Oxycodone hydrochloride

What is Oxycodone hydrochloride?

• Oxycodone hydrochloride (OXYCONTIN) is an opioid agonist used to treat moderate to severe pain.

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Oxycodone

What are the uses of this medicine?

• Oxycodone hydrochloride (OXYCONTIN) pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them.

How does this medicine work?

• Oxycodone is a full opioid agonist and is relatively selective for the mu receptor, although it can bind to other opioid receptors at higher doses.
• The principal therapeutic action of oxycodone is analgesia.
• Like all full opioid agonists, there is no ceiling effect to analgesia for oxycodone.
• The precise mechanism of the analgesic action is unknown.
• However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• severe asthma, trouble breathing, or other lung problems.
• a bowel blockage or have narrowing of the stomach or intestines.
• Hypersensitivity (e.g., anaphylaxis) to oxycodone

What drug interactions can this medicine cause?

• The concomitant use of OXYCONTIN and CYP3A4 inhibitors(e.g: erythromycin, ketoconazole, ritonavir) can increase the plasma concentration of oxycodone, resulting in increased or prolonged opioid effects. If concomitant use is necessary, consider dosage reduction of OXYCONTIN until stable drug effects are achieved. Monitor patients for respiratory depression and sedation at frequent intervals.
• The concomitant use of OXYCONTIN and CYP3A4 inducers(e.g: Rifampin, carbamazepine, phenytoin) can decrease the plasma concentration of oxycodone, resulting in decreased efficacy. If concomitant use is necessary, consider increasing the OXYCONTIN dosage until stable drug effects are achieved.
• Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.
• The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue OXYCONTIN if serotonin syndrome is suspected.
• The use of OXYCONTIN is not recommended for patients taking MAOIs(e.g: phenelzine, tranylcypromine, linezolid) or within 14 days of stopping such treatment.
• Avoid concomitant use with butorphanol, nalbuphine, pentazocine, buprenorphine.
• Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone. Monitor patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed.
• The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.

Is this medicine FDA approved?

• Initial U.S. Approval: 1950

How should this medicine be used?

• Patients considered opioid-tolerant are those taking, 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.

Recommended dosage: Adults:

• For opioid-naïve and opioid non-tolerant patients, initiate with 10 mg tablets orally every 12 hours.

Pediatric Patients 11 Years of Age and Older:

• For use only in pediatric patients 11 years and older already receiving and tolerating opioids for at least 5 consecutive days with a minimum of 20 mg per day of oxycodone or its equivalent for at least two days immediately preceding dosing with OXYCONTIN.

Geriatric Patients:

• In debilitated, opioid non-tolerant geriatric patients, initiate dosing at one third to one half the recommended starting dosage and titrate carefully.

Patients with Hepatic Impairment:

• Initiate dosing at one third to one half the recommended starting dosage and titrate carefully.

• Do not abruptly discontinue OXYCONTIN in a physically dependent patient because rapid discontinuation of opioid analgesics has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide.

Administration:

• Do not change your dose. Take OXYCONTIN exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
• Take your prescribed dose every 12 hours at the same time every day. Do not take more than your prescribed dose in 12 hours. If you miss a dose, take your next dose at your usual time.
• Swallow OXYCONTIN whole. Do not cut, break, chew, crush, dissolve, snort, or inject OXYCONTIN because this may cause you to overdose and die.
• OXYCONTIN should be taken 1 tablet at a time. Do not pre-soak, lick, or wet the tablet before placing in your mouth to avoid choking on the tablet.
• Call your healthcare provider if the dose you are taking does not control your pain.
• Do not stop taking OXYCONTIN without talking to your healthcare provider.
• Dispose of expired, unwanted, or unused OXYCONTIN by promptly flushing down the toilet, if a drug take-back option is not readily available. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicine.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Extended-release tablets: 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, and 80 mg

This medicine is available in fallowing brand namesː

• OXYCONTIN

What side effects can this medication cause?

The most common side effects of this medicine include:

• constipation
• nausea
• sleepiness
• vomiting
• tiredness
• headache
• dizziness
• abdominal pain

What special precautions should I follow?

While taking OXYCONTIN DO NOT:

• Drive or operate heavy machinery until you know how OXYCONTIN affects you. OXYCONTIN can make you sleepy, dizzy, or lightheaded.
• Drink alcohol, or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with OXYCONTIN may cause you to overdose and die.
• Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Monitor closely, particularly during initiation and titration.
• Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid.
• OXYCONTIN may cause severe hypotension, including orthostatic hypotension and syncope in ambulatory patients. Monitor during dosage initiation and titration. Avoid use of OXYCONTIN in patients with circulatory shock.
• In patients who may be susceptible to the intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors), OXYCONTIN may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Monitor for sedation and respiratory depression. Avoid use of OXYCONTIN in patients with impaired consciousness or coma.
• There have been post-marketing reports of difficulty in swallowing OXYCONTIN tablets. These reports included choking, gagging, regurgitation and tablets stuck in the throat. Instruct patients not to pre-soak, lick, or otherwise wet OXYCONTIN tablets prior to placing in the mouth, and to take one tablet at a time with enough water to ensure complete swallowing immediately after placing in the mouth.
• Do not abruptly discontinue OXYCONTIN in a patient physically dependent on opioids. When discontinuing OXYCONTIN in a physically dependent patient, gradually taper the dosage.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death.

Treatment of overdosage:

• Employ other supportive measures (including oxygen, vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life support techniques.
• Opioid antagonists, such as naloxone, are specific antidotes to respiratory depression resulting from opioid overdose.
• OXYCONTIN will continue to release oxycodone and add to the oxycodone load for 24 to 48 hours or longer following ingestion, necessitating prolonged monitoring.

Can this medicine be used in pregnancy?

• There are no available data with OXYCONTIN in pregnant women to inform a drug-associated risk for major birth defects and miscarriage.
• Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome.

Can this medicine be used in children?

• The safety and efficacy of OXYCONTIN have been established in pediatric patients ages 11 to 16 years.

What are the active and inactive ingredients in this medicine?

Active ingredient: OXYCODONE HYDROCHLORIDE

Inactive ingredients: BUTYLATED HYDROXYTOLUENE HYPROMELLOSES POLYETHYLENE GLYCOL 400 MAGNESIUM STEARATE TITANIUM DIOXIDE FERRIC OXIDE YELLOW FD&C BLUE NO. 2 ALUMINUM OXIDE HYDROXYPROPYL CELLULOSE, UNSPECIFIED

Who manufactures and distributes this medicine?

• Manufactured by: Purdue Pharma L.P., Stamford

What should I know about storage and disposal of this medication?

• Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).
• Store OXYCONTIN securely and dispose of properly.
• Expired, unwanted, or unused OXYCONTIN should be disposed of by flushing the unused medication down the toilet if a drug take-back option is not readily available.
• Dispense in tight, light-resistant container.

• Dailymed label info on Oxycodone hydrochloride
• FDA Oxycodone hydrochloride

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