oxycodone: Black Box Warnings

oxycodone: Adult Dosing

Dosage forms: 5,15,30; 10,20,40,80 ER; 5/5 mL; 20/mL

pain, mod-severe acute

5-30 mg PO q4h prn

Info: give w/ food

pain, mod-severe chronic

10-160 mg ER PO q12h

Start: 10 mg ER PO q12h; Info: 80 mg ER tabs for use in opioid-tolerant pts only; do not cut/crush/chew ER form

renal dosing

adjust dose amount

CrCl <60: decr. dose, amount not defined

hepatic dosing

adjust dose amount

hepatic impairment: decr. start dose, amount not defined

oxycodone: Peds Dosing

Dosage forms: 5,15,30; 5/5 mL; 20/mL

pain, mod-severe

0.05-0.15 mg/kg PO q4-6h

Max: 5 mg PO q4-6h; Info: give w/ food

renal dosing

see Adult Dosing

renal impairment: dose adjustment may be required although specific pediatric dosing adjustments not defined; see adult renal dosing for guidance

hepatic dosing

see Adult Dosing

hepatic impairment: dose adjustment may be required although specific pediatric dosing adjustments not defined; see adult hepatic dosing for guidance

oxycodone: Contraindications/Cautions

• hypersens. to drug/class/compon.
• respiratory depression
• asthma, acute or severe
• hypercarbia
• paralytic ileus
• caution in elderly pts
• caution if resp. depressant use
• caution if CNS depression
• caution if head injury
• caution if incr. ICP
• caution if alcohol abuse
• caution if seizure disorder
• caution if adrenal insufficiency
• caution if impaired liver fxn
• caution if impaired renal fxn
• caution if GI motility disorder
• caution if biliary dz hx
• caution if prostatic hypertrophy
• caution if drug abuse hx
• caution if hypovolemia

Contraindicated

• morphine liposomal

Avoid/Use Alternative

• buprenorphine

• butorphanol

• butorphanol nasal

• nalbuphine

• pentazocine

• potassium salts

• sodium oxybate

Monitor/Modify Tx

• pegvisomant

Therapeutic Advantage

• opiate antagonists

Caution Advised

• acetaminophen/butalbital

• acetaminophen/caffeine/CNS depressant combos

• acetaminophen/codeine

• acetaminophen/hydrocodone

• acetaminophen/oxycodone

• acetaminophen/propoxyphene

• acetaminophen/tramadol

• albuterol/ipratropium inhaled

• anticholinergics

• anticholinergics, inhaled

• anticholinergics, ophthalmic

• antidepressants, other

• antihist/decongest/DM combos

• antihist/decongestant combos

• antihistamines, sedating

• apomorphine

• aripiprazole

• aspirin/caffeine/CNS depressant combos

• aspirin/caffeine/orphenadrine

• aspirin/carisoprodol

• aspirin/opiate combos

• azelastine nasal

• baclofen

• baclofen intrathecal

• barbiturates

• BZDs, all

• cannabinoids

• carisoprodol

• central alpha 2 agonists

• cetirizine

• chlorpheniramine/hydrocodone

• chlorzoxazone

• clozapine

• cyclobenzaprine

• cyclopentolate/phenylephrine ophthalmic

• dantrolene

• darifenacin

• decongest/opiate combos

• dexmedetomidine

• disopyramide

• doxazosin

• droperidol

• ethanol

• ethosuximide

• etomidate

• haloperidol

• hydrocodone/ibuprofen

• ibuprofen/oxycodone

• inhaled anesthetics

• ketamine

• levocetirizine

• local anesthetics

• local anesthetics/epinephrine

• loperamide

• loxapine

• meperidine/promethazine

• meprobamate

• metaxalone

• methocarbamol

• metoclopramide

• mitotane

• molindone

• olanzapine

• olanzapine/fluoxetine

• orphenadrine

• oxcarbazepine

• oxymorphone

• paliperidone

• phenothiazines

• pimozide

• pramipexole

• pregabalin

• promethazine/codeine

• propofol

• propoxyphene

• pyridostigmine

• quetiapine

• risperidone

• ropinirole

• rotigotine transdermal

• sedative/hypnotics

• solifenacin

• succinylcholine

• thalidomide

• thiothixene

• tiagabine

• tizanidine

• tramadol

• tricyclic antidepressants

• valproic acid derivatives

• ziconotide intrathecal

• ziprasidone

• zonisamide

oxycodone: Adverse Reactions

Serious Reactions

• respiratory depression
• respiratory arrest
• cardiac arrest
• apnea
• hypotension, severe
• circulatory collapse
• dependency, abuse
• seizures
• biliary spasm
• paralytic ileus

