OXYCODONE HYDROCHLORIDE tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

St Marys Medical Park Pharmacy

INN (Kansainvälinen yleisnimi):

OXYCODONE HYDROCHLORIDE

Koostumus:

OXYCODONE HYDROCHLORIDE 15 mg

Prescription tyyppi:

PRESCRIPTION DRUG

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE TABLET
ST MARYS MEDICAL PARK PHARMACY
----------
OXYCODONE HYDROCHLORIDE TABLETS, USP 8231-06
15 MG AND 30 MG CII
RX ONLY
DESCRIPTION
Oxycodone hydrochloride tablet USP is an opioid analgesic.
Each tablet for oral administration contains 15 mg or 30 mg of
oxycodone hydrochloride USP.
Oxycodone hydrochloride, is a white, odorless crystalline powder
derived from the opium alkaloid,
thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7
mL) and is considered slightly
soluble in alcohol (octanol water partition coefficient is 0.7).
Chemically, oxycodone hydrochloride is 4,
5α-epoxy-14-hydroxy-3-methoxy-17-methyl-morphinan-6-
one hydrochloride and has the following structural formula:
The tablets contain the following inactive ingredients: Corn starch,
D&C Yellow #10 Aluminum Lake
(15 mg tablet), FD&C Blue #2 Aluminum Lake (15 mg and 30 mg tablets),
lactose monohydrate,
microcrystalline cellulose, silicon dioxide, sodium starch glycolate,
and stearic acid.
The 15 mg and 30 mg tablets contain the equivalent of 13.5 mg and 27.0
mg, respectively, of oxycodone
free base.
CLINICAL PHARMACOLOGY
PHARMACOLOGY:
The analgesic ingredient, oxycodone, is a semi-synthetic narcotic with
multiple actions qualitatively
similar to those of morphine; the most prominent of these involves the
central nervous system and
organs composed of smooth muscle.
Oxycodone, as the hydrochloride salt, is a pure agonist opioid whose
principal therapeutic action is
analgesia and has been in clinical use since 1917. Like all pure
opioid agonists, there is no ceiling
effect to analgesia, such as is seen with partial agonists or
non-opioid analgesics. Based upon a single-
dose, relative-potency study conducted in humans with cancer pain, 10
to l5 mg of oxycodone given
intramuscularly produced an analgesic effect similar to 10 mg of
morphine given intramuscularly. Both
drugs have a 3 to 4 hour duration of action. Oxycodone retains
approximately one half of its analgesic
activity when administer