Abacavir and Lamivudine 600 mg/1
Abacavir and Lamivudine · TABLET, FILM COATED · Aurobindo Pharma Limited
Abacavir and Lamivudine is a tablet, film coated containing abacavir and lamivudine at 600 mg/1, taken oral. Manufactured by Aurobindo Pharma Limited.
Key Facts
- Brand Name
- Abacavir and Lamivudine
- Generic Name
- Abacavir and Lamivudine
- NDC Code (Product)
65862-335- Manufacturer
- Aurobindo Pharma Limited
- Strength
- 600 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA090159
- Drug Class
- Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]; Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
- Marketing Start
- 11/15/2018
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Abacavir and lamivudine tablet, a 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 ) Abacavir and lamivudine tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Before initiating abacavir and lamivudine tablets, screen for the HLA-B*5701 allele because abacavir and lamivudine tablets contains 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 tablets is a fixed-dose tablet and cannot be dose adjusted, abacavir and lamivudine tablets is 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 )] . 2.2 Recommended Dosage for Adult Patients The recommended dosage of abacavir and lamivudine tablets for adults is one tablet taken orally once daily, in combination with other antiretroviral agents, with or without food. 2.3 Recommended Dosage for Pediatric Patients The recommended oral dose of abacavir and lamivudine tablets for pediatric patients weighing at least 25 kg is one tablet daily in combinati…
Contraindications
4 CONTRAINDICATIONS Presence of HLA-B*5701 allele. ( 4 ) Prior hypersensitivity reaction to abacavir or lamivudine. ( 4 ) Moderate or severe hepatic impairment. ( 4 , 8.7 ) 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 )].
Drug 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. 7.2 Sorbitol Coadministration of single doses of lamivudine and sorbitol resulted in a sorbitol dose-dependent reduction in lamivudine exposures. When possible, avoid use of sorbitol-containing medicines with lamivudine-containing medicines [see Clinical Pharmacology ( 12.3 )]. 7.3 Riociguat Coadministration with fixed-dose abacavir/dolutegravir/lamivudine resulted in increased riociguat exposure, which may increase the risk of riociguat adverse reac…
Adverse Reactions
6 ADVERSE REACTIONS The most commonly reported adverse reactions of at least moderate intensity (incidence greater than 5%) in an adult HIV-1 clinical trial were drug hypersensitivity, insomnia, depression/depressed mood, headache/migraine, fatigue/malaise, dizziness/vertigo, nausea, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following adverse reactions are discussed in greater detail 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 )]. 6.1 Clinical Trials Experience in Adult Subjects Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in th…
Frequently Asked Questions
What is Abacavir and Lamivudine used for?
Abacavir and Lamivudine contains Abacavir and Lamivudine. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Abacavir and Lamivudine a controlled substance?
Abacavir and Lamivudine is not classified as a controlled substance by the DEA.
What is the generic name for Abacavir and Lamivudine?
The generic name for Abacavir and Lamivudine is Abacavir and Lamivudine. There are 1 other brand versions of Abacavir and Lamivudine.
What is the NDC code for Abacavir and Lamivudine 600 mg/1?
The NDC (National Drug Code) for Abacavir and Lamivudine 600 mg/1 is 65862-335, listed by Aurobindo Pharma Limited.