Oxyfast

Oxyfast 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 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.

Oxycodone can cause serious breathing problems that can become life-threatening, especially if oxycodone 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

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.

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.

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.

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

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 use of this medication. The importance of the drug to the mother should be considered.

In the U.S.

• Dazidox
• Eth-Oxydose
• Oxaydo
• OxyCONTIN
• OxyCONTIN CR
• Oxydose
• Oxyfast
• Oxy IR
• Roxicodone
• Roxicodone Intensol
• Roxybond
• Xtampza ER

Available Dosage Forms:

• Capsule, Extended Release
• Tablet, Extended Release
• Tablet
• Capsule
• Solution

Therapeutic Class: Analgesic

Chemical Class: Opioid

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

It is very important that your doctor check your progress while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

Do not use this medicine if you are using or have used an MAO inhibitor within the past 14 days.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Do not use more of this medicine or take it more often than your doctor tells you to. This can be life-threatening. Symptoms of an overdose include extreme dizziness or weakness, slow heartbeat or breathing, seizures, trouble breathing, and cold, clammy skin. Call your doctor right away if you notice these symptoms.

This medicine will add to the effects of alcohol and other CNS depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop using this medicine. Check with your doctor before taking any of these medicines while you are using this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness.

This medicine may make you dizzy, drowsy, or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

If you have been using this medicine regularly for several weeks or longer, do not change your dose or suddenly stop using it without checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble sleeping.

Using this medicine while you are pregnant may cause serious unwanted effects in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

• 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

• 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

• 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:

• 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:

• Difficulty having a bowel movement (stool)
• drowsiness
• lack or loss of strength
• relaxed and calm feeling
• sleepiness or unusual drowsiness

• 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

• 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.

Applies to oxycodone: oral capsule, oral capsule extended release, oral solution, oral tablet, oral tablet extended release

Along with its needed effects, oxycodone (the active ingredient contained in Oxyfast) 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 while taking oxycodone:

• 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

• 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

• 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 while taking oxycodone:

• 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 of oxycodone 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:

• Difficulty having a bowel movement (stool)
• drowsiness
• lack or loss of strength
• relaxed and calm feeling
• sleepiness or unusual drowsiness

• 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

• 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

Applies to oxycodone: compounding powder, oral capsule, oral capsule extended release, oral concentrate, oral solution, oral tablet, oral tablet extended release

General

The most commonly reported adverse reactions in adults included constipation, nausea, somnolence, dizziness, vomiting, pruritus, headache, dry mouth, asthenia, and sweating. In pediatric patients, the most frequently observed adverse reactions included vomiting, nausea, headache, pyrexia, and constipation.[Ref]

Nervous system

Very common (10% or more): Headache (14%, pediatrics)
Common (1% to 10%): Dizziness (pediatrics)
Frequency not reported: Confusion, hypertonia, hypesthesia, nervousness, neuralgia, personality disorder, tremor, migraine
Postmarketing reports: Serotonin syndrome[Ref]

Respiratory

Severe adverse effects such as respiratory depression can be treated with the opioid antagonist naloxone.[Ref]

Frequency not reported: Apnea, respiratory arrest, bronchitis, cough increased, dyspnea, epistaxis, laryngismus, lung disorder, pharyngitis, rhinitis, sinusitis[Ref]

Gastrointestinal

Very common (10% or more): Nausea (23% to 27%), constipation (23% to 26%), vomiting (12% to 14%)
Frequency not reported: Abdominal pain, anorexia, diarrhea, dyspepsia, dysphagia, gingivitis, glossitis[Ref]

In pediatric studies with the oral extended release product, gastrointestinal adverse events were reported in 40% of patients 11 to 16 years of age (56 of 140); vomiting, nausea, constipation, and diarrhea were experienced by 21%, 15%, 9%, and 6%, respectively. Abdominal pain and gastroesophageal reflux disease were reported in 1% to less than 5% of patients.[Ref]

Psychiatric

Frequency not reported: Paranoia, psychosis, hallucinations, agitation, anxiety[Ref]

Dermatologic

Common (1% to 10%): Pruritus, hyperhidrosis, rash
Frequency not reported: Herpes simplex, rash, sweating, urticaria[Ref]

Hepatic

Frequency not reported: Increased hepatic enzymes

Cardiovascular

Frequency not reported: QTc prolongation at higher doses, deep thrombophlebitis, heart failure, hemorrhage, hypotension, palpitation, tachycardia, edema, peripheral edema, vasodilation, circulatory collapse[Ref]

Genitourinary

Common (1% to 10%): Dysuria, urinary retention
Frequency not reported: Urinary tract infection[Ref]

Hypersensitivity

Frequency not reported: Allergic reaction
Postmarketing reports: Anaphylaxis[Ref]

Immunologic

Frequency not reported: Flu syndrome, infection, sepsis[Ref]

Metabolic

Common (1% to 10%): Decreased appetite (pediatrics)
Frequency not reported: Gout, hyperglycemia, iron deficiency anemia[Ref]

Musculoskeletal

Frequency not reported: Back pain, neck pain, arthralgia, arthritis, bone pain, myalgia, pathological fracture[Ref]

Ocular

Frequency not reported: Photosensitivity reaction, amblyopia[Ref]

Other

Very common (10% or more): Pyrexia (11%, pediatrics)
Frequency not reported: Chills and fever, accidental injury[Ref]

Endocrine

Opioids:
Postmarketing reports: Adrenal insufficiency, androgen deficiency[Ref]

Some side effects of Oxyfast may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.