Oxycontin (Oxycodone Hydrochloride)
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What is Oxycontin (Oxycodone Hydrochloride) and what is it used for?
Oxycontin (Oxycodone Hydrochloride) tablets contain oxycodone hydrochloride. Oxycodone belongs to a group of medicines called opioid analgesics.
OxyContin tablets are used to relieve moderate to severe chronic pain when other forms of treatment have not been effective.
As with all strong painkillers, your body may become used to you taking OxyContin tablets. Taking it may result in physical dependence. Physical dependence means that you may experience withdrawal symptoms if you stop taking OxyContin tablets suddenly, so it is important to take it exactly as directed by your doctor.
This medicine is only available with a doctor’s prescription.
OXYCONTIN is indicated for the management of pain severe enough to require daily, aroundthe- clock, long-term opioid treatment and for which alternative treatment options are inadequate in:
- Adults; and
- Opioid-tolerant pediatric patients 11 years of age and older who are already receiving and tolerate a minimum daily opioid dose of at least 20 mg oxycodone orally or its equivalent.
Limitations Of Use
- Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations.
- OXYCONTIN is not indicated as an as-needed (prn) analgesic.
DOSAGE AND ADMINISTRATION
Important Dosage And Administration Instructions
OXYCONTIN should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.
OXYCONTIN 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. 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, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid.
- Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals
- Initiate the dosing regimen for each patient individually; taking into account the patient’s severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse
- Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with OXYCONTIN and adjust the dosage accordingly .
Instruct patients to swallow OXYCONTIN tablets whole, one tablet at a time, with enough water to ensure complete swallowing immediately after placing in the mouth . Instruct patients not to pre-soak, lick, or otherwise wet the tablet prior to placing in the mouth . Cutting, breaking, crushing, chewing, or dissolving OXYCONTIN tablets will result in uncontrolled delivery of oxycodone and can lead to overdose or death
OXYCONTIN is administered orally every 12 hours.
SIDE EFFECTS of Oxycontin (Oxycodone Hydrochloride)
The following serious adverse reactions are described elsewhere in the labeling:
- Addiction, Abuse, and Misuse
- Life-Threatening Respiratory Depression
- Neonatal Opioid Withdrawal Syndrome
- Interactions With Benzodiazepines and Other CNS Depressants
- Adrenal Insufficiency
- Severe Hypotension
- Gastrointestinal Adverse Reactions
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