OXYCODONE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Novel Laboratories, Inc.

INN (International Name):

OXYCODONE HYDROCHLORIDE

Composition:

OXYCODONE HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.   (1) Limitations of Use (1) Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)] , reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): - Have not been tolerated or are not expected to be tolerated, - Have not provided adequate analgesia or are not expected to provide adequate analgesia. Oxycodone hydrochloride tablets are contraindicated in patients with: - Significant respiratory depression [see Warnings and Precautions (5.2)] . - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment or hypercarbia [see Warnings and Precautions (5.6)] . - Known or suspected gastrointestinal obstruc

Product summary:

Oxycodone hydrochloride tablets USP, 5 mg tablets are white to off-white colored, round, biconvex tablets debossed and bisected with "n" above "20" below on one side and plain on the other side. They are supplied as follows: NDC 40032-432-03: Bottles of 30 tablets NDC 40032-432-01: Bottles of 100 tablets NDC 40032-432-05: Bottles of 500 tablets Oxycodone hydrochloride tablets USP, 10 mg tablets are gray colored, round, biconvex tablets debossed and bisected with "n" above "25" below on one side and plain on the other side. They are supplied as follows: NDC 40032-433-03: Bottles of 30 tablets NDC 40032-433-01: Bottles of 100 tablets NDC 40032-433-05: Bottles of 500 tablets Oxycodone hydrochloride tablets USP, 15 mg tablets are green colored, round, biconvex tablets debossed and bisected with "n" above "21" below on one side and plain on the other side. They are supplied as follows: NDC 40032-430-03: Bottles of 30 tablets NDC 40032-430-01: Bottles of 100 tablets NDC 40032-430-05: Bottles of 500 tablets Oxycodone hydrochloride tablets USP, 20 mg tablets are pink colored, round, biconvex tablets debossed and bisected with "n" above "27" below on one side and plain on the other side. They are supplied as follows: NDC 40032-434-03: Bottles of 30 tablets NDC 40032-434-01: Bottles of 100 tablets NDC 40032-434-05: Bottles of 500 tablets Oxycodone hydrochloride tablets USP, 30 mg tablets are blue colored, round, biconvex tablets debossed and bisected with "n" above "23" below on one side and plain on the other side. They are supplied as follows: NDC 40032-431-03: Bottles of 30 tablets NDC 40032-431-01: Bottles of 100 tablets NDC 40032-431-05: Bottles of 500 tablets 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].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Novel Laboratories, Inc.
----------
Medication Guide
Oxycodone Hydrochloride (ox'' i koe' done hye'' droe klor' ide)
Tablets USP,
CII
Oxycodone Hydrochloride Tablets are:
• A strong prescription pain medicine that contains an opioid
(narcotic)
that is used to manage pain severe enough to require an opioid pain
medicine,
when other pain treatments such as non-opioid pain medicines do not
treat
your pain well enough or you cannot tolerate them.
• An opioid pain medicine that can put you at risk for overdose and
death. Even if you take your dose correctly as prescribed you are at
risk for
opioid addiction, abuse, and misuse that can lead to death.
I mportant information about oxycodone hydrochloride tablets:
• Get emergency help right away if you take too much oxycodone
hydrochloride tablets (overdose). When you first start taking
oxycodone
hydrochloride tablets, when your dose is changed, or if you take too
much
(overdose), serious or life-threatening breathing problems that can
lead to
death may occur.
• Taking oxycodone hydrochloride tablets with other opioid
medicines,
benzodiazepines, alcohol, or other central nervous system depressants
(including street drugs) can cause severe drowsiness, decreased
awareness,
breathing problems, coma, and death.
• Never give anyone else your oxycodone hydrochloride tablets. They
could die from taking it. Store oxycodone hydrochloride tablets away
from
children and in a safe place to prevent stealing or abuse. Sellin or
giving away
oxycodone hydrochloride tablets are against the law.
Do not take oxycodone hydrochloride tablets if you have:
• severe asthma, trouble breathing, or other lung problems.
• a bowel blockage or have narrowing of the stomach or intestines.
• allergy to oxycodone.
Before taking oxycodone hydrochloride tablets, tell your healthcare
provider if
you have a history of:
• head injury, seizures
• problems urinating
• abuse of street or prescription drugs, alcohol addiction, or
mental
health problems.
• liver, kidney, thyroid problems
�

Summary of Product characteristics

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE TABLET
NOVEL LABORATORIES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OXYCODONE HYDROCHLORIDE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OXYCODONE
HYDROCHLORIDE TABLETS
OXYCODONE HYDROCHLORIDE TABLETS, FOR ORAL USE, CII
INITIAL U.S. APPROVAL:1950
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY
DEPRESSION;
ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME
P4503A4
INTERACTION; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR
OTHER CNS
DEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
OXYCODONE HYDROCHLORIDE TABLETS EXPOSE USERS TO RISKS OF ADDICTION,
ABUSE, AND MISUSE, WHICH CAN LEAD
TO OVERDOSE AND DEATH. ASSESS PATIENT'S RISK BEFORE PRESCRIBING AND
MONITOR REGULARLY FOR THESE
BEHAVIORS AND CONDITIONS. (5.1)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY, ESPECIALLY UPON
INITIATION OR FO LLOWING A DOSE INCREASE. (5.2)
ACCIDENTAL INGESTION OF OXYCODONE HYDROCHLORIDE TABLETS, ESPECIALLY BY
CHILDREN, CAN RESULT IN A FATAL
OVERDOSE OF OXYCODONE. (5.2)
PROLONGED USE OF OXYCODONE HYDROCHLORIDE TABLETS DURING PREGNANCY CAN
RESULT IN NEONATAL OPIOID
WITHDRAWAL SYNDROME, WHICH MAY BE LIFE-THREATENING IF NOT RECOGNIZED
AND TREATED. IF PROLONGED
OPIOID USE IS REQUIRED IN A PREGNANT WOMAN, ADVISE THE PATIENT OF THE
RISK OF NEONATAL OPIOID
WITHDRAWAL SYNDROME AND ENSURE THAT APPROPRIATE TREATMENT WILL BE
AVAILABLE. (5.3)
CONCOMITANT USE WITH CYP3A4 INHIBITORS (OR DISCONTINUATION OF CYP3A4
INDUCERS) CAN RESULT IN A FATAL
OVERDOSE OF OXYCODONE FROM OXYCODONE HYDROCHLORIDE TABLETS. (5.4,7,
12.3)
CONCOMITANT USE OF OPIOIDS WITH BENZODIAZEPINES OR OTHER CENTRAL
NERVOUS SYSTEM (CNS) DEPRESSANTS,
INCLUDING ALCOHOL, MAY RESULT IN PROFOUND SEDATION, RESPIRATORY
DEPRESSION, COMA, AND DEATH. RESERVE
CONCOMITANT PRESCRIBING FOR USE IN PATIENTS FOR WHOM ALTERNATIVE
TREATMENT OPTIONS