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APO-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: APO-LAMIVUDINE HBV (lamivudine) is indicated for the treatment of patients with chronic hepatitis B and evidence of hepatitis B virus (HBV) replication. This indication is based on the analysis of histologic and serologic endpoints in patients with compensated chronic hepatitis B, which were mainly derived from…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Discontinuation of lamivudine tablets 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 lamivudine tablets are discontinued, patients should be periodically monitored for evidence of recurrent hepatitis (See 7 WARNINGS AND PRECAUTIONS, Immune).
The formulation and dosage of lamivudine in APO-LAMIVUDINE HBV 100 mg tablets 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 150 mg and 300 mg tablets and Lamivudine 100 mg tablets should be consulted.
2 Recommended Dose and Dosage Adjustment The recommended dose of APO-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.
APO-LAMIVUDINE HBV (Lamivudine tablets) Page 6 of 34 Hepatic Insufficiency No dose adjustment is necessary in patients with hepatic impairment unless accompanied by renal impairment. Renal Insufficiency 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) * Oral Solution containing 5mg/mL lamivudine.
Data available in patients undergoing intermittent hemodialysis (≤ 4 hours dialysis 2 to 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.
4 Administration APO-LAMIVUDINE HBV can be taken with or without food. 5 Missed Dose If the patient forgets to take their medicine, they should take it as soon as they remember, then continue as before.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. APO-LAMIVUDINE HBV (Lamivudine tablets) Page 12 of 34 In clinical studies of patients with chronic hepatitis B, lamivudine was well tolerated.
The incidence of adverse events was similar between placebo and lamivudine treated patients. The most common adverse events reported were malaise and fatigue, respiratory tract infections, headache, abdominal discomfort and pain, nausea, vomiting and diarrhea.
The most common adverse events (≥ 5%), reported in three pivotal trials (NUCB3009, NUCA3010 and NUCB3010) during treatment, are summarized in the table below: Most Common Adverse Events No. (%) of Patients PLA n = 144 LAM100 mg n = 297 During Treatment Malaise and fatigue 36 (25%) 73 (25%) Headache 30 (21%) 63 (21%) Viral respiratory infection 26 (18%) 61 (21%) Abdominal discomfort and pain 25 (17%) 41 (14%) Diarrhea 18 (13%) 41 (14%) Cough 14 (10%) 35 (12%) ENT infections 15 (10%) 35 (12%) Nausea and vomiting 20 (14%) 43 (14%) Throat and tonsil discomfort and pain 12 (8%) 35 (12%) Viral ear nose & throat infections 15 (10%) 29 (10%) Musculoskeletal pain 14 (10%) 23 (8%) Nasal signs & symptoms 10 (7%) 23 (8 %) Dizziness 10 (7%) 22 (7%) Sleep disorders 11 (8%) 20 (7%) Temperature regulations disturbances 10 (7%) 15 (5%) Abnormal; enzyme levels 8 (6%) 16 (5%) The incidence of laboratory abnormalities in chronic hepatitis B patients were similar in the lamivudine and placebo treated groups with the exception of elevations of CK and ALT.
). 2 CONTRAINDICATIONS APO-LAMIVUDINE HBV is contraindicated in patients who previously demonstrated clinically significant hypersensitivity to any of the components of the products (see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING, Table 1).
APO-LAMIVUDINE HBV (Lamivudine tablets) Page 5 of 34 3 SERIOUS WARNINGS AND PRECAUTIONS BOX 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 lamivudine 100 mg tablets.
Lamivudine tablets 100 mg contains lower doses of the same active ingredient (lamivudine) as lamivudine tablets 150 mg and 300 mg, which has activity against HIV (see 7 WARNINGS AND PRECAUTIONS, Immune). • 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 100 mg (lamivudine).
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 lamivudine tablets 100 mg.
1 Dosing Considerations Discontinuation of lamivudine tablets 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 lamivudine tablets are discontinued, patients should be periodically monitored for evidence of recurrent hepatitis (See 7 WARNINGS AND PRECAUTIONS, Immune).
APO-LAMIVUDINE HBV is contraindicated in patients who previously demonstrated clinically significant hypersensitivity to any of the components of the products (see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING, Table 1).
APO-LAMIVUDINE HBV (Lamivudine tablets) Page 5 of 34
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Elevations of CK (≥ 7 times baseline) were more common in the lamivudine treated group during treatment. Elevations of ALT (≥ 2 times baseline) were more common post-treatment in the lamivudine treated groups. In controlled trials, however, there was no appreciable difference post-treatment in clinically severe ALT elevations, associated with bilirubin elevations and/or signs of hepatic insufficiency, between lamivudine and placebo treated patients.
