Oxecta

Included as part of the PRECAUTIONS section.

• 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.

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

Oxecta is an immediate-release oral formulation of oxycodone HCl indicated for the management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate.

Oxecta is supplied as white, debossed tablets in two strengths, 5 mg and 7.5 mg of oxycodone HCl, USP, as noted below.

Clinical Studies

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Serious adverse reactions that may be associated with Oxecta include: respiratory depression, respiratory arrest, circulatory depression, cardiac arrest, hypotension, and/or shock [see WARNINGS AND PRECAUTIONS (5) and OVERDOSAGE (10)].

The common adverse reactions seen on initiation of therapy with Oxecta are dose-dependent, and their frequency depends on the clinical setting, the patient's level of opioid tolerance, and host factors specific to the individual. They should be expected and managed as a part of opioid therapy. The most frequent of the adverse reactions include nausea, constipation, vomiting, headache, and pruritus.

The frequency of adverse reactions during initiation of opioid therapy may be minimized by careful individualization of starting dosage, slow titration and the avoidance of large rapid swings in plasma concentration of the opioid. Many of these adverse reactions will abate as therapy is continued and some degree of tolerance is developed, but others may be expected to remain throughout therapy.

In all patients for whom dosing information was available (n=191) from open-label and double-blind studies involving oxycodone, the following adverse reactions were recorded in oxycodone-treated patients with an incidence of ≥3%. In descending order of frequency they were: nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence.

The following adverse reactions occurred in less than 3% of patients involved in clinical trials with oxycodone:

Body as a Whole: abdominal pain, accidental injury, allergic reaction, back pain, chills and fever, fever, flu syndrome, infection, neck pain, pain, photosensitivity reaction, and sepsis.

Cardiovascular: deep vein thrombophlebitis, heart failure, hemorrhage, hypotension, migraine, palpitation, and tachycardia.

Digestive: anorexia, diarrhea, dyspepsia, dysphagia, gingivitis, glossitis, and nausea and vomiting.

Hematopoietic and Lymphatic: anemia and leukopenia.

Metabolism and Nutrition: edema, gout, hyperglycemia, iron deficiency anemia, and peripheral edema.

Musculoskeletal: arthralgia, arthritis, bone pain, myalgia, and pathological fracture.

Nervous System: agitation, anxiety, confusion, dry mouth, hypertonia, hypesthesia, nervousness, neuralgia, personality disorder, tremor, and vasodilation.

Respiratory: bronchitis, cough increased, dyspnea, epistaxis, laryngismus, lung disorder, pharyngitis, rhinitis, and sinusitis.

Skin and Appendages: herpes simplex, rash, sweating, and urticaria.

Special Senses: amblyopia.

Urogenital: urinary tract infection.

Pregnancy

Teratogenic Effects: Pregnancy Category B: There are no adequate and well-controlled studies of oxycodone use during pregnancy. Based on limited human data in the literature, oxycodone does not appear to increase the risk of congenital malformations. Animal reproduction studies have not revealed evidence of teratogenicity or fetal harm. Because animal reproduction studies are not always predictive of human response, Oxecta should be used during pregnancy only if clearly needed.

Reproduction studies in Sprague-Dawley rats and New Zealand rabbits revealed that when oxycodone was administered orally at doses up to 16 mg/kg and 25 mg/kg (approximately 2 and 5 times the daily oral dose of 90 mg on a mg/m2 basis) respectively, it was not teratogenic or embryo-fetal toxic.

Non-teratogenic Effects

Neonates whose mothers have taken oxycodone chronically may exhibit respiratory depression and/or withdrawal symptoms, either at birth and/or in the nursery.

Labor and Delivery

Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. Oxecta is not recommended for use in women during or immediately prior to labor. Occasionally, opioid analgesics may prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. Neonates, whose mothers received opioid analgesics during labor, must be observed closely for signs of respiratory depression. A specific narcotic antagonist, naloxone, must be available for reversal of narcotic-induced respiratory depression in the neonate.

Nursing Mothers

Low levels of oxycodone have been detected in maternal milk. The amount of oxycodone delivered to the infant depends on the plasma concentration of the mother, the amount of milk ingested by the infant, and the extent of first-pass metabolism. There is potential for serious adverse reactions in nursing infants from oxycodone that includes respiratory depression, sedation and potentially withdrawal symptoms when the mother stops taking oxycodone HCl. As such, one should consider either discontinuing nursing or discontinuing the drug, while taking into account the importance of the drug to the mother.

Pediatric Use

The safety, effectiveness, and pharmacokinetics of Oxecta in pediatric patients below the age of 18 have not been established.

Geriatric Use

Elderly patients (aged 65 years or older) may have increased sensitivity to Oxecta. Use caution when selecting a dose for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, concomitant disease, and use of other drug therapy.

Hepatic Impairment

Since oxycodone is extensively metabolized in the liver, its clearance may decrease in patients with hepatic impairment. Follow a conservative approach to initiate dosing in patients with hepatic impairment. Monitor patients closely and adjust the dose based on clinical response [see DOSAGE AND ADMINISTRATION (2.2)].

Renal Impairment

Information from oxycodone HCl indicates that patients with renal impairment (defined as a creatinine clearance <60 mL/min) had higher plasma concentrations of oxycodone than subjects with normal renal function. Use a conservative approach to initiate dosing in patients with renal impairment. Monitor patients closely and adjust the dose based on clinical response [see DOSAGE AND ADMINISTRATION (2.2)].

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

Oxecta can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never take this medicine in larger amounts, or for longer than prescribed.

Oxecta 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.

Tell your doctor if you are pregnant. Oxycodone may cause life-threatening withdrawal symptoms in a newborn.

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with oxycodone.

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

Call your doctor at once if you have:

• shallow breathing, slow heartbeat, cold, clammy skin;

• seizure (convulsions);

• confusion, severe drowsiness;

• infertility, missed menstrual periods;

• impotence, sexual problems, loss of interest in sex;

• a light-headed feeling, like you might pass out; or

• low cortisol levels - nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Oxycodone is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common Oxecta side effects may include:

• drowsiness, headache, dizziness, tired feeling;

• stomach pain, nausea, vomiting, constipation, loss of appetite;

• dry mouth; or

• mild itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to 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 Oxecta) 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