OXYCODONE HYDROCHLORIDE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

VistaPharm, Inc.

INN (International Name):

OXYCODONE HYDROCHLORIDE

Composition:

OXYCODONE HYDROCHLORIDE 5 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Oxycodone Hydrochloride Oral Solution 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 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 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 gastrointestinal obstruction, including paralyti

Product summary:

Oxycodone Hydrochloride Oral Solution, USP, 5 mg per 5 mL (1 mg/mL) is available as follows: NDC 66689-403-16: 500 mL bottle packaged with calibrated measuring cup NDC 66689-401-01: 5 mL unit dose cup NDC 66689-401-50: Case contains 50 unit-dose cups of 5 mL (NDC 66689-401-01), packaged  in 5 trays of 10 unit-dose cups each Dispense in a tight, light-resistant container as defined in the USP/NF. Store at controlled room temperature 20°-25°C (68°- 77°F); excursions are permitted to 15° - 30°C (59° - 86°F). [See USP Controlled Room Temperature] Store Oxycodone Hydrochloride Oral Solution securely and dispose of properly [see Patient Counseling Information (17) ].

Authorization status:

New Drug Application

Patient Information leaflet

OXYCODONE HYDROCHLORIDE- oxycodone hydrochloride solution
VistaPharm, Inc.
----------
MEDICATION GUIDE
Medication Guide
Oxycodone (ox-ee-CO-dohn) Hydrochloride Oral Solution, CII
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.
•
an allergy to oxycodon

Summary of Product characteristics

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE SOLUTION
VISTAPHARM, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OXYCODONE HYDROCHLORIDE
ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR OXYCODONE
HYDROCHLORIDE ORAL SOLUTION.
OXYCODONE HYDROCHLORIDE ORAL SOLUTION CII
INITIAL U.S. APPROVAL: 1950
WARNING: RISK OF MEDICATION ERRORS; 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.
ENSURE ACCURACY WHEN PRESCRIBING, DISPENSING, AND ADMINISTERING
OXYCODONE
HYDROCHLORIDE ORAL SOLUTION. DOSING ERRORS DUE TO CONFUSION BETWEEN MG
AND ML,
AND OTHER OXYCODONE HYDROCHLORIDE ORAL SOLUTION OF DIFFERENT
CONCENTRATIONS CAN
RESULT IN ACCIDENTAL OVERDOSE AND DEATH. (2.1, 5.1)
OXYCODONE HYDROCHLORIDE ORAL SOLUTION 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,
ESPECIALLY BY
CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF OXYCODONE. (5.4)
PROLONGED USE OF OXYCODONE HYDROCHLORIDE ORAL SOLUTION 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