Lamivudine and Zidovudine 150 mg; 300 mg Tablet, Film Coated, 60-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor class.
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🏭 Manufacturer & labeler
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🩺 Clinical
The combination of lamivudine and zidovudine is used to treat human immunodeficiency virus (HIV) infection. Lamivudine and zidovudine are in a class of medications called nucleoside reverse transcriptase inhibitors (NRTIs). They work by decreasing the amount of HIV in the blood. Although the combination of lamivudine and zidovudine will not cure HIV, it may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses. Taking these medications and making other life-style changes may also decrease the risk of giving the HIV virus to other people.
Read the full MedlinePlus article ↗- No, lamivudine and zidovudine doesn't cure HIV. What it does is help control it. The two drugs in this tablet block an enzyme HIV needs to make copies of itself. Less copying means...
- What exactly does this medicine do — does it cure HIV?
- No — this tablet always needs to be taken alongside at least one other antiretroviral medicine. Using it alone isn't recommended because HIV is more likely to develop resistance an...
- Can I take this tablet on its own to treat my HIV?
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
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Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
7 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $2.47 | $148.18 / 60 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Lamivudine and Zidovudine 150 mg/1; 300 mg 33342-0003-09 | Macleods | 60 tablets | $0.735 | AB | Availability likely | — |
| LAMIVUDINE and ZIDOVUDINE 150 mg/1; 300 mg 31722-0506-05 | Camber | 500 tablets | — | AB | FDA listed | — |
| Lamivudine and Zidovudine 150 mg/1; 300 mg 31722-0739-05 | Camber | 500 tablets | — | AB | FDA listed | — |
| LAMIVUDINE and ZIDOVUDINE 150 mg/1; 300 mg 43063-0900-06 | PD-Rx | 6 tablets | — | AB | FDA listed | — |
| Combivir 150 mg/1; 300 mg 49702-0202-18 | ViiV | 60 tablets | — | — | FDA listed | — |
| Lamivudine and Zidovudine 150 mg/1; 300 mg 65862-0036-10 | Aurobindo | 10 tablets | — | — | FDA listed | — |
| LAMIVUDINE and ZIDOVUDINE 150 mg/1; 300 mg 71335-0639-01 | Bryant | 6 tablets | — | AB | FDA listed | — |
| Lamivudine and Zidovudine 150 mg/1; 300 mg 71335-1916-01 | Bryant | 6 tablets | — | AB | FDA listed | — |
| Lamivudine And Zidovudine 150 mg/1; 300 mg 72865-0144-60 | XLCare | 60 tablets | — | AB | FDA listed | — |
| Lamivudine and Zidovudine 150 mg/1; 300 mgthis 76282-0115-60 | Exelan | 60 tablets | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 76282-0115-05 | 500 TABLET, FILM COATED in 1 BOTTLE (76282-115-05) | 2015-04-29 | Active |
| 76282-0115-60 You're viewing this | 60 TABLET, FILM COATED in 1 BOTTLE (76282-115-60) | 2015-04-29 | Active |
You're viewing the smallest of 2 pack sizes for this product.
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🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: HEMATOLOGIC TOXICITY, MYOPATHY, LACTIC ACIDOSIS, EXACERBATIONS OF HEPATITIS B 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 [See Warnings and Precautions (5.1) ]. Myopathy: Prolonged use of zidovudine has been associated with symptomatic myopathy [see Warnings and Precautions (5.2) ]. 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 [see Warnings and Precautions (5.3) ]. 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 tablet and are co-infected with HIV-1 and HBV.
If appropriate, initiation of anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.4) ]. WARNING: RISK OF HEMATOLOGIC TOXICITY, MYOPATHY, LACTIC ACIDOSIS, EXACERBATONS OF HEPATITIS B See full prescribing information for complete boxed warning. Hematologic toxicity including neutropenia and anemia have been associated with the use of zidovudine, one of the components of lamivudine and zidovudine tablet (5.1) Symptomatic myopathy associated with prolonged use of zidovudine.
