OXYCODONE HYDROCHLORIDE solution

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Morton Grove Pharmaceuticals, Inc.

INN (Medzinárodný Name):

OXYCODONE HYDROCHLORIDE

Zloženie:

OXYCODONE HYDROCHLORIDE 5 mg in 5 mL

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Oxycodone Hydrochloride Oral Solution, USP is indicated in adults 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 (5.2) ], reserve Oxycodone Hydrochloride Oral Solution, USP 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 Oral Solution, USP is contraindicated in patients with: - Significant respiratory depression [see Warnings and Precautions (5.4) ] - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.4) ] - Known or suspected gas

Prehľad produktov:

Oxycodone Hydrochloride Oral Solution, USP, 5 mg per 5 mL (1 mg/mL) is available as follows: NDC 60432-706-05: 500 mL plastic bottle packaged with calibrated measuring cup Dispense in a tight, light-resistant container as defined in the USP/NF. Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions are permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature] Store Oxycodone Hydrochloride Oral Solution securely and dispose of properly [see Patient Counseling Information (17) ].

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

OXYCODONE HYDROCHLORIDE - OXYCODONE HYDROCHLORIDE SOLUTION
Morton Grove Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
Medication Guide
Oxycodone (ox-ee-CO-dohn) Hydrochloride Oral Solution, CII
Rx Only
Oxycodone Hydrochloride Oral Solution is:
•
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 Oral Solution:
•
Get emergency help or call 911 right away if you take too much
Oxycodone Hydrochloride Oral
Solution (overdose). When you first start taking Oxycodone
Hydrochloride Oral Solution, 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. Talk to your healthcare provider
about naloxone, a medicine for the
emergency treatment of an opioid overdose.
•
Taking Oxycodone Hydrochloride Oral Solution 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 Oral Solution.
They could die from taking it.
Selling or giving away Oxycodone Hydrochloride Oral Solution is
against the law.
•
Store Oxycodone Hydrochloride Oral Solution 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 Oral Solution if you have:
•
severe asthma, trouble breathing, or other lung problems.
•
a bowel blockage or have narrowing of the stomach or intestines.
�

Súhrn charakteristických

OXYCODONE HYDROCHLORIDE - OXYCODONE HYDROCHLORIDE SOLUTION
MORTON GROVE PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OXYCODONE HYDROCHLORIDE
ORAL SOLUTION, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR OXYCODONE
HYDROCHLORIDE ORAL SOLUTION, USP.
OXYCODONE HYDROCHLORIDE ORAL SOLUTION, USP CII
INITIAL U.S. APPROVAL: 1950
WARNING: RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND MISUSE; RISK
EVUALATION 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.
ENSURE ACCURACY WHEN PRESCRIBING, DISPENSING, AND ADMINISTERING
OXYCODONE
HYDROCHLORIDE ORAL SOLUTION, USP. DOSING ERRORS DUE TO CONFUSION
BETWEEN MG AND
ML, AND OTHER OXYCODONE HYDROCHLORIDE ORAL SOLUTION, USP OF DIFFERENT
CONCENTRATIONS CAN RESULT IN ACCIDENTAL OVERDOSE AND DEATH. (2.1,5.1)
OXYCODONE HYDROCHLORIDE ORAL SOLUTION, USP 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. (5.2)
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. (5.3)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY,
ESPECIALLY UPON INITIATION OR FOLLOWING A DOSE INCREASE. (5.4)
ACCIDENTAL INGESTION OF OXYCODONE HYDROCHLORIDE ORAL SOLUTION, USP,
ESPECIALLY BY
CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF OXYCODONE. (5.4)
PROLONGED USE OF OXYCODONE HYDROCHLORIDE ORAL SOLUTION, USP DURING
PREGNANCY CAN
RESULT IN NEONATAL OPIOID WITHDRAWAL SYNDROME, WHICH MAY BE
LIFE-THREATENING IF NOT
RECOGNIZE