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Oxycodone and Acetaminophen (Oxycodone / Acetaminophen) - Description and Clinical Pharmacology

 
 



DESCRIPTION

Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths:

  •  Oxycodone Hydrochloride USP..........................................................................5 mg*
  •  Acetaminophen USP........................................................................................325 mg
  •  *5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone.
  •  Oxycodone Hydrochloride USP.......................................................................7.5 mg*
  •  Acetaminophen USP........................................................................................325 mg
  •  *7.5 mg oxycodone HCl is equivalent to 6.7228 mg of oxycodone.
  •  Oxycodone Hydrochloride USP.......................................................................7.5 mg*
  •  Acetaminophen USP........................................................................................500 mg
  •  *7.5 mg oxycodone HCl is equivalent to 6.7228 mg of oxycodone.
  •  Oxycodone Hydrochloride USP.........................................................................10 mg*
  •  Acetaminophen USP.........................................................................................325 mg
  •  *10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone.

All strengths of oxycodone and acetaminophen tablets USP also contain the following inactive ingredients: crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide and stearic acid.

Oxycodone, 4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride, is a semisynthetic opioid analgesic which occurs as a white, odorless, crystalline powder having a saline, bitter taste. It is derived from the opium alkaloid thebaine. Oxycodone hydrochloride may be represented by the following structural formula:

Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. It may be represented by the following structural formula:

CLINICAL PHARMACOLOGY

Pharmacokinetics

Nonteratogenic Effects – Opioids can cross the placental barrier and have the potential to cause neonatal respiratory depression. Opioid use during pregnancy may result in a physically drug-dependent fetus. After birth, the neonate may suffer severe withdrawal symptoms.

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