Abacavir Sulfate 300 mg/1
abacavir sulfate · TABLET, FILM COATED · Safecor Health, LLC
Abacavir Sulfate is a tablet, film coated containing abacavir sulfate at 300 mg/1, taken oral. Manufactured by Safecor Health, LLC.
Key Facts
- Brand Name
- Abacavir Sulfate
- Generic Name
- abacavir sulfate
- NDC Code (Product)
48433-001- Manufacturer
- Safecor Health, LLC
- Strength
- 300 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA091294
- Marketing Start
- 02/23/2026
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Abacavir tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection. Abacavir tablets, a nucleoside analogue human immunodeficiency virus (HIV-1) reverse transcriptase inhibitor, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Before initiating abacavir, screen for the HLA-B*5701 allele. ( 2.1 ) • Adults: 600 mg daily, administered as either 300 mg twice daily or 600 mg once daily. ( 2.2 ) • 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 600 mg daily. ( 2.3 ) • Patients with Hepatic Impairment: Mild hepatic impairment – 200 mg twice daily. ( 2.4 ) 2.1 Screening for HLA-B*5701 Allele Prior to Starting Abacavir Screen for the HLA-B*5701 allele prior to initiating therapy with abacavir [see Boxed Warning , Warnings and Precautions (5.1) ] . 2.2 Recommended Dosage for Adult Patients The recommended dosage of abacavir tablets for adults is 600 mg daily, administered orally as either 300 mg twice daily or 600 mg once daily, in combination with other antiretroviral agents. 2.3 Recommended Dosage for Pediatric Patients The recommended dosage of abacavir oral solution in HIV-1–infected pediatric patients aged 3 months and older is 8 mg per kg orally twice daily or 16 mg per kg orally once daily (up to a maximum of 600 mg daily) in combination with other antiretroviral agents. Aba…
Contraindications
4 CONTRAINDICATIONS Abacavir 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) ]. • with moderate or severe hepatic impairment [see Use in Specific Populations (8.6) ] . • Presence of HLA-B*5701 allele. ( 4 ) • Prior hypersensitivity reaction to abacavir. ( 4 ) • Moderate or severe hepatic impairment. ( 4 )
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. ( 7.2 ) 7.1 Methadone In a trial of 11 HIV-1–infected subjects receiving methadone-maintenance therapy with 600 mg of abacavir 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 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 be reduced. See full prescribing information for ADEMPAS ® (riociguat).
Adverse Reactions
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) ] . • Lactic acidosis and severe hepatomegaly with steatosis [see Warnings and Precautions (5.2) ] . • Immune reconstitution syndrome [see Warnings and Precautions (5.3) ] . • Myocardial infarction [see Warnings and Precautions (5.4) ] . • The most commonly reported adverse reactions of at least moderate intensity (incidence greater than or equal to 10%) in adult HIV-1 clinical trials were nausea, headache, malaise and fatigue, nausea and vomiting, and dreams/sleep disorders. ( 6.1 ) • The most commonly reported adverse reactions of at least moderate intensity (incidence greater than or equal to 5%) in pediatric HIV-1 clinical trials were fever and/or chills, nausea and vomiting, skin rashes, and ear/nose/throat infections. ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience in Adult Subjects Because clinical trials are conducted under widely varying c…
Frequently Asked Questions
What is Abacavir Sulfate used for?
Abacavir Sulfate contains abacavir sulfate. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Abacavir Sulfate a controlled substance?
Abacavir Sulfate is not classified as a controlled substance by the DEA.
What is the generic name for Abacavir Sulfate?
The generic name for Abacavir Sulfate is abacavir sulfate. There are 5 other brand versions of abacavir sulfate.
What is the NDC code for Abacavir Sulfate 300 mg/1?
The NDC (National Drug Code) for Abacavir Sulfate 300 mg/1 is 48433-001, listed by Safecor Health, LLC.