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:

KVK-TECH,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. 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 ( 5.2)] - 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 o

Product summary:

Oxycodone hydrochloride tablets, USP are available as follows: Oxycodone hydrochloride tablets, USP 5 mg are supplied as white round biconvex tablets debossed "K" on left and "18" on right of the bisect on one side and plain on the other side. NDC 10702-018-01   Bottles of 100 tablets NDC 10702-018-50   Bottles of 500 tablets Oxycodone hydrochloride tablets, USP 10 mg are supplied as pink round biconvex tablets debossed "K" on left and "56" on right of the bisect on one side and plain on the other side. NDC 10702-056-01   Bottles of 100 tablets NDC 10702-056-50   Bottles of 500 tablets Oxycodone hydrochloride tablets, USP 15 mg are supplied as green round biconvex tablets debossed "K" on left and "8" on right of the bisect on one side and plain on the other side. NDC 10702-008-01   Bottles of 100 tablets NDC 10702-008-50   Bottles of 500 tablets Oxycodone hydrochloride tablets, USP 20 mg are supplied as gray round biconvex tablets debossed "K" on left and "57" on right of the bisect on one side and plain on the other side. NDC 10702-057-01   Bottles of 100 tablets NDC 10702-057-50   Bottles of 500 tablets Oxycodone hydrochloride tablets, USP 30 mg are supplied as blue round biconvex tablets debossed "K" on left and "9" on right of the bisect on one side and plain on the other side. NDC 10702-009-01   Bottles of 100 tablets NDC 10702-009-50   Bottles of 500 tablets Dispense in a tight, light-resistant container. Protect from moisture. Store at 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE TABLET
KVK-TECH,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.
Important information about Oxycodone Hydrochloride Tablets:
•
Get emergency help right away if you take too muchOxycodone
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 str

Summary of Product characteristics

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE TABLET
KVK-TECH,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 USP,
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 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 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 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 optio