Oxycodone Extended-Release (ER) 10 mg

Oxycodone is a semisynthetic opiate partial agonist derived from the opioid alkaloid, thebaine. Oxycodone is used to control moderate to severe pain. It is available as immediate release tablets (IR), extended release (ER), and in combination with acetaminophen. Oxycodone undergoes low first-pass metabolism and has a higher bioavailability (60%-87%) compared with morphine. It is slightly more potent than morphine (Oral Oxycodone is roughly 1.5 times more potent than oral morphine).

Therapeutic Fields​

Long Term Opioid Therapy

Chronic Pain Relief

Intermediate Onset of Action (1 Hour)

Reduction in Pill Burden

For Long Term Opioid Therapy

Enhance Patient Adherence

Comparative Dissoluion Profile of Oxycodone From Test

(FAROXY SR. 40mg FC. Tablets, Endofar) Vs. Reference

(OLBETESR. 40mg FC. Tablets, Tecnimede, Canada) Drugs

Faroxy-ER 40mg (manufactured by Endofar pharmaceutical Company) and Olbete®-SR 40mg (manufactured by Tecnimede in Canada) according to FDA guidance for industry entitled “Bioavailability and Bioequivalence studies submitted in NDAs or INDs_General considerations” were bioequivalent. Also, it is worth to remark that this study was approved by Local Food and Drug Administration.

Clinical Research

Oral OXYCODONE is as effective as IV Morphine Sulfate (MS) in Management of Acute Pain Following limb trauma

Based on clinical trial performed in 2018 there was no significant difference between the two groups regarding decrease in pain within the 0, 30 and 60 minutes after administration of either 5mg IV MS or 5mg oral oxycodone. Drowsiness was reported more frequently in MS group after 30 minutes. Eight participants asked for rescue analgesic in MS group, while only one patient asked for more analgesia in oxycodone group. Other adverse effects were similar in both groups.​

Calculating Total Daily Dose of OXYCODONE for Safer Dosage

Calculating total daily doses of opioids is important to appropriately and effectively prescribe, manage, and taper opioid medications. Patients prescribed higher opioid dosages are at higher risk of overdose death. The daily dose calculating of new opioid is as follows

Total Daily Dose of New Opioid

The obtained total daily dose divided by 2 is for OXYCODONE ER and divided by 4 is for OXYCODONE IR.These dose conversions are estimated and cannot account for all individual differences in genetics and pharmacokinetics.

Dosing

Pediatrics & Adults

Patients ≥11 years: 10 mg BD

* Titrate dose according to patient response

Administration

Onset

1 h

Half life

4.5 h

Maximum Dose

320 mg / day

Recommended dose of ER Cap oxycodone base is 288 mg/ day and 9mg oxycodone based equivalent to 10mg oxycodone hydrochloride.

Contraindication

• Hypersensitivity to oxycodone or other
• Patients with circulatory shock and
• Significant respiratory depression, acute or severe bronchial asthma, moderate to severe sleep-disorder
• Known or suspected paralytic ileus and gastrointestinal
• not recommended during pregnancy and breast

Warning and Precautions

• Use with caution: in CNS depression, Severe hypotension, Respiratory depression, Seizures, Constipation, Mental health conditions, Obesity, Thyroid dysfunction, adrenal insufficiency, Prostatic hyperplasia/urinary stricture, acute alcoholism, underlying GI disorders, difficulty in swallow, Pancreatic and Biliary disease, Head trauma, Hepatic and renal impairment G6PD deficiency.
• Cytochrome P450 3A4 inhibitors: The concomitant use may result in an increase in oxycodone plasma
• Hepatotoxicity: Most of the cases of liver injury are associated with the use of Acetaminophen at doses that exceed 4g/day in
• Skin reactions: Discontinue therapy at the first appearance of skin rash.

Drug Interactions

• Risk X: Abametapir, Azelastine (Nasal), Bromperidol, Eluxadoline, Fusidic Acid, MAOls, opioids (Mixed Agonist/ Antagonist), Orphenadrine, paraldehyde, Samidorphan,
• SSRls, SNRls, MAOls, 5-HT1, 3 receptor antagonists, Buspirone, Dextromethorphan, Lithium, Cyclobenzaprine, linezolid, John’s wort: concomitant use may cause serotonin syndrome.
• CNS depressants (other opioid analgesics, general anesthetics, phenothiazines, tranquilizers, centrally-acting anti-emetics, sedative hypnotics and alcohol): concomitant use may cause hypotension, respiratory depression, coma and

Side Effects

• Drowsiness, headache, dizziness, Pruritus, Nausea, constipation, vomiting, Fever,

References
References

1. Kamaljeet Boora, in xPharm: The Comprehensive Pharmacology Reference, 2007.
2.  www.Uptodate/oxycodone, 2022. 
3. www.FDA.gov
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6.  De Santis, Stefano et al. “Oxycodone/Acetaminophen: The Tailoring Combination Treatment for Specific Clinical Profile of Opioid Well-Responsive Cancer Pain.” Cancer management and research vol. 13 174719 .1756- Feb. 2021, doi:10.2147/CMAR.S290551.
7.  https://www.cdc.gov/opioids/providers/prescribing/guideline.
   
8. Olesen, Anne Estrup et al. “Different effects of morphine and oxycodone in experimentally evoked hyperalgesia: a human translational study.” British journal of clinical pharmacology vol. 70,2 (2010): 189200-. doi:10.1111/j.136503700 .2125.2010-.x.
9. Charlotte Martin et. all. “Release of opioids for improved pain management”, science Direct, Vol. 19, Issue 9,2016.
10.  Kaplan R, Parris WC, et al. Comparison of controlled-release and immediate-release oxycodone tablets in patients with cancer pain. J Clin Oncol. 1998; 16(10):32303237-. doi:10.1200/JC0.1998.16.10.3230.
11.  Eizadi, Parisa et al. “Oral Oxycodone Compared with Intravenous Morphine Sulfate for Pain Management of Isolated Limb Trauma; a Randomized Clinical Trial.” Emergency (Tehran. Iran) vol. 6,1 (2078):e59.e5