OXYCODONE HYDROCHLORIDE- oxycodone hydrochloride tablet, extended release

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

oxycodone hydrochloride (UNII: C1ENJ2TE6C) (oxycodone - UNII:CD35PMG570)

Disponible des:

Ethex Corporation

Designació comuna internacional (DCI):

oxycodone hydrochloride

Composición:

oxycodone hydrochloride 10 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Oxycodone HCl Controlled-Release Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. Oxycodone HCl Controlled-Release Tablets are NOT intended for use as a prn analgesic. Physicians should individualize treatment in every case, initiating therapy at the appropriate point along a progression from non-opioid analgesics, such as non-steroidal anti-inflammatory drugs and acetaminophen to opioids in a plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality (formerly known as the Agency for Health Care Policy and Research), the Federation of State Medical Boards Model Guidelines, or the American Pain Society. Oxycodone HCl Controlled-Release Tablets are not indicated for pain in the immediate postoperative period (the first 12-24 hours following surgery), or if the pain is mild, or n

Resumen del producto:

Oxycodone HCl Controlled-Release Tablets 10 mg are round, unscored, white-colored, convex tablets imprinted with OC on one side and 10 on the other. They are supplied as follows: Oxycodone HCl Controlled-Release Tablets 20 mg are round, unscored, pink-colored, convex tablets imprinted with OC on one side and 20 on the other. They are supplied as follows: Oxycodone HCl Controlled-Release Tablets 40 mg are round, unscored, yellow-colored, convex tablets imprinted with OC on one side and 40 on the other. They are supplied as follows: Oxycodone HCl Controlled-Release Tablets 80 mg are round, unscored, green-colored, convex tablets imprinted with OC on one side and 80 on the other. They are supplied as follows: Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F). Dispense in tight, light-resistant container.

Estat d'Autorització:

New Drug Application Authorized Generic

Fitxa tècnica

OXYCODONE HYDROCHLORIDE CONTROLLED-RELEASE - OXYCODONE
HYDROCHLORIDE TABLET, EXTENDED RELEASE
ETHEX CORPORATION
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OXYCODONE HCL CONTROLLED-RELEASE TABLETS
10 MG, 20 MG, 40 MG, 80 MG*
CII
*80 mg and 160 mg is for use in opioid-tolerant patients only
WARNING:
OXYCODONE HCL CONTROLLED-RELEASE TABLETS ARE AN OPIOID AGONIST AND A
SCHEDULE II
CONTROLLED SUBSTANCE WITH AN ABUSE LIABILITY SIMILAR TO MORPHINE.
Oxycodone can be abused in a manner similar to other opioid agonists,
legal or illicit. This
should be considered when prescribing or dispensing Oxycodone HCl
Controlled-Release
Tablets in situations where the physician or pharmacist is concerned
about an increased risk of
misuse, abuse, or diversion.
OXYCODONE HCL CONTROLLED-RELEASE TABLETS ARE A CONTROLLED-RELEASE ORAL
FORMULATION OF
OXYCODONE HYDROCHLORIDE INDICATED FOR THE MANAGEMENT OF MODERATE TO
SEVERE PAIN WHEN A
CONTINUOUS, AROUND-THE-CLOCK ANALGESIC IS NEEDED FOR AN EXTENDED
PERIOD OF TIME.
OXYCODONE HCL CONTROLLED-RELEASE TABLETS ARE NOT INTENDED FOR USE AS A
PRN ANALGESIC.
OXYCODONE HCL CONTROLLED-RELEASE 80 MG AND 160 MG TABLETS, OR A SINGLE
DOSE GREATER THAN 40 MG, ARE FOR USE IN OPIOID-TOLERANT PATIENTS ONLY.
A
SINGLE DOSE GREATER THAN 40 MG, OR TOTAL DAILY DOSES GREATER THAN 80
MG, may cause fatal
respiratory depression when administered to patients who are not
tolerant to the respiratory
depressant effects of opioids.
OXYCODONE HCL CONTROLLED-RELEASE TABLETS ARE TO BE SWALLOWED
WHOLE AND ARE NOT TO BE BROKEN, CHEWED, OR CRUSHED. TAKING
BROKEN, CHEWED, OR CRUSHED OXYCODONE HCL CONTROLLED-RELEASE
TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY
FATAL DOSE OF OXYCODONE.
DESCRIPTION
Oxycodone HCl Controlled-Release Tablets are an opioid analgesic
supplied in 10 mg, 20 mg, 40 mg,
and 80 mg tablet strengths for oral administration. The tablet
strengths describe the amount of
oxycodone per tablet as the hydrochloride salt. The structural formula
for oxycodone hydrochloride is
as follows:
The chemical formula is 4,
5α-epoxy-14-hydrox