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Dosages are expressed in terms of abacavir. Absorption and Bioavailability: Following oral administration, abacavir is rapidly absorbed and extensively distributed. Plasma abacavir AUC was similar following administration of the oral solution or tablets. Distribution: The apparent volume of distribution after IV administration of abacavir was 0. Total blood and plasma drug-related radioactivity concentrations are identical, demonstrating that abacavir readily distributes into erythrocytes.
Renal Impairment: The pharmacokinetic properties of ZIAGEN have not been determined in patients with impaired renal function. Renal excretion of unchanged abacavir is a minor route of elimination in humans. Hepatic Impairment: The pharmacokinetics of abacavir have been studied in subjects with mild hepatic impairment Child-Pugh Class A.
Pregnancy: Abacavir: Abacavir pharmacokinetics were studied in 25 pregnant women during the last trimester of pregnancy receiving abacavir 300 mg twice daily. Abacavir exposure AUC during pregnancy was similar to those in postpartum and in HIV-infected non-pregnant historical controls.
Special patient populations Abacavir is metabolised primarily by the liver. No definitive recommendation on dosage reduction is possible in patients with mild hepatic impairment due to the substantial variability of abacavir exposure.
Abacavir is not recommended in patients with moderate or severe hepatic impairment. The pharmacokinetics of abacavir in patients with end-stage renal disease is similar to patients with normal renal function. Therefore no dosage reduction is required in patients with renal impairment. Based on limited experience Ziagen should be avoided in patients with end-stage renal disease.
Paediatric populationAccording to clinical trials performed in children abacavir is rapidly and well absorbed from oral solution and tablet formulations administered to children. Plasma abacavir exposure has been shown to be the same for both formulations when administered at the same dose. Children receiving abacavir oral solution according to the recommended dosage regimen achieve plasma abacavir exposure similar to adults. There are insufficient safety data to recommend the use of Ziagen in infants less than three months old.
Pharmacokinetic data were derived from 3 pharmacokinetic studies PENTA 13, PENTA 15 and ARROW PK substudy enrolling children under 12 years of age. ElderlyThe pharmacokinetics of abacavir has not been studied in patients over 65 years of age.
This is consistent with the known activity of other nucleoside analogues.
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If overdose occurs, the patient should be monitored and standard supportive treatment applied as required. It is not known whether abacavir can be removed by peritoneal dialysis or hemodialysis. ZIAGEN is the brand name for abacavir sulfate, a synthetic carbocyclic nucleoside analogue with inhibitory activity against HIV-1. Abacavir sulfate is the enantiomer with 1S, 4R absolute configuration on the cyclopentene ring.
In vivo, abacavir sulfate dissociates to its free base, abacavir. Dosages are expressed in terms of abacavir. Absorption and Bioavailability: Following oral administration, abacavir is rapidly absorbed and extensively distributed.
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Physicians should use their clinical judgment in their individual patients. Furthermore, physicians should not initiate patients on a once-daily regimen of Epivir, Ziagen and Viread. All Rights Reserved TheBodyPRO. The information provided through TheBodyPRO.
Because it contains information that may no longer be accurate, this article should only be considered a historical document. Since the first release of the drugs, abacavir Ziagen and tenofovir DF Vireadscientists and researchers were caught in a quandary. What seemed at the outset like a no-brainer, administering two very potent and promising agents in combination once-daily, should have resulted in satisfactory results.
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Where can I get more information. What is abacavir Ziagen. Abacavir may also be used for purposes not listed in this medication guide. Ziagen 250 mgoblong, yellow, imprinted with GX623Ziagen Solutionyellow, strawberry-banana featuredcontentslider. Once you have had an allergic reaction to abacavir, you must never use it again. This is not a complete list of side effects and others may occur.
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M184V or I substitutions resulted in an approximately 2-fold decrease in susceptibility to abacavir.
No firm conclusion could be drawn due to the limited data derived from this study.
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HOW SUPPLIED Dosage Forms And Strengths ZIAGEN tablets contain 300 mg of abacavir as abacavir sulfate. They are packaged as follows: Bottles of 60 tablets NDC 49702-221-18. Unit dose blister packs of 60 tablets NDC 49702-221-44. It is packaged in plastic bottles as follows: Bottles of 240 mL NDC 49702-222-48 with child-resistant closure. Clinical Trials Experience In Adult Subjects Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
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In patients with moderate or severe hepatic impairment, no clinical data are available, therefore the use of abacavir is not recommended unless judged necessary.
Specifics Abacavir is one of the most potent antiviral drugs.