Lamivudine

LAMIVUDINE- lamivudine tablet, film coated
American Health Packaging

WARNING: EXACERBATIONS OF HEPATITIS B, and DIFFERENT FORMULATIONS OF LAMIVUDINE.

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 human immunodeficiency virus (HIV-1) and have discontinued lamivudine. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue lamivudine and are co-infected with HIV-1 and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted [see Warnings and Precautions ( 5.1)].

Important Differences among Lamivudine-Containing Products Lamivudine tablets (used to treat HIV-1 infection) contain a higher dose of the active ingredient (lamivudine) than EPIVIR-HBV tablets and oral solution (used to treat chronic HBV infection). Patients with HIV-1 infection should receive only dosage forms appropriate for treatment of HIV-1 [see Warnings and Precautions ( 5.1)].

1 INDICATIONS AND USAGE

Lamivudine tablets are a 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.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage for Adult Patients

The recommended dosage of lamivudine tablets 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 ( 5.1)].

2.2 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 ( 5.6)]. The recommended oral dosage of lamivudine tablets for HIV-1-infected pediatric patients is presented in Table 1.

Table 1. Dosing Recommendations for Lamivudine Scored (150 mg) Tablets in Pediatric Patients
*
Data regarding the efficacy of once-daily dosing is limited to subjects who transitioned from twice-daily dosing to once-daily dosing after 36 weeks of treatment [see Clinical Studies (14.2)].
Patients may alternatively take one 300 mg tablet, which is not scored.

Weight (kg)

Once-Daily Dosing Regimen *

Twice-Daily Dosing Regimen Using Scored 150 mg Tablet

AM Dose

PM Dose

Total Daily Dose

14 to <20

1 tablet (150 mg)

½ tablet (75 mg)

½ tablet (75 mg)

150 mg

≥ 20 to <25

1½ tablets (225 mg)

½ tablet (75 mg)

1 tablet (150 mg)

225 mg

≥25

2 tablets (300 mg)

1 tablet (150 mg)

1 tablet (150 mg)

300 mg

Oral Solution The recommended dosage of lamivudine oral solution in HIV-1-infected pediatric patients aged 3 months and older is 5 mg per kg taken orally twice daily or 10 mg per kg taken orally once daily (up to a maximum of 300 mg daily), administered in combination with other antiretroviral agents [see Clinical Pharmacology ( 12.3)]. Consider HIV-1 viral load and CD4+ cell count/percentage when selecting the dosing interval for patients initiating treatment with oral solution [see Warnings and Precautions ( 5.6), Clinical Pharmacology ( 12.3)].

2.3 Patients with Renal Impairment

Dosing of lamivudine tablets is adjusted in accordance with renal function. Dosage adjustments are listed in Table 2 [see Clinical Pharmacology ( 12.3)].

Table 2. Adjustment of Dosage of Lamivudine in Adults and Adolescents (Greater than or Equal to 25 kg) in Accordance with Creatinine Clearance

Creatinine Clearance (mL/min)

Recommended Dosage of Lamivudine

≥50 30 to 49 15 to 29 5 to 14 <5

150 mg twice daily or 300 mg once daily 150 mg once daily 150 mg first dose, then 100 mg once daily 150 mg first dose, then 50 mg once daily 50 mg first dose, then 25 mg once daily

No additional dosing of lamivudine tablets is required after routine (4-hour) hemodialysis or peritoneal dialysis.

Although there are insufficient data to recommend a specific dose adjustment of lamivudine tablets in pediatric patients with renal impairment, a reduction in the dose and/or an increase in the dosing interval should be considered.

3 DOSAGE FORMS AND STRENGTHS

  • Lamivudine Tablets USP, 150 mg (Scored)
    White to off-white, film-coated, oval shaped tablets, debossed with ‘52’ and ‘Y’ on either side of the score line on one side and plain with a score line on the other side.
  • Lamivudine Tablets USP, 300 mg
    White to off-white, film-coated, oval shaped tablets, debossed with ‘C’ on one side and ‘64’ on the other side.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.