Common Reactions

• constipation
• nausea/vomiting
• headache
• pruritus
• insomnia
• dizziness
• asthenia
• somnolence
• hypotension, orthostatic
• sweating
• miosis
• euphoria
• dysphoria
• rash

oxycodone: Safety Monitoring

Pregnancy: B

Lactation: Probably Safe

Monitoring Parameters: Cr at baseline

Avoid Abrupt Cessation: taper dose gradually to D/C if at risk for physical dependence (abrupt cessation of opioids may cause a withdrawal syndrome including restlessness, irritability, anxiety, insomnia, mydriasis, lacrimation, rhinorrhea, sneezing, yawning, perspiration, incr. body temp., chills, piloerection, myalgia, backache, arthralgia, weakness, abdominal and muscle cramps, muscle twitching, anorexia, nausea, vomiting, diarrhea, incr. BP, respiratory rate, heart rate)

oxycodone: Pharmacology

Metabolism: liver extensively; CYP450: 2D6 substrate; Info: active metabolite

Excretion: urine primarily (19% unchanged); Half-life: 3.2h, 4.5h (ER form)

Class: Narcotics

Mechanism Of Action
binds to various opioid receptors, producing analgesia and sedation (opioid agonist)

oxycodone: Manufacturer/Pricing

Manufacturer: generic DEA/FDA: Schedule II Approximate Retail Price tablet: 5 mg (20 ea): $16.66 15 mg (20 ea): $17.99 30 mg (20 ea): $24.66 capsule: 5 mg (20 ea): $11.99 concentrate: 20 mg/ml (20 ml): $22.66 tablet extended release, 12 hr: 10 mg (20 ea): $29.33 20 mg (20 ea): $53.33 40 mg (20 ea): $93.33 80 mg (20 ea): $166.68

oxycodone: Patient Education

• Generic Name: oxycodone

• Pronounced: ox i KOE done

• Brand Names: Endocodone, ETH-Oxydose, M-Oxy, OxyContin, Oxyfast, OxyIR, Percolone, Roxicodone, Roxicodone Intensol

What is the most important information I should know about oxycodone?

Oxycodone may be habit-forming and should be used only by the person it was prescribed for. Oxycodone should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Do not drink alcohol while you are taking oxycodone. Dangerous side effects or death can occur when alcohol is combined with a narcotic pain medicine. Check your food and medicine labels to be sure these products do not contain alcohol.

Never take more than your prescribed dose of oxycodone. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Oxycodone can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Do not stop using oxycodone suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

What is oxycodone?

Oxycodone is in a group of drugs called narcotic pain relievers. It is similar to morphine.

Oxycodone is used to treat moderate to severe pain. The extended-release form of this medication is for around-the-clock treatment of pain. Oxycodone is not for treating pain just after a surgery unless you were already taking oxycodone before the surgery.

Oxycodone may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before using oxycodone?

Do not use this medication if you have ever had an allergic reaction to a narcotic medicine (examples include methadone, morphine, Oxycontin, Darvocet, Percocet, Vicodin, Lortab, and many others), or to a narcotic cough medicine that contains codeine, hydrocodone, or dihydrocodeine.

You should also not take oxycodone if you are having an asthma attack or if you have a bowel obstruction called paralytic ileus.

Oxycodone may be habit-forming and should be used only by the person it was prescribed for. Oxycodone should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Before using oxycodone, tell your doctor if you are allergic to any drugs, or if you have:

• asthma, COPD, sleep apnea, or other breathing disorders;
• liver or kidney disease;
• underactive thyroid;
• curvature of the spine;
• a history of head injury or brain tumor;
• epilepsy or other seizure disorder;
• low blood pressure;
• gallbladder disease;
• Addison's disease or other adrenal gland disorders;
• enlarged prostate, urination problems;
• mental illness; or
• a history of drug or alcohol addiction.

FDA pregnancy category C. This medication may be harmful to an unborn baby, and could cause addiction or withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Oxycodone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may be more sensitive to the effects of this medicine.

How should I use oxycodone?

Take this medication exactly as it was prescribed for you. Never take oxycodone in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Take the pill form of this medicine with a full glass of water.

Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It will release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.

Measure the liquid form of oxycodone with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Drink plenty of water daily to help prevent constipation while you are using oxycodone. Ask your doctor about ways to increase the fiber in your diet. Do not use a stool softener (laxative) without first asking your doctor.

