Lamivudine/Zidovudine Tablets USP 150 mg/300 mg_

Lamivudine is nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Limitations of Use: • The dosage of this product is for HIV-1 and not for HBV. Lamivudine is a nucleoside analogue reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Limitations of Use: The dosage of this product is for HIV-1 and not for HBV.( 1 )

• Adults: 300 mg daily, administered as either 150 mg twice daily or 300 mg once daily. • Pediatric Patients Aged 3 Months and Older: Administered either once or twice daily
• Dose should be calculated on body weight (kg) and should not exceed 300 mg daily. • Patients with Renal Impairment: Doses of lamivudine must be adjusted in accordance with renal function
• Recommended Dosage for Adult Patients The recommended dosage of lamivudine in HIV-1-infected
• Adults is 300 mg daily, administered as either 150 mg taken orally twice daily or 300 mg taken orally once daily with or without food
• If lamivudine is administered to a patient infected with HIV-1 and HBV, the dosage indicated for HIV-1 therapy should be used as part of an appropriate combination regimen [see Warnings and Precautions ]
• Recommended Dosage for
• Pediatric Patients Lamivudine scored tablet is the preferred formulation for HIV-1-infected
• Pediatric patients who weigh at least 14 kg and for whom a solid dosage form is appropriate
• Before prescribing lamivudine scored tablets, pediatric patients should be assessed for the ability to
• Swallow tablets.For patients unable to safely and reliably
• Swallow lamivudine tablets, the oral solution formulation may be prescribed [see Warnings and Precautions ]
• The recommended oral dosage of lamivudine for HIV-1-infected
• Pediatric patients is presented in Table 1
• Table 1. …

• Lamivudine Tablets USP (Scored) 150 mg tablets are white coloured, biconvex, capsule shaped, film-coated tablets, having score on one side and ‘ML 1’ debossed on the other side. • Lamivudine Tablets USP 300 mg tablets are grey coloured, biconvex, capsule shaped, film-coated tablets, debossed with ‘U27’ on one side and plain on the other side. …

• The safety and effectiveness of lamivudine in combination with other antiretroviral agents have been established
• Pediatric patients aged 3 months and older
• Lamivudine scored tablet is the preferred formulation for HIV-1-infected
• Pediatric patients who weigh at least 14 kg and for whom a solid dosage form is appropriate because pediatric subjects who received lamivudine oral solution had lower rates of virologic suppression, lower plasma lamivudine exposure, and developed viral resistance more frequently than those receiving lamivudine tablets in the ARROW trial [see Dosage and Administrati …

Clinical trials of lamivudine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, caution should be exercised in the administration of lamivudine in elderly patients reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see Dosage and Administration ( 2.3 ), Clinical Pharmacolo …

• Advise the patient to read the FDA-approved patient labeling (Patient Information)
• Patients with Hepatitis B or C Co-infection Inform patients co-infected with HIV-1 and HBV that deterioration of liver disease has occurred in some cases when treatment with lamivudine was discontinued
• Advise patients to discuss any changes in regimen with their healthcare provider [see Warnings and Precautions ]
• Differences in Formulations of Lamivudine Advise patients that lamivudine tablets contain a higher dose of the same active ingredient (lamivudine) as EPIVIR-HBV tablets and oral solution. …

• Lamivudine is contraindicated in patients with a previous hypersensitivity reaction to lamivudine
• Lamivudine is contraindicated in patients with previous hypersensitivity reaction to lamivudine

Sorbitol: Coadministration of lamivudine and sorbitol may decrease lamivudine concentrations; when possible, avoid chronic coadministration. ( 7.2 ) 7.1 Drugs Inhibiting Organic Cation Transporters Lamivudine is predominantly eliminated in the urine by active organic cationic secretion. The possibility of interactions with other drugs administered concurrently should be considered, particularly when their main route of elimination is active renal secretion via the organic cationic transport system (e.g., trimethoprim) [see Clinical Pharmacology ( 12.3 )]. No data are available regarding interactions with other drugs that have renal clearance mechanisms similar to that of lamivudine. …

• Co-infected HIV-1/HBV Patients: Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported. ( 5.1 ) • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues. ( 5.2 ) • Pancreatitis: Use with caution in pediatric patients with a history of pancreatitis or other significant risk factors for pancreatitis. Discontinue treatment as clinically appropriate. ( 5.3 ) • Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy. …

The following adverse reactions are discussed in other sections of the labeling: • Exacerbations of hepatitis B [see Boxed Warning, Warnings and Precautions ( 5.1 )]. • Lactic acidosis and severe hepatomegaly with steatosis [see Warnings and Precautions ( 5.2 )]. • Pancreatitis [see Warnings and Precautions ( 5.3 )]. • Immune reconstitution syndrome [see Warnings and Precautions ( 5.4 )]. • The most common reported adverse reactions (incidence greater than or equal to 15%) in adults were headache, nausea, malaise and fatigue, nasal signs and symptoms, diarrhea, and cough. …

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lamivudine during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. …

There is no known specific treatment for overdose with lamivudine. If overdose occurs, the patient should be monitored and standard supportive treatment applied as required. 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.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.