OxyContin

Oxycontin is part of the drug class:

• Natural opium alkaloids

• 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 Oxycontin. 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 Oxycontin 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.

Oxycontin can cause serious breathing problems that can become life-threatening, especially if Oxycontin is used the wrong way. Call your healthcare provider or get medical help 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

Oxycontin 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.

There is a chance of abuse or addiction with Oxycontin. 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.

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

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Oxycontin falls into category B. There are no well-done studies that have been done in humans with Oxycontin. But in animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Oxycontin comes as an extended-release tablet and is taken every 12 hours.

The instructions for use will vary depending on which form of the medication you have been prescribed. Follow the directions carefully.

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

If you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once unless your doctor tells you to.

Take Oxycontin exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you. The dosage of Oxycontin must be individualized.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of Oxaydo®, Roxicodone®, and Xtampza™ ER in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Oxycontin® in children. However, safety and efficacy have not been established in children younger than 11 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of oxycodone in the elderly. However, elderly patients are more likely to have age-related lung, liver, or kidney problems, which may require caution and an adjustment in the dose for patients receiving oxycodone in order to avoid potentially serious side effects.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amifampridine
• Nalmefene
• Naltrexone
• Safinamide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abiraterone
• Acepromazine
• Alfentanil
• Almotriptan
• Alprazolam
• Alvimopan
• Amineptine
• Amiodarone
• Amisulpride
• Amitriptyline
• Amitriptylinoxide
• Amobarbital
• Amoxapine
• Amphetamine
• Amprenavir
• Anileridine
• Aprepitant
• Aripiprazole
• Asenapine
• Atazanavir
• Baclofen
• Benperidol
• Benzphetamine
• Boceprevir
• Bromazepam
• Bromopride
• Brompheniramine
• Buprenorphine
• Buspirone
• Butabarbital
• Butorphanol
• Carbamazepine
• Carbinoxamine
• Carisoprodol
• Carphenazine
• Ceritinib
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpheniramine
• Chlorpromazine
• Chlorzoxazone
• Citalopram
• Clarithromycin
• Clobazam
• Clomipramine
• Clonazepam
• Clorazepate
• Clozapine
• Cobicistat
• Cocaine
• Codeine
• Conivaptan
• Cyclobenzaprine
• Darunavir
• Desipramine
• Desmopressin
• Desvenlafaxine
• Dexmedetomidine
• Dextroamphetamine
• Dextromethorphan
• Dezocine
• Diazepam
• Dibenzepin
• Dichloralphenazone
• Difenoxin
• Dihydrocodeine
• Diphenhydramine
• Diphenoxylate
• Dolasetron
• Donepezil
• Doxepin
• Doxylamine
• Droperidol
• Duloxetine
• Eletriptan
• Enflurane
• Enzalutamide
• Erythromycin
• Escitalopram
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Ethopropazine
• Ethylmorphine
• Fentanyl
• Flibanserin
• Fluoxetine
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fluvoxamine
• Fosaprepitant
• Fosphenytoin
• Fospropofol
• Frovatriptan
• Furazolidone
• Granisetron
• Halazepam
• Haloperidol
• Halothane
• Hexobarbital
• Hydrocodone
• Hydromorphone
• Hydroxytryptophan
• Hydroxyzine
• Idelalisib
• Imipramine
• Indinavir
• Iproniazid
• Isocarboxazid
• Isoflurane
• Itraconazole
• Ketamine
• Ketazolam
• Ketobemidone
• Ketoconazole
• Levomilnacipran
• Levorphanol
• Linezolid
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lopinavir
• Lorazepam
• Lorcaserin
• Loxapine
• Lumacaftor
• Meclizine
• Melitracen
• Melperone
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Mesoridazine
• Metaxalone
• Methadone
• Methamphetamine
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methylene Blue
• Methylnaltrexone
• Midazolam
• Milnacipran
• Mirtazapine
• Mitotane
• Moclobemide
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Nalorphine
• Naloxone
• Naratriptan
• Nefazodone
• Nelfinavir
• Nialamide
• Nicomorphine
• Nitrazepam
• Nitrous Oxide
• Nortriptyline
• Olanzapine
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Orphenadrine
• Oxazepam
• Oxymorphone
• Palonosetron
• Papaveretum
• Paregoric
• Paroxetine
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenelzine
• Phenobarbital
• Phenytoin
• Pimozide
• Piperacetazine
• Pipotiazine
• Piritramide
• Posaconazole
• Prazepam
• Primidone
• Procarbazine
• Prochlorperazine
• Promazine
• Promethazine
• Propofol
• Protriptyline
• Quazepam
• Quetiapine
• Ramelteon
• Rasagiline
• Remifentanil
• Remoxipride
• Ribociclib
• Ritonavir
• Rizatriptan
• Samidorphan
• Saquinavir
• Secobarbital
• Selegiline
• Sertindole
• Sertraline
• Sibutramine
• Sodium Oxybate
• Sufentanil
• Sulpiride
• Sumatriptan
• Suvorexant
• Tapentadol
• Telaprevir
• Telithromycin
• Temazepam
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Tianeptine
• Tilidine
• Tizanidine
• Tolonium Chloride
• Topiramate
• Tramadol
• Tranylcypromine
• Trazodone
• Triazolam
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimeprazine
• Trimipramine
• Tryptophan
• Venlafaxine
• Vilazodone
• Vortioxetine
• Zaleplon
• Ziprasidone
• Zolmitriptan
• Zolpidem
• Zopiclone
• Zotepine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Miconazole
• Rifampin
• St John's Wort
• Voriconazole

