Abacavir
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Abacavir tablets USP, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection.
Additional important information on the use of abacavir tablets USP for treatment of HIV-1 infection:
Abacavir tablets USP are one of multiple products containing abacavir. Before starting abacavir tablets USP, review medical history for prior exposure to any abacavir-containing product in order to avoid reintroduction in a patient with a history of hypersensitivity to abacavir [see Warnings and Precautions (5.1), Adverse Reactions (6)].
History
There is currently no drug history available for this drug.
Other Information
Abacavir sulfate is a synthetic carbocyclic nucleoside analogue with inhibitory activity against HIV-1. The chemical name of abacavir sulfate is (1S,cis)-4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]-2-cyclopentene-1-methanol sulfate (salt) (2:1). Abacavir sulfate is the enantiomer with 1S, 4R absolute configuration on the cyclopentene ring. It has a molecular formula of (C14H18N6O)2•H2SO4 and a molecular weight of 670.76 daltons. It has the following structural formula:
Abacavir sulfate USP is a white to off-white solid with a solubility of approximately 77 mg/mL in distilled water at 25°C. It has an octanol/water (pH 7.1 to 7.3) partition coefficient (log P) of approximately 1.2 at 25°C.
Abacavir tablets USP are for oral administration. Each tablet contains abacavir sulfate USP equivalent to 300 mg of abacavir as active ingredient and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablets are coated with a film that is made of hypromellose, iron oxide yellow, polysorbate 80, titanium dioxide, and triacetin.
In vivo, abacavir sulfate dissociates to its free base, abacavir. All dosages for abacavir sulfate are expressed in terms of abacavir.
Sources
Abacavir Manufacturers
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American Health Packaging
![Abacavir (Abacavir Sulfate) Tablet, Film Coated [American Health Packaging]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Abacavir | American Health Packaging
• A Medication Guide and Warning Card that provide information about recognition of hypersensitivity reactions should be dispensed with each new prescription and refill. • Abacavir tablets may be taken with or without food. 2.1 Adult PatientsThe recommended oral dose of abacavir tablets for adults is 600 mg daily, administered as either 300 mg twice daily or 600 mg once daily, in combination with other antiretroviral agents.
2.2 Pediatric PatientsAbacavir tablets are available as scored tablets 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 tablets. If a child is unable to reliably swallow abacavir tablets, the oral solution formulation should be prescribed. The recommended oral dosage of abacavir tablets for HIV-1-infected pediatric patients is presented in Table 1.
Table 1. Dosing Recommendations for Abacavir Tablets in Pediatric PatientsWeight
(kg)Dosage Regimen Using Scored Tablet
Total
Daily DoseAM Dose
PM Dose
14 to 21
½ tablet (150 mg)
½ tablet (150 mg)
300 mg
>21 to <30
½ tablet (150 mg)
1 tablet (300 mg)
450 mg
≥30
1 tablet (300 mg)
1 tablet (300 mg)
600 mg
2.3 Patients with Hepatic ImpairmentThe recommended dose of abacavir tablets in patients with mild hepatic impairment (Child-Pugh score 5 to 6) is 200 mg twice daily. To enable dose reduction, abacavir sulfate oral solution (10 mL twice daily) should be used for the treatment of these patients. The safety, efficacy, and pharmacokinetic properties of abacavir have not been established in patients with moderate to severe hepatic impairment; therefore, abacavir tablets are contraindicated in these patients.
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Aurobindo Pharma Limited
Abacavir | Aurobindo Pharma Limited
A Medication Guide and Warning Card that provide information about recognition of hypersensitivity reactions should be dispensed with each new prescription and refill. Abacavir tablets may be taken with or without food. 2.1 Adult PatientsThe recommended oral dose of abacavir tablets for adults is 600 mg daily, administered as either 300 mg twice daily or 600 mg once daily, in combination with other antiretroviral agents.
2.2 Pediatric PatientsAbacavir 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 tablets. If a child is unable to reliably swallow abacavir tablets, the oral solution formulation should be prescribed. The recommended oral dosage of abacavir tablets for HIV-1-infected pediatric patients is presented in Table 1.
Table 1. Dosing Recommendations for Abacavir Scored Tablets in Pediatric Patients Weight
(kg)
Twice-daily Dosing Regimen
AM Dose
PM Dose
Total
Daily Dose
14 to <20
½ tablet
(150 mg)
½ tablet
(150 mg)
300 mg
>20 to <25
½ tablet
(150 mg)
1 tablet
(300 mg)
450 mg
≥25
1 tablet
(300 mg)
1 tablet
(300 mg)
600 mg
Additional pediatric use information for patients aged 3 months and above is approved for ViiV Healthcare Company’s ZIAGEN® (abacavir sulfate) tablets. However, due to ViiV Healthcare Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
2.3 Patients with Hepatic ImpairmentThe recommended dose of abacavir tablets in patients with mild hepatic impairment (Child-Pugh score 5 to 6) is 200 mg twice daily. To enable dose reduction, abacavir sulfate oral solution (10 mL twice daily) should be used for the treatment of these patients. The safety, efficacy, and pharmacokinetic properties of abacavir have not been established in patients with moderate to severe hepatic impairment; therefore, abacavir tablets are contraindicated in these patients.
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Camber Pharmaceuticals, Inc.
Abacavir | Camber Pharmaceuticals, Inc.
• A Medication Guide and Warning Card that provide information about recognition of hypersensitivity reactions should be dispensed with each new prescription and refill.
2.1 Adults Patients
• Abacavir tablet may be taken with or without food.The recommended oral dose of abacavir tablet for adults is 600 mg daily, administered as either 300 mg twice daily or 600 mg once daily, in combination with other antiretroviral agents.
2.2 Pediatric PatientsAbacavir sulfate is also available as a 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 tablets. If a child is unable to reliably swallow abacavir tablets, the oral solution formulation should be prescribed. The recommended oral dosage of abacavir tablets for HIV-1-infected pediatric patients is presented in Table 1.
Table 1. Dosing Recommendations for Abacavir Tablets in Pediatric Patients
Weight
(kg)
Dosage Regimen Using Scored Tablet
Total Daily Dose
AM Dose
PM Dose
14 to 21
½ tablet (150 mg)
½ tablet (150 mg)
300 mg
>21 to <30
½ tablet (150 mg)
1 tablet (300 mg)
450 mg
≥30
1 tablet (300 mg)
1 tablet (300 mg)
600 mg
2.3 Patients With Hepatic ImpairmentThe recommended dose of abacavir tablet in patients with mild hepatic impairment (Child-Pugh score 5 to 6) is 200 mg twice daily. To enable dose reduction, abacavir oral solution (10 mL twice daily) should be used for the treatment of these patients. The safety, efficacy, and pharmacokinetic properties of abacavir have not been established in patients with moderate to severe hepatic impairment; therefore, abacavir tablet is contraindicated in these patients.
![Abacavir Tablet [Camber Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=44fb1e25-ad03-4a7f-9f35-2e29f5025661&name=carton.jpg)
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