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Lamivudine and Zidovudine 150 mg; 300 mg Tablet, Film Coated, 60-count — NDC 76282-0115-60 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Lamivudine and Zidovudine 150 mg; 300 mg Tablet, Film Coated, 60-count — NDC 76282-115-60 (Billing 76282-0115-60)

by Exelan Pharmaceuticals Inc. · 60 TABLET, FILM COATED in 1 BOTTLE

This is a package of 60 tablets of Lamivudine and Zidovudine 150 mg; 300 mg Tablet, Film Coated from Exelan Pharmaceuticals Inc., marketed since Apr 2015 and currently FDA-listed.

NDC 76282-0115-60
🏷️ FDA NDC (as labeled) 76282-115-60 billing pads the product segment with a zero
This package
Contains60-count Pack sizes2 compare ↓
Also priced by: Part D plans $2.47/unit — full pricing hub ↓
Product page 76282-0115-05 Also comes in: 500 tablets 76282-115-05
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 76282-115-60 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
76282 labeler · 115 product · 60 package
Package marketed since
Apr 29, 2015
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
60 EA per package
Barcode (UPC)
0376282115603
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 76282-115-60
Product NDC 76282-115
11-digit billing NDC 76282011560
NCPDP billing unit EA — each (per item)
RxCUI 200082
UNII 2T8Q726O95, 4B9XT59T7S
UPC 0376282115603
Application # ANDA203259
SPL Set ID 4cf565c3-bdec-4c18-93c1-cc7fa8331c90
Established class (EPC) Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor; Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of action Nucleoside Reverse Transcriptase Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-04-29
Route ORAL
Dosage form TABLET, FILM COATED
Substance LAMIVUDINE; ZIDOVUDINE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 034186
GCN 89621
HICL code 014014
Ingredient (HICL) Lamivudine/Zidovudine
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W5
Therapeutic class — intermediate (HIC2) Antiviral Agents
HIC3 code W5L
Therapeutic class — specific (HIC3) Antivirals, Hiv-Spec., Nucleoside Analog, Rti Comb
AHFS code 08:18.08.20
AHFS class Hiv Nucleoside, Nucleotide Rt Inhibitors
FDB label name LAMIVUDINE-ZIDOVUDINE TABLET
FDB brand name Lamivudine-Zidovudine
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 034186
  • GCN: 89621
  • HICL (First Databank): 014014
  • AHFS class code: 08:18.08.20
  • RxCUI (RxNorm): 200082
Why two NDCs? The FDA registers this code as 76282-115-60 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 76282-0115-60. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor class.

Pharmacologic class Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Drug family (ATC) Nucleoside and nucleotide reverse transcriptase inhibitors
How it works Nucleoside Reverse Transcriptase Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name LAMIVUDINE-ZIDOVUDINE TABLET Ingredient Lamivudine/Zidovudine
📗 Our plain-language guide HelloPharmacist
  • No, it doesn't cure HIV, and it's important to understand that going in. What lamivudine and zidovudine does is block a key step HIV needs to copy itself in your body. By keeping t...
  • What exactly does this medication do — does it cure HIV?
  • Please don't stop without talking to your doctor first — even if you feel completely fine. HIV treatment works by keeping the virus consistently suppressed. Stopping on your own ca...
  • Can I miss a dose or stop taking it if I feel fine?
📖 Read our full Lamivudine and Zidovudine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer eachPer 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
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
76282-0115-05 76282-115-05 Main listing 500 TABLET, FILM COATED in 1 BOTTLE 2015-04-29 — Active
76282-0115-60 You're viewing this 60 TABLET, FILM COATED in 1 BOTTLE 2015-04-29 — Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 60-count package — 60 tablet, film coated in 1 bottle.
How does this package differ from NDC 76282-0115-05?
Both are Lamivudine and Zidovudine 150 mg; 300 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 60-count one, while NDC 76282-0115-05 is the 500 tablets package.
What NDC number is used to bill for this package of Lamivudine and Zidovudine 150 mg; 300 mg Tablet, Film Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lamivudine and Zidovudine 150 mg/1; 300 mg 33342-0003-09 Macleods 60 tablets $0.771 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 —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2015
On the market since
Apr 2015
📍
2026
Currently FDA-listed
11 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color White
ShapeCapsule
ImprintT;115
Size18 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

