OXYCODONE HYDROCHLORIDE tablet

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Aurolife Pharma, LLC

INN (Международно Name):

OXYCODONE HYDROCHLORIDE

Композиция:

OXYCODONE HYDROCHLORIDE 5 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Oxycodone Hydrochloride Tablets is 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 is 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, in

Каталог на резюме:

Oxycodone hydrochloride tablets, USP are available as follows: 5 mg White to off white, round tablets, debossed with “U22” on one side and breakline on the other side. Bottles of 30       NDC 13107-055-30 Bottles of 100     NDC 13107-055-01 Bottles of 1000   NDC 13107-055-99 15 mg Light green to green, round tablets, debossed with “U23” on one side and breakline on the other side. Bottles of 30        NDC 13107-056-30 Bottles of 100      NDC 13107-056-01 Bottles of 1000    NDC 13107-056-99 30 mg Light blue to blue, round tablets, debossed with “U24” on one side and breakline on the other side. Bottles of 30         NDC13107-057-30 Bottles of 100       NDC13107-057-01 Bottles of 1000     NDC 13107-057-99 DEA Order Form Required 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)].

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

OXYCODONE HYDROCHLORIDE - OXYCODONE HYDROCHLORIDE TABLET
AUROLIFE 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._
• 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 FROM OXYCODONE HYDROCHLORIDE
TAB