(5.1) Symptomatic myopathy associated with prolonged use of zidovudine. (5.2) Lactic acidosis and hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues including zidovudine. Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur.
(5.3) Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immuno deficiency virus (HIV-l) and have discontinued lamivudine, a component of lamivudine and zidovudine tablet. Monitor hepatic function closely in these patients and, if appropriate, initiate anti-hepatitis B treatment. (5.4)
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Lamivudine and Zidovudine Tablet, USP a combination of two nucleoside analogues, is indicated in combination with other antiretrovirals for the treatment of HIV-1 infection. Lamivudine and Zidovudine Tablets USP, a combination of two nucleoside analogue reverse transcriptase inhibitors, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. (1)
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Adults and Adolescents weighing ≥30 kg: 1 tablet twice daily. (2.1) Pediatrics: Dosage should be based on body weight not to exceed adult doses. (2.2) Lamivudine and Zidovudine Tablets, a fixed-dose product, should not be prescribed for pediatric patients weighing less than 30 kg or patients requiring dosage adjustment, such as those with renal or hepatic impairment, or patients experiencing dose-limiting adverse reactions.
(2.3)
2.1Adults and Adolescents Weighing ≥30 kg The recommended oral dose of lamivudine and zidovudine tablet 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.
2.2Pediatric Patients The recommended oral dosage of lamivudine and zidovudine tablets for pediatric patients who weigh greater than or equal to 30 kg and for whom a solid oral dosage form is appropriate is 1 tablet administered twice daily. Before prescribing lamivudine and zidovudine tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow a lamivudine and zidovudine tablet, the liquid oral formulations should be prescribed: lamivudine oral solution and zidovudine oral solution.
2.3Patients Requiring Dosage Adjustment Because lamivudine and zidovudine is a fixed-dose combination tablet, it should not be prescribed for pediatric patients weighing less than 30 kg or patients requiring dosage adjustment, such as those with reduced renal function (creatinine clearance less than 50 mL/min), patients with hepatic impairment, or patients experiencing dose-limiting adverse reactions. Liquid and solid oral formulations of the individual components of lamivudine and zidovudine tablet are available for these populations.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Lamivudine and Zidovudine Tablets, containing 150 mg lamivudine and 300 mg zidovudine are white to off-white, scored, capsule shaped, biconvex, film coated tablets, debossed with ‘T’ on one side and '115' on other side. Scored lamivudine and zidovudine tablets, 150 mg/300 mg (3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS 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. Lamivudine and Zidovudine Tablets are contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., anaphylaxis, Stevens-Johnson syndrome). (4)
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS See boxed warning for information about the following: hematologic toxicity, symptomatic myopathy, lactic acidosis and severe hepatomegaly, and severe acute exacerbations of hepatitis B. (5.1 , 5.2 , 5.3 , 5.4) Lamivudine and Zidovudine should not be administered with other lamivudine- or zidovudine-containing products or emtricitabine-containing products. (5.5) Hepatic decompensation, some fatal, has occurred in HIV-1/HCV co-infected patients receiving combination antiretroviral therapy and interferon alfa with/without ribavirin.
Discontinue lamivudine and zidovudine tablet as medically appropriate and consider dose reduction or discontinuation of interferon alfa, ribavirin, or both. (5.6) Exacerbation of anemia has been reported in HIV-1/HCV co-infected patients receiving ribavirin and zidovudine. Coadministration of ribavirin and zidovudine is not advised.
(5.6) Pancreatitis: Use with caution in pediatric patients with a history of pancreatitis or other significant risk factors for pancreatitis. Discontinue treatment as clinically appropriate. (5.7) Immune reconstitution syndrome (5.8) and redistribution/accumulation of body fat (5.9) have been reported in patients treated with combination antiretroviral therapy.
