Roxicodone

Name: Roxicodone

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An oxycodone overdose can be fatal, especially in a child or other person using the medicine without a prescription.

Overdose symptoms may include slow heartbeats, severe muscle weakness, cold and clammy skin, noisy breathing, and very slow breathing.

Before Using Roxicodone

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.

Proper Use of oxycodone

This section provides information on the proper use of a number of products that contain oxycodone. It may not be specific to Roxicodone. 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.

Roxicodone Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common
  • Chills
  • cold sweats
  • confusion
  • difficult or labored breathing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fever
  • tightness in the chest
  • twitching
Rare
  • Abdominal or stomach pain
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blood in the urine
  • burning while urinating burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain
  • convulsions
  • cough
  • decrease in the frequency of urination
  • decrease in urine volume
  • decreased urine output
  • difficult or painful urination
  • difficulty in passing urine (dribbling)
  • difficulty with swallowing
  • dizziness
  • dry mouth
  • fainting
  • fast, irregular, pounding, or racing heartbeat or pulse
  • feeling of warmth or heat
  • flushing or redness of the skin, especially on the face and neck
  • frequent urination
  • headache
  • hives, itching, or skin rash
  • increase in heart rate
  • increased thirst
  • increased volume of pale, dilute urine
  • lightheadedness
  • muscle pain or cramps
  • nausea or vomiting
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid breathing
  • rapid weight gain
  • severe constipation
  • severe vomiting
  • shakiness in the legs, arms, hands, or feet
  • sunken eyes
  • sweating
  • swelling or puffiness of the face
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • thirst
  • tingling of the hands or feet
  • trembling or shaking of the hands or feet
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • wrinkled skin
Incidence not known
  • Blurred vision
  • choking
  • clay-colored stools
  • cold, clammy skin
  • dark urine
  • diarrhea
  • fast, weak pulse
  • gagging
  • irregular, fast, slow, or shallow breathing
  • loss of appetite
  • pale or blue lips, fingernails, or skin
  • unconsciousness
  • unpleasant breath odor
  • very slow heartbeat
  • yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose
  • Change in consciousness
  • chest pain or discomfort
  • constricted, pinpoint, or small pupils (black part of the eye)
  • decreased awareness or responsiveness
  • extreme drowsiness
  • loss of consciousness
  • no muscle tone or movement
  • severe sleepiness
  • slow or irregular heartbeat

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Difficulty having a bowel movement (stool)
  • drowsiness
  • lack or loss of strength
  • relaxed and calm feeling
  • sleepiness or unusual drowsiness
Less common
  • Abnormal dreams
  • acid or sour stomach
  • anxiety
  • belching
  • burning feeling in the chest or stomach
  • false or unusual sense of well-being
  • heartburn
  • hiccups
  • indigestion
  • stomach discomfort, upset, or pain
  • tenderness in the stomach area
  • trouble sleeping
  • weight loss
Rare
  • Absent, missed, or irregular menstrual periods
  • bad, unusual or unpleasant (after) taste
  • bloated or full feeling
  • body aches or pain
  • change in taste
  • change in walking and balance
  • changes in vision
  • clumsiness or unsteadiness
  • congestion
  • continuous ringing or buzzing or other unexplained noise in the ears
  • crying
  • decreased interest in sexual intercourse
  • dental caries or tooth decay
  • depersonalization
  • depression
  • difficulty with speaking
  • dry skin
  • dryness or soreness of the throat
  • excess air or gas in the stomach or intestines
  • excessive muscle tone
  • feeling of constant movement of self or surroundings
  • feeling of unreality
  • general feeling of discomfort or illness
  • headache, severe and throbbing
  • hearing loss
  • hoarseness
  • hyperventilation
  • inability to have or keep an erection
  • increase in body movements
  • increased appetite
  • increased cough
  • irritability
  • loss in sexual ability, desire, drive, or performance
  • loss of heat from the body
  • loss of memory
  • loss of strength or energy
  • muscle pain or weakness
  • muscle stiffness
  • muscle tension or tightness
  • neck pain
  • paranoia
  • passing of gas
  • problems with memory
  • quick to react or overreact emotionally
  • rapidly changing moods
  • red, swollen skin
  • restlessness
  • runny nose
  • scaly skin
  • sensation of spinning
  • sense of detachment from self or body
  • severe sleepiness
  • stomach pain, fullness, or discomfort
  • swelling or inflammation of the mouth
  • tender, swollen glands in the neck
  • unusual weak feeling
  • voice changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Drug Interactions

Table 1 includes clinically significant drug interactions with Roxicodone.

