OXYCODONE HYDROCHLORIDE tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Physicians Total Care, Inc.

ІПН (Міжнародна Ім'я):

OXYCODONE HYDROCHLORIDE

Склад:

OXYCODONE HYDROCHLORIDE 5 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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-medi

Огляд продуктів:

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 20 (NDC 54868-4983-2), bottles of 30 (NDC 54868-4983-4), bottles of 50 (NDC 54868-4983-1), bottles of 60 (NDC 54868-4983-0), bottles of 90 (NDC 54868-4983-3), bottles of 100 (NDC 54868-4983-5), bottles of 120 (NDC 54868-4983-8), bottles of 150 (NDC 54868-4983-9). 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 30 (NDC 54868-4980-2), bottles of 60 (NDC 54868-4980-0), bottles of 90 (NDC 54868-4980-3), bottles of 100 (NDC 54868-4980-4), bottles of 120 (NDC 54868-4980-1), bottles of 150 (NDC 54868-4980-5), bottles of 180 (NDC 54868-4980-6). 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 20 (NDC 54868-5390-2), bottles of 30 (NDC 54868-5390-1), bottles of 60 (NDC 54868-5390-0), bottles of 90 (NDC 54868-5390-5), bottles of 100 (NDC 54868-5390-3), bottles of 120 (NDC 54868-5390-4), bottles of 150 (NDC 54868-5390-6), bottles of 180 (NDC 54868-5390-7), bottles of 200 (NDC 54868-5390-8). DEA Order Form Required Dispense in a tight, light-resistant container. Protect from moisture. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Manufactured for: QUALITEST PHARMACEUTICALS Huntsville, AL 35811 8181892 R4/09-R3 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK     74146

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

OXYCODONE HYDROCHLORIDE - OXYCODONE HYDROCHLORIDE TABLET
PHYSICIANS TOTAL CARE, INC.
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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 half of its analgesic
activity when administered orally.
Effect