OXYCODONE HYDROCHLORIDE- 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:

Par Pharmaceutical

INN (International Name):

OXYCODONE HYDROCHLORIDE

Composition:

OXYCODONE HYDROCHLORIDE 10 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. Limitations of Use 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 (5.3)] -   Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment or hypercarbia [see Warnings and Precautions (5.7)] -   Known or suspected gastrointestinal obstruction, including paralytic ileus

Product summary:

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 as follows: Bottles of 100: NDC 0603-4990-21 Bottles of 500: NDC 0603-4990-28 10 mg: pink, round, convex, scored tablets, debossed “4993” on one side and debossed “V” on the reverse side, are supplied as follows: Bottles of 100: NDC 0603-4993-21 15 mg: light green, round, convex, scored tablets, debossed “4811” on one side and debossed “V” on the reverse side, are supplied as follows: Bottles of 100: NDC 0603-4991-21 Bottles of 500: NDC 0603-4991-28 20 mg: gray, round, convex, scored tablets, debossed “4994” on one side and debossed “V” on the reverse side, are supplied as follows: Bottles of 100: NDC 0603-4994-21 30 mg: light blue, round, convex, scored tablets, debossed “4812” on one side and debossed “V” on the reverse side, are supplied as follows: Bottles of 100: NDC 0603-4992-21 Bottles of 500: NDC 0603-4992-28 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

Par Pharmaceutical
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Medication Guide
Oxycodone Hydrochloride (ox" i koe' done hye" droe klor' ide) Tablets,
USP C-II
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.
Important 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. Selling or giving away oxycodone
hydrochloride
tablets is 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
•
liver, kidney, thyroid problems
•
problems urinating
•
pancreas or gallbladder problems
•
abuse of street or prescription drugs, alcohol addiction,

Summary of Product characteristics

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE TABLET
PAR PHARMACEUTICAL
----------
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; RISK EVALUATION AND MITIGATION
STRATEGY
(REMS);LIFE- THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION;
NEONATAL
OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 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)
TO ENSURE THAT THE BENEFITS OF OPIOID ANALGESICS OUTWEIGH THE RISKS OF
ADDICTION, ABUSE, AND MISUSE, THE
FOOD AND DRUG ADMINISTRATION (FDA) HAS REQUIRED A RISK EVALUATION AND
MITIGATION STRATEGY (REMS)
FOR THESE PRODUCTS. (5.2)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY, ESPECIALLY UPON
INITIATION OR FOLLOWING A DOSE INCREASE. (5.3)
ACCIDENTAL INGESTION OF OXYCODONE HYDROCHLORIDE TABLETS, ESPECIALLY BY
CHILDREN, CAN RESULT IN A FATAL
OVERDOSE OF OXYCODONE. (5.3)
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. (5.4)
CONCOMITANT USE WITH CYP3A4 INHIBITORS (OR DISCONTINUATION OF CYP3A4
INDUCERS) CAN RESULT IN A FATAL
OVERDOSE OF OXYCODONE FROM OXYCODONE HYDROCHLORIDE TABLETS. (5.5, 7,
12.3)
CONCOMI