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 5 mg

Prescription tyyppi:

PRESCRIPTION DRUG

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE TABLET
ST MARYS MEDICAL PARK PHARMACY
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OXYCODONE HYDROCHLORIDE TABLETS
DESCRIPTION
Oxycodone hydrochloride tablets USP is an opioid analgesic.
Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 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-methylmorphinan-6-
one hydrochloride and has the following structural formula:
The tablets contain the following inactive ingredients: anhydrous
lactose, colloidal silicon dioxide,
magnesium stearate, microcrystalline cellulose, pregelatinized starch,
and sodium starch glycolate. In
addition, the 10 mg tablet also contains D&C Red #27 aluminum lake and
D&C Red # 30 aluminum lake,
the 15 mg tablet contains D&C Yellow #10 aluminum lake and FD&C Blue
#2 aluminum lake, the 20 mg
tablet contains FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum
lake, FD&C Yellow #6
aluminum lake and FD&C Red #40 aluminum lake and the 30 mg tablet
contains FD&C Blue #2 aluminum
lake.
The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent
of 4.5 mg, 8.96 mg, 13.5 mg,
17.93 mg, and 27 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