🧪 Avoiding an ingredient? See Lamivudine and Zidovudine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 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.
  • 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.
  • UNII OP1R32D61U
    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.
  • UNII 3WJQ0SDW1A
    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.
  • UNII 6OZP39ZG8H
    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.
  • UNII 5856J3G2A2
    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.
  • 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.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerExelan Pharmaceuticals Inc.
Application holderHETERO LABS LTD UNIT V
FDA applicationANDA203259 (ANDA)
Labeler code76282
First marketedApr 2015
Product typeHuman Prescription Drug
Portfolio88 products on file

More NDCs from Exelan Pharmaceuticals Inc. labeler code 76282

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~2 min read ▾

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 57 words ▾

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 ~1 min read ▾

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 48 words ▾

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 47 words ▾

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 ~2 min read ▾

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… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

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… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

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 ~3 min read ▾

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… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

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… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use 32 words ▾

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 89 words ▾

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 158 words ▾

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 ~3 min read ▾

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… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 17 words ▾

12.1Mechanism of Action Lamivudine and Zidovudine Tablet is an antiviral agent [see Clinical Pharmacology (12.4) ].

📦 How Supplied / Storage and Handling 72 words ▾

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 190 words ▾

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 ~3 min read ▾

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… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 153 words ▾

8.3Nursing Mothers The Centers for Disease Control and Prevention recommend that HIV-1-infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection. Because of both the potential for HIV-1 transmission and serious adverse reactions in nursing infants, mothers should be instructed not to breastfeed if they are receiving lamivudine and zidovudine. Although no studies of lamivudine and zidovudine excretion in breast milk have been performed, lactation studies performed with lamivudine and zidovudine show that both drugs are excreted in human breast milk.

Samples of breast milk obtained from 20 mothers receiving lamivudine monotherapy (300 mg twice daily) or combination therapy (150 mg lamivudine twice daily and 300 mg zidovudine twice daily) had measurable concentrations of lamivudine. In another study, after administration of a single dose of 200 mg zidovudine to 13 HIV-1-infected women, the mean concentration of zidovudine was similar in human milk and serum.

🧬 Pharmacokinetics ~3 min read ▾

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 determined. Drug Interactions: See Drug Interactions (7) . No drug interaction studies have been conducted using lamivudine and zidovudine ta… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES There have been no clinical trials conducted with lamivudine and zidovudine tablet. See Clinical Pharmacology (12.3) for information about bioequivalence. One lamivudine and zidovudine tablet given twice daily is an alternative regimen to lamivudine tablets 150 mg twice daily plus zidovudine 600 mg per day in divided doses.

14.1Adults Lamivudine Plus Zidovudine: The NUCB3007 (CAESAR) study was conducted using lamivudine 150 mg tablets (150 mg twice daily) and zidovudine 100 mg capsules (2 x 100 mg 3 times daily). CAESAR was a multi-center, double-blind, placebo-controlled study comparing continued current therapy (zidovudine alone [62% of patients] or zidovudine with didanosine or zalcitabine [38% of patients]) to the addition of lamivudine or lamivudine plus an investigational non-nucleoside reverse transcriptase inhibitor, randomized 1:2:1.

A total of 1,816 HIV-1-infected adults with 25 to 250 (median 122) CD4 cells/mm 3 at baseline were enrolled: median age was 36 years, 87% were male, 84% were nucleoside-experienced, and 16% were therapy-naive. The median duration on study was 12 months. Results are summarized in Table 5.

Table 5. Number of Patients (%) With At Least 1 HIV-1 Disease-Progression Event or Death Endpoint Current Therapy (n = 460) Lamivudine plus Current Therapy (n = 896) Lamivudine plus a NNRTI* plus Current Therapy (n = 460) * An investigational non-nucleoside reverse transcriptase inhibitor not approved in the United States. HIV-1 progression or death 90 (19.6%) 86 (9.6%) 41 (8.9%) Death 27 (5.9%) 23 (2.6%) 14 (3%)

14.2Prevention of Maternal-Fetal HIV-1 Transmission The utility of zidovudine alone for the prevention of maternal-fetal HIV-1 transmission was demonstrated in a randomized, double-blind, placebo-controlled trial conducted in HIV-1-infected pregnant women with CD4+ cell counts of 200 to 1,818 cells/mm 3 (median in the treated group: 560 cells/mm 3 ) who had little or no previous exposure to zidovudine. Oral zidovudine was initiated between 14 and 34 weeks of gestation (median 11 weeks of therapy) followed by IV administration of zidovudine during labor and delivery.