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Addison disease (adrenal gland problem) or
• Alcohol abuse, or history of or
• Brain tumor, history of or
• Breathing or lung problems (eg, hypoxia) or
• Cancer of the esophagus or colon or
• Central nervous system (CNS) depression or
• Chronic obstructive pulmonary disease (COPD) or
• Cor pulmonale (serious heart condition) or
• Drug dependence, especially with narcotics, or history of or
• Enlarged prostate (BPH, prostatic hypertrophy) or
• Gallbladder disease or gallstones or
• Head injuries, history of or
• Hypothyroidism (an underactive thyroid) or
• Hypovolemia (low blood volume) or
• Kyphoscoliosis (curvature of the spine with breathing problems) or
• Problems with passing urine or
• Psychosis (a mental disease) or
• Trouble swallowing or
• Weakened physical condition—Use with caution. May increase risk for more serious side effects.

• Hypotension (low blood pressure) or
• Pancreatitis (inflammation or swelling of the pancreas) or
• Seizures, history of—Use with caution. May make these conditions worse.

• Kidney disease, severe or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

This section provides information on the proper use of a number of products that contain oxycodone. It may not be specific to Oxycontin. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence).

This medicine comes with a Medication Guide and a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Oxycodone extended-release capsules or tablets should only be used by patients who have already been taking narcotic pain medicines, also called opioids. These patients are called opioid-tolerant. If you are uncertain whether or not you are opioid-tolerant, check with your doctor before using this medicine.

Measure the oral liquid concentrate with the calibrated dropper that comes with the package. Your doctor may have you mix the concentrate with a small amount of liquid or food. Carefully follow the instructions and take the medicine mixture right away.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Swallow the Oxaydo® or OxyContin® tablet whole with water. Do not break, crush, cut, chew, or dissolve it. Do not pre-soak, lick, or wet the tablet before placing it in the mouth. Take one tablet at a time. Also, do not give this medicine through nasogastric or feeding tubes.

If you are using the extended release capsules:

• Take this medicine with food and with approximately the same amount of food each time.
• If you have trouble swallowing, you may open the capsule and sprinkle the contents on soft foods (eg, applesauce, pudding, ice cream, or jam) or into a cup and then give it directly into the mouth and swallow immediately. Drink a glass of water to make sure all medicine has been taken.
• This medicine may also be given through a feeding tube.

Oxycodone extended-release capsules or tablets work differently from the regular oxycodone oral solution or tablets, even at the same dose. Do not switch from one brand or form to the other unless your doctor tells you to.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (extended-release capsules):
  • For severe pain:
    • Patients who are not taking narcotic medicines or are not opioid tolerant:
      • Adults—At first, 9 milligrams (mg) every 12 hours with food. Your doctor may adjust your dose if needed. However, the dose is usually not more than 288 mg per day.
      • Children—Use and dose must be determined by your doctor.
    • Patients switching from other narcotic medicines:
      • Adults—The total amount of milligrams (mg) per day will be determined by your doctor and depends on which narcotic you were using. Your doctor may adjust your dose if needed.
      • Children—Use and dose must be determined by your doctor.
• For oral dosage form (extended-release tablets):
  • For moderate to severe pain:
    • Patients switching from regular oxycodone forms:
      • Adults—The tablet is given every 12 hours. The total amount of milligrams (mg) per day is the same as the total amount of regular oxycodone that is taken per day. The total amount per day will be divided and given as 2 doses during the day. Your doctor may adjust your dose if needed.
      • Children 11 years of age and older—Dose must be determined by your doctor. The patient must already be 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 2 days before taking OxyContin®.
      • Children younger than 11 years of age—Use and dose must be determined by your doctor.
    • Patients switching from other narcotic medicines:
      • Adults—The tablet is given every 12 hours. The total amount of milligrams (mg) per day will be determined by your doctor and depends on which narcotic you were using. The total amount per day will be divided and given as 2 doses during the day. Your doctor may adjust your dose if needed.
      • Children 11 years of age and older—Dose must be determined by your doctor. The patient must already be 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 2 days before taking OxyContin®.
      • Children younger than 11 years of age—Use and dose must be determined by your doctor.
    • Patients who are not taking narcotic medicines:
      • Adults—At first, 10 milligrams (mg) every 12 hours. Your doctor may adjust your dose if needed.
      • Children—Use and dose must be determined by your doctor.
• For oral dosage form (immediate-release tablets):
  • For moderate to severe pain:
    • Patients who are not taking narcotic medicines:
      • Adults—At first, 5 to 15 milligrams (mg) every 4 to 6 hours as needed. Your doctor may adjust your dose if needed.
      • Children—Use and dose must be determined by your doctor.
    • Patients switching from other narcotic medicines:
      • Adults—The total amount of milligrams (mg) per day will be determined by your doctor and depends on which narcotic you were using. Your doctor may adjust your dose if needed.
      • Children—Use and dose must be determined by your doctor.
• For oral dosage forms (liquid concentrate, solution, or tablets):
  • For moderate to severe pain:
    • Adults—10 to 30 milligrams (mg) every 4 hours as needed. Your doctor may adjust your dose if needed.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Oxycodone can cause serious unwanted effects if taken by adults who are not used to strong narcotic pain medicines, children, or pets. Make sure you store the medicine in a safe and secure place to prevent others from getting it.

