Description
Generic Name
Oxycodone hydrochloride
Active Ingredient
Oxycodone hydrochloride
Chemical Name
Oxycodone hydrochloride is chemically described as 4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride.
Oxycodone hydrochloride is a white to off-white, odorless crystalline powder derived from the opium alkaloid thebaine. It is soluble in water and slightly soluble in alcohol. It has a molecular weight of about 351.82.
Medication Classification
OxyContin is an opioid analgesic (a narcotic pain reliever) and a full opioid agonist. It works by binding to opioid receptors in the central nervous system to change how the body senses and responds to pain. The extended-release design releases oxycodone slowly over about 12 hours to provide around-the-clock pain control.
OxyContin is formulated with abuse-deterrent properties. The tablet is designed to be difficult to crush, break, or dissolve. If someone tries to dissolve it, it forms a thick gel that is hard to inject. These features may reduce, but do not eliminate, the risk of abuse by snorting or injection.
OxyContin is a Schedule II (CII) controlled substance under U.S. federal law.
Indication
OxyContin is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment, and for which alternative treatments are inadequate. It is not for use as an as-needed (PRN) pain reliever.
Dosage Forms and Available Strengths
- Dosage Form: Extended-release oral tablets
- Route of Administration: Oral
- Available Strengths: 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, and 80 mg
The 60 mg and 80 mg tablets, or a single dose greater than 40 mg, are only for use in patients who are already opioid-tolerant.
Inactive Ingredients
Inactive ingredients vary by strength and manufacturer. OxyContin tablets may contain butylated hydroxytoluene, hypromellose, polyethylene glycol, polyethylene oxide, magnesium stearate, titanium dioxide, and colorants that differ by tablet strength. The polyethylene oxide contributes to the tablet's abuse-deterrent, gel-forming properties. Refer to the specific product packaging or your pharmacist for exact ingredient details, especially if you have allergies or intolerances.
Dosage & Administration
Important: Take OxyContin exactly as prescribed by your healthcare provider. Use the lowest effective dose for the shortest time needed. Your provider will set your dose based on your pain, your prior opioid use, and your overall health. Do not change your dose on your own.
How to Take OxyContin
- Swallow one tablet at a time, whole, with enough water to make sure it goes down right away.
- Never crush, chew, break, cut, or dissolve an OxyContin tablet. Doing so can release a fatal dose all at once.
- Do not pre-soak, lick, or wet the tablet before placing it in your mouth.
- Take your tablets on a regular schedule, usually every 12 hours, exactly as directed.
- Do not take more than prescribed, and do not take it more often than directed.
- If you have trouble swallowing whole tablets, tell your provider. OxyContin must not be given through feeding tubes because it may cause a blockage.
General Dosing Principles
- Dosing is individualized based on the severity of pain, your response, and your prior opioid experience.
- The 60 mg and 80 mg tablets, or a single dose above 40 mg, are only for patients who are already opioid-tolerant. Using these strengths in patients who are not opioid-tolerant can cause fatal respiratory depression.
- OxyContin is not interchangeable milligram-for-milligram with immediate-release oxycodone or other opioids.
- Your provider will select the exact dose, strength, and schedule for your situation.
Food Considerations
OxyContin may be taken with or without food. Avoid grapefruit and grapefruit juice, which may increase oxycodone levels in the body. Avoid alcohol entirely while taking OxyContin. Drinking alcohol or taking products that contain alcohol can cause the extended-release tablet to release oxycodone too quickly, leading to a fatal overdose.
Missed Dose Instructions
- If you miss a dose, take it as soon as you remember, then take the next dose about 12 hours later.
- If it is almost time for your next dose, skip the missed dose and continue your regular schedule.
- Do not take two doses at once to make up for a missed dose.
- If you are unsure what to do, contact your healthcare provider or pharmacist.
Storage
- Store at 20° to 25°C (68° to 77°F), with brief excursions permitted between 15° to 30°C (59° to 86°F).
- Keep in a tightly closed container, away from moisture, heat, and light.
- Keep out of the reach of children. Accidental use by a child can be fatal.
Disposal
Because OxyContin is a controlled substance, store and dispose of it carefully to prevent theft, misuse, or accidental exposure. Dispose of unused or expired medication through a drug take-back program when possible. If no take-back program is available, the FDA recommends flushing certain opioid products, including OxyContin, down the toilet to prevent accidental exposure. Follow the disposal instructions on your product label or ask your pharmacist. Accidental exposure, especially in children, can cause serious harm or death.
