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Generic Ziagen Abacavir 300mg

If you are pregnant or plan to become pregnant, tell your doctor immediately.Since Any medication taken in excess can have serious consequences. Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including Ziagen. Fatal hypersensitivity reactions have been associated with Ziagen (abacavir sulfate). Five percent (5%) of patients receiving Ziagen 600 mg once daily had severe drug hypersensitivity reactions compared to 2% of patients receiving Ziagen 300 mg twice daily. In addition to adverse reactions reported from clinical trials, the following events have been identified during use of abacavir in clinical practice. Abacavir induced chromosomal aberrations both in the presence and absence of metabolic activation in an in vitro cytogenetic study in human lymphocytes.

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Abacavir Precautions

Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance" have been observed in patients receiving antiretroviral therapy. The mechanism and long-term consequences of these events are currently unknown. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made.

Abacavir Adverse Reactions

Results showed an increase in the incidence of malignant and non-malignant tumors. Malignant tumors occurred in the preputial gland of males and the clitoral gland of females of both species, and in the liver of female rats. In addition, non-malignant tumors also occurred in the liver and thyroid gland of female rats. These observations were made at systemic exposures in the range of 6 to 32 times the human exposure at the recommended dose. It is not known how predictive the results of rodent carcinogenicity studies may be for humans. Abacavir was mutagenic in the absence of metabolic activation, although it was not mutagenic in the presence of metabolic activation in an L5178Y mouse lymphoma assay.

Ziagen Drug Interactions

Pregnancy Category C. Studies in pregnant rats showed that abacavir is transferred to the fetus through the placenta. Fetal malformations (increased incidences of fetal anasarca and skeletal malformations) and developmental toxicity (depressed fetal body weight and reduced crown-rump length) were observed in rats at a dose which produced 35 times the human exposure, based on AUC. Abacavir was clastogenic in males and not clastogenic in females in an in vivo mouse bone marrow micronucleus assay. Embryonic and fetal toxicities (increased resorptions, decreased fetal body weights) and toxicities to the offspring (increased incidence of stillbirth and lower body weights) occurred at half of the above-mentioned dose in separate fertility studies conducted in rats.

Ziagen Overdosage

Abacavir was not mutagenic in bacterial mutagenicity assays in the presence and absence of metabolic activation. In the rabbit, no developmental toxicity and no increases in fetal malformations occurred at doses that produced 8.5 times the human exposure at the recommended dose based on AUC. There is no known antidote for Ziagen. There are no adequate and well-controlled studies in pregnant women. Abacavir was administered orally at 3 dosage levels to separate groups of mice and rats in 2-year carcinogenicity studies.