Table 1: Clinically Significant Drug Interactions with Roxicodone 

Inhibitors of CYP3A4 and CYP2D6

Clinical Impact:

The concomitant use of Roxicodone and CYP3A4 inhibitors can increase the plasma concentration of oxycodone, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of Roxicodone and CYP2D6 and CYP3A4 inhibitors, particularly when an inhibitor is added after a stable dose of Roxicodone is achieved [see Warnings and Precautions (5.4)]. After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the oxycodone plasma concentration will decrease [see Clinical Pharmacology (12.3)], resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to oxycodone.

Intervention:

If concomitant use is necessary, consider dosage reduction of Roxicodone until stable drug effects are achieved. Monitor patients for respiratory depression and sedation at frequent intervals.

If a CYP3A4 inhibitor is discontinued, consider increasing the Roxicodone dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal.

Examples:

Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), protease inhibitors (e.g., ritonavir).

CYP3A4 Inducers

Clinical Impact:

The concomitant use of Roxicodone and CYP3A4 inducers can decrease the plasma concentration of oxycodone [see Clinical Pharmacology (12.3)], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to oxycodone [see Warnings and Precautions (5.12)].

After stopping a CYP3A4 inducer, as the effects of the inducer decline, the oxycodone plasma concentration will increase [see Clinical Pharmacology (12.3)], which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression.

Intervention:

If concomitant use is necessary, consider increasing the Roxicodone dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal. If a CYP3A4 inducer is discontinued, consider Roxicodone dosage reduction and monitor for signs of respiratory depression.

Examples:

Rifampin, carbamazepine, phenytoin

Benzodiazepines and Other Central Nervous System (CNS) Depressants

Clinical Impact:

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.

Intervention:

Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients closely for signs of respiratory depression and sedation [see Warnings and Precautions (5.5)].

Examples:

Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol.

Serotonergic Drugs

Clinical Impact:

The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome [see Adverse Reactions (6.2)].

Intervention:

If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue Roxicodone if serotonin syndrome is suspected.

Examples:

Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).

Monoamine Oxidase Inhibitors (MAOIs)

Clinical Impact:

MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma) [see Warnings and Precautions (5.2)].

Intervention:

The use of Roxicodone is not recommended for patients taking MAOIs or within 14 days of stopping such treatment.

If urgent use of an opioid is necessary, use test doses and frequent titration of small doses to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression.

Examples:

phenelzine, tranylcypromine, linezolid

Mixed Agonist/Antagonist Opioid Analgesics

Clinical Impact:

May reduce the analgesic effect of Roxicodone and/or may precipitate withdrawal symptoms.

Intervention:

Avoid concomitant use

Examples:

Butorphanol, nalbuphine, pentazocine, buprenorphine

Muscle Relaxants

Clinical Impact:

Oxycodone may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.

Intervention:

Monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of Roxicodone and/or the muscle relaxant as necessary.

Diuretics

Clinical Impact:

Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.

Intervention:

Monitor patients for signs of dismissed diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed.

Anticholinergic Drugs

Clinical Impact:

The concomitant risk of anticholinergic drugs may result in increased risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.

Intervention:

Monitor patients for signs of urinary retention or reduced gastric motility when Roxicodone is used concurrently with anticholinergic drugs.


Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Addiction, Abuse and Misuse

Inform patients that the use of Roxicodone, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see Warnings and Precautions (5.1)]. Instruct patients not to share Roxicodone with others and to take steps to protect Roxicodone from theft and misuse.

Life-Threatening Respiratory Depression

Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting Roxicodone or when the dosage is increased, and that it can occur even at recommended dosages [see Warnings and Precautions (5.2)]. Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop.

Accidental Ingestion

Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see Warnings and Precautions (5.2)]. Instruct patients to take steps to store Roxicodone securely and to dispose of unused Roxicodone by flushing the tablets down the toilet or disposing of in accordance with local state guidelines and/or regulations.

Interactions with Benzodiazepines and Other CNS Depressants

Inform patients and caregivers that potentially fatal additive effects may occur if Roxicodone is used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider [see Warnings and Precautions (5.5), Drug Interactions (7)].

Serotonin Syndrome

Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their healthcare providers if they are taking, or plan to take serotonergic medication [see Drug Interactions (7)].

MAOI Interaction

Inform patients to avoid taking Roxicodone while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking ROXICIDONE [see Drug Interactions (7)].

Adrenal Insufficiency

Inform patients that opioids could cause adrenal insufficiency, a potentially life-threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms [see Warnings and Precautions (5.7)].

