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:

Epic Pharma, LLC

INN (International Name):

OXYCODONE HYDROCHLORIDE

Composition:

OXYCODONE HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Oxycodone hydrochloride tablets USP 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): Oxycodone Hydrochloride Tablets USP is contraindicated in patients with: Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.4)] . Available data with oxycodone hydrochloride tablets in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. Animal reproduction studies with oral administrations of oxycodone HCl in rats and rabbits during the period of organogenesis at doses 2.6 and 8.1 times, respectivel

Product summary:

Oxycodone Hydrochloride Tablets USP, 5 mg are white, round biconvex tablets debossed the “ϵ” to the left of bisect and “5” to the right of bisect on one side and plain on the other side. NDC 42806-005-01 Bottles of 100 Oxycodone Hydrochloride Tablets USP, 10 mg are yellow, round biconvex tablets debossed “ϵ” to the left of bisect and “6” to the right of bisect on one side and plain on the other side. NDC 42806-006-01 Bottles of 100 Oxycodone Hydrochloride Tablets USP, 15 mg are green, round biconvex tablets debossed “ϵ” to the left of bisect and “7” to the right of bisect on one side and plain on the other side. NDC 42806-007-01 Bottles of 100 Oxycodone Hydrochloride Tablets USP, 20 mg are gray, round biconvex tablets, debossed ”ϵ” to the left of bisect and “9” to the right of bisect on one side and plain on the other side. NDC 42806-009-01 Bottles of 100 Oxycodone Hydrochloride Tablets USP, 30 mg are blue, round biconvex tablets debossed “ϵ” to the left of bisect and “8” to the right of bisect on one side and plain on the other side. NDC 42806-008-01 Bottles of 100 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]. Store oxycodone hydrochloride tablets securely and dispose of properly [see Patient Counseling Information (17)] .

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Epic Pharma, LLC
----------
DISPENSE WITH MEDICATION GUIDE
AVAILABLE AT: WWW.EPIC-
PHARMA.COM/MEDGUIDE/MEPERIDINE-
HYDROCHLORIDE-TABLET.PDF
MEDICATION GUIDE
Medication Guide
Oxycodone Hydrochloride Tablets USP, CII
(ox" i koe' done hye" droe klor' ide)
Rx Only
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.
Selling or giving away oxycodone hydrochloride tablets is against the
law.
•
Store oxycodone hydrochloride tablets securely, out of sight and reach
of children, and in a
location not accessible by others, including visitors to the home.
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 histo

Summary of Product characteristics

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE TABLET
EPIC PHARMA, LLC
----------
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._
•
•
•
•
•
•
•
RECENT MAJOR CHANGES
Dosage and Administration (2.4) 10/2019
Warnings and Precautions (5.3,5.13) 10/2019
INDICATIONS AND USAGE
Oxycodone hydrochloride tablet is an opioid agonist 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)
•
•
DOSAGE AND ADMINISTRATION
OXYCODONE HYDROCHLORIDE TABLETS EXPOSES 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) 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-THREATENI