Lamivudine and Zidovudine
Generic: LAMIVUDINE AND ZIDOVUDINE
Basic Information
Manufacturer
Aurobindo Pharma Limited
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
d40292ff-046c-4a04-b801-10768667951a
Indications & Usage
1 INDICATIONS AND USAGE Lamivudine and Zidovudine tablets, a combination of 2 nucleoside analogues, are indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.
Lamivudine and zidovudine tablets, a combination of 2 nucleoside analogue reverse transcriptase inhibitors, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
(1)
Lamivudine and zidovudine tablets, a combination of 2 nucleoside analogue reverse transcriptase inhibitors, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
(1)
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: Hematologic toxicity, including neutropenia and anemia [see Boxed Warning , Warnings and Precautions (5.1) ].
Symptomatic myopathy [see Boxed Warning , Warnings and Precautions (5.2) ].
Lactic acidosis and severe hepatomegaly with steatosis [see Boxed Warning , Warnings and Precautions (5.3) ].
Exacerbations of hepatitis B [see Boxed Warning , Warnings and Precautions (5.4) ].
Hepatic decompensation in patients co-infected with HIV-1 and hepatitis C [see Warnings and Precautions (5.5) ].
Exacerbation of anemia in HIV-1/HCV co-infected patients receiving ribavirin and zidovudine [see Warnings and Precautions (5.5) ].
Pancreatitis [see Warnings and Precautions (5.6) ].
Immune reconstitution syndrome [see Warnings and Precautions (5.7) ].
Lipoatrophy [see Warnings and Precautions (5.8) ].
Most commonly reported adverse reactions (incidence greater than or equal to 15%) in clinical trials of combination lamivudine and zidovudine were headache, nausea, malaise and fatigue, nasal signs and symptoms, diarrhea, and cough.
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc.
at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Lamivudine plus Zidovudine Administered as Separate Formulations In 4 randomized, controlled trials of EPIVIR 300 mg per day plus RETROVIR 600 mg per day, the following selected adverse reactions and laboratory abnormalities were observed (Tables 1 and 2).
Table 1.
Selected Clinical Adverse Reactions (Greater than or Equal to 5% Frequency) in 4 Controlled Clinical Trials with EPIVIR 300 mg per day and RETROVIR 600 mg per day Adverse Reaction EPIVIR plus RETROVIR (n = 251) Body as a whole Headache 35% Malaise & fatigue 27% Fever or chills 10% Digestive Nausea 33% Diarrhea 18% Nausea & vomiting 13% Anorexia and/or decreased appetite 10% Abdominal pain 9% Abdominal cramps 6% Dyspepsia 5% Nervous system Neuropathy 12% Insomnia & other sleep disorders 11% Dizziness 10% Depressive disorders 9% Respiratory Nasal signs & symptoms 20% Cough 18% Skin Skin rashes 9% Musculoskeletal Musculoskeletal pain 12% Myalgia 8% Arthralgia 5% Pancreatitis was observed in 9 of the 2,613 adult subjects (0.3%) who received EPIVIR in controlled clinical trials [see Warnings and Precautions (5.6) ].
Selected laboratory abnormalities observed during therapy are listed in Table 2.
Table 2.
Frequencies of Selected Laboratory Abnormalities among Adults in 4 Controlled Clinical Trials of EPIVIR 300 mg per day plus RETROVIR 600 mg per day a Test (Abnormal Level) EPIVIR plus RETROVIR % (n) ULN = Upper limit of normal.
ANC = Absolute neutrophil count.
n = Number of subjects assessed.
a Frequencies of these laboratory abnormalities were higher in subjects with mild laboratory abnormalities at baseline.
Neutropenia (ANC <750/mm 3 ) 7.2% (237) Anemia (Hgb <8.0 g/dL) 2.9% (241) Thrombocytopenia (platelets <50,000/mm 3 ) 0.4% (240) ALT (>5.0 x ULN) 3.7% (241) AST (>5.0 x ULN) 1.7% (241) Bilirubin (>2.5 x ULN) 0.8% (241) Amylase (>2.0 x ULN) 4.2% (72) 6.2 Postmarketing Experience The following adverse reactions have been identified during postmarketing use.
Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Body as a Whole Redistribution/accumulation of body fat [see Warnings and Precautions (5.8) ] .
Cardiovascular Cardiomyopathy.
Endocrine and Metabolic Gynecomastia, hyperglycemia.
Gastrointestinal Oral mucosal pigmentation, stomatitis.
General Vasculitis, weakness.
Hemic and Lymphatic Anemia, (including pure red cell aplasia and anemias progressing on therapy), lymphadenopathy, splenomegaly.
Hepatic and Pancreatic Lactic acidosis and hepatic steatosis, pancreatitis, posttreatment exacerbations of hepatitis B [see Boxed Warning , Warnings and Precautions (5.3) , (5.4) , (5.6) ].