Important Administration Instructions

Instruct patients how to properly take Roxicodone. Patients should be advised not to adjust the dose of Roxicodone without consulting the prescribing healthcare provider [see Dosage and Administration (2), Warnings and Precautions (5.12)].

Hypotension

Inform patients that Roxicodone may cause orthostatic hypotension and syncope. Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from sitting or lying position) [see Warnings and Precautions (5.8)].

Anaphylaxis

Inform patients that anaphylaxis has been reported with ingredients contained in Roxicodone. Advise patients how to recognize such a reaction and when to seek medical attention [see Contraindications (4), Adverse Reactions (6.2)].

Pregnancy

Neonatal Opioid Withdrawal Syndrome

Inform female patients of reproductive potential that prolonged use of Roxicodone during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated [see Warnings and Precautions (5.3), Use in Specific Populations (8.1)].

Embryo-Fetal Toxicity

Inform female patients of reproductive potential that Roxicodone can cause fetal harm and to inform their healthcare provider of a known or suspected pregnancy [see Use in Specific Populations (8.1)].

Lactation

Advise nursing mothers to monitor infants for increased sleepiness (more than usual), breathing difficulties, or limpness. Instruct nursing mothers to seek immediate medical care if they notice these signs [see Use in Specific Populations (8.2)].

Infertility

Inform patients that chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible [see Use in Specific Populations (8.3)].

Driving or Operating Machinery

Inform patients that Roxicodone may impair the ability to perform potentially hazardous activities such as driving a car or operating dangerous machinery. Advise patients not to perform such tasks until they know how they will react to the medication [see Warnings and Precautions (5.13)].

Constipation

Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention [see Adverse Reactions (6), Clinical Pharmacology (12.1)].

Disposal of Unused Roxicodone

Advise patients to dispose of unused Roxicodone by flushing the tablets down the toilet or disposing of in accordance with local state guidelines and/or regulations.

Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and other brands are trademarks of a Mallinckrodt company.
© 2016 Mallinckrodt.

Distributed by:
Mallinckrodt Brand Pharmaceuticals, Inc.
Hazelwood, MO 63042 USA

To request medical information or to report suspected adverse reactions, contact Mallinckrodt at 1‑800‑778‑7898.

960B00

Rev 12/2016

Mallinckrodt™
Pharmaceutical

Medication Guide
Roxicodone® (rox-i-KOE-done)
(oxycodone hydrochloride) Tablets USP, CII 

Roxicodone is:

  • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require an opioid pain medicine, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
  • An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Important information about Roxicodone:

  • Get emergency help right away if you take too much Roxicodone (overdose). When you first start taking Roxicodone, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
  • Taking Roxicodone with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
  • Never give anyone else your Roxicodone. They could die from taking it. Store Roxicodone away from children and in a safe place to prevent stealing or abuse. Selling or giving away Roxicodone is against the law.

Do not take Roxicodone if you have:

  • severe asthma, trouble breathing, or other lung problems.
  • a bowel blockage or have narrowing of the stomach or intestines.
  • allergy to oxycodone.

Before taking Roxicodone, tell your healthcare provider if you have a history of:

  • head injury, seizures
  • problems urinating
  • abuse of street or prescription drugs, alcohol addiction, or mental health problems.
  • liver, kidney, thyroid problems 
  • pancreas or gallbladder problems 

Tell your healthcare provider if you are:

  • pregnant or planning to become pregnant. Prolonged use of Roxicodone during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
  • breastfeeding. Roxicodone passes into breast milk and may harm your baby.
  • taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Roxicodone with certain other medicines can cause serious side effects that could lead to death.

When taking Roxicodone:

  • Do not change your dose. Take Roxicodone exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
  • Take your prescribed dose every 4 to 6 hours. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
  • Call your healthcare provider if the dose you are taking does not control your pain.
  • If you have been taking Roxicodone regularly, do not stop taking Roxicodone without talking to your healthcare provider.
  • After you stop taking Roxicodone, flush any unused tablets down the toilet.

While taking Roxicodone DO NOT:

  • Drive or operate heavy machinery, until you know how Roxicodone affects you. Roxicodone 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 Roxicodone may cause you to overdose and die.

The possible side effects of Roxicodone are:

  • constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.

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, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.

These are not all the possible side effects of Roxicodone. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov

Distributed by: Mallinckrodt Brand Pharmaceuticals Inc., Hazelwood, MO 63042 USA, www.Mallinckrodt.com or call 1-800-778-7898

960B00-P

Mallinckrodt™

This Medication Guide has been approved by the U.S. Food and Drug Administration. 

Issued: 12/2016

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