Abacavir 20 mg/mL
Abacavir Sulfate · SOLUTION · Rising Pharma Holdings, Inc.
Abacavir is a solution containing abacavir sulfate at 20 mg/mL, taken oral. Manufactured by Rising Pharma Holdings, Inc..
Key Facts
- Brand Name
- Abacavir
- Generic Name
- Abacavir Sulfate
- NDC Code (Product)
64980-405- Manufacturer
- Rising Pharma Holdings, Inc.
- Strength
- 20 mg/mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA077950
- Marketing Start
- 03/14/2018
Recall History
GlaxoSmithKline Inc
Adulterated Presence of Foreign Tablets: Trizivir 300/150/300 mg tables, Lot 0ZP5128 may incorrectly contain Lexiva 700 mg tablets.
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Side 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 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 Tablets Screen for the HLA-B*5701 allele prior to initiating therapy with abacavir tablets [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 Abacavir tablets are available as scored tablet for HIV-1-infected pediatric patients weighing greater than or equal to 14 kg for whom a solid dosage form is appropriate. Before prescribing abacavir tablets, children should be assessed for the ability to swallow ta…
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 Aurobindo Pharma USA, Inc. at 1-866-850-2876 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 conditions, adver…
Frequently Asked Questions
What is Abacavir used for?
Abacavir contains Abacavir Sulfate. It is a solution taken oral. Consult your doctor for specific uses.
Is Abacavir a controlled substance?
Abacavir is not classified as a controlled substance by the DEA.
What is the generic name for Abacavir?
The generic name for Abacavir is Abacavir Sulfate. There are 6 other brand versions of Abacavir Sulfate.
What is the NDC code for Abacavir 20 mg/mL?
The NDC (National Drug Code) for Abacavir 20 mg/mL is 64980-405, listed by Rising Pharma Holdings, Inc..