Following birth, neonates received oral zidovudine syrup for 6 weeks. The study showed a statistically significant difference in the incidence of HIV-1 infection in the neonates (based on viral culture from peripheral blood) between the group receiving zidovudine and the group receiving placebo. Of 363 neonates evaluated in the study, the estimated risk of HIV-1 infection was 7.8% in the group receiving zidovudine and 24.9% in the placebo group, a relative reduction in transmission risk of 68.7%.

Zidovudine was well tolerated by mothers and infants. There was no difference in pregnancy-related adverse events between the treatment groups.

🧪 Nonclinical Toxicology ~3 min read ▾

13 NON CLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity: Lamivudine: Long-term carcinogenicity studies with lamivudine in mice and rats showed no evidence of carcinogenic potential at exposures up to 10 times (mice) and 58 times (rats) those observed in humans at the recommended therapeutic dose for HIV-1 infection. Zidovudine: Zidovudine was administered orally at 3 dosage levels to separate groups of mice and rats (60 females and 60 males in each group). Initial single daily doses were 30, 60, and 120 mg/kg/day in mice and 80, 220, and 600 mg/kg/day in rats.

The doses in mice were reduced to 20, 30, and 40 mg/kg/day after day 90 because of treatment-related anemia, whereas in rats only the high dose was reduced to 450 mg/kg/day on day 91 and then to 300 mg/kg/day on day 279. In mice, 7 late-appearing (after 19 months) vaginal neoplasms (5 nonmetastasizing squamous cell carcinomas, 1 squamous cell papilloma, and 1 squamous polyp) occurred in animals given the highest dose. One late-appearing squamous cell papilloma occurred vagina of a middle-dose animal.

No vaginal tumors were found at the lowest dose. In rats, 2 late-appearing (after 20 months), nonmetastasizing vaginal squamous cell carcinomas occurred in animals given the highest dose. No vaginal tumors occurred at the low or middle dose in rats.

No other drug-related tumors were observed in either sex of either species. At doses that produced tumors in mice and rats, the estimated drug exposure (as measured by AUC) was approximately 3 times (mouse) and 24 times (rat) the estimated human exposure at the recommended therapeutic dose of 100 mg every 4 hours. It is not known how predictive the results of rodent carcinogenicity studies may be for humans.

Mutagenicity: Lamivudine: Lamivudine was mutagenic in an L5178Y/TK +/- mouse lymphoma assay and clastogenic in a cytogenetic assay using cultured human lymphocytes. Lamivudine was negative in a microbial mutagenicity assay, in an in vitro cell transformation assay, in a rat micronucleus test, in a rat bone marrow cytogenetic assay, and in an assay for unscheduled DNA synthesis in rat liver. Zidovudine: Zidovudine was mutagenic in an L5178Y/TK +/- mouse lymphoma assay, positive in an in vitro cell transformation assay, clastogenic in a cytogenetic assay using cultured human lymphocytes, and positive in mouse and rat micronucleus tests after repeated doses.

It was negative in a cytogenetic study in rats given a single dose. Impairment of Fertility: Lamivudine: In a study of reproductive performance, lamivudine, administered to male and female rats at doses up to 130 times the usual adult dose based on body surface area considerations, revealed no evidence of impaired fertility (judged by conception rates) and no effect on the survival, growth, and development to weaning of the offspring. Zidovudine: Zidovudine, administered to male and female rats at doses up to 7 times the usual adult dose based on body surface area considerations, had no effect on fertility judged by conception rates.

13.2Reproductive and Developmental Toxicology Studies Lamivudine: Reproduction studies have been performed in rats and rabbits at orally administered doses up to 4,000 mg/kg/day and 1,000 mg/kg/day, respectively, producing plasma levels up to approximately 35 times that for the adult HIV dose. No evidence of teratogenicity due to lamivudine was observed. Evidence of early embryo lethality was seen in the rabbit at exposure levels similar to those observed in humans, but there was no indication of this effect in the rat at exposure levels up to 35 times those in humans.

