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ROXICODONE® could impair the mental and/or Bodily abilities demanded for that general performance of potentially hazardous responsibilities which include driving a car or truck or functioning machinery. The individual applying this drug should be cautioned appropriately.
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These highlights do not consist of all the information needed to use ROXICODONE® securely and efficiently. See comprehensive prescribing information for ROXICODONE.
ROXICODONE is indicated to the administration of soreness significant sufficient to need an opioid analgesic and for which different remedies are inadequate.
Oxycodone hydrochloride was genotoxic within an in vitro mouse lymphoma assay inside the presence of metabolic activation. There was no evidence of genotoxic probable within an in vitro bacterial reverse mutation assay (Salmonella typhimurium and Escherichia coli) or in an assay for chromosomal aberrations (in vivo mouse bone marrow micronucleus assay).
Focus on the Risk-free use, serious threats, and suitable storage and disposal of opioid analgesics with patients and/or their caregivers whenever these medicines are prescribed. The Patient Counseling Tutorial (PCG) is often obtained at this backlink: .
Prolonged usage of ROXICODONE in the course of pregnancy may end up in neonatal opioid withdrawal syndrome, which can be existence-threatening Otherwise identified and dealt with.
ROXICODONE is contraindicated in individuals with gastrointestinal obstruction, which includes paralytic ileus.
If the decision is made to prescribe a benzodiazepine or other CNS depressant concomitantly with an opioid analgesic, prescribe the lowest successful dosages and minimum durations of concomitant use. In people by now getting an opioid analgesic, prescribe a lower initial dose from the benzodiazepine or other CNS depressant than indicated in the absence of an opioid, and titrate dependant on clinical reaction. If an opioid analgesic is initiated inside a individual currently taking a benzodiazepine or other CNS depressant, prescribe a lessen Original dose on the opioid analgesic, and titrate based upon medical response. Adhere to clients intently for indications and signs or symptoms of respiratory melancholy and sedation.
If this SPL incorporates inactivated NDCs mentioned because of the check here FDA initiated compliance action, They are going to be specified therefore.
If a CYP3A4 inhibitor is discontinued, look at raising the ROXICODONE dosage until eventually steady drug outcomes are realized. Keep an eye on for indications of opioid withdrawal.
Populace pharmacokinetic analyses carried out during the medical examine guidance the lack of gender effect on the pharmacokinetics of oxycodone from ROXICODONE® .
People need to be encouraged not to regulate the dose of ROXICODONE® without the need of consulting the prescribing professional.