Roxicodone 30 mg/1

oxycodone hydrochloride · TABLET · SpecGx LLC

No Recall HistoryCurrently in Shortage

Plain English

Roxicodone is a tablet containing oxycodone hydrochloride at 30 mg/1, taken oral. Manufactured by SpecGx LLC.

Key Facts

Brand Name: Roxicodone
Generic Name: oxycodone hydrochloride
NDC Code (Product): 23635-582
Manufacturer: SpecGx LLC
Strength: 30 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
DEA Schedule: Schedule II (Controlled)
Application #: NDA021011
Marketing Start: 08/31/2000

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug dependence26,996 reports

pain18,867 reports

overdose17,471 reports

emotional distress15,337 reports

death14,169 reports

toxicity to various agents12,536 reports

drug withdrawal syndrome10,073 reports

fatigue3,913 reports

drug ineffective3,841 reports

drug abuse3,650 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE ROXICODONE 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, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions ( 5.1 )] , reserve opioid analgesics, including ROXICODONE for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. ROXICODONE is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) Limitations of Use: Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including ROXICODONE for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. ( 1 , 5.1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION ROXICODONE should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. ( 2.1 ) Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals. Reserve titration to higher doses of ROXICODONE for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. ( 2.1 , 5 ) Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic. Clinical guidelines on opioid prescribing for some acute pain conditions are available. ( 2.1 ) Initiate the dosing regimen for each patient individually, taking into account the patient’s underlying case and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse. ( 2.1 , 5.1 ) Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with ROXICODONE. Consider…

Contraindications

4 CONTRAINDICATIONS ROXICODONE is contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions ( 5.2 )] . Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment or hypercarbia [see Warnings and Precautions ( 5.8 )] . Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions ( 5.12 )] . Known hypersensitivity (e.g., anaphylaxis) to oxycodone [see Adverse Reactions ( 6.2 )] . Significant respiratory depression ( 4 ) Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment ( 4 ) Known or suspected gastrointestinal obstruction, including paralytic ileus ( 4 ) Hypersensitivity to oxycodone ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Table 1 includes clinically significant drug interactions with ROXICODONE. Table 1: Clinically Significant Drug Interactions with ROXICODONE Inhibitors of CYP3A4 and CYP2D6 Clinical Impact: The concomitant use of ROXICODONE and CYP3A4 inhibitors can increase the plasma concentration of oxycodone, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of ROXICODONE and CYP2D6 and CYP3A4 inhibitors, particularly when an inhibitor is added after a stable dose of ROXICODONE is achieved [see Warnings and Precautions ( 5.3 )] . After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the oxycodone plasma concentration will decrease [see Clinical Pharmacology ( 12.3 )] , resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to oxycodone. Intervention: If concomitant use is necessary, consider dosage reduction of ROXICODONE until stable drug effects are achieved. Evaluate patients at frequent intervals for respiratory depression and sedation. If a CYP3A4 inhibitor is discontinued, consider increasing the ROXICODONE dosage until stable d…

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, Abuse, and Misuse [see Warnings and Precautions ( 5.1 )] Life-Threatening Respiratory Depression [see Warnings and Precautions ( 5.2 )] Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions ( 5.3 )] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions ( 5.4 )] Opioid-Induce Hyperalgesia and Allodynia [see Warnings and Precautions ( 5.7 )] Adrenal Insufficiency [see Warnings and Precautions ( 5.9 )] Severe Hypotension [see Warnings and Precautions ( 5.10 )] Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.12 )] Seizures [see Warnings and Precautions ( 5.13 )] Withdrawal [see Warnings and Precautions ( 5.14 )] Most common adverse reactions (≥3%) were nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Par Health at 1-800-778-7898 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adv…

Frequently Asked Questions

What is Roxicodone used for?

Roxicodone contains oxycodone hydrochloride. It is a tablet taken oral. Consult your doctor for specific uses.

Is Roxicodone a controlled substance?

Yes, Roxicodone is classified as CII under the DEA Controlled Substances Act.

What is the generic name for Roxicodone?

The generic name for Roxicodone is oxycodone hydrochloride. There are 11 other brand versions of oxycodone hydrochloride.

What is the NDC code for Roxicodone 30 mg/1?

The NDC (National Drug Code) for Roxicodone 30 mg/1 is 23635-582, listed by SpecGx LLC.

Product NDC

23635-582

Package NDC

23635-582-10

Other Oxycodone Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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