5.1Hemotologic Toxicity/Bone Marrow Suppression Zidovudine, a component of lamivudine and zidovudine tablet, has been associated with hematologic toxicity including neutropenia and anemia, particularly in patients with advanced HIV-1 disease. Lamivudine and zidovudine should be used with caution in patients who have bone marrow compromise evidenced by granulocyte count less than 1,000 cells/mm 3 or hemoglobin less than 9.5 g/dL [see Adverse Reactions (6.1) ]. Frequent blood counts are strongly recommended in patients with advanced HIV-1 disease who are treated with lamivudine and zidovudine.
Periodic blood counts are recommended for other HIV-1-infected patients. If anemia or neutropenia develops, dosage interruption may be needed.
5.2Myopathy Myopathy and myositis, with pathological changes similar to that produced by HIV-1 disease, have been associated with prolonged use of zidovudine, and therefore may occur with therapy with lamivudine and zidovudine.
5.3Lactic Acidosis/Hepatomegaly With Steatosis 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. A majority of these cases have been in women. Obesity and prolonged nucleoside exposure may be risk factors.
Particular caution should be exercised when administering lamivudine and zidovudine to any patient with known risk factors for liver disease; however, cases have also been reported in patients with no known risk factors. Treatment with lamivudine and zidovudine should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations).
5.4Patients With HIV-1 and Hepatitis B Virus Co-infection Posttreatment Exacerbations of Hepatitis: In clinical trials in non-HIV-1-infected patients treated with lamivudine for chronic HBV, clinical and laboratory evidence of exacerbations of hepatitis have occurred after discontinuation of lamivudine. These exacerbations have been detected primarily by serum ALT elevations in addition to re-emergence of hepatitis B viral DNA (HBV DNA). Although most events appear to have been self-limited, fatalities have been reported in some cases.
Similar events have been reported from postmarketing experience after changes from lamivudine-containing HIV-1 treatment regimens to non-lamivudine-containing regimens in patients infected with both HIV-1 and HBV. The causal relationship to discontinuation of lamivudine treatment is unknown. Patients should be closely monitored with both clinical…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail 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 hepatomegaly with steatosis [see Boxed Warning , Warnings and Precautions (5.3) ].
Acute 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 (5.6) ]. Exacerbation of anemia in HIV-1/HCV co-infected patients receiving ribavirin and zidovudine [see Warnings and Precautions (5.6) ].
Pancreatitis [see Warnings and Precautions (5.7) ]. Most commonly reported adverse reactions (incidence greater than or equal to 15%) in adult and pediatric HIV-1 clinical studies 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 Exelan Pharmaceuticals, Inc., 1-855-295-7455 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical 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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Lamivudine Plus Zidovudine Administered As Separate Formulations: In 4 randomized, controlled trials of lamivudine 300 mg per day plus zidovudine 600 mg per day, the following selected adverse reactions and laboratory abnormalities were observed (see Tables 1 and 2).
Table 1. Selected Clinical Adverse Reactions (≥5% Frequency) in 4 Controlled Clinical Trials With lamivudine 300 mg/day and zidovudine 600 mg/day Adverse Reaction Lamivudine plus Zidovudine (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 patients (0.3%) who received lamivudine in controlled clinical trials [see Warnings and Precautions (5.7) ].
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 lamivudine 300 mg/day plus zidovudine 600 mg/day a Test (Abnormal Level) Lamivudine plus Zidovudine % (n) ULN = Upper limit of normal.
ANC = Absolute neutrophil count. n = Number of patients assessed. * Frequencies of these laboratory abnormalities were higher in patients with mild laboratory abnormalities at baseline. Neutropenia (ANC<750/mm 3 ) 7.2% (237) Anemia (Hgb<8 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 (>2.5x ULN) 0.8% (241) Amylase (>2.0 x ULN) 4.2% (72)
6.2Postmarketing Experience In addition to adverse reactions reported from clinical trials, the following reactions have been identified during post-approval use of lamivudine, zidovudine, and/or lamivudine and zidovudine tablet. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to lamivudine, zidovudine, and/or lamivudine and zidovudine tablet.
