Oxycodone and naloxone (Oral)

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Oxycodone and naloxone (Oral)
Oxycodone and naloxone (Oral)

Hovevn Health chia sẻ các bài viết về: Oxycodone và naloxone (uống), tác dụng phụ – liều lượng, Oxycodone và naloxone (uống) điều trị bệnh gì. Vui lòng tham khảo các chi tiết dưới đây.

ox-i-KOE-xong hye-droe-KLOR-ide, nal-OX-one hye-droe-KLOR-ide

Đường uống (Máy tính bảng, Phát hành mở rộng)

Nghiện, Lạm dụng và MisuseOxycodone và naloxone ER khiến bệnh nhân và những người dùng khác gặp nguy cơ nghiện opioid, lạm dụng và lạm dụng, có thể dẫn đến quá liều và tử vong. Đánh giá nguy cơ của từng bệnh nhân trước khi kê toa oxycodone và naloxone ER và theo dõi tất cả bệnh nhân thường xuyên để phát triển các hành vi và điều kiện này. Chiến lược đánh giá và giảm thiểu rủi ro giảm đau (REMS) Để đảm bảo rằng lợi ích của thuốc giảm đau opioid và sử dụng sai mục đích, Cơ quan Quản lý Thực phẩm và Dược phẩm Hoa Kỳ (FDA) đã yêu cầu NHỚ cho các sản phẩm này. Theo yêu cầu của REMS, các công ty dược phẩm với các sản phẩm giảm đau opioid được phê duyệt phải cung cấp các chương trình giáo dục tuân thủ REMS cho các nhà cung cấp dịch vụ chăm sóc sức khỏe. Các nhà cung cấp dịch vụ chăm sóc sức khỏe được khuyến khích: hoàn thành chương trình giáo dục tuân thủ REMS, tư vấn cho bệnh nhân và / hoặc người chăm sóc của họ, với mỗi đơn thuốc, sử dụng an toàn, rủi ro nghiêm trọng, lưu trữ và thải bỏ các sản phẩm này, nhấn mạnh tầm quan trọng của bệnh nhân và người chăm sóc đọc Hướng dẫn sử dụng thuốc mỗi khi dược sĩ của họ cung cấp và xem xét các công cụ khác để cải thiện an toàn cho bệnh nhân, hộ gia đình và cộng đồng. Suy hô hấp đe dọa có thể xảy ra khi sử dụng oxycodone và naloxone ER. Theo dõi tình trạng suy hô hấp, đặc biệt là khi bắt đầu sử dụng oxycodone và naloxone ER hoặc sau khi tăng liều. Hướng dẫn bệnh nhân nuốt cả viên thuốc oxycodone và naloxone ER; nghiền, nhai hoặc hòa tan viên nén oxycodone và naloxone ER có thể gây ra sự giải phóng và hấp thu nhanh chóng một liều oxycodone có khả năng gây tử vong. Nuốt phải vô tình Việc nuốt phải một liều oxycodone và naloxone ER, đặc biệt là ở trẻ em, có thể dẫn đến quá liều oxycodone gây tử vong. – Điều trị nếu không được công nhận và điều trị, và yêu cầu quản lý theo các giao thức được phát triển bởi các chuyên gia sơ sinh. Nếu việc sử dụng opioid là cần thiết trong một thời gian dài ở phụ nữ mang thai, hãy thông báo cho bệnh nhân về nguy cơ mắc hội chứng cai nghiện opioid ở trẻ sơ sinh và đảm bảo sẽ có phương pháp điều trị thích hợp. Tương tác với P450 3A4 Sử dụng đồng thời oxycodone và naloxone ER Các chất ức chế có thể dẫn đến sự gia tăng nồng độ oxycodone trong huyết tương, có thể làm tăng hoặc kéo dài tác dụng phụ của thuốc và có thể gây ức chế hô hấp có thể gây tử vong. Ngoài ra, việc ngừng sử dụng thuốc cảm ứng cytochrom P450 3A4 được sử dụng đồng thời có thể dẫn đến sự gia tăng nồng độ oxycodone trong huyết tương. Theo dõi bệnh nhân đang sử dụng oxycodone và naloxone ER và bất kỳ chất ức chế hoặc chất gây cảm ứng CYP3A4 nào. Việc sử dụng đồng thời với Benzodiazepin hoặc các thuốc ức chế thần kinh trung ương khác Việc sử dụng opioid với thuốc ức chế hệ thần kinh trung ương (CNS) có thể gây trầm cảm , hôn mê và tử vong. Dự trữ đồng thời kê đơn oxycodone và naloxone giải phóng kéo dài và các thuốc nhóm benzodiazepin hoặc thuốc ức chế thần kinh trung ương khác để sử dụng ở những bệnh nhân không có lựa chọn điều trị thay thế. Giới hạn liều lượng và thời lượng đến mức tối thiểu cần thiết. Theo dõi bệnh nhân về các dấu hiệu và triệu chứng của suy hô hấp và an thần.

