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JAMP LAMIVUDINE HBV 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: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ..................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
JAMP
Lamivudine HBV is only available in a 100 mg tablet. Dosing Considerations Discontinuation of JAMP Lamivudine HBV may be considered in immunocompetent patients when HBeAg and/or HBsAg seroconversion occurs and when loss of efficacy occurs as indicated by recurrent signs of hepatitis.
There are limited data regarding the maintenance of seroconversion long term after stopping treatment with lamivudine tablets. If JAMP Lamivudine HBV is discontinued, patients should be periodically monitored for evidence of recurrent hepatitis (See WARNINGS AND PRECAUTIONS).
The formulation and dosage of lamivudine in JAMP Lamivudine HBV are not appropriate in patients dually infected with Hepatitis B and HIV. If lamivudine is administered to such patients, the higher dosage indicated for HIV therapy should be used as part of a combination treatment regimen and the Product Monographs for lamivudine tablets 150 mg and 300 mg and lamivudine tablets 100 mg should be consulted.
Recommended Dose and Dosage Adjustment The recommended dose of JAMP Lamivudine HBV for adults and adolescents who are 16 years and older is 100 mg lamivudine once daily (one tablet). Optimum duration of therapy has not been established.
Renal Impairment:
Lamivudine serum concentrations are increased in patients with moderate to severe renal impairment due to decreased renal clearance. The dosage should therefore be reduced for patients with a creatinine clearance of < 50 mL/min. When doses below 100 mg are required Lamivudine 5 mg/mL oral solution should be used (see table below).
Creatinine clearance mL/min First Dose of lamivudine oral solution* Maintenance Dose Once Daily 30 to < 50 20 mL (100 mg) 10 mL (50 mg) 15 to < 30 20 mL (100 mg) 5 mL (25 mg) 5 to < 15 7 mL (35 mg) 3 mL (15 mg) < 5 7 mL (35 mg) 2 mL (10 mg) * Lamivudine Oral Solution containing 5mg/mL lamivudine.
Data available in patients undergoing intermittent hemodialysis (≤ 4 hours dialysis 2-3 times weekly), indicate that following the initial dosage reduction of lamivudine to correct for the patient’s creatinine clearance, no further dosage adjustments are required while undergoing dialysis.
Hepatic Impairment:
JAMP
Lamivudine HBV is contraindicated in patients who previously demonstrated clinically significant hypersensitivity to any of the components of the products (see the DOSAGE FORMS, COMPOSITION AND PACKAGING section). WARNINGS AND PRECAUTIONS Serious Warnings and Precautions HIV resistance may emerge in chronic hepatitis B patients with unrecognized or untreated human immunodeficiency virus (HIV) infection when treated with JAMP Lamivudine HBV.
JAMP Lamivudine HBV contains lower doses of the same active ingredient (lamivudine) as lamivudine tablets 150 mg and 300 mg, which has activity against HIV (see WARNINGS AND PRECAUTIONS). Post-Treatment Exacerbation of Hepatitis Severe acute exacerbations of hepatitis have been reported in patients who have discontinued anti-hepatitis B therapy, including therapy with lamivudine tablets.
Hepatic function should be monitored closely in patients who discontinue anti-hepatitis B therapy. If appropriate, resumption of anti-hepatitis B therapy may be warranted. Patients coinfected with HIV and HBV should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment with JAMP Lamivudine HBV.
General Patients should be monitored at initiation of treatment and regularly during maintenance of treatment by a physician experienced in the management of chronic hepatitis B. Optimum duration of therapy has not been established.
The efficacy of lamivudine has not been established in patients not responding to alpha- interferon therapy. e. g. increased HBV DNA and improved liver histology). Since there are no strong correlations between serological and histological markers of response, the decision on whether or not to continue JAMP Lamivudine HBV therapy should be based on clinical status and serological marker trends rather than a single result.
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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No dose adjustment is necessary in patients with hepatic impairment unless accompanied by renal impairment. Page 14 of 32 Missed Dose If the patient forgets to take their medicine, they should take it as soon as they remember, then continue as before.
Administration JAMP Lamivudine HBV can be taken with or without food. OVERDOSAGE For management of a suspected drug overdose, contact your regional Poison Control Centre. Limited data are available on the consequences of ingestion of acute overdoses in humans.
No fatalities occurred, and the patients recovered. No specific signs or symptoms have been identified following such overdosage. If overdose occurs the patient should be monitored and standard supportive treatment applied. Although no data is available, administration of activated charcoal may be used to aid in removal of unabsorbed drug.
Since lamivudine is dialysable, continuous hemodialysis could be used in the treatment of overdose, although this has not been studied. ACTION AND CLINICAL PHARMACOLOGY Mechanism of Action Lamivudine is an antiviral agent which is active against hepatitis B virus (HBV) in all cell lines tested and in experimentally infected animals.
Pharmacodynamics Lamivudine is metabolised by both infected and uninfected cells to the triphosphate (TP) derivative which is the active form of the parent compound. The intracellular half life of the triphosphate in hepatocytes is 17-19 hours in vitro.
Lamivudine-TP acts as a substrate for the HBV viral polymerase. The formation of further viral DNA is blocked by incorporation of lamivudine MP into the chain and subsequent chain termination. Lamivudine-TP is also a substrate for mammalian DNA polymerases, with the subsequent incorporation into mammalian DNA.
