OXYCODONE HYDROCHLORIDE tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

STAT RX USA LLC

INN (Kansainvälinen yleisnimi):

OXYCODONE HYDROCHLORIDE

Koostumus:

OXYCODONE HYDROCHLORIDE 15 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Oxycodone hydrochloride tablets are an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate. Oxycodone hydrochloride tablets are contraindicated in patients with known hypersensitivity to oxycodone, or in any situation where opioids are contraindicated. This includes patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe bronchial asthma or hypercarbia. Oxycodone hydrochloride tablets are contraindicated in any patient who has or is suspected of having paralytic ileus. Oxycodone hydrochloride tablets contain oxycodone, a mu-agonist opioid of the morphine type and is a Schedule II controlled substance. Oxycodone hydrochloride tablets, like other opioids used in analgesia, can be abused and is subject to criminal diversion. Drug addiction is characterized by compulsive use, use for non-medical purposes

Tuoteyhteenveto:

Oxycodone Hydrochloride Tablets, USP 5 mg: white, round, convex, scored tablets, debossed "4810" on one side and debossed "V" on the reverse side, are supplied in bottles of 10, 100, 500, and 1000. 15 mg: light green, round, convex, scored tablets, debossed "4811" on one side and debossed "V" on the reverse side, are supplied in bottles of 10, 100, 500, and 1000. 30 mg: light blue, round, convex, scored tablets, debossed "4812" on one side and debossed "V" on the reverse side, are supplied in bottles of 10, 100, 500, and 1000. DEA Order Form Required

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

OXYCODONE HYDROCHLORIDE - OXYCODONE HYDROCHLORIDE TABLET
STAT RX USA LLC
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OXYCODONE HYDROCHLORIDE TABLETS, USP
5 MG, 15 MG, AND 30 MG
CII
RX ONLY
DESCRIPTION
Oxycodone Hydrochloride Tablets, USP are opioid analgesics.
Each tablet for oral administration contains 5 mg, 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-methylmorphinan-6-
one hydrochloride and has the following structural formula:
The tablets contain the following inactive ingredients: lactose
monohydrate, magnesium stearate,
microcrystalline cellulose, povidone, sodium starch glycolate, stearic
acid. In addition, the 15 mg and
30 mg tablets contain FD&C Blue #1 aluminum lake, and the 15 mg
tablets also contain D&C Yellow
#10 aluminum lake.
The 5 mg, 15 mg, and 30 mg tablets contain the equivalent of 4.5 mg,
13.5 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 a single-
dose, relative-potency study conducted in humans with cancer pain, 10
to 15 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 hal