Body as a Whole: Redistribution/accumulation of body fat [see Warnings and Precautions (5.9) ]. Cardiovascular: Car…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS No drug interaction studies have been conducted using lamivudine and zidovudine tablets [see Clinical Pharmacology (12.3) ]. Concomitant use with the following drugs should be avoided: stavudine (7.1) , zalcitabine (7.1) , doxorubicin. (7.2) Bone marrow suppressive/cytotoxic agents: May increase the hematologic toxicity of zidovudine. (7.3)
7.1Antiretroviral Agents Lamivudine: Zalcitabine: Lamivudine and zalcitabine may inhibit the intracellular phosphorylation of one another. Therefore, use of lamivudine and zidovudine tablet in combination with zalcitabine is not recommended. Zidovudine: Stavudine: Concomitant use of lamivudine and zidovudine tablet with stavudine should be avoided since an antagonistic relationship with zidovudine has been demonstrated in vitro .
Nucleoside Analogues Affecting DNA Replication: Some nucleoside analogues affecting DNA replication, such as ribavirin, antagonize the in vitro antiviral activity of zidovudine against HIV-1; concomitant use of such drugs should be avoided.
7.2Doxorubicin Zidovudine: Concomitant use of lamivudine and zidovudine tablet with doxorubicin should be avoided since an antagonistic relationship with zidovudine has been demonstrated in vitro .
7.3Hematologic/Bone Marrow Suppressive/Cytotoxic Agents Zidovudine: Coadministration of ganciclovir, interferon alfa, ribavirin, and other bone marrow suppressive or cytotoxic agents may increase the hematologic toxicity of zidovudine.
7.4Interferon- and Ribavirin-Based Regimens Lamivudine: Although no evidence of a pharmacokinetic or pharmacodynamic interaction (e.g., loss of HIV-1/HCV virologic suppression) was seen when ribavirin was coadministered with lamivudine in HIV-1/HCV co-infected patients, hepatic decompensation (some fatal) has occurred in HIV-l/HCV co-infected patients receiving combination antiretroviral therapy for HIV-1 and interferon alfa with or without ribavirin [see Warnings and Precautions (5.5) , Clinical Pharmacology (12.3) ].
7.5Trimethoprim/Sulfamethoxazole (TMP/SMX) Lamivudine: No change in dose of either drug is recommended. There is no information regarding the effect on lamivudine pharmacokinetics of higher doses of TMP/SMX such as those used to treat PCP.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Nursing Mothers: HIV-1 infected mothers in the United States should not breastfeed to avoid potential postnatal transmission of HIV-1. (8.3)
8.1Pregnancy Teratogenic Effects: Pregnancy Category C. Fetal Risk Summary: There are no adequate and well-controlled studies of lamivudine and zidovudine tablet in pregnant women. Clinical trial data demonstrate that maternal zidovudine treatment during pregnancy reduces vertical transmission of HIV-1 infection to the fetus.
Animal reproduction studies performed with lamivudine and zidovudine showed increased embryotoxicity fetal malformations (zidovudine), and increased embryolethality (lamivudine). Lamivudine and Zidovudine Tablet should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Clinical Considerations: Treatment of HIV during pregnancy optimizes the health of both mother and fetus.
Clinical trial data reviewed by FDA demonstrate that maternal zidovudine treatment significantly reduces vertical transmission of HIV-1 infection to the fetus [see Clinical Studies (14.2) ]. Published data suggest that combination antiretroviral regimens may reduce the rate of vertical transmission even further. Pharmacokinetics of lamivudine and zidovudine in pregnant women are similar to the pharmacokinetics in nonpregnant women.
No dose adjustments are needed during pregnancy. In a clinical trial, adverse events among HIV-1-infected women were not different among untreated women and women treated with zidovudine. It is not known whether risks of adverse events associated with lamivudine are altered in pregnant women compared with other HIV-1-infected patients (see Human data below).
Data: Human Data: Lamivudine: Lamivudine pharmacokinetics were studied in pregnant women during 2 clinical studies conducted in South Africa. The study assessed pharmacokinetics in: 16 women at 36 weeks gestation using 150 mg lamivudine twice daily with zidovudine, 10 women at 38 weeks gestation using 150 mg lamivudine twice daily with zidovudine, and 10 women at 38 weeks gestation using lamivudine 300 mg twice daily without other antiretrovirals. Lamivudine pharmacokinetics in pregnant women were similar to those seen in nonpregnant adults and in postpartum women.