Holevn.org xem xét y tế. Cập nhật lần cuối vào ngày 3 tháng 11 năm 2019.

Tên thương hiệu thường được sử dụng

Tại Hoa Kỳ

  • Targiniq ER

Ở Canada

  • Targin

Lớp dược lý: Naloxone

Lớp hóa học: Oxycodone

Sử dụng cho oxycodone và naloxone

Sự kết hợp Oxycodone và naloxone được sử dụng để điều trị cơn đau đủ nghiêm trọng để điều trị opioid hàng ngày, suốt ngày, và khi các thuốc giảm đau khác không hoạt động đủ tốt hoặc không thể dung nạp được.

Oxycodone thuộc nhóm thuốc gọi là thuốc giảm đau gây nghiện (thuốc giảm đau). Nó hoạt động trên hệ thống thần kinh trung ương (CNS) để giảm đau. Naloxone được sử dụng để điều trị cấp cứu opioid như quá liều hoặc quá liều có thể của thuốc gây nghiện.

Không nên sử dụng kết hợp Oxycodone và naloxone nếu bạn cần dùng thuốc giảm đau chỉ trong một thời gian ngắn, chẳng hạn như khi hồi phục sau phẫu thuật. Không sử dụng oxycodone và naloxone để giảm đau nhẹ, hoặc trong các tình huống khi thuốc không gây nghiện có hiệu quả. Oxycodone và naloxone không nên được sử dụng để điều trị cơn đau mà bạn chỉ thỉnh thoảng mới có hoặc “khi cần thiết”.

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 oxycodone and naloxone 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 oxycodone and naloxone, or give you special instructions about the use of food, alcohol, or tobacco.

  • Ethanol
  • Grapefruit Juice

Other medical problems

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

  • Adrenal problems or
  • Alcohol abuse, or history of or
  • Brain tumor, history of or
  • Breathing problems (eg, hypoxia) or
  • Chronic obstructive pulmonary disease (COPD) or
  • Cor pulmonale (serious heart condition) or
  • Depression or
  • Drug dependence, especially with narcotics, or history of or
  • Gallbladder disease or gallstones or
  • Head injuries, history of or
  • Weakened physical condition—Use with caution. May increase risk for more serious side effects.
  • Asthma, acute or severe or
  • Liver disease, moderate to severe or
  • Respiratory depression (very slow breathing) or
  • Stomach or bowel blockage (eg, paralytic ileus), known or suspected—Should not be used in patients with these conditions.
  • Hypotension (low blood pressure) or
  • Pancreatitis (swelling of the pancreas) or
  • Seizures, history of—Use with caution. May make these conditions worse.
  • Kidney disease or
  • Liver disease, mild—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper use of oxycodone and naloxone

Take oxycodone and naloxone 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 oxycodone and naloxone is taken for a long time, it may become habit-forming (causing mental or physical dependence).

It is very important that you understand the rules of the Opioid Analgesic REMS program to prevent addiction, abuse, and misuse of oxycodone. Oxycodone and naloxone should also come with a Medication Guide. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions.

Swallow the extended-release tablet whole. Do not break, crush, cut, chew, or dissolve it.

Dosing

The dose of oxycodone and naloxone 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 oxycodone and naloxone. 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 tablets):
      • For moderate to severe pain:
        • Patients who are not taking narcotic medicines:
          • Adults—At first, 10 milligrams (mg) of oxycodone and 5 mg of naloxone every 12 hours. Your doctor may adjust your dose as needed.
          • Children—Use and dose must be determined by your doctor.
        • Patients who are taking regular oxycodone:
          • Adults—The tablet is given every 12 hours. The total amount of milligrams (mg) per day is half of the total amount of regular oxycodone that is taken per day. The total amount per day will be given as 2 divided doses during the day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 80 mg of oxycodone and 40 mg of naloxone per day.
          • Children—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 given as 2 divided doses during the day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 80 mg of oxycodone and 40 mg of naloxone per day.
          • Children—Use and dose must be determined by your doctor.

