Notify patients of the potential risk of life-threatening respiratory melancholy, which includes data that the chance is biggest when beginning OXYCONTIN or if the dosage is elevated, Which it may possibly arise even at proposed dosages.
Less than the necessities with the REMS, drug providers with accepted opioid analgesic products and solutions ought to make REMS-compliant teaching programs available to Health care providers. Healthcare suppliers are strongly encouraged to
Oxycodone depresses the cough reflex by immediate impact on the cough Heart from the medulla. Antitussive results may possibly manifest with doses lessen than People generally demanded for analgesia. Oxycodone causes miosis, even in full darkness.
Not for use in youngsters lower than 11 several years of age and that are not presently using opioid pain medicines regularly to handle agony extreme more than enough to demand day-to-day around-the-clock very long-term cure of soreness with an opioid.
Within the pediatric age team of eleven decades of age and older, systemic exposure of oxycodone is anticipated for being just like Older people at any provided dose of OXYCONTIN.
Within a medical trial supporting the event of oxycodone hydrochloride tablets, far too couple individuals with lowered hepatic operate were being evaluated to review these potential distinctions.
Supplemental info, which include epidemiological data, when obtainable, may well provide even further info on the effects of the present formulation of OXYCONTIN on the abuse liability with the drug. Appropriately, this portion could possibly be current Down the road as correct.
Tell individuals and caregivers not to click here enhance opioid dosage without initial consulting a clinician. Advise individuals to hunt health care notice when they encounter signs or symptoms of hyperalgesia, which includes worsening soreness, enhanced sensitivity to ache, or new pain [see WARNINGS AND Safety measures and ADVERSE REACTIONS].
Discuss the availability of naloxone for that unexpected emergency therapy of opioid overdose with the affected person and caregiver and assess the likely will need for use of naloxone, both of those when initiating and renewing treatment with OXYCONTIN [see WARNINGS AND Safety measures].
The next adverse ordeals happened in below 3% of here clients involved with clinical trials with oxycodone:
There are no sufficient and properly-controlled research of oxycodone in pregnant women. Because animal reproductive studies are certainly not often predictive of human responses, oxycodone hydrochloride tablets need to be used all through pregnancy provided that potential advantage justifies the potential possibility on the fetus.
Before getting oxycodone, tell your medical website professional or pharmacist In case you are allergic to it; or to other opioid ache relievers (which include oxymorphone); or In case you have almost every other allergy symptoms.
This medication may perhaps interfere with more info particular check here lab exams (including amylase/lipase amounts), potentially causing Untrue take a look at results. Make certain lab personnel and your Medical doctors know you employ this drug.
Concomitant utilization of OXYCONTIN with CYP3A4 inducers or discontinuation of the CYP3A4 inhibitor could decrease oxycodone plasma concentrations, minimize opioid efficacy or, quite possibly, bring about a withdrawal syndrome in a client who experienced formulated physical dependence to oxycodone.