Lamivudine concentrations were generally similar in maternal, neonatal, and umbilical cord serum samples. Zidovudine: A randomized, double-blind, placebo-controlled trial was conducted in HIV-1-infected pregnant women to determine the utility of zidovudine for the prevention of maternal-fetal HIV-1 transmission. Zidovudine treatment during pregnancy reduced the rate of maternal-fetal HIV-1 transmission from 24.9% for infants born to placebo-treated mothers to 7.8% for infants born to mothers treated with zidovudine.
There were no differences in pregnancy-related adverse events between the treatment groups. Congenital abnormalities occurred with similar frequency between neonates born to mothers who received zidovudine and neonates born to mothers who received placebo. The observed abnormalities included problems in embryogenesis (prior to 14 weeks) or were recognized on ultrasound before or immediately after initiation of study drug [see Clinical Studies (14.2) ].
Zidovudine pharmacokinetics were studied in a Phase 1 study of 8 women during the last trimester of pregnancy. As pregnancy progressed, there was no evidence of drug accumulation. The pharmacokinetics of zidovudine were similar to that of nonpregnant adults.
Consistent with passive transmission of the drug across the placenta, zidovudine concentrations in neonatal plasma at birth were essentially equal to those in maternal plasma at delivery. Animal Data: Lamivudine: Animal reproduction studies performed at oral doses up to 130 and 60 times the adult dose in rats and rabbits, respectively, revealed no evidence of teratogenicity due to lamivudine. Increased early embryolethality occurred in rabbits at exposure levels sim…
🤰 Pregnancy ▾
8.1Pregnancy Teratogenic Effects: Pregnancy Category C. Fetal Risk Summary: There are no adequate and well-controlled studies of lamivudine and zidovudine tablet in pregnant women. Clinical trial data demonstrate that maternal zidovudine treatment during pregnancy reduces vertical transmission of HIV-1 infection to the fetus.
Animal reproduction studies performed with lamivudine and zidovudine showed increased embryotoxicity fetal malformations (zidovudine), and increased embryolethality (lamivudine). Lamivudine and Zidovudine Tablet should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Clinical Considerations: Treatment of HIV during pregnancy optimizes the health of both mother and fetus.
Clinical trial data reviewed by FDA demonstrate that maternal zidovudine treatment significantly reduces vertical transmission of HIV-1 infection to the fetus [see Clinical Studies (14.2) ]. Published data suggest that combination antiretroviral regimens may reduce the rate of vertical transmission even further. Pharmacokinetics of lamivudine and zidovudine in pregnant women are similar to the pharmacokinetics in nonpregnant women.
No dose adjustments are needed during pregnancy. In a clinical trial, adverse events among HIV-1-infected women were not different among untreated women and women treated with zidovudine. It is not known whether risks of adverse events associated with lamivudine are altered in pregnant women compared with other HIV-1-infected patients (see Human data below).
Data: Human Data: Lamivudine: Lamivudine pharmacokinetics were studied in pregnant women during 2 clinical studies conducted in South Africa. The study assessed pharmacokinetics in: 16 women at 36 weeks gestation using 150 mg lamivudine twice daily with zidovudine, 10 women at 38 weeks gestation using 150 mg lamivudine twice daily with zidovudine, and 10 women at 38 weeks gestation using lamivudine 300 mg twice daily without other antiretrovirals. Lamivudine pharmacokinetics in pregnant women were similar to those seen in nonpregnant adults and in postpartum women.
Lamivudine concentrations were generally similar in maternal, neonatal, and umbilical cord serum samples. Zidovudine: A randomized, double-blind, placebo-controlled trial was conducted in HIV-1-infected pregnant women to determine the utility of zidovudine for the prevention of maternal-fetal HIV-1 transmission. Zidovudine treatment during pregnancy reduced the rate of maternal-fetal HIV-1 transmission from 24.9% for infants born to placebo-treated mothers to 7.8% for infants born to mothers treated with zidovudine.