However, incorporated lamivudine is removed from mammalian DNA by 3'-5' exonuclease DNA repair enzymes. Viral polymerases do not possess such a DNA repair function. Consequently, at concentrations in vitro which inhibit replication of HBV DNA in infected cells, lamivudine has no effect on mammalian mitochondrial DNA synthesis and has no cytotoxicity.
In vitro concentrations of lamivudine which cause reductions of mammalian DNA and cytotoxicity are approximately 1000 times or greater than those which inhibit HBV replication. Thus, lamivudine has a high therapeutic index.
Page 15 of 32 Pharmacokinetics Absorption:
Lamivudine is well absorbed from the gastrointestinal tract.
Distribution:
The bioavailability of oral lamivudine in adults is normally between 80 and 85%. Following oral administration, the mean time (tmax) to maximal serum concentrations (Cmax) is about an hour. e. 5 mcg/mL. Coadministration of lamivudine with food resulted in a delay of tmax and a lower Cmax (decreased by up to 47%).
However, the extent (based on the AUC) of lamivudine absorbed was not influenced, therefore lamivudine tablets can be administered with or without food. STORAGE AND STABILITY JAMP Lamivudine HBV tablets should be stored between 15 and 30°C.
SPECIAL HANDLING INSTRUCTIONS Not applicable. DOSAGE FORMS, COMPOSITION AND PACKAGING Dosage Forms and Packaging JAMP Lamivudine HBV 100 mg tablets are beige colored, capsule shaped, biconvex, film coated engraved with ‘’LMV’’ on one side and ‘’100’’ on the other side.
Composition Each JAMP Lamivudine HBV tablet contains 100 mg of lamivudine and the non-medicinal ingredients: microcryrstalline cellulose, sodium starch glycolate, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol, polysorbate 80, iron oxide yellow and iron oxide red.
Page 16 of 32 PART II:
SCIENTIFIC INFORMATION PHARMACEUTICAL INFORMATION Drug Substance Proper name: lamivudine Chemical name: 2(1H)-Pyrimidinone, […]
Patients should be advised that therapy of chronic hepatitis B, with lamivudine tablets has not been proven to reduce the risk of transmission of hepatitis B virus to others through sexual contact or blood contamination and therefore, appropriate precautions should still be taken.
Page 5 of 32 Several serious adverse events have been reported with use of lamivudine in HIV- infected patients. Reports of anaphylaxis, rhabdomyolysis and peripheral neuropathy have been rare (< 1 in 1000). Hematologic Lamivudine use at higher doses in HIV disease has resulted in very rare occurrences of pure red cell aplasia.
To date no definitive occurrences have been seen in hepatitis B patients at the recommended dose. Hepatic/Biliary/Pancreatic The safety and efficacy of lamivudine tablets have not been established in patients with decompensated liver disease.
Patients with marginal liver function are at greater risk from active viral replication. In these patients, hepatitis reactivation at discontinuation of lamivudine or loss of efficacy during treatment may induce severe and even fatal decompensation.
It is recommended that these patients are monitored for parameters associated with hepatitis B, for liver and renal functions, and for antiviral response during treatment. If treatment is discontinued for any reason, it is recommended that these patients are monitored closely for at least 6 months after cessation of treatment.
Lactic Acidosis/Severe Hepatomegaly with Steatosis Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of antiretroviral nucleoside analogues alone or in combination, including lamivudine, in the treatment of HIV infection.
A majority of these cases have been in women. Female sex and obesity may be risk factors. Most of these reports have described patients receiving nucleoside analogues for the treatment of HIV infection, but there have been rare reports of lactic acidosis in patients receiving lamivudine for hepatitis B.
Particular caution should be exercised when administering lamivudine tablets 150 mg and 300 mg or JAMP Lamivudine HBV to any patient with known risk factors for liver disease (other than hepatitis B). However, cases have been reported in patients with no known risk factors.
Treatment with JAMP Lamivudine HBV should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity.
Pancreatitis:
Pancreatitis has been reported in patients receiving lamivudine tablets 150 mg and 300 mg, particularly in HIV-infected pediatric patients with prior nucleoside exposure. Immune In HBeAg positive or negative patients, the development of YMDD (tyrosine- methionineaspartate-aspartate) mutant HBV may result in a diminished therapeutic response to lamivudine, indicated by a rise in HBV DNA and ALT from previous on- treatment levels.
In order to reduce the risk of resistance in patients receiving lamivudine Page 6 of 32 monotherapy, a switch to or addition of an alternative agent without cross-resistance to lamivudine should be considered if serum HBV DNA remains detectable at or beyond 24 weeks of treatment.
If JAMP Lamivudine HBV is discontinued or there is a loss of efficacy, some patients may experience clinical or laboratory evidence of recurrent hepatitis. Exacerbation of hepatitis has primarily been detected by serum ALT elevations, in addition to the re- emergence of HBV DNA.
Most events appear to have been self-limited. Fatalities due to exacerbation of hepatitis after discontinuation of lamivudine tablets are uncommon. Some chronic hepatitis B patients may be coinfected with HIV. The possibility of such coinfection should be considered prior to initiating JAMP Lamivudine HBV therapy.
Coinfected patients receiving or requiring an antiretroviral treatment regimen including lamivudine for HIV should be treated with […]