Special Instructions
Children: The safety and effectiveness of OxyContin have been established only for certain opioid-tolerant children 11 years and older who are already receiving and tolerating opioids. It should be used in children only under specialist care. Keep the medication where children cannot reach it. Accidental ingestion by a child can cause fatal respiratory depression. If a child swallows this medication, seek emergency care immediately.
Elderly or Debilitated Patients: Older patients may be more sensitive to the effects of oxycodone, including sedation, confusion, dizziness, constipation, and breathing problems. A provider may start at a lower dose and monitor closely, given the higher risk of falls and possible reduced liver, kidney, or lung function.
Patients with Liver or Kidney Problems: Use with caution. A lower starting dose may be needed, since impaired organ function can increase drug levels and prolong effects. Your provider may start with a reduced dose and adjust slowly based on your response.
Caregivers: Give the medication exactly as prescribed. Watch for excessive sleepiness, slowed or shallow breathing, confusion, or trouble waking the patient, and seek emergency care right away if these occur. Keep the medication secured and out of sight.
Tapering and Discontinuation
- Do not stop taking OxyContin suddenly after prolonged use. Abrupt discontinuation can cause opioid withdrawal symptoms.
- If you and your provider decide to stop treatment, the dose should be reduced gradually using a plan set by your provider.
- Withdrawal symptoms may include restlessness, watery eyes, runny nose, yawning, sweating, chills, muscle aches, widened pupils, irritability, anxiety, backache, joint pain, weakness, stomach cramps, trouble sleeping, nausea, loss of appetite, vomiting, diarrhea, and a rapid heartbeat.
- Tell your provider if withdrawal symptoms occur so the taper can be adjusted.
Overdose Warning
An overdose of OxyContin can be serious and may be fatal, especially when combined with benzodiazepines, alcohol, or other CNS depressants. Symptoms of overdose may include:
- Slowed, shallow, or stopped breathing
- Extreme drowsiness or difficulty staying awake
- Loss of consciousness or coma
- Limp or weak muscles
- Cold, clammy skin
- Pinpoint pupils
- Slow heartbeat or low blood pressure
In case of a suspected overdose, call the Poison Control Center at 1-800-222-1222 or seek emergency medical care immediately. Naloxone may be used to reverse an opioid overdose. Because OxyContin releases oxycodone over an extended period, its effects can last a long time. Repeated doses of naloxone may be needed, and the patient should be watched closely for an extended period, even after the first dose.
Side Effects
Serious Side Effects Requiring Immediate Medical Attention
Stop taking OxyContin and seek emergency care or contact your healthcare provider right away if you experience any of the following:
- Respiratory depression: Slow, shallow, or stopped breathing; extreme sleepiness; or difficulty waking. This risk is highest when starting treatment, after a dose increase, or when combined with other CNS depressants.
- Serotonin syndrome: Agitation, hallucinations, fast heartbeat, fever, excessive sweating, shivering, shaking, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea, especially when taken with certain other medicines.
- Adrenal insufficiency: Ongoing nausea, vomiting, loss of appetite, dizziness, or severe weakness.
- Severe allergic reactions: Rash, hives, swelling of the face, lips, tongue, or throat, or trouble breathing or swallowing.
- Seizures
- Severe low blood pressure: Dizziness, lightheadedness, or fainting, especially when standing up.
- Severe constipation or bowel obstruction: Ongoing constipation, stomach pain, or inability to have a bowel movement.
Common Side Effects
The following side effects may occur and are not always cause for urgent concern. Talk to your healthcare provider if they persist or become bothersome:
- Constipation
- Nausea or vomiting
- Drowsiness or sleepiness
- Dizziness or lightheadedness
- Dry mouth
- Itching
- Headache
- Sweating
This is not a complete list of possible side effects. Contact your healthcare provider for guidance about any symptoms that concern you.
To report suspected adverse reactions, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Warnings & Precautions
FDA Boxed Warning: Addiction, Abuse, and Misuse; Life-Threatening Respiratory Depression; Accidental Ingestion; Neonatal Opioid Withdrawal Syndrome; and Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants
- Addiction, abuse, and misuse: OxyContin exposes users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk before prescribing and monitor throughout treatment. The abuse-deterrent properties do not prevent addiction, abuse, or misuse.