There were no differences in pregnancy-related adverse events between the treatment groups. Congenital abnormalities occurred with similar frequency between neonates born to mothers who received zidovudine and neonates born to mothers who received placebo. The observed abnormalities included problems in embryogenesis (prior to 14 weeks) or were recognized on ultrasound before or immediately after initiation of study drug [see Clinical Studies (14.2) ].
Zidovudine pharmacokinetics were studied in a Phase 1 study of 8 women during the last trimester of pregnancy. As pregnancy progressed, there was no evidence of drug accumulation. The pharmacokinetics of zidovudine were similar to that of nonpregnant adults.
Consistent with passive transmission of the drug across the placenta, zidovudine concentrations in neonatal plasma at birth were essentially equal to those in maternal plasma at delivery. Animal Data: Lamivudine: Animal reproduction studies performed at oral doses up to 130 and 60 times the adult dose in rats and rabbits, respectively, revealed no evidence of teratogenicity due to lamivudine. Increased early embryolethality occurred in rabbits at exposure levels similar to those in humans.
However, there was no indication of this effect in rats at exposure levels up to 35 times those in humans. Based on animal studies, lamivudine cro…
🧒 Pediatric Use ▾
8.4Pediatric Use Lamivudine and Zidovudine should not be administered to pediatric patients weighing less than 30 kg, because it is a fixed-dose combination that cannot be adjusted for this patient population.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of lamivudine and zidovudine tablet did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Lamivudine and Zidovudine is not recommended for patients with impaired renal function (i.e., creatinine clearance less than 50 mL/min) because it is a fixed-dose combination that cannot be adjusted.
🆘 Overdosage ▾
10 OVERDOSAGE Lamivudine and Zidovudine Tablet: There is no known antidote for lamivudine and zidovudine tablet. Lamivudine: One case of an adult ingesting 6 grams of lamivudine was reported; there were no clinical signs or symptoms noted and hematologic tests remained normal. Because a negligible amount of lamivudine was removed via (4-hour) hemodialysis, continuous ambulatory peritoneal dialysis, and automated peritoneal dialysis, it is not known if continuous hemodialysis would provide clinical benefit in a lamivudine overdose event.
Zidovudine: Acute overdoses of zidovudine have been reported in pediatric patients and adults. These involved exposures up to 50 grams. The only consistent findings were nausea and vomiting.
Other reported occurrences included headache, dizziness, drowsiness, lethargy, confusion, and 1 report of a grand mal seizure. Hematologic changes were transient. All patients recovered.
Hemodialysis and peritoneal dialysis appear to have a negligible effect on the removal of zidovudine, while elimination of its primary metabolite, 3’-azido-3’-deoxy-5’- O -β- D -glucopyranuronosylthymidine (GZDV), is enhanced.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Lamivudine and Zidovudine Tablet is an antiviral agent [see Clinical Pharmacology (12.4) ].
12.3Pharmacokinetics Pharmacokinetics in Adults: Lamivudine and Zidovudine Tablet: One lamivudine and zidovudine tablet was bioequivalent to 1 lamivudine tablet (150 mg) plus 1 zidovudine tablet (300 mg) following single-dose administration to fasting healthy subjects (n = 24). Lamivudine: The pharmacokinetic properties of lamivudine in fasting patients are summarized in Table 3. Following oral administration, lamivudine is rapidly absorbed and extensively distributed.
Binding to plasma protein is low. Approximately 70% of an intravenous dose of lamivudine is recovered as unchanged drug in the urine. Metabolism of lamivudine is a minor route of elimination.
In humans, the only known metabolite is the trans-sulfoxide metabolite (approximately 5% of an oral dose after 12 hours). Zidovudine: The pharmacokinetic properties of zidovudine in fasting patients are summarized in Table 3. Following oral administration, zidovudine is rapidly absorbed and extensively distributed.
