OXYCODONE HYDROCHLORIDE tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

DIRECT RX

INN (International namn):

OXYCODONE HYDROCHLORIDE

Sammansättning:

OXYCODONE HYDROCHLORIDE 30 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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. Controlled Substance: 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. Abuse: Drug addiction is characterized by compulsive use,

Produktsammanfattning:

Oxycodone Hydrochloride Tablets, USP are available as follows: 5 mg: White colored, round-shaped, biconvex, beveled edge, uncoated tablets, debossed with ‘223’ on one side and scored on the other side. NDC 57664-223-88 Bottles of 100 CRC 10 mg: Pink colored, round-shaped, biconvex, beveled edge, uncoated tablets, debossed with ‘370’ on one side and scored on the other side. NDC 57664-370-88 Bottles of 100 CRC 15 mg: Green colored, round-shaped, biconvex, beveled edge, uncoated tablets, debossed with ‘187’ on one side and scored on the other side. NDC 57664-187-88 Bottles of 100 CRC 20 mg: Gray colored, round-shaped, biconvex, beveled edge, uncoated tablets, debossed with ‘371’ on one side and scored on the other side. NDC 57664-371-88 Bottles of 100 CRC 30 mg: Blue colored, round-shaped, biconvex, beveled edge, uncoated tablets, debossed with ‘224’ on one side and scored on the other side. NDC 57664-224-88 Bottles of 100 CRC DEA Order Form Required: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure. Store at 20° - 25°C (68° - 77°F). (See USP for Controlled Room Temperature). Protect from moisture. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 6405T06 Rev. 08/2014

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE TABLET
DIRECT RX
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OXYCODONE HCL C-II
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:
[chemical-structure]
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.
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 conducte