OXYCODONE HYDROCHLORIDE tablet

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

Oxycodone Hydrochloride (UNII: C1ENJ2TE6C) (Oxycodone - UNII:CD35PMG570)

Dostupné z:

Mayne Pharma Inc.

INN (Medzinárodný Name):

Oxycodone Hydrochloride

Zloženie:

Oxycodone Hydrochloride 5 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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 [see

Prehľad produktov:

Oxycodone hydrochloride tablets USP are available as follows: The 5 mg tablets are white, round, standard convex, scored tablets debossed with 112 above the score on one side of the tablet and blank on the other side. They are available as follows: NDC 68308-108-01 bottles of 100 tablets NDC 68308-505-47 Blisters 100 (10 × 10) Unit-dose Tablets The 10 mg tablets are white to off-white oval tablets debossed with 110 on one side and scored on the other side. They are available as follows: NDC 68308-110-01 bottles of 100 tablets The 15 mg tablets are peach, round, standard convex, scored tablets debossed with 113 above the score on one side of the tablet and blank on the other side. They are available as follows: NDC 68308-111-01 bottles of 100 tablets The 20 mg tablets are peach oval tablets debossed with 120 on one side and scored on the other side. They are available as follows: NDC 68308-120-01 bottles of 100 tablets The 30 mg tablets are white, round, standard convex, scored tablets debossed with 114 above the score on one side of the tablet and blank on the other side. They are available as follows: NDC 68308-112-01 bottles of 100 tablets Dispense in a tight, light-resistant container. Protect from moisture. Store at 25°C (77°F); excursions are permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store oxycodone hydrochloride tablets securely and dispose of properly [see Patient Counseling Information (17)] .

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

Mayne Pharma Inc.
Reference Label Set Id: 206a6da0-2411-48e7-94e6-8a115fc9ff07
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MEDICATION GUIDE
OXYCODONE (OX-EE-CO-DOHN) HYDROCHLORIDE TABLETS USP, CII
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Issued: 10/2019
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 hist

Súhrn charakteristických

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE TABLET
MAYNE PHARMA INC.
REFERENCE LABEL SET ID: 206A6DA0-2411-48E7-94E6-8A115FC9FF07
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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 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)
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 F