OXYCODONE HYDROCHLORIDE tablet

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Lake Erie Medical DBA Quality Care Products LLC

INN (Isem Internazzjonali):

OXYCODONE HYDROCHLORIDE

Kompożizzjoni:

OXYCODONE HYDROCHLORIDE 10 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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

Sommarju tal-prodott:

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. 10 mg: Pink colored, round-shaped, biconvex, beveled edge, uncoated tablets, debossed with ‘370’ on one side and scored on the other side. NDC: 55700-020-30  Bottles of 30 NDC: 55700-020-60  Bottles of 60 NDC: 55700-020-90  Bottles of 90 15 mg: Green colored, round-shaped, biconvex, beveled edge, uncoated tablets, debossed with ‘187’ on one side and scored on the other side. 20 mg: Gray colored, round-shaped, biconvex, beveled edge, uncoated tablets, debossed with ‘371’ on one side and scored on the other side. 30 mg: Blue colored, round-shaped, biconvex, beveled edge, uncoated tablets, debossed with ‘224’ on one side and scored on the other side. 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:          Caraco Pharmaceutical Laboratories, Ltd.                                    Detroit, MI 48202 Manufactured by:     Sun Pharmaceutical Industries, Inc.                                    Cranbury, NJ 08512 6405T04 Rev. 11/2012

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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OXYCODONE HYDROCHLORIDE TABLETS, USP, 5 MG, 10 MG, 15 MG, 20 MG, 30 MG
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
wit