Oxycodone and naltrexone

Oxycodone and Naltrexone is part of the drug class:

• Natural opium alkaloids

This is not a complete list of Oxycodone and Naltrexonedrug interactions. Ask your doctor or pharmacist for more information.

In the U.S.

• Troxyca ER

Available Dosage Forms:

• Capsule, Extended Release

Therapeutic Class: Analgesic Combination, Opioid

Pharmacologic Class: Naltrexone

Chemical Class: Oxycodone

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

oxycodone and naltrexone 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 oxycodone and naltrexone.

Do not use more of oxycodone and naltrexone 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.

oxycodone and naltrexone will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or 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, including some dental anesthetics. Check with your doctor before taking any of these medicines while you are using oxycodone and naltrexone.

oxycodone and naltrexone 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.

oxycodone and naltrexone may make you dizzy, drowsy, or lightheaded. Make sure you know how you react to oxycodone and naltrexone 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 oxycodone and naltrexone 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 chills, runny nose, muscle pain, sweating, restlessness, or yawning.

Using oxycodone and naltrexone 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 oxycodone and naltrexone.

Talk with your doctor before using oxycodone and naltrexone if you plan to have children. Some men and women who use oxycodone and naltrexone have become infertile (unable to have children).

Make sure your doctor knows about all the other medicines you are using. oxycodone and naltrexone may cause a serious condition called serotonin syndrome when taken with certain medicines such as linezolid, mirtazapine, trazodone, MAO inhibitors, some pain medicines (eg, tramadol (Ultram®), sumatriptan (Imitrex®), zolmitriptan (Zomig®), or rizatriptan (Maxalt®). Check with your doctor first before taking any other medicines.

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.

• Naltrexone and Oxycodone
• Oxycodone Hydrochloride and Naltrexone Hydrochloride
• Troxyca ER

There are no dosage adjustments provided in the manufacturer’s labeling. Use with caution; monitor closely for signs of CNS or respiratory depression due to elevated levels of oxycodone and for signs of withdrawal due to elevated levels of naltrexone and adjust dose based on clinical response.

Pain relief; respiratory and mental status, blood pressure; constipation; signs of misuse, abuse, and addiction; signs or symptoms of hypogonadism or hypoadrenalism (Brennan 2013).

Chronic pain (long-term therapy outside of end-of-life or palliative care, active cancer treatment, sickle cell disease, or medication-assisted treatment for opioid use disorder): Evaluate benefits/risks of opioid therapy within 1 to 4 weeks of treatment initiation and with dose increases. Re-evaluate benefits/risks every 3 months during therapy or more frequently in patients at increased risk of overdose or opioid use disorder. Urine drug testing is recommended prior to initiation and re-checking should be considered at least yearly (includes controlled prescription medications and illicit drugs of abuse). State prescription drug monitoring program (PDMP) data should be reviewed by clinicians prior to initiation and periodically during therapy (frequency ranging from every prescription to every 3 months) (Dowell [CDC 2016]).

Applies to naltrexone / oxycodone: oral capsule extended release

General

The most frequently reported adverse effects have included nausea, constipation, vomiting, headache, and somnolence.[Ref]

Respiratory

Rhinorrhea, chronic bronchitis, dyspnea, and dysphonia were reported in less than 2% of patients.[Ref]

Common (1% to 10%): Oropharyngeal pain, cough
Frequency not reported: Rhinorrhea, chronic bronchitis, dyspnea, dysphonia[Ref]

Gastrointestinal

Dyspepsia was reported in less than 2% of patients.[Ref]

Very common (10% or more): Nausea (up to 20.5%), constipation (up to 14.9%)
Common (1% to 10%): Abdominal pain, diarrhea, dry mouth, nausea
Frequency not reported: Dyspepsia[Ref]

Hypersensitivity

Drug hypersensitivity was reported in less than 2% of patients. Anaphylaxis and pharyngeal edema have been reported with ingredients contained in this drug.[Ref]

Frequency not reported: Drug hypersensitivity
Postmarketing reports: Anaphylaxis, pharyngeal edema[Ref]

