ABACAVIR, LAMIVUDINE AND ZIDOVUDINE 300 mg/1
ABACAVIR , LAMIVUDINE AND ZIDOVUDINE · TABLET · Lupin Pharmaceuticals, Inc.
ABACAVIR, LAMIVUDINE AND ZIDOVUDINE is a prescription tablet containing abacavir , lamivudine and zidovudine at 300 mg/1, taken oral. Manufactured by Lupin Pharmaceuticals, Inc..
Key Facts
- Brand Name
- ABACAVIR, LAMIVUDINE AND ZIDOVUDINE
- Generic Name
- ABACAVIR , LAMIVUDINE AND ZIDOVUDINE
- NDC Code (Product)
68180-286- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Strength
- 300 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- HUMAN PRESCRIPTION DRUG
- Application #
- ANDA202912
- Drug Class
- Cytochrome P450 1A1 Inhibitors [MoA]; Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
- Marketing Start
- 12/17/2013
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, lamivudine and zidovudine tablet, a combination of abacavir, lamivudine, and zidovudine, each nucleoside analogue HIV-1 reverse transcriptase inhibitors, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.( 1 ) Abacavir, lamivudine and zidovudine tablet is indicated in combination with other antiretrovirals or alone for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Limitations of Use: Limited data exist on the use of abacavir, lamivudine and zidovudine tablets alone in patients with higher baseline viral load levels (greater than 100,000 copies per mL) [see CLINICAL STUDIES ( 14 )] .
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Before initiating abacavir, lamivudine and zidovudine tablets, screen for the HLA-B*5701 allele because abacavir, lamivudine and zidovudine tablet contains abacavir. ( 2.1 ) Adults and pediatric patients weighing at least 40 kg: 1 tablet twice daily. ( 2.2 ) Because abacavir, lamivudine and zidovudine tablet is a fixed-dose tablet and cannot be dose adjusted, abacavir, lamivudine and zidovudine tablets are not recommended in patients requiring dosage adjustment or patients with hepatic impairment. ( 2.3 , 4 ) 2.1 Screening for HLA-B*5701 Allele prior to Starting Abacavir, Lamivudine and Zidovudine Tablets Screen for the HLA-B*5701 allele prior to initiating therapy with abacavir, lamivudine and zidovudine tablets [see BOXED WARNING , WARNINGS AND PRECAUTIONS ( 5.1 )] . 2.2 Recommended Dosage for Adults and Pediatric Patients Weighing at Least 40 kg The recommended dosage of abacavir, lamivudine and zidovudine tablet is one tablet taken orally twice daily with or without food. 2.3 Not Recommended Due to Lack of Dosage Adjustment Because abacavir, lamivudine and zidovudine tablet is a fixed-dose tablet and cannot be dose adjusted, abacavir, lamivudine and …
Contraindications
4 CONTRAINDICATIONS Presence of HLA-B*5701 allele. ( 4 ) Prior hypersensitivity reaction to abacavir, lamivudine, or zidovudine ( 4 ) Moderate or severe hepatic impairment. ( 4 , 8.7 ) Abacavir, lamivudine and zidovudine 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 )], lamivudine, or zidovudine. 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 ) Riociguat: The riociguat dose may need to be reduced. ( 7.1 ) Sorbitol: Coadministration of lamivudine and sorbitol may decrease lamivudine concentrations; when possible, avoid chronic coadministration. ( 7.2 ) Agents antagonistic with zidovudine: Concomitant use should be avoided. ( 7.3 ) Hematologic/bone marrow suppressive/cytotoxic agents: May increase the hematologic toxicity of zidovudine. ( 7.3 ) 7.1 Abacavir 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. Riociguat Coadministration with fixed-dose abacavir/dolutegravir/lamivudine resulted in increased riociguat exposure, which may increase the risk of riociguat adverse reactions [ see Clinical Pharmacology ( 12.3 ) ]. The riociguat dose may need to …
Adverse Reactions
6 ADVERSE REACTIONS The most commonly reported adverse reactions (incidence at least 10%) in clinical trials were nausea, headache, malaise and fatigue, and nausea and vomiting. ( 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 other sections of the labeling: Serious and sometimes fatal hypersensitivity reactions [see BOXED WARNING , WARNINGS AND PRECAUTIONS ( 5.1 )] . Hematologic toxicity, including neutropenia and anemia [see BOXED WARNING , WARNINGS AND PRECAUTIONS ( 5.2 )] . Symptomatic myopathy [see BOXED WARNING , WARNINGS AND PRECAUTIONS ( 5.3 )] . Lactic acidosis and severe hepatomegaly with steatosis [see BOXED WARNING , WARNINGS AND PRECAUTIONS ( 5.4 )] . Exacerbations of hepatitis B [see BOXED WARNING , WARNINGS AND PRECAUTIONS ( 5.5 )] . Hepatic decompensation in patients co-infected with HIV-1 and hepatitis C [see WARNINGS AND PRECAUTIONS ( 5.6 )] . Exacerbation of anemia in HIV-1/HCV co-infected patients receiving ribavirin and zidovudine [see WARNINGS AND PRECAUTIONS ( 5.6 )] . Immune reconstitution syndrome [see WARNI…
Frequently Asked Questions
What is ABACAVIR, LAMIVUDINE AND ZIDOVUDINE used for?
ABACAVIR, LAMIVUDINE AND ZIDOVUDINE contains ABACAVIR , LAMIVUDINE AND ZIDOVUDINE. It is a tablet taken oral. Consult your doctor for specific uses.
Is ABACAVIR, LAMIVUDINE AND ZIDOVUDINE a controlled substance?
ABACAVIR, LAMIVUDINE AND ZIDOVUDINE is not classified as a controlled substance by the DEA.
What is the generic name for ABACAVIR, LAMIVUDINE AND ZIDOVUDINE?
The generic name for ABACAVIR, LAMIVUDINE AND ZIDOVUDINE is ABACAVIR , LAMIVUDINE AND ZIDOVUDINE. There are no other listed brand versions of ABACAVIR , LAMIVUDINE AND ZIDOVUDINE.
What is the NDC code for ABACAVIR, LAMIVUDINE AND ZIDOVUDINE 300 mg/1?
The NDC (National Drug Code) for ABACAVIR, LAMIVUDINE AND ZIDOVUDINE 300 mg/1 is 68180-286, listed by Lupin Pharmaceuticals, Inc..
Product NDC
68180-286
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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