Do not stop using oxycodone suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

Never crush a tablet or other pill to mix into a liquid for injecting the drug into your vein. This practice has resulted in death with the misuse of oxycodone and similar prescription drugs.

Store this medication at room temperature, away from heat, moisture, and light.

Keep track of how many pills have been used from each new bottle of this medicine. Oxycodone is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

After you have stopped using this medication, flush any unused pills down the toilet.

Throw away any unused liquid oxycodone that is older than 90 days.

What happens if I miss a dose?

Since oxycodone is sometimes used as needed, you may not be on a dosing schedule. If you are using the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

Extended-release oxycodone is not for use on an as-needed basis for pain.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of oxycodone can be fatal.

Overdose symptoms may include extreme drowsiness, muscle weakness, confusion, cold and clammy skin, pinpoint pupils, shallow breathing, slow heart rate, fainting, or coma.

What should I avoid while using oxycodone?

Do not drink alcohol while you are taking this medication. Dangerous side effects or death can occur when alcohol is combined with oxycodone. Check your food and medicine labels to be sure these products do not contain alcohol.

Oxycodone can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What are the possible side effects of oxycodone?

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

Call your doctor at once if you have any of these serious side effects:

• shallow breathing, slow heartbeat;
• seizure (convulsions);
• cold, clammy skin;
• confusion;
• severe weakness or dizziness; or
• feeling light-headed, fainting.

Less serious side effects are more likely to occur, such as:

• nausea, vomiting, constipation, loss of appetite;
• dizziness, headache, tired feeling;
• dry mouth;
• sweating; or
• itching.

This list is not complete and other side effects may occur. Tell your doctor about any unusual or bothersome side effect.

What other drugs will affect oxycodone?

Do not take oxycodone with alcohol, other narcotic pain medications, sedatives, tranquilizers, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result.

Before taking oxycodone, tell your doctor if you are using pentazocine (Talwin), nalbuphine (Nubain), butorphanol (Stadol), or buprenorphine (Buprenex, Subutex). If you are using any of these drugs, you may not be able to use oxycodone, or you may need dosage adjustments or special tests during treatment.

This list is not complete and there may be other drugs that can interact with oxycodone. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about oxycodone.

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

oxycodone: Pill Pictures

How should I use oxycodone?

Take this medication exactly as it was prescribed for you. Never take oxycodone in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Take the pill form of this medicine with a full glass of water. Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It will release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.

Measure the liquid form of oxycodone with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Drink plenty of water daily to help prevent constipation while you are using oxycodone. Ask your doctor about ways to increase the fiber in your diet. Do not use a stool softener (laxative) without first asking your doctor. Do not stop using oxycodone suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

Never crush a tablet or other pill to mix into a liquid for injecting the drug into your vein. This practice has resulted in death with the misuse of oxycodone and similar prescription drugs.

Store this medication at room temperature, away from heat, moisture, and light.

Keep track of how many pills have been used from each new bottle of this medicine. Oxycodone is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

After you have stopped using this medication, flush any unused pills down the toilet.

Throw away any unused liquid oxycodone that is older than 90 days.

Brand names

• OxyContin®
• Oxydose®
• OxyIR®
• Roxicodone®
• Roxicodone® Intensol®

U.S. Brand Names

• ETH-Oxydose™
• OxyContin®
• OxyFast®
• OxyIR®
• Roxicodone®

Canadian Brand Names

• Oxy.IR®
• OxyContin®
• Supeudol®

International Brand Names

• Endone
• Ircodon
• Oxicontin
• Oxycod
• OxyContin
• Oxycontin CR
• Oxycontin LP
• Oxygesic
• Oxynorm
• Plexicodim

Brand names of combination products

• Combunox® containing Oxycodone and Ibuprofen
• Endocet® containing Oxycodone and Acetaminophen
• Endodan® containing Oxycodone and Aspirin
• Percocet® containing Oxycodone and Acetaminophen
• Percodan® containing Oxycodone and Aspirin
• Roxicet® containing Oxycodone and Acetaminophen
• Roxiprin ® containing Oxycodone and Aspirin
• Tylox® containing Oxycodone and Acetaminophen

oxybutynin: overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• difficulty breathing or slowed or stopped breathing
• excessive sleepiness
• dizziness
• fainting
• limp or weak muscles
• increase or decrease in pupil (dark circle in the eye) size
• cold, clammy skin
• slow or stopped heartbeat
• blue color of skin, fingernails, lips, or area around the mouth
• loss of consciousness or coma