Oxycodone

Oxycodone is a prescription medication used to treat moderate to severe pain. This medication belongs to a group of drugs called opioids which work by stopping pain signals made in the brain.

Oxycodone comes in several forms including tablets, capsules, oral solution (liquid), extended-release tablets, and extended-release capsules. It is also found in combination with other medications such as acetaminophen, ibuprofen, and aspirin.

The dose and how often you will take oxycodone will vary depending on the formulation you have been prescribed as well as many other factors. Your dose will be individualized to you. 

Swallow extended-release tablets and capsules whole. Do not crush extended-release forms. 

Common side effects of oxycodone include constipation, nausea, drowsiness, and dizziness. Do not drive or operate heavy machinery until you know how it affects you.

Oxycodone is a prescription medicine used to treat moderate to severe pain for which other treatments have not managed pain well. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Oxycodone may be found in some form under the following brand names:

• Combunox

• Dazidox

• Endocet

• Endocodone

• Endodan

• Endodan Reformulated May 2009

• ETH-Oxydose

• Lynox

• M-Oxy

• Magnacet

• Narvox

• Oxecta

• Oxy IR

• Oxycontin

• Oxyfast

• Percocet

• Percodan

• Percodan Reformulated May 2009

• Percolone

• Perloxx

• Primalev

• Roxicet

• Roxicodone

• Roxilox

• Roxiprin

• Roxybond

• Tylox

• Xolox

Serious side effects have been reported. See "Drug Precautions" section.

Common side effects include:

• nausea
• constipation
• vomiting
• headache
• itching
• feeling tired
• dizziness

This is not a complete list of oxycodone side effects. Ask your doctor or pharmacist for more information.

Tell your healthcare provider if you have any side effect that bothers you or does not go away. 

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Be especially careful about taking other medicines that make you sleepy such as:

• pain medicines
• sleeping pills
• anxiety medicines
• antihistamines
• muscle relaxants
• anti-depressants
• tranquilizers
• anti-nausea medicine
• alcohol

Additionally, tell your healthcare provider if you take:

• inhibitors of CYP3A4, such as clarithromycin (Biaxin), indinavir, ritonavir (Norvir), boceprevir (Victrelis), ketoconazole (Nizoral, Extina), itraconazole (Sporanox), posaconazole (Noxafil), nefazodone (Serzone)
• inducers of CYP3A4, such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), and St. John's Wort 
• antipsychotic medications including olanzapine (Zyprexa), clozapine (Clozaril), haloperidol (Haldol), fluphenazine (Prolixin), quetiapine (Seroquel), prochlorperazine (Compazine)
• serotonergic drugs including citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), nefazodone (Serzone), trimipramine (Surmontil), nortriptyline (Pamelor, Aventyl), linezolid (Zyvox)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), tranylcypromine (Parnate), selegiline (Emsam, Eldepryl, Zelapar), rasagiline (Azilect)
• mixed agonist/antagonists such as buprenorphine (Suboxone, Subutex, Zubsolv, Bunavail, Probuphine)
• diuretics such as acetazolamide (Diamox), amiloride (Midamor), bumetanide (Bumex), chlorothiazide (Diuril), chlorothiazide (Thalitone), furosemide (Lasix), hydrochlorothiazide (Microzide, HCTZ), metolazone (Zaroxolyn, torsemide (Demadex), triamterene (Dyrenium, Dyazide, Maxzide)
• anticholinergics such as glycopyrrolate (Cuvposa, Robinul), trospium (Sanctura), oxybutynin (Anturol, Gelnique, Oxytrol, Ditropan), solifenacin (Vesicare), dicyclomine (Bentyl), propantheline (Pro-Banthine), atropine (Atropen, Sal-Tropine)

This is not a complete list of oxycodone drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with oxycodone including the following:

Addiction, Abuse, Misuse. There is a chance of abuse or addiction with oxycodone. The chance is higher if you are or have been addicted to or abused other medicines, street drugs, or alcohol, or if you have a history of mental problems.

Serious breathing problems (Respiratory Depression). Oxycodone can cause serious breathing problems that can become life-threatening, especially in patients with chronic lung disease, elderly patients, or disabled patients. Increased risk if oxycodone is used the wrong way. Call your healthcare provider right away if:

• your breathing slows down
• you have shallow breathing (little chest movement with breathing)
• you feel faint, dizzy, confused, or
• you have any other unusual symptoms

Opioid Withdrawal Syndrome in Infants. Oxycodone can cause harm, potentially death, to the baby if administered to pregnant women.

Adrenal Insufficiency (adrenal glands don't make enough of these hormones). Adrenal insufficiency is confirmed, your doctor will give you steroids and slowly decrease you oxycodone dose.

Severe Low Blood Pressure. Oxycodone can cause your blood pressure to drop. This can make you feel dizzy and faint if you get up too fast from sitting or lying down. Low blood pressure is also more likely to happen if you take other medicines that can also lower your blood pressure. Severe low blood pressure can happen if you lost blood or take certain other medicines.

