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LAMIVUDINE is a brand name for Lamivudine, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ....................................................................................................3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Serious Warnings and Precautions Lactic Acidosis and Severe Hepatomegaly with Steatosis Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including lamivudine and other antiretrovirals (see WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic).
Post-Treatment Exacerbations of Hepatitis B Severe acute exacerbations of hepatitis B have been reported in patients who are infected with hepatitis B virus (HBV) and have discontinued lamivudine. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue lamivudine.
If appropriate, initiation of anti-hepatitis B therapy may be warranted. Pancreatitis in Pediatric Patients In pediatric patients with a history of prior antiretroviral nucleoside exposure, a history of pancreatitis, or other significant risk factors for the development of pancreatitis, lamivudine should be used with caution.
Treatment with lamivudine should be stopped immediately if clinical signs, symptoms, or laboratory abnormalities suggestive of pancreatitis occur (see ADVERSE REACTIONS section). General Lamivudine oral solution should not be administered concomitantly with other products containing lamivudine including HEPTOVIR® Tablets and Oral solution, COMBIVIR® Tablets, KIVEXA® Tablets, or TRIZIVIR® Tablets.
Lamivudine oral solution should also not be administered concomitantly with emtricitabine containing products, including ATRIPLA® Tablets, EMTRIVA® Capsules, TRUVADA® Tablets, COMPLERA® Tablets, or STRIBILD™ Tablets. Evidence for once-daily dosing using the 300 mg dose is mainly in antiretroviral naive patients.
Patients receiving lamivudine oral solution or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection. Therefore, patients should remain under close observation by physicians experienced in the treatment of patients with HIV-associated diseases.
Patients should be advised that current antiretroviral therapy, including lamivudine, has not been proven to prevent the risk of transmission of HIV to others through sexual contact or blood contamination. Appropriate precautions should continue to be employed.
5 of 41 Diabetic patients should be advised that an adult dose of lamivudine oral solution contains 3 g of sucrose. Endocrine and Metabolism Serum lipids and blood glucose Serum lipid and blood glucose levels may increase during antiretroviral therapy.
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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Disease control and life style changes may also be contributing factors. Consideration should be given to the measurement of serum lipids and blood glucose. Lipid disorders and blood glucose elevations should be managed as clinically appropriate.
Hematologic Very rare occurrences of pure red cell aplasia have been reported with lamivudine use. Discontinuation of lamivudine has resulted in normalization of hematologic parameters in patients with suspected lamivudine-induced pure red cell aplasia.
Hepatic/Biliary/Pancreatic Pancreatitis Pancreatitis has been observed in some patients receiving nucleoside analogues, including lamivudine. However it is unclear whether this was due to treatment with the medicinal product or to the underlying HIV disease.
Pancreatitis must be considered whenever a patient develops abdominal pain, nausea, vomiting or elevated biochemical markers. Discontinue use of lamivudine until diagnosis of pancreatitis is excluded. Use With Interferon-and Ribavirin-Based Regimens In vitro studies have shown ribavirin can reduce the phosphorylation of pyrimidine nucleoside analogues such as lamivudine.
, loss of HIV/HCV virologic suppression) was seen when ribavirin was coadministered with lamivudine in HIV/HCV co-infected patients, hepatic decompensation (some fatal) has occurred in HIV/HCV co-infected patients receiving combination antiretroviral therapy for HIV and interferon alfa with or without ribavirin.
Patients receiving interferon alfa with or without ribavirin and lamivudine should be closely monitored for treatment-associated toxicities, especially hepatic decompensation. Discontinuation of lamivudine should be considered as medically appropriate.
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 either alone or in combination, including lamivudine.
A majority of these cases have been in women. Clinical features which may be indicative of the development of lactic acidosis include generalized weakness, anorexia and sudden unexplained weight loss, gastrointestinal symptoms and respiratory symptoms (dyspnea and tachypnea).
Caution should be exercised when administering lamivudine oral solution or other nucleoside analogues, particularly to those with known risk factors for liver disease. Treatment with 6 of 41 lamivudine oral solution should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis with or without hepatitis (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations).
Patients Co-infected with Hepatitis B virus Clinical trials and marketed use of lamivudine oral solution have shown that some patients with chronic hepatitis B virus (HBV) disease may experience clinical or laboratory evidence of recurrent hepatitis upon discontinuation of lamivudine oral solution, which may have more severe consequences in patients with decompensated liver disease.
If lamivudine oral solution is discontinued in a patient with HIV and HBV coinfection, periodic monitoring of both liver function tests and markers of HBV replication should be considered. Emergence of Lamivudine-Resistant HBV In non–HIV-1-infected patients […]