Abacavir And Lamivudine
Generic Name: abacavir and lamivudine
Brand Names:
Abacavir And Lamivudine
11 DESCRIPTION Abacavir and Lamivudine Abacavir and lamivudine tablets, USP contain the following 2 synthetic nucleoside analogues: abacavir (ZIAGEN, also a component of TRIZIVIR) and lamivudine (also known as EPIVIR or 3TC) with inhibitory activity against HIV-1. Abacavir and lamivudine tablets, USP are for oral administration.
Overview
11 DESCRIPTION Abacavir and Lamivudine Abacavir and lamivudine tablets, USP contain the following 2 synthetic nucleoside analogues: abacavir (ZIAGEN, also a component of TRIZIVIR) and lamivudine (also known as EPIVIR or 3TC) with inhibitory activity against HIV-1. Abacavir and lamivudine tablets, USP are for oral administration.
Uses
1 INDICATIONS AND USAGE Abacavir and lamivudine tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Abacavir and lamivudine tablets, are combination of abacavir and lamivudine, both nucleoside analogue HIV-1 reverse transcriptase inhibitors, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. (1)
Dosage
2 DOSAGE AND ADMINISTRATION Before initiating abacavir and lamivudine tablets, screen for the HLA-B*5701 allele because abacavir and lamivudine tablets contain abacavir. (2.1) Adults: One tablet orally once daily. (2.2) Pediatric patients weighing at least 25 kg: One tablet daily. (2.3) Because abacavir and lamivudine tablet is a fixed-dose tablet and cannot be dose adjusted, abacavir and lamivudine tablets are not recommended in patients with creatinine clearance less than 30 mL per minute or patients with hepatic impairment. (2.4, 4) 2.1 Screening for HLA-B*5701 Allele Prior to Starting Abacavir and Lamivudine Tablets Screen for the HLA-B*5701 allele prior to initiating therapy with abacavir and lamivudine tablets [see Boxed Warning, Warnings and Precautions (5.1) ] .
Side Effects
6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: Serious and sometimes fatal hypersensitivity reactions [see Boxed Warning, Warnings and Precautions (5.1) ] . Exacerbations of hepatitis B [see Boxed Warning, Warnings and Precautions (5.2) ] . Lactic acidosis and severe hepatomegaly with steatosis [see Warnings and Precautions (5.3) ] . Immune reconstitution syndrome [see Warnings and Precautions (5.4) ] . Myocardial infarction [see Warnings and Precautions (5.5) ] .
Interactions
7 DRUG INTERACTIONS Methadone: An increased methadone dose may be required in a small number of patients. (7.1) Sorbitol: Coadministration of lamivudine and sorbitol may decrease lamivudine concentrations; when possible, avoid chronic coadministration. (7.2) Riociguat: The riociguat dose may need to be reduced. (7.3) 7.1 Methadone In a trial of 11 HIV-1-infected subjects receiving methadone-maintenance therapy with 600 mg of ZIAGEN twice daily (twice the currently recommended dose), oral methadone clearance increased [see Clinical Pharmacology (12.3) ] . This alteration will not result in a methadone dose modification in the majority of patients; however, an increased methadone dose may be required in a small number of patients.
Warnings
WARNING: HYPERSENSITIVITY REACTIONS and EXACERBATIONS OF HEPATITIS B Hypersensitivity Reactions Serious and sometimes fatal hypersensitivity reactions, with multiple organ involvement, have occurred with abacavir, a component of abacavir and lamivudine. 5 WARNINGS AND PRECAUTIONS Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues. (5.3) Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy. (5.4) 5.1 Hypersensitivity Reactions Serious and sometimes fatal hypersensitivity reactions have occurred with abacavir, a component of abacavir and lamivudine. These hypersensitivity reactions have included multi-organ failure and anaphylaxis and typically occurred within the first 6 weeks of treatment with abacavir (median time to onset was 9 days); although abacavir hypersensitivity reactions have occurred any time during treatment [see Adverse Reactions (6.1) ] . 4 CONTRAINDICATIONS Abacavir and lamivudine tablets are contraindicated in patients: who have the HLA-B*5701 allele [see Warnings and Precautions (5.1) ] . with prior hypersensitivity reaction to abacavir [see Warnings and Precautions (5.1) ] or lamivudine. with moderate or severe hepatic impairment [see Use in Specific Populations (8.7) ] . Presence of HLA-B*5701 allele.
Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abacavir and lamivudine during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Available data from the APR show no difference in the overall risk of birth defects for abacavir or lamivudine compared with the background rate for birth defects of 2.7% in the Metropolitan Atlanta Congenital Defects Program (MACDP) reference population (see Data) .
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Abacavir and lamivudine tablets, USP contain 600 mg of abacavir as abacavir sulfate USP and 300 mg of lamivudine USP. The tablets are orange colored, capsule-shaped, biconvex film coated tablets, debossed with “LT” on one side and plain on other side.
Frequently Asked Questions
What is Abacavir And Lamivudine used for?▼
1 INDICATIONS AND USAGE Abacavir and lamivudine tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Abacavir and lamivudine tablets, are combination of abacavir and lamivudine, both nucleoside analogue HIV-1 reverse transcriptase inhibitors, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. (1)
What are the side effects of Abacavir And Lamivudine?▼
6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: Serious and sometimes fatal hypersensitivity reactions [see Boxed Warning, Warnings and Precautions (5.1) ] . Exacerbations of hepatitis B [see Boxed Warning, Warnings and Precautions (5.2) ] . Lactic acidosis and severe hepatomegaly with steatosis [see Warnings and Precautions (5.3) ] . Immune reconstitution syndrome [see Warnings and Precautions (5.4) ] . Myocardial infarction [see Warnings and Precautions (5.5) ] .
Can I take Abacavir And Lamivudine during pregnancy?▼
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abacavir and lamivudine during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Available data from the APR show no difference in the overall risk of birth defects for abacavir or lamivudine compared with the background rate for birth defects of 2.7% in the Metropolitan Atlanta Congenital Defects Program (MACDP) reference population (see Data) .
What are the important warnings for Abacavir And Lamivudine?▼
WARNING: HYPERSENSITIVITY REACTIONS and EXACERBATIONS OF HEPATITIS B Hypersensitivity Reactions Serious and sometimes fatal hypersensitivity reactions, with multiple organ involvement, have occurred with abacavir, a component of abacavir and lamivudine. 5 WARNINGS AND PRECAUTIONS Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues. (5.3) Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy. (5.4) 5.1 Hypersensitivity Reactions Serious and sometimes fatal hypersensitivity reactions have occurred with abacavir, a component of abacavir and lamivudine. These hypersensitivity reactions have included multi-organ failure and anaphylaxis and typically occurred within the first 6 weeks of treatment with abacavir (median time to onset was 9 days); although abacavir hypersensitivity reactions have occurred any time during treatment [see Adverse Reactions (6.1) ] . 4 CONTRAINDICATIONS Abacavir and lamivudine tablets are contraindicated in patients: who have the HLA-B*5701 allele [see Warnings and Precautions (5.1) ] . with prior hypersensitivity reaction to abacavir [see Warnings and Precautions (5.1) ] or lamivudine. with moderate or severe hepatic impairment [see Use in Specific Populations (8.7) ] . Presence of HLA-B*5701 allele.
Related Medications
Menera
menera
Balance reproductive hormones Ease menopausal symptoms Regulate menstrual cycles Improve fertility
Maropltant Cltrate
maropltant cltrate
Dosage form: TABLET. Active ingredients: MAROPITANT CITRATE (24 mg/24mg). Category: BULK INGREDIENT.
Meclizine Hcl 12.5 Mg
meclizine hcl 12.5 mg
Purpose Antiemetic
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.