studies ....................................................................
33 15 MICROBIOLOGY ......................................................................................................... 35 16 NON-CLINICAL TOXICOLOGY ......................................................................................
37 17 SUPPORTING PRODUCT MONOGRAPHS ......................................................................... 44 PATIENT MEDICATION INFORMATION .................................................................................. 45 JAMP Lamivudine / Zidovudine (lamivudine and zidovudine tablets) Page 4 of 51 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS JAMP Lamivudine / Zidovudine (lamivudine and zidovudine), in combination with other antiretrovirals, is indicated for the treatment of HIV infection.
1 Pediatrics Pediatrics (< 12 years of age): The safety and efficacy of lamivudine and zidovudine in pediatric patients less than 12 years of age have not been established. JAMP Lamivudine / Zidovudine is not recommended in children less than 12 years of age, as appropriate dose reduction for the weight of the child cannot be made.
(see 4 DOSAGE AND ADMINISTRATION section). 2 Geriatrics Geriatrics (> 65 years of age): No specific data are available, however special care is advised in this age group due to age associated changes such as the decrease in renal function and alteration of hematological parameters.
2 CONTRAINDICATIONS • JAMP Lamivudine / Zidovudine (lamivudine and zidovudine) is […]