OXYCODONE HYDROCHLORIDE tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

STAT RX LLC USA

Designación común internacional (DCI):

OXYCODONE HYDROCHLORIDE

Composición:

OXYCODONE HYDROCHLORIDE 5 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 nonmedic

Resumen del producto:

HOW SUPPLIED Each Oxycodone Hydrochloride Tablet USP 5 mg is available as a white round convex tablet with a LOGO IMPRINT IMAGE on one side and “0552” with a vertical bisect between the fives on the other. Bottles of 100 ......................... NDC 0406-0552-01 Unit Dose (10 x 10) ................ NDC 0406-0552-62 Each Oxycodone Hydrochloride Tablet USP 15 mg is available as a light green round convex tablet with a LOGO IMPRINT IMAGE on one side and “15” above a bisect on the other. Bottles of 100 ........................ NDC 0406-8515-01 Each Oxycodone Hydrochloride Tablet USP 30 mg is available as a light blue round convex tablet with a  LOGO IMPRINT IMAGE on one side and “15” above a bisect on the other. Bottles of 100 ........................ NDC 0406-8515-01 Each Oxycodone Hydrochloride Tablet USP 30 mg is available as a light blue round convex tablet with a   LOGO IMPRINT IMAGE on one side and “30” above a bisect on the other. Bottles of 100 ........................ NDC 0406-8530-01 Dispense in a tight, light-resistant container with child-resistant closure. Protect from moisture. Protect from light. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. To request medical information or to report suspected adverse reactions, contact Product Monitoring at 1-800-778-7898. LOGO IMPRINT IMAGE is a trademark of Mallinckrodt Inc. Mallinckrodt Inc., Hazelwood, MO 63042 USA. COVIDIEN™ Mallinckrodt Printed in U.S.A. Rev 05/2009

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

OXYCODONE HYDROCHLORIDE - OXYCODONE HYDROCHLORIDE TABLET
STAT RX LLC USA
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DESCRIPTION
DESCRIPTION
Oxycodone Hydrochloride Tablets USP are an opioid analgesic.
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:
OXYCODONE STRUCTURE IMAGE
The tablets contain the following inactive ingredients:
microcrystalline cellulose, lactose monohydrate,
stearic acid, DandC Yellow No. 10 (15 mg tablet), and FDandC Blue No.
2 (15 mg and 30 mg tablets).
The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.5 mg,
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 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 half of its analgesic
activity when administered orally.
EFFECTS ON CENTRAL NERVOUS SYSTEM – The precise mechanism of the
analgesic action is unknow