OXYCODONE HYDROCHLORIDE- 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:

Major Pharmaceuticals

INN (International Name):

OXYCODONE HYDROCHLORIDE

Composition:

OXYCODONE HYDROCHLORIDE 20 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Oxycodone Hydrochloride Oral Solution 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 (5.2)], 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 (5.3)] • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.7)] • Known or suspected gastrointestinal obstruction, including paralytic ileus [see Wa

Product summary:

Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg per mL). is a yellow solution, supplied as: NDC # 0904-6701-30 : Bottle of 30 mL supplied with a calibrated oral syringe Store at Controlled Room Temperature, 25 °C (77 °F); excursions are permitted to 15° - 30 °C (59° - 86 °F). PROTECT from MOISTURE and LIGHT.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Major Pharmaceuticals
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MEDICATION GUIDE
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 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.
• Taking Oxycodone Hydrochloride Oral
Solution with other opioid medicines,
benzodiazepines, alcohol, or other central
nervous system depressants (including street
The possible side effects of Oxycodone Hydrochloride
Oral Solution:
• constipation, nausea, sleepiness, vomiting, tiredness,
headache, dizziness, abdominal pain. Call your healthcare
provider if you have any of these symptoms and they are
severe.
Get emergency medical help if you have:
• trouble breathing, shortness of breath, fast heartbeat,
chest pain, swelling of your face, tongue, or throat,
extreme drowsiness, light-headedness when changing
positions, feeling faint, agitation, high body temperature,
trouble walking, stiff muscles, or mental changes such as
confusion.
These are not all the possible side effects of Oxycodone
Hydrochloride Oral Solution. Call your doctor for medical
advice about side effects. You may report side effects to
drugs) can cause severe drowsiness, decreased
awareness, breathing problems, coma,
and de

Summary of Product characteristics

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE SOLUTION
MAJOR PHARMACEUTICALS
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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.
INITIAL U.S. APPROVAL: 1950 WARNING: RISK OF MEDICATION ERRORS;
ADDICTION, ABUSE AND MISUSE;
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 RESULTS
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)
• 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 ORAL SOLUTION,
ESPECIALLY BY CHILDREN, CAN
RESULT IN A FATAL OVERDOSE OF OXYCODONE. (5.3)
• 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 PREGNANT WOMAN,
ADVISE THE PATIENT OF THE
RISK OF NEONATAL OPIOID WITHDRAWAL SYNDROME AND ENSURE THAT
APPROPRIATE TREATMENT WILL BE
AVAILABLE. (5.4)
• THE CONCOMITANT USE WITH CYP3A4 INHIBITORS (OR DISCONTINUATION OF
CYP3A4 INDUCERS) CAN
RESULT IN A FATAL OVERDOSE OF OXYCODONE. (5.5, 7, 1