Brand name for oxycodone hydrochloride



OXYCODONE HYDROCHLORIDE (Impax Generics) FDA Package

5/6/2016
03:38 | Madison Holmes
Brand name for oxycodone hydrochloride
OXYCODONE HYDROCHLORIDE (Impax Generics) FDA Package

Impax Generics: OXYCODONE HCl EXTENDED-RELEASE Brand names beginning with the letter 'O' (OXYCODONE HYDROCHLORIDE).

Prolonged use of OXYCODONE HCl EXTENDED-RELEASE TABLETS during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions ( 5.3 )].

Neonatal Opioid Withdrawal Syndrome.

​ If switching from other oral oxycodone formulations to OXYCODONE HCl EXTENDED-RELEASE TABLETS, administer one half of the patient’s total daily oral oxycodone dose as OXYCODONE HCl EXTENDED-RELEASE TABLETS every 12 hours.

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​ OXYCODONE HCl EXTENDED-RELEASE TABLETS are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate in:

Posted 04/15/2015. Drug Safety Labeling Changes includes 35 products with revisions to Prescribing Information. Fri, 15 Apr 2016.

Use Trial Bulletin to search for clinical trials involving this product:

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Cytochrome P450 3A4 Interaction.

Monitor patients receiving OXYCODONE HCl EXTENDED-RELEASE TABLETS and any CYP3A4 inhibitor or inducer [see Warnings and Precautions ( 5.14 ) and Clinical Pharmacology ( 12.3 )]. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. The concomitant use of OXYCODONE HCl EXTENDED-RELEASE TABLETS with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression.

Accidental ingestion of even one dose of OXYCODONE HCl EXTENDED-RELEASE TABLETS, especially by children, can result in a fatal overdose of oxycodone [see Warnings and Precautions ( 5.2 )]

OXYCODONE HYDROCHLORIDE- oxycodone hydrochloride tablet, film coated, extended release Impax Generics.

Sat, 16 Apr 2016. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.

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Discontinue all other around-the-clock opioid drugs when OXYCODONE HCl EXTENDED-RELEASE TABLETS therapy is initiated and initiate dosing using OXYCODONE HCl EXTENDED-RELEASE TABLETS 10 mg orally every 12 hours. ​ There are no established conversion ratios for conversion from other opioids to OXYCODONE HCl EXTENDED-RELEASE TABLETS defined by clinical trials.

​ Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression [see Warnings and Precautions ( 5.2 )]

Accidental Ingestion. Instruct patients to swallow OXYCODONE HCl EXTENDED-RELEASE TABLETS whole; crushing, chewing, or dissolving OXYCODONE HCl EXTENDED-RELEASE TABLETS can cause rapid release and absorption of a potentially fatal dose of oxycodone. Monitor for respiratory depression, especially during initiation of OXYCODONE HCl EXTENDED-RELEASE TABLETS or following a dose increase. Serious, life-threatening, or fatal respiratory depression may occur with use of OXYCODONE HCl EXTENDED-RELEASE TABLETS.

Follow the patient closely during conversion from transdermal fentanyl to OXYCODONE HCl EXTENDED-RELEASE TABLETS, as there is limited documented experience with this conversion. ​ If switching from transdermal fentanyl patch to OXYCODONE HCl EXTENDED-RELEASE TABLETS, ensure that the patch has been removed for at least 18 hours prior to starting OXYCODONE HCI EXTENDED-RELEASE TABLETS. Although there has been no systematic assessment of such conversion, start with a conservative conversion: substitute 10 mg of OXYCODONE HCI EXTENDED-RELEASE TABLETS every 12 hours for each 25 mcg per hour fentanyl transdermal patch.

​ Conversion from Other Opioids to OXYCODONE HCl EXTENDED-RELEASE TABLETS.

​ The starting dosage for patients who are not opioid tolerant is OXYCODONE HCl EXTENDED-RELEASE TABLETS 10 mg orally every 12 hours. Adult patients who are opioid tolerant are those receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, or an equianalgesic dose of another opioid.

The URL of this page is: /lib/rx/meds/oxycodone-hydrochloride-41/

​ Conversion from Transdermal Fentanyl to OXYCODONE HCl EXTENDED-RELEASE TABLETS.

Within the ‘Prescription Medications’ section:

​ Limitations of Use.

Addiction, Abuse, and Misuse.

​ Close monitoring is of particular importance when converting from methadone to other opioid agonists. The ratio between methadone and other opioid agonists may vary widely as a function of previous dose exposure. Methadone has a long half-life and can accumulate in the plasma.

​ OXYCODONE HCl EXTENDED-RELEASE TABLETS 60 mg and 80 mg tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are only for use in patients in whom tolerance to an opioid of comparable potency has been established.

​ It is safer to underestimate a patient’s 24-hour oral oxycodone requirements and provide rescue medication (e.g., immediate-release opioid) than to overestimate the 24-hour oral oxycodone requirements which could result in adverse reactions. While useful tables of opioid equivalents are readily available, there is substantial inter-patient variability in the relative potency of different opioids.

​ OXYCODONE HCl EXTENDED-RELEASE TABLETS should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.

​ Conversion from Methadone to OXYCODONE HCl EXTENDED-RELEASE TABLETS.

OXYCODONE HCl EXTENDED-RELEASE TABLETS expose patients and other users to the risks of opioid addiction, abuse and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing OXYCODONE HCl EXTENDED-RELEASE TABLETS and monitor all patients regularly for the development of these behaviors or conditions [see Warnings and Precautions ( 5.1 )]. Life-Threatening Respiratory Depression.

​ Conversion from Other Oral Oxycodone Formulations to OXYCODONE HCl EXTENDED-RELEASE TABLETS.