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:

McKesson Corporation

INN (International Name):

OXYCODONE HYDROCHLORIDE

Composition:

OXYCODONE HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Oxycodone hydrochloride (HCl) 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 HCl 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 HCl is 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 obstruction, including paralytic ileus [see Warnings and Precautions (5

Product summary:

Product: 63739-177 NDC: 63739-177-10 10 TABLET in a BLISTER PACK / 10 in a BOX, UNIT-DOSE Product: 63739-365 NDC: 63739-365-10 10 TABLET in a BLISTER PACK / 10 in a BOX, UNIT-DOSE

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

McKesson Corporation
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SPL MEDGUIDE
Medication Guide
Oxycodone (ox-i-KOE-done) HCl Tablets USP, CII
Oxycodone HCl 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 HCl tablets:
Get emergency help right away if you take too many oxycodone HCl
tablets (overdose).
When you first start taking oxycodone HCl 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 HCl 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 HCl tablets. They could die from
taking it. Store
oxycodone HCl tablets away from children and in a safe place to
prevent stealing or abuse. Selling
or giving away oxycodone HCl tablets is against the law.
Do not take oxycodone HCl 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 HCl 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
pancreas or gallbladder problems
Tell your healthcare provider if you are:
pregnant or planning to become pregnant. Prolonged use of oxycodone
HCl tablets during
pregnancy can

Summary of Product characteristics

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE TABLET
MCKESSON CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OXYCODONE HCL TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OXYCODONE HCL
TABLETS
INITIAL U.S. APPROVAL: 1950
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY
DEPRESSION;
ACCIDENTAL INGESTION; NEONOTAL 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 HCL 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)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY, ESPECIALLY UPON
INITIATION OR FOLLOWING A DOSE INCREASE. (5.2)
ACCIDENTAL INGESTION OF OXYCODONE HCL, ESPECIALLY BY CHILDREN, CAN
RESULT IN A FATAL OVERDOSE OF
OXYCODONE. (5.2)
PROLONGED USE OF OXYCODONE HCL 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 HCL 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
ARE INADEQUATE; LIMIT DOSAGES AND DURATIONS TO THE MINIMUM REQUIRED;
AND FOLLOW PATIENTS FOR SIGNS
AND SYMPTOMS OF RESPIRATORY DEPRESSIO