Description

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 [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 (5.1)]
• 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 (5.3)].

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.

What happens if I miss a dose?

Since OxyContin is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An oxycodone overdose can be fatal, especially in a child or other person using the medicine without a prescription.

Overdose can cause severe muscle weakness, pinpoint pupils, very slow breathing, extreme drowsiness, or coma.

What should I avoid while using OxyContin?

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or operating machinery until you know how oxycodone will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Avoid medication errors. Always check the brand and strength of oxycodone you get from the pharmacy.

OxyContin side effects

Get emergency medical help if you have signs of an allergic reaction to OxyContin: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
• a slow heart rate or weak pulse;
• a light-headed feeling, like you might pass out;
• confusion, unusual thoughts or behavior;

• Further information

  Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use OxyContin only for the indication prescribed.

  Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

  Important Information

  You should not use OxyContin if you have severe asthma or breathing problems, or a blockage in your stomach or intestines.

  MISUSE OF OXYCONTIN CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

  Taking oxycodone during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

  Fatal side effects can occur if you use OxyContin with alcohol, or with other drugs that cause drowsiness or slow your breathing.