Use OxyContin as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take by mouth only.
• Do not inject or snort this medicine. Doing any of these things can cause very bad side effects like trouble breathing and death from overdose.
• To gain the most benefit, do not miss doses.
• Swallow whole. Do not chew, break, crush, or melt before swallowing. Doing these things can cause very bad side effects and death.
• Do not use for fast pain relief or on an as needed basis.
• Do not use for pain relief after surgery if you have not been taking drugs like OxyContin (oxycodone sustained-release tablets).
• Take 1 tablet at a time if your dose is more than 1 tablet. Do not lick or wet the tablet before putting it in your mouth. Swallow the tablet with lots of water right after putting it in your mouth.
• If you have trouble swallowing, talk with your doctor.
• Do not put this medicine down a feeding tube.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Hard stools (constipation).
• Dizziness.
• Feeling sleepy.
• Headache.
• Not able to sleep.
• Feeling tired or weak.
• Itching.
• Dry mouth.
• Belly pain.
• Loose stools (diarrhea).
• Not hungry.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

OxyContin (oxycodone hydrochloride) extended-release tablets 10 mg are film-coated, round, white-colored, bi-convex tablets debossed with OP on one side and 10 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 59011-410-10) and unit dose packaging with 10 individually numbered tablets per card; two cards per glue end carton (NDC 59011-410-20).

OxyContin (oxycodone hydrochloride) extended-release tablets 15 mg are film-coated, round, gray-colored, bi-convex tablets debossed with OP on one side and 15 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 59011-415-10) and unit dose packaging with 10 individually numbered tablets per card; two cards per glue end carton (NDC 59011-415-20).

OxyContin (oxycodone hydrochloride) extended-release tablets 20 mg are film-coated, round, pink-colored, bi-convex tablets debossed with OP on one side and 20 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 59011-420-10) and unit dose packaging with 10 individually numbered tablets per card; two cards per glue end carton (NDC 59011-420-20).

OxyContin (oxycodone hydrochloride) extended-release tablets 30 mg are film-coated, round, brown-colored, bi-convex tablets debossed with OP on one side and 30 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 59011-430-10) and unit dose packaging with 10 individually numbered tablets per card; two cards per glue end carton (NDC 59011-430-20).

OxyContin (oxycodone hydrochloride) extended-release tablets 40 mg are film-coated, round, yellow-colored, bi-convex tablets debossed with OP on one side and 40 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 59011-440-10) and unit dose packaging with 10 individually numbered tablets per card; two cards per glue end carton (NDC 59011-440-20).

OxyContin (oxycodone hydrochloride) extended-release tablets 60 mg are film-coated, round, red-colored, bi-convex tablets debossed with OP on one side and 60 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 59011-460-10) and unit dose packaging with 10 individually numbered tablets per card; two cards per glue end carton (NDC 59011-460-20).

OxyContin (oxycodone hydrochloride) extended-release tablets 80 mg are film-coated, round, green-colored, bi-convex tablets debossed with OP on one side and 80 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 59011-480-10) and unit dose packaging with 10 individually numbered tablets per card; two cards per glue end carton (NDC 59011-480-20).

Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Dispense in tight, light-resistant container.

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

Oxycodone can slow or stop your breathing.

Oxycodone may be habit-forming, even at regular doses. Take this medicine exactly as prescribed by your doctor. Never share the medicine with another person. MISUSE OF NARCOTIC PAIN MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

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

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

• OxyContin is a brand (trade name) of controlled-release oxycodone. OxyContin releases oxycodone slowly over a period of 12 hours.
• Oxycodone is a morphine-like, strong pain-relief medicine used for the relief of severe pain that is unresponsive to less potent pain-relief medicines (analgesics). Oxycodone is relatively selective for the mu opioid receptor, although it may bind to other opioid receptors at higher dosages. Oxycodone is a full agonist at the mu receptor (full agonists have a larger effect at higher dosages).
• OxyContin belongs to the group of drugs known as opioids or opioid analgesics. Oxycontin may also be called a narcotic analgesic.