OXYCODONE HYDROCHLORIDE tablet, film coated, extended release

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

RedPharm Drug, Inc.

INN（国際名）:

OXYCODONE HYDROCHLORIDE

構図:

OXYCODONE HYDROCHLORIDE 10 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

OXYCODONE HCl EXTENDED-RELEASE TABLETS are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate in: Adults; and Opioid-tolerant pediatric patients 11 years of age and older who are already receiving and tolerate a minimum daily opioid dose of at least 20 mg oxycodone orally or its equivalent. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions (5.1)], reserve OXYCODONE HCl EXTENDED-RELEASE TABLETS for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. OXYCODONE HCl EXTENDED-RELEASE TABLETS are not indicated as an as-needed (prn) a

製品概要:

OXYCODONE HCl EXTENDED-RELEASE TABLETS (oxycodone hydrochloride) extended-release tablets 10 mg are film-coated, round, white-colored, bi-convex tablets debossed with OP on one side and 10 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 0115-1556-01) OXYCODONE HCl EXTENDED-RELEASE TABLETS (oxycodone hydrochloride) extended-release tablets 15 mg are film-coated, round, gray-colored, bi-convex tablets debossed with OP on one side and 15 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 0115-1557-01) OXYCODONE HCl EXTENDED-RELEASE TABLETS (oxycodone hydrochloride) extended-release tablets 20 mg are film-coated, round, pink-colored, bi-convex tablets debossed with OP on one side and 20 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 0115-1558-01) OXYCODONE HCl EXTENDED-RELEASE TABLETS (oxycodone hydrochloride) extended-release tablets 30 mg are film-coated, round, brown-colored, bi-convex tablets debossed with OP on one side and 30 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 0115-1559-01) OXYCODONE HCl EXTENDED-RELEASE TABLETS (oxycodone hydrochloride) extended-release tablets 40 mg are film-coated, round, yellow-colored, bi-convex tablets debossed with OP on one side and 40 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 0115-1560-01) OXYCODONE HCl EXTENDED-RELEASE TABLETS (oxycodone hydrochloride) extended-release tablets 60 mg are film-coated, round, red-colored, bi-convex tablets debossed with OP on one side and 60 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 0115-1561-01) OXYCODONE HCl EXTENDED-RELEASE TABLETS (oxycodone hydrochloride) extended-release tablets 80 mg are film-coated, round, green-colored, bi-convex tablets debossed with OP on one side and 80 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 0115-1562-01) Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F). Dispense in tight, light-resistant container. CAUTION DEA FORM REQUIRED

認証ステータス:

New Drug Application Authorized Generic

情報リーフレット

OXYCODONE HYDROCHLORIDE- oxycodone hydrochloride tablet, film coated,
extended release
RedPharm Drug, Inc.
----------
MEDICATION GUIDE
OXYCODONE Hydrochloride (ox-e-KO-don hye-droe-KLOR-ide)
Extended-release Tablets, for oral use,
CII
OXYCODONE HCl EXTENDED-RELEASE TABLETS are:
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage pain severe
enough to require daily around-the-clock, long-term treatment with an
opioid, when other pain treatments
such as non-opioid pain medicines or immediate-release opioid
medicines do not treat your pain well enough
or you cannot tolerate them.
A long-acting (extended-release) 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.
Not for use to treat pain that is not around-the-clock.
Not for use in children less than 11 years of age and who are not
already using opioid pain medicines
regularly to manage pain severe enough to require daily
around-the-clock long-term treatment of pain with an
opioid.
Important information about OXYCODONE HCl EXTENDED-RELEASE TABLETS:
Get emergency help right away if you take too much OXYCODONE HCl
EXTENDED-RELEASE
TABLETS (overdose). When you first start taking OXYCODONE HCl
EXTENDED-RELEASE 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.
Never give anyone else your OXYCODONE HCl EXTENDED-RELEASE TABLETS.
They could die from
taking it. Store OXYCODONE HCl EXTENDED-RELEASE TABLETS away from
children and in a safe
place to prevent stealing or abuse. Selling or giving away OXYCODONE
HCl EXTENDED-RELEASE
TABLETS is against the law.
Do not take OXYCODONE HCl EXTENDED-RELEASE TABLETS if you have:
severe asthma, trouble breathing, or other lung problems.
a bowel blockage or have narrowing of the stomach or intestines.
Before taking OXYCODONE HCl EXTENDED-RELEASE TABL

製品の特徴

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE TABLET, FILM COATED,
EXTENDED RELEASE
REDPHARM DRUG, INC.
----------
BOXED WARNING
WARNING: ADDICTION, ABUSE AND MISUSE; LIFE-THREATENING RESPIRATORY
DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL
SYNDROME; AND CYTOCHROME P450 3A4 INTERACTION
Addiction, Abuse, and Misuse
OXYCODONE HCl EXTENDED-RELEASE TABLETS expose patients and other users
to the risks of opioid addiction, abuse and misuse, which can lead to
overdose and
death. Assess each patient’s risk prior to prescribing OXYCODONE HCl
EXTENDED-
RELEASE TABLETS and monitor all patients regularly for the development
of these
behaviors or conditions [see Warnings and Precautions (5.1)].
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur
with use of
OXYCODONE HCl EXTENDED-RELEASE TABLETS. Monitor for respiratory
depression, especially during initiation of OXYCODONE HCl
EXTENDED-RELEASE
TABLETS or following a dose increase. Instruct patients to swallow
OXYCODONE
HCl EXTENDED-RELEASE TABLETS whole; crushing, chewing, or dissolving
OXYCODONE HCl EXTENDED-RELEASE TABLETS can cause rapid release and
absorption of a potentially fatal dose of oxycodone [see Warnings and
Precautions
(5.2)].
Accidental Ingestion
Accidental ingestion of even one dose of OXYCODONE HCl
EXTENDED-RELEASE
TABLETS, especially by children, can result in a fatal overdose of
oxycodone [see
Warnings and Precautions (5.2)].
Neonatal Opioid Withdrawal Syndrome
Prolonged use of OXYCODONE HCl EXTENDED-RELEASE TABLETS during
pregnancy can result in neonatal opioid withdrawal syndrome, which may
be life-
threatening if not recognized and treated, and requires management
according to
protocols developed by neonatology experts. If opioid use is required
for a
prolonged period in a pregnant woman, advise the patient of the risk
of neonatal
opioid withdrawal syndrome and ensure that appropriate treatment will
be available
[see Warnings and Precautions (5.3)].
Cytochrome P450 3A4 Interact