Studies in pregnant rats and rabbits showed that lamivudine is transferred to the fetus through the placenta. Zidovudine: Oral teratology studies in the rat and in the rabbit at doses up to 500 mg/kg/day revealed no evidence of teratogenicity with zidovudine. Zidovudine treatment resulted in embryo/fetal toxicity as evidenced by an inc… [Excerpted — this section continues on DailyMed.]

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity: Lamivudine: Long-term carcinogenicity studies with lamivudine in mice and rats showed no evidence of carcinogenic potential at exposures up to 10 times (mice) and 58 times (rats) those observed in humans at the recommended therapeutic dose for HIV-1 infection. Zidovudine: Zidovudine was administered orally at 3 dosage levels to separate groups of mice and rats (60 females and 60 males in each group). Initial single daily doses were 30, 60, and 120 mg/kg/day in mice and 80, 220, and 600 mg/kg/day in rats.

The doses in mice were reduced to 20, 30, and 40 mg/kg/day after day 90 because of treatment-related anemia, whereas in rats only the high dose was reduced to 450 mg/kg/day on day 91 and then to 300 mg/kg/day on day 279. In mice, 7 late-appearing (after 19 months) vaginal neoplasms (5 nonmetastasizing squamous cell carcinomas, 1 squamous cell papilloma, and 1 squamous polyp) occurred in animals given the highest dose. One late-appearing squamous cell papilloma occurred vagina of a middle-dose animal.

No vaginal tumors were found at the lowest dose. In rats, 2 late-appearing (after 20 months), nonmetastasizing vaginal squamous cell carcinomas occurred in animals given the highest dose. No vaginal tumors occurred at the low or middle dose in rats.

No other drug-related tumors were observed in either sex of either species. At doses that produced tumors in mice and rats, the estimated drug exposure (as measured by AUC) was approximately 3 times (mouse) and 24 times (rat) the estimated human exposure at the recommended therapeutic dose of 100 mg every 4 hours. It is not known how predictive the results of rodent carcinogenicity studies may be for humans.

Mutagenicity: Lamivudine: Lamivudine was mutagenic in an L5178Y/TK +/- mouse lymphoma assay and clastogenic in a cytogenetic assay using cultured human lymphocytes. Lamivudine was negative in a microbial mutagenicity assay, in an in vitro cell transformation assay, in a rat micronucleus test, in a rat bone marrow cytogenetic assay, and in an assay for unscheduled DNA synthesis in rat liver. Zidovudine: Zidovudine was mutagenic in an L5178Y/TK +/- mouse lymphoma assay, positive in an in vitro cell transformation assay, clastogenic in a cytogenetic assay using cultured human lymphocytes, and positive in mouse and rat micronucleus tests after repeated doses.

It was negative in a cytogenetic study in rats given a single dose. Impairment of Fertility: Lamivudine: In a study of reproductive performance, lamivudine, administered to male and female rats at doses up to 130 times the usual adult dose based on body surface area considerations, revealed no evidence of impaired fertility (judged by conception rates) and no effect on the survival, growth, and development to weaning of the offspring. Zidovudine: Zidovudine, administered to male and female rats at doses up to 7 times the usual adult dose based on body surface area considerations, had no effect on fertility judged by conception rates.

📄 Recent Major Changes 8 words ▾

Warnings and Precautions, Immune Reconstitution Syndrome (5.8) (11/2011)

📄 Package Label / Principal Display Panel 20 words ▾

PRINCIPAL DISPLAY PANEL NDC 76282-115-60 Lamivudine and Zidovudine Tablets, USP 150/300 mg Rx only 60 Tablets EXELAN PHARMACEUTICALS, INC. 7.5mg-100

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Lamivudine and Zidovudine — the ingredient across all brands.

Top reported reactions

Drug Exposure During Pregnancy1,146
Foetal Exposure During Pregnancy720
Pain604
Anxiety570
Emotional Distress559
Anhedonia506
Anaemia453

Reporter sex

7,713 reports
Male · 47%
Female · 52%
Unknown · 1%

Serious outcomes

Death596
Disabling213
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 339 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
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.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Exelan Pharmaceuticals Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 500 tablets (76282-0115-05). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Exelan Pharmaceuticals Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 76282-0103-39 · EXELAN 76282-0152-01 · Exelan →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.