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Lamivudine and Zidovudine
Overview
What is Lamivudine and Zidovudine?
Lamivudine and zidovudine tablets USP are combination tablets containing lamivudine and zidovudine. Lamivudine (EPIVIR ) and zidovudine (RETROVIR , azidothymidine, AZT, or ZDV) are synthetic nucleoside analogues with activity against HIV-1.
Lamivudine and zidovudine tablets USP are for oral administration. Each film-coated tablet contains 150 mg of lamivudine, 300 mg of zidovudine, and the inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide.
Lamivudine:
The chemical name of lamivudine is (-)-1-[(2
,5
)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl] cytosine. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has the following structural formula:
C
H
N
O
S M.W. 229.26
Lamivudine is a white to off-white solid with a solubility of approximately 70 mg/mL in water at 20°C.
Zidovudine:
The chemical name of zidovudine is 3′-azido-3′-deoxy-thymidine. It has the following structural formula:
C
H
N
O
M.W. 267.24
Zidovudine is a white to yellowish powder sparingly soluble in water and freely soluble in alcohol.
What does Lamivudine and Zidovudine look like?
What are the available doses of Lamivudine and Zidovudine?
Tablets: Scored 150 mg lamivudine and 300 mg zidovudine (
)
What should I talk to my health care provider before I take Lamivudine and Zidovudine?
Pregnancy: Physicians are encouraged to register patients in the Antiretroviral Pregnancy Registry by calling 1-800-258-4263. (
)
Nursing Mothers: HIV-1 infected mothers in the United States should not breastfeed to avoid potential postnatal transmission of HIV-1. (
)
How should I use Lamivudine and Zidovudine?
Lamivudine and zidovudine tablets, a combination of two nucleoside analogues, are indicated in combination with other antiretrovirals for the treatment of HIV-1 infection.
The recommended oral dose of lamivudine and zidovudine tablets USP in HIV-1-infected adults and adolescents weighing greater than or equal to 30 kg is 1 tablet (containing 150 mg of lamivudine and 300 mg of zidovudine) twice daily.
What interacts with Lamivudine and Zidovudine?
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What are the warnings of Lamivudine and Zidovudine?
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What are the precautions of Lamivudine and Zidovudine?
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What are the side effects of Lamivudine and Zidovudine?
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What should I look out for while using Lamivudine and Zidovudine?
Lamivudine and zidovudine tablets are contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., anaphylaxis, Stevens-Johnson syndrome) to any of the components of the product.
Hematologic Toxicity: Zidovudine, one of the 2 active ingredients in lamivudine and zidovudine tablets, has been associated with hematologic toxicity including neutropenia and anemia, particularly in patients with advanced HIV-1 disease [
].
Myopathy: Prolonged use of zidovudine has been associated with symptomatic myopathy [
].
Lactic Acidosis and Severe Hepatomegaly: Lactic acidosis and hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including lamivudine, zidovudine, and other antiretrovirals. Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur [
].
Exacerbations of Hepatitis B: Severe, acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and HIV-1 and have discontinued lamivudine, which is one component of lamivudine and zidovudine tablets. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue lamivudine and zidovudine tablets and are co-infected with HIV-1 and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted [
].
What might happen if I take too much Lamivudine and Zidovudine?
Lamivudine and zidovudine tablets:
Lamivudine:
Zidovudine:
O
D
How should I store and handle Lamivudine and Zidovudine?
Protect from light. Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [].Lamivudine and zidovudine tablets USP, containing 150 mg lamivudine and 300 mg zidovudine, are available as white, scored, film-coated, convex, oval tablets, debossed on both tablet faces, such that when broken in half, the full "TVL2" code is present on both halves of the tablet ("TV" on one face and "L2" on the opposite face of the tablet) in bottles of 60 (NDC 42291-363-60).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Lamivudine and zidovudine tablets USP, containing 150 mg lamivudine and 300 mg zidovudine, are available as white, scored, film-coated, convex, oval tablets, debossed on both tablet faces, such that when broken in half, the full "TVL2" code is present on both halves of the tablet ("TV" on one face and "L2" on the opposite face of the tablet) in bottles of 60 (NDC 42291-363-60).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Lamivudine and zidovudine tablets USP, containing 150 mg lamivudine and 300 mg zidovudine, are available as white, scored, film-coated, convex, oval tablets, debossed on both tablet faces, such that when broken in half, the full "TVL2" code is present on both halves of the tablet ("TV" on one face and "L2" on the opposite face of the tablet) in bottles of 60 (NDC 42291-363-60).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Lamivudine and zidovudine tablets USP, containing 150 mg lamivudine and 300 mg zidovudine, are available as white, scored, film-coated, convex, oval tablets, debossed on both tablet faces, such that when broken in half, the full "TVL2" code is present on both halves of the tablet ("TV" on one face and "L2" on the opposite face of the tablet) in bottles of 60 (NDC 42291-363-60).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Lamivudine and zidovudine tablets are an antiviral agent [
].
Non-Clinical Toxicology
Lamivudine and zidovudine tablets are contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., anaphylaxis, Stevens-Johnson syndrome) to any of the components of the product.Hematologic Toxicity: Zidovudine, one of the 2 active ingredients in lamivudine and zidovudine tablets, has been associated with hematologic toxicity including neutropenia and anemia, particularly in patients with advanced HIV-1 disease [ ].
Myopathy: Prolonged use of zidovudine has been associated with symptomatic myopathy [ ].
Lactic Acidosis and Severe Hepatomegaly: Lactic acidosis and hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including lamivudine, zidovudine, and other antiretrovirals. Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur [ ].
Exacerbations of Hepatitis B: Severe, acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and HIV-1 and have discontinued lamivudine, which is one component of lamivudine and zidovudine tablets. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue lamivudine and zidovudine tablets and are co-infected with HIV-1 and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted [ ].
Ketorolac is highly bound to human plasma protein (mean 99.2%). There is no evidence in animal or human studies that ketorolac tromethamine induces or inhibits hepatic enzymes capable of metabolizing itself or other drugs.
Zidovudine, a component of lamivudine and zidovudine tablets, has been associated with hematologic toxicity including neutropenia and anemia, particularly in patients with advanced HIV-1 disease. Lamivudine and zidovudine tablets should be used with caution in patients who have bone marrow compromise evidenced by granulocyte count less than 1,000 cells/mm or hemoglobin less than 9.5 g/dL [ ].
Frequent blood counts are strongly recommended in patients with advanced HIV-1 disease who are treated with lamivudine and zidovudine tablets. Periodic blood counts are recommended for other HIV-1-infected patients. If anemia or neutropenia develops, dosage interruption may be needed.
The following adverse reactions are discussed in greater detail in other sections of the labeling:
Hematologic toxicity, including neutropenia and anemia [ ].
Symptomatic myopathy [ ].
Lactic acidosis and hepatomegaly with steatosis [ ].
Acute exacerbations of hepatitis B [ ].
Hepatic decompensation in patients co-infected with HIV-1 and hepatitis C [ ].
Exacerbation of anemia in HIV-1/HCV co-infected patients receiving ribavirin and zidovudine [ ].
Pancreatitis [ ].
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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