Binding to plasma protein is low. Zidovudine is eliminated primarily by hepatic metabolism. The major metabolite of zidovudine is GZDV.
GZDV area under the curve (AUC) is about 3-fold greater than the zidovudine AUC. Urinary recovery of zidovudine and GZDV accounts for 14% and 74% of the dose following oral administration, respectively. A second metabolite, 3’-amino-3’-deoxythymidine (AMT), has been identified in plasma.
The AMT AUC was one-fifth of the zidovudine AUC. Table 3. Pharmacokinetic Parameters* for Lamivudine and Zidovudine in Adults Parameter Lamivudine Zidovudine * Data presented as mean ± standard deviation except where noted. † Median [range]. ‡ Children. § Adults. ║ Approximate range.
Oral bioavailability (%) 86 ± 16 N=12 64 ± 10 n = 5 Apparent volume of distribution (L/kg) 1.3 ±
0.4N = 20 1.6 ± 0.6 n = 8 Plasma protein binding (%) <36 <38 CSF:plasma ratio † 0.12 [0.04 to 0.47] n = 38 ‡ 0.60 [0.04 to 2.62] N = 39 § Systemic clearance (L/hr/kg) 0.33 ±
0.06N = 20 1.6 ± 0.6 n = 6 Renal clearance (L/hr/kg) 0.22 ±
0.06N = 20 0.34 ± 0.05 n = 9 Elimination half-life (hr) ║ 5 to 7 0.5 to 3 Effect of Food on Absorption of Lamivudine and Zidovudine: Lamivudine and Zidovudine may be administered with or without food. The lamivudine and zidovudine AUC following administration of lamivudine and zidovudine with food was similar when compared to fasting healthy subjects (n = 24). Special Populations: Pregnancy: See Use in Specific Populations (8.1) .
Lamivudine and Zidovudine: No data are available. Zidovudine: Zidovudine pharmacokinetics has been studied in a Phase 1 study of 8 women during the last trimester of pregnancy. As pregnancy progressed, there was no evidence of drug accumulation.
The pharmacokinetics of zidovudine was similar to that of nonpregnant adults. Consistent with passive transmission of the drug across the placenta, zidovudine concentrations in neonatal plasma at birth were essentially equal to those in maternal plasma at delivery. Although data are limited, methadone maintenance therapy in 5 pregnant women did not appear to alter zidovudine pharmacokinetics.
In a nonpregnant adult population, a potential for interaction has been identified. Nursing Mothers: See Use in Specific Populations (8.3) . Pediatric Patients: Lamivudine and Zidovudine Tablet should not be administered to pediatric patients weighing less than 30 kg.
Geriatric Patients: The pharmacokinetics of lamivudine and zidovudine have not been studied in patients over 65 years of age. Gender: A pharmacokinetic study in healthy male (n = 12) and female (n = 12) subjects showed no gender differences in zidovudine AUC ∞ or lamivudine AUC ∞ normalized for body weight. Race: Lamivudine: There are no significant racial differences in lamivudine pharmacokinetics.
Zidovudine: The pharmacokinetics of zidovudine with respect to race have not been…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Lamivudine and Zidovudine Tablet is an antiviral agent [see Clinical Pharmacology (12.4) ].
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Lamivudine and Zidovudine Tablets, USP containing 150 mg lamivudine USP and 300 mg zidovudine USP are white to off-white, scored, capsule shaped, biconvex, film coated tablets, debossed with ‘T’ on one side and '115' on other side. They are supplied as follows: Bottle of 60 Tablets (NDC 76282-115-60) Bottle of 500 Tablets (NDC 76282-115-05) Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION Lamivudine and Zidovudine Tablets, USP: Lamivudine and Zidovudine Tablets, USP are combination tablets containing lamivudine and zidovudine. Lamivudine and zidovudine (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 USP, 300 mg of zidovudine USP, 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 2(1H) - Pyrimidinone, 4-amino-1- [2- (hydroxymethyl)-1,3-oxathio-lan-5-yl], (2R-cis)-. It has a molecular formula of C 8 H 11 N 3 O 3 S and a molecular weight of 229.26.