    Missed dose

    If you miss a dose of oxycodone and naloxone, 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.

    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.

    Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm

    Precautions while using oxycodone and naloxone

    It is very important that your doctor check your progress while you are using oxycodone and naloxone, especially within the first 24 to 72 hours of treatment. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

    Do not use oxycodone and naloxone if you have used an MAO inhibitor (MAOI) (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.

    Oxycodone and naloxone may cause a serious type of allergic reaction called anaphylaxis, which 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 naloxone.

    Do not use more of oxycodone and naloxone 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 naloxone 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 naloxone.

    Oxycodone and naloxone 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 naloxone may make you dizzy, drowsy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how oxycodone and naloxone affects you.

    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 naloxone 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 oxycodone and naloxone while you are pregnant may cause serious unwanted effects, including neonatal opioid withdrawal syndrome 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 naloxone.

    For nursing mothers taking Belbuca®:

    • Talk to your doctor if you have any questions about taking oxycodone and naloxone combination or about how oxycodone and naloxone may affect your baby.
    • Call your doctor if you become extremely tired and have difficulty caring for your baby.
    • Your baby should generally nurse every 2 to 3 hours and should not sleep for more than 4 hours at a time.
    • Check with your doctor or hospital emergency room immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention.

    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.

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

    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.

    Oxycodone and naloxone 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:

    Incidence not known

    • Agitation
    • blurred vision
    • confusion
    • cough
    • darkening of the skin
    • diarrhea
    • difficult or troubled breathing
    • difficulty swallowing
    • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
    • fast heartbeat
    • fever
    • hives, itching, skin rash
    • irregular, fast or slow, or shallow breathing
    • loss of appetite
    • mental depression
    • nausea
    • overactive reflexes
    • pale or blue lips, fingernails, or skin
    • poor coordination
    • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    • restlessness
    • seizures
    • shivering
    • sweating
    • talking or acting with excitement you cannot control
    • tightness in the chest
    • trembling or shaking
    • twitching
    • unusual tiredness or weakness
    • vomiting

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

    Symptoms of overdose

    • Bigger, dilated, or enlarged pupils (black part of the eye)
    • change in consciousness
    • chest pain or discomfort
    • cold, clammy skin
    • coughing that sometimes produces a pink frothy sputum
    • decreased awareness or responsiveness
    • difficult, fast, noisy breathing
    • increased sensitivity of the eyes to light
    • increased sweating
    • loss of consciousness
    • severe sleepiness
    • sleepiness or unusual drowsiness
    • slow or irregular heartbeat
    • swelling in the legs and ankles

    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:

    Less common

    • Back pain
    • difficulty having a bowel movement
    • difficulty with moving
    • fear or nervousness
    • feeling of warmth
    • headache
    • muscle pain or stiffness
    • pain in the joints
    • redness of the face, neck, arms, and occasionally, upper chest
    • stomach pain
    • sudden sweating
    • trouble sleeping

    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.

