OXYCODONE HYDROCHLORIDE solution

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Novel Laboratories, Inc.

INN (इंटरनेशनल नाम):

OXYCODONE HYDROCHLORIDE

रचना:

OXYCODONE HYDROCHLORIDE 20 mg in 1 mL

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Oxycodone hydrochloride oral solution USP, 100 mg per 5 mL (20 mg per mL) an opioid agonist is indicated for the relief of moderate to severe acute and chronic pain in opioid-tolerant patients. Oxycodone hydrochloride oral solution USP, 100 mg per 5 mL (20 mg per mL) may cause fatal respiratory depression when administered to patients not previously exposed to opioids. Patients considered to be opioid tolerant are those who are taking at least 30 mg of oral oxycodone per day, or at least 60 mg oral morphine per day, or at least 12 mg hydromorphone per day, or an equianalgesic dose of another opioid, for a week or longer. Oxycodone hydrochloride is contraindicated in patients with respiratory depression in the absence of resuscitative equipment. Oxycodone hydrochloride is contraindicated in any patient who has or is suspected of having paralytic ileus. Oxycodone hydrochloride is contraindicated in patients with acute or severe bronchial asthma or hypercarbia. Oxycodone hydrochloride is contraindicated in pati

उत्पाद समीक्षा:

Oxycodone Hydrochloride Oral Solution, USP Oxycodone Hydrochloride Oral Solution USP, 100 mg per 5 mL (20 mg per mL) is a yellow solution available in one strength as follows: 100 mg per 5 mL (20 mg per mL) oral solution NDC# 40032-920-60: Bottle of 30 mL supplied with a calibrated oral syringe Storage Store at Controlled Room Temperature, 25°C (77°F); excursions are permitted to 15° - 30°C (59° - 86°F). ). [See USP Controlled Room Temperature.] PROTECT from MOISTURE and LIGHT. Handling All opioids, including oxycodone hydrochloride, are liable to diversion and misuse both by the general public and healthcare workers and should be handled accordingly. DEA Order Form Required

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

OXYCODONE HYDROCHLORIDE - OXYCODONE HYDROCHLORIDE SOLUTION
Novel Laboratories, Inc.
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MEDICATION GUIDE
Oxycodone Hydrochloride (ox-ee-CO-dohn) (CII) Oral Solution
IMPORTANT: Keep Oxycodone Hydrochloride Oral Solution in a safe place
away from children.
Accidental use by a child is a medical emergency and can cause death.
If a child accidentally takes
Oxycodone Hydrochloride Oral Solution, get emergency help right away.
Read the Medication Guide that comes with Oxycodone Hydrochloride Oral
Solution before you start
taking it and each time you get a new prescription. There may be new
information. This Medication
Guide does not take the place of talking to your healthcare provider
about your medical condition or your
treatment.
What is the most important information I should know about Oxycodone
Hydrochloride Oral Solution?
Oxycodone Hydrochloride Oral solution can cause serious side effects,
including, death.
1.
Take Oxycodone Hydrochloride Oral Solution exactly as prescribed by
your healthcare provider.
If you take the wrong dose or strength of Oxycodone Hydrochloride Oral
Solution, you could
overdose and die.
2.
It is especially important when you take Oxycodone Hydrochloride Oral
Solution that you know
exactly what dose and strength to take, and the right way to measure
your medicine. Your
healthcare provider or pharmacist should show you the right way to
measure your medicine.
3.
Oral Syringe. Always use the oral syringe provided with Oxycodone
Hydrochloride Oral Solution,
100 mg per 5 mL (20 mg per mL) to help make sure you measure the right
amount.
4.
Do not drink alcohol. Using alcohol with Oxycodone Hydrochloride Oral
Solution may increase
your risk of dangerous side effects, including death.
5.
Opioid Tolerance. Do not take Oxycodone Hydrochloride Oral Solution,
100 mg per 5 mL (20 mg
per mL), unless you are “opioid tolerant.” Opioid tolerant means
that you take another opioid
medicine for your constant (around the clock) pain and your body is
used to it.
What is Oxycodone Hydrochloride Oral S

उत्पाद विशेषताएं

OXYCODONE HYDROCHLORIDE - OXYCODONE HYDROCHLORIDE SOLUTION
NOVEL LABORATORIES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OXYCODONE HYDROCHLORIDE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OXYCODONE
HYDROCHLORIDE.
OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE) SOLUTION FOR ORAL
USE.
INITIAL U.S. APPROVAL: 1950
WARNINGS: RISK OF MEDICATION ERRORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
OXYCODONE HYDROCHLORIDE ORAL SOLUTION IS AVAILABLE IN 100 MG PER 5 ML
(20 MG PER ML) CONCENTRATION.
THE 100 MG PER 5 ML (20 MG PER ML) CONCENTRATION IS INDICATED FOR USE
IN OPIOID-TOLERANT PATIENTS ONLY.
TAKE CARE TO AVOID DOSING ERRORS DUE TO CONFUSION BETWEEN MG AND ML,
AND OTHER OXYCODONE SOLUTIONS
WITH DIFFERENT CONCENTRATIONS, WHICH COULD RESULT IN ACCIDENTAL
OVERDOSE AND DEATH. (5.1)
KEEP OXYCODONE HYDROCHLORIDE ORAL SOLUTION OUT OF THE REACH OF
CHILDREN.
INDICATIONS AND USAGE
Oxycodone Hydrochloride 100 mg per 5 mL (20 mg per mL) solution is
indicated for the relief of moderate to severe acute
and chronic pain in opioid-tolerant patients. (1)
DOSAGE AND ADMINISTRATION
Individualize dosage based on the severity of pain, the patient
response, and prior analgesic treatment. (2.1)
Patients who have not been receiving opioid analgesics should be
started in a dosing range of 5 to 15 mg every 4 to 6
hours as needed. (2.2)
DOSAGE FORMS AND STRENGTHS
Oral Solution 100 mg per 5 mL (20 mg per mL): Each mL contains 20 mg
of oxycodone hydrochloride. (3)
CONTRAINDICATIONS
Respiratory depression in the absence of resuscitative equipment. (4)
Paralytic ileus. (4)
Acute or severe bronchial asthma or hypercarbia. (4)
Known hypersensitivity to oxycodone. (4)
WARNINGS AND PRECAUTIONS
Risk of Medication Errors: Use caution when prescribing, dispensing,
and administering to avoid dosing errors due to
confusion between different concentrations and between mg and mL,
which could result in accidental overdose and
death. (5.1)
Respi