Abacavir indications and usage: Difference between revisions

Jump to navigation Jump to search
VisualWikitext
No edit summary
Line 9: Line 9:
Additional important information on the use of ZIAGEN for treatment of HIV-1 infection:
Additional important information on the use of ZIAGEN for treatment of HIV-1 infection:


ZIAGEN is one of multiple products containing abacavir. Before starting ZIAGEN, 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.
ZIAGEN is one of multiple products containing abacavir. Before starting ZIAGEN, 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.<ref name="Dellinger-2013">{{Cite journal  | last1 = Dellinger | first1 = RP. | last2 = Levy | first2 = MM. | last3 = Rhodes | first3 = A. | last4 = Annane | first4 = D. | last5 = Gerlach | first5 = H. | last6 = Opal | first6 = SM. | last7 = Sevransky | first7 = JE. | last8 = Sprung | first8 = CL. | last9 = Douglas | first9 = IS. | title = Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock, 2012. | journal = Intensive Care Med | volume = 39 | issue = 2 | pages = 165-228 | month = Feb | year = 2013 | doi = 10.1007/s00134-012-2769-8 | PMID = 23361625 }}</ref>
===DOSAGE AND ADMINISTRATION===
 
•A Medication Guide and Warning Card that provide information about recognition of hypersensitivity reactions should be dispensed with each new prescription and refill.
•ZIAGEN may be taken with or without food.
 
====Adult Patients====
 
The recommended oral dose of ZIAGEN for adults is 600 mg daily, administered as either 300 mg twice daily or 600 mg once daily, in combination with other antiretroviral agents.
 
====Pediatric Patients====
 
The recommended oral dose of ZIAGEN Oral Solution in HIV-1-infected pediatric patients aged 3 months and older is 8 mg/kg twice daily (up to a maximum of 300 mg twice daily) in combination with other antiretroviral agents.
 
ZIAGEN 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 ZIAGEN Tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow ZIAGEN Tablets, the oral solution formulation should be prescribed. The recommended oral dosage of ZIAGEN Tablets for HIV-1-infected pediatric patients is presented in Table 1.
 
{|
| [[File:Ziagen Ped recommendation.JPG|400px|thumb]]
|}
 
===DOSAGE FORMS AND STRENGTHS===
 
ZIAGEN Tablets contain 300 mg of abacavir as abacavir sulfate. The tablets are yellow, biconvex, scored, capsule-shaped, film-coated, and imprinted with “GX 623” on both sides.
 
ZIAGEN Oral Solution contains 20 mg/mL of abacavir as abacavir sulfate. The solution is a clear to opalescent, yellowish, strawberry-banana-flavored liquid.
===Patients With Hepatic Impairment===
 
The recommended dose of ZIAGEN in patients with mild hepatic impairment (Child-Pugh score 5 to 6) is 200 mg twice daily. To enable dose reduction, ZIAGEN 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, ZIAGEN is contraindicated in these patients.<ref name="Dellinger-2013">{{Cite journal  | last1 = Dellinger | first1 = RP. | last2 = Levy | first2 = MM. | last3 = Rhodes | first3 = A. | last4 = Annane | first4 = D. | last5 = Gerlach | first5 = H. | last6 = Opal | first6 = SM. | last7 = Sevransky | first7 = JE. | last8 = Sprung | first8 = CL. | last9 = Douglas | first9 = IS. | title = Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock, 2012. | journal = Intensive Care Med | volume = 39 | issue = 2 | pages = 165-228 | month = Feb | year = 2013 | doi = 10.1007/s00134-012-2769-8 | PMID = 23361625 }}</ref>


==References==
==References==

Revision as of 21:25, 30 December 2013

Abacavir
ZIAGEN® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Overdosage
Clinical Studies
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [2]

INDICATIONS AND USAGE

ZIAGEN Tablets and Oral Solution, 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 ZIAGEN for treatment of HIV-1 infection:

ZIAGEN is one of multiple products containing abacavir. Before starting ZIAGEN, 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.[1]

References

  1. ↑ Dellinger, RP.; Levy, MM.; Rhodes, A.; Annane, D.; Gerlach, H.; Opal, SM.; Sevransky, JE.; Sprung, CL.; Douglas, IS. (2013). "Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock, 2012". Intensive Care Med. 39 (2): 165–228. doi:10.1007/s00134-012-2769-8. PMID 23361625. Unknown parameter |month= ignored (help)

Adapted from the FDA Package Insert.

Retrieved from "https://www.wikidoc.org/index.php?title=Abacavir_indications_and_usage&oldid=921406"