Cardiovascular

Common (1% to 10%): Peripheral edema
Frequency not reported: Tachycardia, palpitations, bradycardia, chest pain, increased blood pressure
Postmarketing reports: Myocardial ischemia, ventricular fibrillation (with oxycodone overdose)[Ref]

Tachycardia, palpitations, bradycardia, chest pain, and increased blood pressure were reported in less than 2% of patients.[Ref]

Psychiatric

Common (1% to 10%): Insomnia, depression, restlessness
Frequency not reported: Irritability, abnormal dreams, confusional state, disorientation, decreased libido, drug abuse[Ref]

Irritability, abnormal dreams, confusional state, disorientation, decreased libido, and drug abuse were reported in less than 2% of patients.[Ref]

Nervous system

Postmarketing reports of serotonin syndrome have been received among patients with concomitant use of opioids and serotonergic drugs.[Ref]

Common (1% to 10%): Dizziness, headache, hypoesthesia, somnolence, tremor
Postmarketing reports: Serotonin syndrome[Ref]

Dermatologic

Rash and urticaria were reported in less than 2% of patients.[Ref]

Common (1% to 10%): Hyperhidrosis, pruritus
Frequency not reported: Rash, urticaria[Ref]

Endocrine

Decreased blood testosterone was reported in less than 2% of patients.[Ref]

Frequency not reported: Decreased blood testosterone
Postmarketing reports: Adrenal insufficiency, androgen deficiency[Ref]

Genitourinary

Frequency not reported: Dysuria, hematuria[Ref]

Dysuria and hematuria were reported in less than 2% of patients.[Ref]

Hematologic

Anemia and lymphadenopathy were reported in less than 2% of patients.[Ref]

Frequency not reported: Anemia, lymphadenopathy[Ref]

Hepatic

Frequency not reported: Abnormal liver function test[Ref]

Abnormal liver function test was reported in less than 2% of patients.[Ref]

Metabolic

Frequency not reported: Decreased appetite, gout[Ref]

Decreased appetite and gout were reported in less than 2% of patients.[Ref]

Musculoskeletal

Myalgia, muscle twitching, musculoskeletal stiffness, and arthritis were reported in less than 2% of patients.[Ref]

Common (1% to 10%): Back pain, arthralgia, muscle spasms
Frequency not reported: Myalgia, muscle twitching, musculoskeletal stiffness, arthritis[Ref]

Ocular

Increased lacrimation was reported in less than 2% of patients.[Ref]

Frequency not reported: Increased lacrimation[Ref]

Other

Common (1% to 10%): Drug withdrawal syndrome, fatigue, hot flush
Frequency not reported: Vertigo, tinnitus, chills, pain, influenza like illness, pyrexia, malaise, intentional surgical and medical procedure misuse[Ref]

Vertigo, tinnitus, chills, pain, influenza like illness, pyrexia, malaise, and intentional surgical/medical procedure misuse were reported in less than 2% of patients.[Ref]

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

Advise pregnant women of the potential risk to fetus US FDA pregnancy category: Not assigned Risk Summary: Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal; there are no available data to inform a drug-associated risk for major birth defects and miscarriage. Comments: -Pregnant women should be advised of the risk of neonatal abstinence syndrome and ensure that appropriate treatment will be available. -Naltrexone may precipitate withdrawal in the fetus due to the immaturity of the fetal blood-brain barrier. -Long-acting opioids should not be used during and immediately prior to labor, when short acting analgesics or other analgesic techniques are more appropriate.

Animal studies with immediate-release oxycodone during organogenesis have not revealed evidence of teratogenicity or embryo-fetal toxicity; however published studies have shown neurobehavioral effects in rat pups at clinically relevant doses. Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. During clinical trials, plasma naltrexone levels were detectable in some patients receiving this combination drug, therefore, there is a possibility that naltrexone could precipitate withdrawal in a fetus due to the immaturity of the fetal blood-brain barrier. There are no adequate well-controlled studies with this combination drug in human pregnancies. Chronic opioid use may cause reduced fertility in males and females; it is not known whether these effects are reversible. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.