OXYCODONE HYDROCHLORIDE solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Precision Dose, Inc.

INN (Internationale Bezeichnung):

Oxycodone Hydrochloride

Zusammensetzung:

Oxycodone Hydrochloride 100 mg in 5 mL

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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. Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for the relief of pain in opioid-tolerant adults. 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 resus

Produktbesonderheiten:

Oxycodone Hydrochloride Oral Solution, USP 100 mg per 5 mL (20 mg/mL), is a yellow solution available as follows: NDC 68094-801-58 0.5 mL per unit dose syringe Fifty (50) syringes per shipper NDC 68094-057-58 0.5 mL per unit dose ENFit syringe Fifty (50) syringes per shipper NDC 68094-157-58 1 mL per unit dose ENFit syringe Fifty (50) syringes per shipper Storage Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature] PROTECT from MOISTURE and LIGHT. Store Oxycodone Hydrochloride Oral Solution securely and dispose of properly [see Patient Counseling Information (17)] .

Berechtigungsstatus:

Abbreviated New Drug Application

Gebrauchsinformation

Precision Dose, Inc.
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Medication Guide
Oxycodone Hydrochloride (ox-ee-CO-dohn) 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 oxycodone or any of the ingredients in Oxycodone
Hydrochloride Oral Solution.
Bef

Fachinformation

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE SOLUTION
PRECISION DOSE, INC.
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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 SOLUTIONS 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 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