    Further information

    Reference from: https://www.drugs.com/cons/oxycodone-and-naloxone.html

  • Chlordiazepoxide
  • Chlorpheniramine
  • Chlorpromazine
  • Chlorzoxazone
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clobazam
  • Clomipramine
  • Clonazepam
  • Clopidogrel
  • Clorazepate
  • Clozapine
  • Cobicistat
  • Cocaine
  • Codeine
  • Conivaptan
  • Crizotinib
  • Cyclobenzaprine
  • Cyclosporine
  • Darunavir
  • Delavirdine
  • Desipramine
  • Desmopressin
  • Desvenlafaxine
  • Dexamethasone
  • Dexmedetomidine
  • Dextroamphetamine
  • Dextromethorphan
  • Dezocine
  • Diazepam
  • Dibenzepin
  • Dichloralphenazone
  • Difenoxin
  • Dihydrocodeine
  • Diltiazem
  • Diphenhydramine
  • Diphenoxylate
  • Dolasetron
  • Donepezil
  • Doxepin
  • Doxylamine
  • Dronedarone
  • Droperidol
  • Duloxetine
  • Efavirenz
  • Eletriptan
  • Enflurane
  • Enzalutamide
  • Erdafitinib
  • Erythromycin
  • Escitalopram
  • Esketamine
  • Eslicarbazepine Acetate
  • Estazolam
  • Eszopiclone
  • Ethchlorvynol
  • Ethopropazine
  • Ethylmorphine
  • Etravirine
  • Fentanyl
  • Flibanserin
  • Fluconazole
  • Fluoxetine
  • Fluphenazine
  • Flurazepam
  • Fluspirilene
  • Fluvoxamine
  • Fosamprenavir
  • Fosaprepitant
  • Fosnetupitant
  • Fosphenytoin
  • Fospropofol
  • Frovatriptan
  • Furazolidone
  • Gabapentin
  • Gabapentin Enacarbil
  • Granisetron
  • Halazepam
  • Haloperidol
  • Halothane
  • Hexobarbital
  • Hydrocodone
  • Hydromorphone
  • Hydroxytryptophan
  • Hydroxyzine
  • Idelalisib
  • Imatinib
  • Imipramine
  • Indinavir
  • Iproniazid
  • Isocarboxazid
  • Isoflurane
  • Itraconazole
  • Ivacaftor
  • Ketamine
  • Ketazolam
  • Ketobemidone
  • Ketoconazole
  • Lanreotide
  • Lasmiditan
  • Lefamulin
  • Levomilnacipran
  • Levorphanol
  • Linezolid
  • Lisdexamfetamine
  • Lithium
  • Lofepramine
  • Lofexidine
  • Lomitapide
  • Lopinavir
  • Lorazepam
  • Lorcaserin
  • Lorlatinib
  • Loxapine
  • Lumacaftor
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  • Melperone
  • Meperidine
  • Mephobarbital
  • Meprobamate
  • Meptazinol
  • Mesoridazine
  • Metaxalone
  • Methadone
  • Methamphetamine
  • Methdilazine
  • Methocarbamol
  • Methohexital
  • Methotrimeprazine
  • Methylene Blue
  • Methylnaltrexone
  • Metoclopramide
  • Mibefradil
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  • Mifepristone
  • Milnacipran
  • Mirtazapine
  • Mitotane
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  • Modafinil
  • Molindone
  • Moricizine
  • Morphine
  • Morphine Sulfate Liposome
  • Nafcillin
  • Nalbuphine
  • Naldemedine
  • Nalorphine
  • Naloxegol
  • Naloxone
  • Naratriptan
  • Nefazodone
  • Nelfinavir
  • Netupitant
  • Nevirapine
  • Nialamide
  • Nicomorphine
  • Nilotinib
  • Nitrazepam
  • Nitrous Oxide
  • Nortriptyline
  • Olanzapine
  • Ondansetron
  • Opipramol
  • Opium
  • Opium Alkaloids
  • Orphenadrine
  • Oxazepam
  • Oxcarbazepine
  • Oxycodone
  • Oxymorphone
  • Palbociclib
  • Palonosetron
  • Papaveretum
  • Paregoric
  • Paroxetine
  • Pentazocine
  • Pentobarbital
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  • Perazine
  • Periciazine
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  • Phenobarbital
  • Phenytoin
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  • Pipotiazine
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  • Pregabalin
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  • Rifampin
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  • Ritonavir
  • Rizatriptan
  • Samidorphan
  • Saquinavir
  • Scopolamine
  • 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
  • Verapamil
  • Vilazodone
  • Voriconazole
  • Vortioxetine
  • Voxelotor
  • Zaleplon
  • Ziprasidone
  • Zolmitriptan
  • Zolpidem
  • Zopiclone
  • Zotepine

Using oxycodone and naloxone 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.

  • Clonidine
  • St John’s Wort
  • Yohimbine

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 oxycodone and naloxone 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 oxycodone and naloxone, or give you special instructions about the use of food, alcohol, or tobacco.

  • Ethanol
  • Grapefruit Juice

Other medical problems

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

  • Adrenal problems or
  • Alcohol abuse, or history of or
  • Brain tumor, history of or
  • Breathing problems (eg, hypoxia) or
  • Chronic obstructive pulmonary disease (COPD) or
  • Cor pulmonale (serious heart condition) or
  • Depression or
  • Drug dependence, especially with narcotics, or history of or
  • Gallbladder disease or gallstones or
  • Head injuries, history of or
  • Weakened physical condition—Use with caution. May increase risk for more serious side effects.
  • Asthma, acute or severe or
  • Liver disease, moderate to severe or
  • Respiratory depression (very slow breathing) or
  • Stomach or bowel blockage (eg, paralytic ileus), known or suspected—Should not be used in patients with these conditions.
  • Hypotension (low blood pressure) or
  • Pancreatitis (swelling of the pancreas) or
  • Seizures, history of—Use with caution. May make these conditions worse.
  • Kidney disease or
  • Liver disease, mild—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper use of oxycodone and naloxone

Take oxycodone and naloxone 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 oxycodone and naloxone is taken for a long time, it may become habit-forming (causing mental or physical dependence).