Risk of Use in Patients with Increased Intracranial Pressure. Patients with brain tumors, head injury, coma, or impaired consciousness are at an increased risk of sedation or respiratory problems while taking oxycodone.

Risk of Use in Patients with Seizure Disorders. Oxycodone can increase the frequency of seizures. 

Withdrawals. Do not stop oxycodone without first talking to your healthcare provider. Stopping oxycodone suddenly may cause serious symptoms including:

• anxiety
• sweating
• insomnia
• shaking/shivering
• pain
• nausea
• diarrhea
• upper airway symptoms
• goosebumps

Get emergency medical help if you have: trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, lightheadedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.

Never give anyone else your medication. They could die from taking it. Store this medication away from children and in a safe place to prevent stealing or abuse. Selling or giving away oxycodone is against the law. 

Do not drive, operate heavy machinery, or participate in any other possibly dangerous activities until you know how you react to this medicine. This medication can make you sleepy.

Do not drink alcohol while using oxycodone. It may increase the chance of getting dangerous side effects.

Do not take other medicines without your doctor’s approval. Other medicines include prescription and non-prescription medicines, vitamins, and supplements. Be especially careful about products that make you sleepy.

Do not take oxycodone if

• your doctor did not prescribe it for you
• are allergic to any of its ingredients
• have had a severe allergic reaction to a medicine that contains oxycodone. Ask your healthcare provider if you are not sure.
• are having an asthma attack or have severe asthma, trouble breathing, or any lung problems
• have a bowel blockage called paralytic ileus
• have recently had a head injury
• you have a history of drug or alcohol dependence
• you have had a severe allergic reaction to codeine, hydrocodone, dihydrocodeine, or oxycodone (such as Tylox, Tylenol with Codeine, or Vicodin). A severe allergic reaction includes a severe rash, hives, breathing problems, or dizziness.

Grapefruit and grapefruit juice may interact with oxycodone and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.
 

Before taking oxycodone, tell your doctor if you:

• are allergic to oxycodone
• have trouble breathing or lung problems
• have had a head injury
• have liver or kidney problems
• have adrenal gland problems, such as Addison's disease
• have severe scoliosis that affects your breathing
• have thyroid problems
• have enlargement of your prostate or a urethral stricture
• have or had convulsions or seizures
• have a past or present drinking problem or alcoholism
• have hallucinations or other severe mental problems
• have past or present substance abuse or drug addiction
• have any other medical conditions
• are pregnant or plan to become pregnant
• are breastfeeding

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. 

Tell your doctor if you are pregnant or plan to become pregnant.

There are no well-done studies that have been done in humans with oxycodone. Prolonged use of this medication during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Oxycodone has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from oxycodone, a choice should be made whether to stop nursing or to stop the use of this medication. The importance of the drug to the mother should be considered.

Take oxycodone exactly as prescribed. Follow the directions carefully.

Do not change your dose without talking to your healthcare provider. Use the lowest dose possible for the shortest time needed.

Oxycodone comes as a tablet, a capsule, in an oral solution, an extended-release tablet, and an extended-release capsule.

Extended-release tablets and capsules should be swallowed whole. Do not break, crush, or chew extended-release tablets or capsules. If you cannot swallow the extended-release capsules, then the contents of the capsules may be sprinkled on soft food, sprinkled into a cup and then put directly into the mouth, or given through a nasogastric or gastrostomy tube. The instructions for use will vary depending on which form of the medication you have been prescribed. 

Oxycodone may cause stomach upset. Taking it with food may help.

Take oxycodone exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose and how often you will take oxycodone will vary depending on the formulation you have been prescribed as well as many other factors. One factor is if you were taking an opioid already, which one, and at what dose. Your dose will also depend on how well it has been controlling your pain. 

Your dose will be individualized to you which will be determined by your doctor. 

If you take more oxycodone than prescribed, or overdose, call your local emergency number (such as 911) or your local Poison Control Center right away, or get emergency help.

• Keep oxycodone out of the reach of children. Accidental overdose by a child is dangerous and can lead to death.
• Store oxycodone at 59˚F to 86˚F (15˚C to 30˚C).
• Keep oxycodone in the container it comes in.
• Keep the container tightly closed and away from light.

Oxycodone is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep this medication in a safe place to prevent misuse and abuse. Selling or giving away oxycodone may harm others, and is against the law.

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and CYTOCHROME P450 3A4 INTERACTION

• Oxycodone exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk before prescribing and monitor regularly for development of these behaviors and conditions.
• Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase.
• Accidental ingestion of oxycodone, especially by children, can result in fatal overdose of oxycodone.
• Prolonged maternal use of oxycodone during pregnancy can result in neonatal opioid withdrawal syndrome, which may be lifethreatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
• Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of oxycodone.