OXYCODONE HYDROCHLORIDE tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

Oxycodone Hydrochloride (UNII: C1ENJ2TE6C) (Oxycodone - UNII:CD35PMG570)

Доступна з:

H.J. Harkins Company, Inc.

ІПН (Міжнародна Ім'я):

Oxycodone Hydrochloride

Склад:

Oxycodone Hydrochloride 30 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Oxycodone hydrochloride tablets, USP 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, 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, a

Огляд продуктів:

Oxycodone hydrochloride tablets, USP are supplied as follows: The 5 mg tablets are white, round, standard convex, scored tablets debossed with 112 above the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-6112-01 bottles of 100 tablets The 15 mg tablets are peach, round, standard convex, scored tablets debossed with 113 above the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-6113-01 bottles of 100 tablets The 30 mg tablets are white, round, standard convex, scored tablets debossed with 114 above the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-6114-01 bottles of 100 tablets Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. DEA ORDER FORM REQUIRED

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

OXYCODONE HYDROCHLORIDE - OXYCODONE HYDROCHLORIDE TABLET
H.J. HARKINS COMPANY, INC.
----------
OXYCODONE HYDROCHLORIDE TABLETS USP CII
R ONLY
DESCRIPTION
Oxycodone hydrochloride tablet, USP is 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:
C
N NO •HCl 351.82
The tablets contain the following inactive ingredients:
microcrystalline cellulose; lactose monohydrate;
sodium starch glycolate; colloidal silicon dioxide; corn starch;
stearic acid; FD&C Yellow No. 6 (15
mg tablet).
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