- Life-threatening respiratory depression: Serious, life-threatening, or fatal respiratory depression may occur. The risk is greatest during treatment initiation and after a dose increase. Monitor closely, especially when starting treatment and after dose increases.
- Accidental ingestion: Accidental ingestion of even one dose, especially by children, can result in fatal overdose. Store securely and out of reach.
- Neonatal opioid withdrawal syndrome (NOWS): Prolonged use during pregnancy can result in NOWS, which may be life-threatening if not recognized and treated.
- Risks from concomitant use with benzodiazepines or other CNS depressants: Combining OxyContin with these substances may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with no alternative options, and limit the dose and duration.
Conditions to Disclose to Your Healthcare Provider
Before taking OxyContin, tell your healthcare provider if you have or have had any of the following:
- Breathing problems, such as asthma, chronic obstructive pulmonary disease (COPD), or sleep apnea
- Liver or kidney problems
- A head injury, brain tumor, or a condition causing increased pressure in the brain
- Adrenal gland problems, such as Addison's disease
- Low blood pressure or fainting spells
- Enlarged prostate or urination problems
- Gallbladder, pancreas, or thyroid problems
- Seizures or a seizure disorder
- Trouble swallowing, or a narrowing or blockage in your stomach or intestines
- Mental health conditions, including depression
- Stomach or bowel problems, such as blockage or ongoing constipation
- A history of alcohol, prescription medicine, or street drug abuse or dependence
- Pregnancy or plans to become pregnant
- Breastfeeding or plans to breastfeed
Contraindications
Do not take OxyContin if you:
- Have significant respiratory depression
- Have acute or severe bronchial asthma in an unmonitored setting or without resuscitative equipment
- Have a known or suspected gastrointestinal obstruction, including paralytic ileus
- Have a known hypersensitivity to oxycodone or any component of the formulation
Drug Interactions
Tell your healthcare provider and pharmacist about all medications, supplements, and herbal products you take. Because oxycodone is processed mainly by the CYP3A4 and CYP2D6 liver enzymes, many drugs can affect its levels. Key interactions include:
- Benzodiazepines and other CNS depressants: Combined use increases the risk of profound sedation, respiratory depression, coma, and death. This includes sedatives, tranquilizers, muscle relaxants, sleep medications, other opioids, and alcohol.
- Alcohol: Drinking alcohol or taking products that contain alcohol can cause the extended-release tablet to release oxycodone too quickly, dangerously raising drug levels and increasing the risk of fatal overdose. Avoid alcohol entirely.
- Serotonergic drugs: Combined use with certain antidepressants (such as SSRIs, SNRIs, and tricyclics), MAO inhibitors, or other serotonergic medicines may increase the risk of serotonin syndrome.
- Monoamine oxidase inhibitors (MAOIs): May increase the effects of oxycodone. Use within 14 days of an MAOI is not recommended.
- CYP3A4 inhibitors: Drugs such as certain antibiotics (for example, erythromycin, clarithromycin), antifungals (for example, ketoconazole, itraconazole), and HIV medications may increase oxycodone levels and the risk of serious side effects, including respiratory depression.
- CYP3A4 inducers: Drugs such as rifampin, carbamazepine, and phenytoin may reduce oxycodone's effectiveness and, if stopped, may increase the risk of side effects.
- CYP2D6 inhibitors: Drugs such as certain antidepressants may affect oxycodone levels and its effects.
- Mixed agonist/antagonist and partial agonist opioids: Drugs such as buprenorphine, nalbuphine, or pentazocine may reduce the pain-relieving effect and may trigger withdrawal.
- Anticholinergic drugs: May increase the risk of severe constipation, urinary retention, or bowel obstruction.
- Diuretics: Oxycodone may reduce their effectiveness.
Monitoring Requirements
Your healthcare provider may monitor:
- Signs of respiratory depression and sedation, especially early in treatment and after dose increases
- Your pain relief and overall response to treatment
- Your risk for abuse, misuse, and diversion throughout treatment
- Blood pressure, particularly in patients at risk for low blood pressure
- Bowel function, given the risk of constipation
- Signs of withdrawal if the dose is reduced or the medication is stopped
Abuse, Dependence, and Misuse Warnings
OxyContin is a Schedule II controlled substance.
