OXYCODONE AND ACETAMINOPHEN hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OXYCODONE HYDROCHLORIDE (UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570)

Available from:

St Marys Medical Park Pharmacy

INN (International Name):

OXYCODONE HYDROCHLORIDE

Composition:

OXYCODONE HYDROCHLORIDE 7.5 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OXYCODONE AND ACETAMINOPHEN- OXYCODONE HYDROCHLORIDE, ACETAMINOPHEN
TABLET
ST MARYS MEDICAL PARK PHARMACY
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OXYCODONE AND ACETAMINOPHEN TABLETS USP
DESCRIPTION
Each tablet, for oral administration, contains oxycodone hydrochloride
and acetaminophen in the
following strengths:
Oxycodone Hydrochloride, USP 5mg*
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.
Oxycodone Hydrochloride, USP 10 mg*
Acetaminophen, USP 650 mg
* 10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone.
In addition, each tablet also contains the following inactive
ingredients: colloidal silicon dioxide,
magnesium stearate, microcrystalline cellulose, pregelatinized starch
or starch 826 and stearic acid.
The 7.5 mg/500 mg tablets and 10 mg/650 mg tablets also contain
croscarmellose sodium, and povidone.
Oxycodone, 14-hydroxydihydrocodeinone, is a semisynthetic opioid
analgesic which occurs as a
white, odorless, crystalline powder having a saline, bitter taste. The
molecular formula for oxycodone
hydrochloride is
and the molecular weight 351.83. It is derived from the opium alkaloid
thebaine, and 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. The molecular
formula for acetaminophen is C
H
NO
and the molecular weight is 151.17. It may be represented by
C18H21NO4•HCl
8
9
2
the following structural formula:
CLINICAL PHARMACOLOGY
CENTRAL NERVOUS SYSTEM
Oxycodone is a semisynthetic pure opioid agonist whose principal
therapeutic acti