OxyContin (oxycodone) is an opioid pain medication sometimes called a narcotic. OxyContin is a strong prescription medicine used when an opioid medicine is needed to manage severe pain enough to require daily around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid…
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 [see Warnings and Precautions (5)].
- 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 [see Warnings and Precautions (1)].
- 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 [see Warnings and Precautions (3)].
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 [see Patient Counseling Information (17)]. Instruct patients not to pre-soak, lick, or otherwise wet the tablet prior to placing in the mouth [see Warnings and Precautions (5.11)]. Cutting, breaking, crushing, chewing, or dissolving OXYCONTIN tablets will result in uncontrolled delivery of oxycodone and can lead to overdose or death [see Warnings and Precautions (5.1)].
OXYCONTIN is administered orally every 12 hours.
For the Consumer
Applies to oxycodone: oral capsule, oral capsule extended release, oral solution, oral tablet, oral tablet extended release
Along with its needed effects, oxycodone (the active ingredient contained in OxyContin) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking oxycodone:
- cold sweats
- difficult or labored breathing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- tightness in the chest
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- blood in the urine
- burning while urinating burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
- chest pain
- decrease in the frequency of urination
- decreased urine output
- difficult or painful urination
- difficulty in passing urine (dribbling)
- difficulty with swallowing
- dry mouth
- fast, irregular, pounding, or racing heartbeat or pulse
- feeling of warmth or heat
- flushing or redness of the skin, especially on the face and neck
- frequent urination
- hives, itching, or skin rash
- increase in heart rate
- increased thirst
- increased volume of pale, dilute urine
- muscle pain or cramps
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rapid breathing
- rapid weight gain
- severe constipation
- severe vomiting
- stomach pain
- sunken eyes
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- trembling or shaking of the hands or feet
- unusual tiredness or weakness
- unusual weight gain or loss
- wrinkled skin
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