Lamivudine Oral
Generic Name: lamivudine oral
Brand Names:
Lamivudine
11 DESCRIPTION Lamivudine (also known as 3TC) is a synthetic nucleoside analogue with activity against HIV-1 and HBV. The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C 8 H 11 N 3 O 3 S and a molecular weight of 229.3 g per mol.
Overview
11 DESCRIPTION Lamivudine (also known as 3TC) is a synthetic nucleoside analogue with activity against HIV-1 and HBV. The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C 8 H 11 N 3 O 3 S and a molecular weight of 229.3 g per mol.
Uses
1 INDICATIONS AND USAGE Lamivudine oral solution, USP is 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. Lamivudine oral solution, USP 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 )
Dosage
2 DOSAGE AND ADMINISTRATION Adults: 300 mg daily, administered as either 150 mg twice daily or 300 mg once daily. ( 2.1 ) 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. ( 2.2 ) Patients with Renal Impairment: Doses of lamivudine must be adjusted in accordance with renal function. ( 2.3 ) 2.1 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.
Side Effects
6 ADVERSE REACTIONS 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. ( 6.1 ) The most common reported adverse reactions (incidence greater than or equal to 15%) in pediatric subjects were fever and cough.
Interactions
7 DRUG INTERACTIONS 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.
Warnings
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. 5 WARNINGS AND PRECAUTIONS 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. 4 CONTRAINDICATIONS Lamivudine oral solution is contraindicated in patients with a previous hypersensitivity reaction to lamivudine. Lamivudine oral solution is contraindicated in patients with previous hypersensitivity reaction to lamivudine. ( 4 )
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Lamivudine Oral Solution, USP is a clear, colorless to pale yellow, strawberry flavored liquid. Each mL of the solution contains 10 mg of lamivudine. Packaged as follows: Unit-Dose cup 30 mL NDC 68999-706-30 20 Unit-Dose Cups of 30 mL each NDC 68999-706-24. This product does not require reconstitution.
Frequently Asked Questions
What is Lamivudine Oral used for?▼
1 INDICATIONS AND USAGE Lamivudine oral solution, USP is 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. Lamivudine oral solution, USP 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 )
What are the side effects of Lamivudine Oral?▼
6 ADVERSE REACTIONS 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. ( 6.1 ) The most common reported adverse reactions (incidence greater than or equal to 15%) in pediatric subjects were fever and cough.
What are the important warnings for Lamivudine Oral?▼
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. 5 WARNINGS AND PRECAUTIONS 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. 4 CONTRAINDICATIONS Lamivudine oral solution is contraindicated in patients with a previous hypersensitivity reaction to lamivudine. Lamivudine oral solution is contraindicated in patients with previous hypersensitivity reaction to lamivudine. ( 4 )
Related Medications
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.