Hypersensitivity Sensitization reactions (including anaphylaxis), urticaria.
Musculoskeletal Muscle weakness, CPK elevation, rhabdomyolysis.
Nervous Paresthesia, peripheral neuropathy, seizures.
Respiratory Abnormal breath sounds/wheezing.
Skin Alopecia, erythema multiforme, Stevens-Johnson syndrome.
Symptomatic myopathy [see Boxed Warning , Warnings and Precautions (5.2) ].
Lactic acidosis and severe hepatomegaly with steatosis [see Boxed Warning , Warnings and Precautions (5.3) ].
Exacerbations of hepatitis B [see Boxed Warning , Warnings and Precautions (5.4) ].
Hepatic decompensation in patients co-infected with HIV-1 and hepatitis C [see Warnings and Precautions (5.5) ].
Exacerbation of anemia in HIV-1/HCV co-infected patients receiving ribavirin and zidovudine [see Warnings and Precautions (5.5) ].
Pancreatitis [see Warnings and Precautions (5.6) ].
Immune reconstitution syndrome [see Warnings and Precautions (5.7) ].
Lipoatrophy [see Warnings and Precautions (5.8) ].
Most commonly reported adverse reactions (incidence greater than or equal to 15%) in clinical trials of combination lamivudine and zidovudine were headache, nausea, malaise and fatigue, nasal signs and symptoms, diarrhea, and cough.
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc.
at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Lamivudine plus Zidovudine Administered as Separate Formulations In 4 randomized, controlled trials of EPIVIR 300 mg per day plus RETROVIR 600 mg per day, the following selected adverse reactions and laboratory abnormalities were observed (Tables 1 and 2).
Table 1.
Selected Clinical Adverse Reactions (Greater than or Equal to 5% Frequency) in 4 Controlled Clinical Trials with EPIVIR 300 mg per day and RETROVIR 600 mg per day Adverse Reaction EPIVIR plus RETROVIR (n = 251) Body as a whole Headache 35% Malaise & fatigue 27% Fever or chills 10% Digestive Nausea 33% Diarrhea 18% Nausea & vomiting 13% Anorexia and/or decreased appetite 10% Abdominal pain 9% Abdominal cramps 6% Dyspepsia 5% Nervous system Neuropathy 12% Insomnia & other sleep disorders 11% Dizziness 10% Depressive disorders 9% Respiratory Nasal signs & symptoms 20% Cough 18% Skin Skin rashes 9% Musculoskeletal Musculoskeletal pain 12% Myalgia 8% Arthralgia 5% Pancreatitis was observed in 9 of the 2,613 adult subjects (0.3%) who received EPIVIR in controlled clinical trials [see Warnings and Precautions (5.6) ].
Selected laboratory abnormalities observed during therapy are listed in Table 2.
Table 2.
Frequencies of Selected Laboratory Abnormalities among Adults in 4 Controlled Clinical Trials of EPIVIR 300 mg per day plus RETROVIR 600 mg per day a Test (Abnormal Level) EPIVIR plus RETROVIR % (n) ULN = Upper limit of normal.
ANC = Absolute neutrophil count.
n = Number of subjects assessed.
a Frequencies of these laboratory abnormalities were higher in subjects with mild laboratory abnormalities at baseline.
Neutropenia (ANC <750/mm 3 ) 7.2% (237) Anemia (Hgb <8.0 g/dL) 2.9% (241) Thrombocytopenia (platelets <50,000/mm 3 ) 0.4% (240) ALT (>5.0 x ULN) 3.7% (241) AST (>5.0 x ULN) 1.7% (241) Bilirubin (>2.5 x ULN) 0.8% (241) Amylase (>2.0 x ULN) 4.2% (72) 6.2 Postmarketing Experience The following adverse reactions have been identified during postmarketing use.
Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Body as a Whole Redistribution/accumulation of body fat [see Warnings and Precautions (5.8) ] .
Cardiovascular Cardiomyopathy.
Endocrine and Metabolic Gynecomastia, hyperglycemia.
Gastrointestinal Oral mucosal pigmentation, stomatitis.
General Vasculitis, weakness.
Hemic and Lymphatic Anemia, (including pure red cell aplasia and anemias progressing on therapy), lymphadenopathy, splenomegaly.
Hepatic and Pancreatic Lactic acidosis and hepatic steatosis, pancreatitis, posttreatment exacerbations of hepatitis B [see Boxed Warning , Warnings and Precautions (5.3) , (5.4) , (5.6) ].
Hypersensitivity Sensitization reactions (including anaphylaxis), urticaria.
Musculoskeletal Muscle weakness, CPK elevation, rhabdomyolysis.
Nervous Paresthesia, peripheral neuropathy, seizures.
Respiratory Abnormal breath sounds/wheezing.
Skin Alopecia, erythema multiforme, Stevens-Johnson syndrome.