It has the following structural formula: Lamivudine is white to an off-white solid. Soluble in water. Zidovudine: The chemical name of zidovudine is Thymidine, 3’-azido-3’-deoxy-.
It has a molecular formula of C 10 H 13 N 5 O 4 and a molecular weight of 267.24. It has the following structural formula: Zidovudine is a white to yellowish powder. Sparingly soluble in water and soluble in alcohol.
This product meets USP Dissolution Test 2. Lamivudine Chemical Structure Zidovudine Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION
17.1Advice for the Patient Neutropenia and Anemia : Patients should be informed that the important toxicities associated with zidovudine are neutropenia and/or anemia. They should be told of the extreme importance of having their blood counts followed closely while on therapy, especially for patients with advanced HIV-1 disease [see Boxed Warning, Warnings and Precautions (5.1) ]. Myopathy: Patients should be informed that myopathy and myositis with pathological changes, similar to that produced by HIV‑1 disease, have been associated with prolonged use of zidovudine [see Warnings and Precautions (5.2) ] .
Lactic Acidosis/Hepatomegaly: Patients should be informed that some HIV medicines, including lamivudine and zidovudine tablet, can cause a rare, but serious condition called lactic acidosis with liver enlargement (hepatomegaly) [see Warnings and Precautions (5.3) ] . HIV‑1/HBV Co‑Infection: Patients co‑infected with HIV‑1 and HBV should be informed that deterioration of liver disease has occurred in some cases when treatment with lamivudine was discontinued. Patients should be advised to discuss any changes in regimen with their physician [see Warnings and Precautions (5.4) ] .
Use With Other Lamivudine-, Zidovudine-, and/or Emtricitabine‑Containing Products: Lamivudine and Zidovudine tablet should not be coadministered with drugs containing lamivudine, zidovudine, or emtricitabine, including lamivudine, EPIVIR-HBV (lamivudine), zidovudine, EPZICOM (abacavir sulfate and lamivudine), TRIZIVIR (abacavir sulfate, lamivudine, and zidovudine), ATRIPLA (efavirenz, emtricitabine, and tenofovir), EMTRIVA (emtricitabine), TRUVADA (emtricitabine and tenofovir), or COMPLERA ™ (rilpivirine/emtricitabine/tenofovir) [see Warnings and Precautions (5.5) ].
HIV‑1/HCV Co‑Infection: Patients with HIV-1/HCV co-infection should be informed that hepatic decompensation (some fatal) has occurred in HIV‑1/HCV co-infected patients receiving combination antiretroviral therapy for HIV‑1 and interferon alfa with or without ribavirin [see Warnings and Precautions (5.6) ] . Drug Interactions: Patients should be cautioned about the use of other medications, including ganciclovir, interferon alfa, and ribavirin, which may exacerbate the toxicity of zidovudine [see Drug Interactions (7.3) ] .
Redistribution/Accumulation of Body Fat: Patients should be informed that redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy and that the cause and long-term health effects of these conditions are not known at this time [see Warnings and Precautions (5.9) ] . Information About HIV-1 Infection: Lamivudine and zidovudine tablet is not a cure for HIV‑1 infection and patients may continue to experience illnesses associated with HIV‑1 infection, including opportunistic infections.
Patients should remain under the care of a physician when using lamivudine and zidovudine tablet. Patients should be advised to avoid doing things that can spread HIV-1 infection to others. Do not share needles or other injection equipment.
Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades. Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom or other barrier method to lower the chance of sexual contact with semen, vaginal secretions, or blood.
Do not breastfeed. Lamivudine and zidovudine are excreted in human breast milk. Mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk.
Patients should be informed to take all HIV medications exactly as prescribed. EPZICOM and TRIZIVIR are registered trademarks of ViiV Healthcare. The other brands listed are trademarks of their respective owners and are not trademarks of Exelan Pharmaceuticals, Inc.
The makers of these brands are not affiliated with and do not endorse Exelan Pharmaceuticals, Inc or its products. Manufac…