- Oxycodone is a potent opioid and may be a target for people who abuse prescription medicines or street drugs.
- The abuse-deterrent formulation makes the tablet harder to misuse by crushing, snorting, or injecting, but it does not make the product abuse-proof. Abuse is still possible, including by swallowing intact tablets.
- Physical dependence and tolerance can develop with continued use. Physical dependence is not the same as addiction, but it means you should not stop suddenly.
- Do not increase your dose on your own.
- Do not sell or give away OxyContin. Doing so may harm others and is against the law. Even a single dose can be fatal to someone who is not opioid-tolerant, especially a child.
- Misusing this medication, including crushing, snorting, or injecting it or taking it in ways other than prescribed, can cause overdose and death.
Long-Term Use Considerations
- If long-term treatment is needed, your provider should regularly reassess whether it is still appropriate.
- Physical dependence and tolerance are expected with continued use. Any decision to stop treatment should involve a gradual, supervised taper.
- Long-term opioid use may affect hormone levels, leading to symptoms such as low energy, reduced sex drive, or menstrual changes. Tell your provider if these occur.
- Ongoing constipation is common with continued use and may require a management plan from your provider.
Patient Counseling Information
Safe Medication Use
- Take OxyContin exactly as prescribed. Do not take more than directed or use it more often than prescribed.
- Swallow tablets whole, one at a time. Never crush, chew, break, or dissolve them, as this can release a fatal dose all at once.
- Take your tablets on a regular schedule, usually every 12 hours. OxyContin is not for as-needed pain relief.
- Understand that the abuse-deterrent design does not make the medication safe to misuse or immune to abuse.
- Do not stop taking OxyContin suddenly after prolonged use. Talk to your healthcare provider about a safe tapering plan.
- Do not share OxyContin with anyone else. Sharing is dangerous and against the law.
- Keep OxyContin in a safe, secure place, away from children and others, to prevent accidental exposure, misuse, or theft.
- Read the FDA-approved Medication Guide provided with your prescription.
Risk Prevention
- Benzodiazepines, alcohol, and CNS depressants: Do not use these with OxyContin unless directed by your healthcare provider. The combination can cause severe drowsiness, breathing problems, coma, and death.
- Alcohol: Do not drink alcohol while taking OxyContin. Alcohol can cause the tablet to release oxycodone too quickly, leading to a fatal overdose.
- Grapefruit: Avoid grapefruit and grapefruit juice, which can increase oxycodone levels in your body.
- Driving and machinery: OxyContin can make you sleepy or dizzy and can slow your thinking and reaction time. Do not drive or operate heavy machinery until you know how it affects you.
- Naloxone preparedness: Ask your provider about naloxone, a medicine that can reverse an opioid overdose. Make sure family members or caregivers know how to recognize an overdose and use naloxone. Because OxyContin is long-acting, more than one dose of naloxone may be needed.
- Pregnancy: Tell your provider right away if you are pregnant or plan to become pregnant, as prolonged use can cause neonatal opioid withdrawal syndrome in your baby.
- Breastfeeding: Oxycodone can pass into breast milk and may harm a nursing baby. Talk to your provider before breastfeeding while taking OxyContin.
- Constipation: Ask your provider about ways to prevent or manage constipation while taking OxyContin.
- All medicines: Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, and herbal supplements you take. Do not start or stop other medicines without talking to your provider first.
When to Contact a Healthcare Provider
Contact your healthcare provider or seek emergency care right away if you:
- Have slow, shallow, or stopped breathing, or extreme sleepiness you cannot fight off
- Cannot be easily woken up
- Feel faint, very dizzy, or lightheaded
- Develop signs of serotonin syndrome, such as agitation, hallucinations, fast heartbeat, fever, or muscle stiffness
- Develop signs of adrenal problems, such as ongoing nausea, vomiting, loss of appetite, or severe weakness
- Have a severe allergic reaction, such as swelling of the face or throat, hives, or trouble breathing
- Have a seizure
- Experience withdrawal symptoms such as restlessness, sweating, muscle aches, nausea, or diarrhea after reducing or stopping the medication
- Have severe constipation, stomach pain, or are unable to have a bowel movement
- Have any symptom that concerns you or does not go away