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Oxycontin

[oxycodone hydrochloride]

Use with CNS Depressants

OxyContin, like all opioid analgesics, should be started at 1/ 3 to 1/ 2 of the usual dosage in patients who are concurrently receiving other central nervous system depressants including sedatives or hypnotics, general anesthetics, phenothiazines, centrally acting anti-emetics, tranquilizers, and alcohol because respiratory depression, hypotension, and profound sedation or coma may result. No specific interaction between oxycodone and monoamine oxidase inhibitors has been observed, but caution in the use of any opioid in patients taking this class of drugs is appropriate.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Text Continues Below



Studies of oxycodone to evaluate its carcinogenic potential have not been conducted. Oxycodone was not mutagenic in the following assays: Ames Salmonella and E. coli test with and without metabolic activation at doses of up to 5000 µg, chromosomal aberration test in human lymphocytes in the absence of metabolic activation at doses of up to 1500 µg/ mL and with activation 48 hours after exposure at doses of up to 5000 µg/ mL, and in the in vivo bone marrow micronucleus test in mice (at plasma levels of up to 48 µg/ mL). Oxycodone was clastogenic in the human lymphocyte chromosomal assay in the presence of metabolic activation in the human chromosomal aberration test (at greater than or equal to 1250 µg/ mL) at 24 but not 48 hours of exposure and in the mouse lymphoma assay at doses of 50 µg/ mL or greater with metabolic activation and at 400 µg/ mL or greater without metabolic activation.


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