Lamivudine and Zidovudine

LAMIVUDINE AND ZIDOVUDINE- lamivudine and zidovudine tablet
Strides Shasun Limited

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 tablets 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) ].

1 INDICATIONS AND USAGE

Lamivudine and zidovudine tablets, USP a combination of two nucleoside analogues, are indicated in combination with other antiretrovirals for the treatment of HIV-1 infection.

2 DOSAGE AND ADMINISTRATION

2.1 Adults and Adolescents Weighing ≥ 30 kg

The recommended oral dose of lamivudine and zidovudine tablets USP, in HIV-1-infected adults and adolescents weighing greater than or equal to 30 kg is 1 tablet (containing 150 mg of lamivudine, USP and 300 mg of zidovudine, USP) twice daily.

2.2 Pediatric Patients

The recommended oral dosage of scored lamivudine and zidovudine tablets, USP 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, USP children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow a lamivudine and zidovudine tablet, USP the liquid oral formulations should be prescribed: EPIVIR® (lamivudine, USP) Oral Solution and RETROVIR® (zidovudine, USP) Syrup.

2.3 Patients Requiring Dosage Adjustment

Because lamivudine and zidovudine tablets, USP are 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 tablets, USP are available for these populations.

3 DOSAGE FORMS AND STRENGTHS

Lamivudine and zidovudine tablets, 150 mg/300 mg, are white to off-white colored, oval, film-coated tablets with “LZ” engraved on one side and breakline on other side.

4 CONTRAINDICATIONS

Lamivudine and zidovudine tablets, USP are contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., anaphylaxis, Stevens-Johnson syndrome) to any of the components of the product.

5 WARNINGS AND PRECAUTIONS

5.1 Hemotologic Toxicity/Bone Marrow Suppression

Zidovudine, a component of lamivudine and zidovudine tablets, has been associated with hematologic toxicity including neutropenia and anemia, particularly in patients with advanced HIV-1 disease. Lamivudine and zidovudine should be used with caution in patients who have bone marrow compromise evidenced by granulocyte count less than 1,000 cells/mm3 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 tablets. Periodic blood counts are recommended for other HIV-1-infected patients. If anemia or neutropenia develops, dosage interruption may be needed.

5.2 Myopathy

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 tablets.

5.3 Lactic 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).

5.4 Patients with HIV-1 and Hepatitis B Virus Co-infection

Post-treatment 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 post-marketing 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 and laboratory follow-up for at least several months after stopping treatment. There is insufficient evidence to determine whether re-initiation of lamivudine alters the course of post-treatment exacerbations of hepatitis.

Important Differences Among Lamivudine-Containing Products: Lamivudine and zidovudine tablets contain a higher dose of the same active ingredient (lamivudine) than EPIVIR-HBV® (lamivudine) Tablets and Oral Solution. EPIVIR-HBV was developed for treating chronic hepatitis B. Safety and efficacy of lamivudine have not been established for treatment of chronic hepatitis B in patients co-infected with HIV-1 and HBV.

Emergence of Lamivudine-Resistant HBV: In non-HIV-infected patients treated with lamivudine for chronic hepatitis B, emergence of lamivudine-resistant HBV has been detected and has been associated with diminished treatment response (see full prescribing information for EPIVIR-HBV for additional information). Emergence of hepatitis B virus variants associated with resistance to lamivudine has also been reported in HIV-1-infected patients who have received lamivudine-containing antiretroviral regimens in the presence of concurrent infection with hepatitis B virus.

5.5 Use with Other, Lamivudine-, Zidovudine-, and/or Emtricitabine-Containing Products

Lamivudine and zidovudine tablets are a fixed-dose combination of lamivudine and zidovudine. Lamivudine and zidovudine tablets should not be administered concomitantly with other lamivudine- or zidovudine-containing products including EPIVIR® (lamivudine) Tablets and Oral Solution, EPIVIR-HBV Tablets and Oral Solution, RETROVIR® (zidovudine) Tablets, Capsules, Syrup, and IV Infusion, EPZICOM® (abacavir sulfate and lamivudine) Tablets, or TRIZIVIR® (abacavir sulfate, lamivudine, and zidovudine) Tablets; or emtricitabine-containing products, including ATRIPLA® (efavirenz, emtricitabine, and tenofovir), EMTRIVA® (emtricitabine), or TRUVADA® (emtricitabine and tenofovir) or COMPLERA™ (rilpivirine/emtricitabine/tenofovir).

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