The relationship of these recurrent hepatitis events to lamivudine treatment or to the previous underlying disease is uncertain (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic). In patients with HIV infection, cases of pancreatitis and peripheral neuropathy (or paraesthesia) have been reported, although no relationship to treatment with lamivudine (Lamivudine tablets 150 mg and 300 mg) has been clearly established.
In patients with chronic hepatitis B there was APO-LAMIVUDINE HBV (Lamivudine tablets) Page 13 of 34 no observed difference in incidence of these events between placebo and lamivudine 100 mg tablets treated patients. Cases of lactic acidosis, usually associated with severe hepatomegaly and hepatic steatosis, have been reported with the use of combination nucleoside analogue therapy in patients with HIV.
There have been occasional reports of these adverse events in hepatitis B patients with decompensated liver disease, however, the association of lamivudine with these events has not been established. The following convention has been utilized for the classification of undesirable effects: Very common (>1/10), common (>1/100, <1/10), uncommon (>1/1,000, <1/100), rare (>1/10,000, <1/1,000), very rare (<1/10,000).
Hepatobiliary disorders Very common:
Elevations of ALT Musculoskeletal and connective tissue disorders Common: Elevations of CK Skin and subcutaneous tissue disorders Common: Rash, pruritus Several serious adverse events reported with lamivudine (lactic acidosis and severe hepatomegaly with steatosis, posttreatment exacerbations of hepatitis B, pancreatitis, and emergence of viral mutants associated with reduced drug susceptibility and diminished treatment response) are also described in 7 WARNINGS AND PRECAUTIONS Hepatic/Biliary/Pancreatic.
5 Post-Market Adverse Reactions The following events have been reported during therapy for HIV disease with lamivudine alone and in combination with other anti-retroviral agents. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made.
With many it is unclear whether they are related to the medicinal products or are as a result of the underlying disease process. Blood and lymphatic systems disorders Anaemia, neutropenia, pure red cell aplasia, thrombocytopenia, lymphadenopathy, splenomegaly APO-LAMIVUDINE HBV (Lamivudine tablets) Page 14 of 34 Metabolism and nutrition disorders Hyperlactataemia, hyperglycemia, lactic acidosis (see in 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic), redistribution/accumulation of body fat.
The incidence of this event is dependent on multiple factors including the particular antiretroviral drug combination. Nervous system disorders Headache, paraesthesia, peripheral neuropathy Gastrointestinal disorders Diarrhea, nausea, pancreatitis, rises in serum amylase, upper abdominal pain, vomiting Skin and subcutaneous tissue disorders Alopecia Musculoskeletal and connective tissue disorders Arthralgia, muscle disorders, including myalgia and cramps, rhabdomyolysis General disorders and administration site conditions Fatigue, fever, malaise Respiratory Abnormal breath sounds/wheezing
The formulation and dosage of lamivudine in APO-LAMIVUDINE HBV 100 mg tablets 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 150 mg and 300 mg tablets and Lamivudine 100 mg tablets should be consulted.
2 Recommended Dose and Dosage Adjustment The recommended dose of APO-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.
APO-LAMIVUDINE HBV (Lamivudine tablets) Page 6 of 34 Hepatic Insufficiency No dose adjustment is necessary in patients with hepatic impairment unless accompanied by renal impairment. Renal Insufficiency 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) * Oral Solution containing 5mg/mL lamivudine.
Data available in patients undergoing intermittent hemodialysis (≤ 4 hours dialysis 2 to 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.
4 Administration APO-LAMIVUDINE HBV can be taken with or without food. 5 Missed Dose If the patient forgets to take their medicine, they should take it as soon as they remember, then continue as before. 5 OVERDOSAGE For management of a suspected drug overdose, contact your regional poison control centre.
No specific signs or symptoms have been identified following acute overdose with lamivudine, apart from those listed as adverse reactions. If overdose occurs the patient should be monitored and standard supportive treatment applied.
APO-LAMIVUDINE HBV (Lamivudine tablets) Page 7 of 34 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.
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Route of Administration, Dosage Forms/Strengths, and Non-medicinal Ingredients Route of Administration Dosage Form / Strength Non-medicinal Ingredients Oral Tablets / 100 mg colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose anhydrous, magnesium stearate, polyethylene glycol, red ferric iron oxide #34690, titanium dioxide and yellow ferric oxide.
Dosage Forms and Packaging APO-LAMIVUDINE HBV (lamivudine) 100 mg tablets:
Each orange-brown, capsule shaped, biconvex film coated tablet, engraved “APO” on one side and “LMV 100” on the other side contains lamivudine methanol solvate equivalent to 100 mg lamivudine. Available in bottles of 60 and 100 tablets.
7 WARNINGS AND PRECAUTIONS Please see the 3 SERIOUS WARNINGS AND PRECAUTIONS BOX at the beginning of Part I: Health Professional Information. 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. viral load increase or increase in liver enzyme levels) or other discordant […]