It is very important that you understand the rules of the Opioid Analgesic REMS program to prevent addiction, abuse, and misuse of oxycodone. Oxycodone and naloxone should also come with a Medication Guide. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions.

Swallow the extended-release tablet whole. Do not break, crush, cut, chew, or dissolve it.

Dosing

The dose of oxycodone and naloxone 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 oxycodone and naloxone. 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 tablets):
    • For moderate to severe pain:
      • Patients who are not taking narcotic medicines:
        • Adults—At first, 10 milligrams (mg) of oxycodone and 5 mg of naloxone every 12 hours. Your doctor may adjust your dose as needed.
        • Children—Use and dose must be determined by your doctor.
      • Patients who are taking regular oxycodone:
        • Adults—The tablet is given every 12 hours. The total amount of milligrams (mg) per day is half of the total amount of regular oxycodone that is taken per day. The total amount per day will be given as 2 divided doses during the day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 80 mg of oxycodone and 40 mg of naloxone per day.
        • Children—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 given as 2 divided doses during the day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 80 mg of oxycodone and 40 mg of naloxone per day.
        • Children—Use and dose must be determined by your doctor.

Missed dose

If you miss a dose of oxycodone and naloxone, 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.

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.

Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm

Precautions while using oxycodone and naloxone

It is very important that your doctor check your progress while you are using oxycodone and naloxone, especially within the first 24 to 72 hours of treatment. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

Do not use oxycodone and naloxone if you have used an MAO inhibitor (MAOI) (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.

Oxycodone and naloxone may cause a serious type of allergic reaction called anaphylaxis, which 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 naloxone.

Do not use more of oxycodone and naloxone 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 naloxone 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 naloxone.

Oxycodone and naloxone 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 naloxone may make you dizzy, drowsy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how oxycodone and naloxone affects you.

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 naloxone 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 oxycodone and naloxone while you are pregnant may cause serious unwanted effects, including neonatal opioid withdrawal syndrome 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 naloxone.

For nursing mothers taking Belbuca®:

  • Talk to your doctor if you have any questions about taking oxycodone and naloxone combination or about how oxycodone and naloxone may affect your baby.
  • Call your doctor if you become extremely tired and have difficulty caring for your baby.
  • Your baby should generally nurse every 2 to 3 hours and should not sleep for more than 4 hours at a time.
  • Check with your doctor or hospital emergency room immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention.

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.

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

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.

Oxycodone and naloxone 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:

Incidence not known

  • Agitation
  • blurred vision
  • confusion
  • cough
  • darkening of the skin
  • diarrhea
  • difficult or troubled breathing
  • difficulty swallowing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fast heartbeat
  • fever
  • hives, itching, skin rash
  • irregular, fast or slow, or shallow breathing
  • loss of appetite
  • mental depression
  • nausea
  • overactive reflexes
  • pale or blue lips, fingernails, or skin
  • poor coordination
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • restlessness
  • seizures
  • shivering
  • sweating
  • talking or acting with excitement you cannot control
  • tightness in the chest
  • trembling or shaking
  • twitching
  • unusual tiredness or weakness
  • vomiting

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

Symptoms of overdose

  • Bigger, dilated, or enlarged pupils (black part of the eye)
  • change in consciousness
  • chest pain or discomfort
  • cold, clammy skin
  • coughing that sometimes produces a pink frothy sputum
  • decreased awareness or responsiveness
  • difficult, fast, noisy breathing
  • increased sensitivity of the eyes to light
  • increased sweating
  • loss of consciousness
  • severe sleepiness
  • sleepiness or unusual drowsiness
  • slow or irregular heartbeat
  • swelling in the legs and ankles

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:

Less common

  • Back pain
  • difficulty having a bowel movement
  • difficulty with moving
  • fear or nervousness
  • feeling of warmth
  • headache
  • muscle pain or stiffness
  • pain in the joints
  • redness of the face, neck, arms, and occasionally, upper chest
  • stomach pain
  • sudden sweating
  • trouble sleeping

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.

Further information

Reference from: https://www.drugs.com/cons/oxycodone-and-naloxone.html

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