Buprenorphine and naloxone sublingual tablet is used to treat opioid (narcotic) dependence or addiction. Buprenorphine and naloxone buccal film, sublingual film, or sublingual tablet is used for induction and maintenance treatment of opioid (narcotic) dependence. It should be used in patients who have already been treated with buprenorphine sublingual tablets.

When a narcotic medicine is used for a long time, it may become habit-forming, causing mental or physical dependence. Physical dependence may lead to withdrawal side effects if the narcotic is stopped suddenly. Severe withdrawal side effects can usually be prevented when a person is switched to buprenorphine and naloxone combination. It acts on the central nervous system (CNS) to help prevent the withdrawal side effects.

This medicine is available only with your doctor’s prescription.

Before using buprenorphine/naloxone

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of buprenorphine and naloxone buccal film, sublingual film, or sublingual tablet in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of buprenorphine and naloxone combination in the elderly. However, elderly patients are more likely to have age-related kidney, liver, heart, or lung problems, which may require caution and an adjustment in the dose for patients receiving buprenorphine and naloxone combination.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bepridil
• Cisapride
• Dronedarone
• Fluconazole
• Ketoconazole
• Levoketoconazole
• Mesoridazine
• Nalmefene
• Naltrexone
• Pimozide
• Piperaquine
• Posaconazole
• Safinamide
• Samidorphan
• Saquinavir
• Sparfloxacin
• Terfenadine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acecainide
• Acepromazine
• Aclidinium
• Adagrasib
• Alfentanil
• Alfuzosin
• Almotriptan
• Alprazolam
• Amantadine
• Amiloride
• Amineptine
• Amiodarone
• Amisulpride
• Amitriptyline
• Amitriptylinoxide
• Amobarbital
• Amoxapine
• Amphetamine
• Amprenavir
• Anagrelide
• Anileridine
• Apalutamide
• Apomorphine
• Aprepitant
• Aripiprazole
• Aripiprazole Lauroxil
• Armodafinil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Atropine
• Azithromycin
• Baclofen
• Bedaquiline
• Belladonna
• Bemetizide
• Bendroflumethiazide
• Benperidol
• Bentazepam
• Benzhydrocodone
• Benzphetamine
• Benzthiazide
• Benztropine
• Biperiden
• Boceprevir
• Bosentan
• Bromazepam
• Bromopride
• Brompheniramine
• Bumetanide
• Bupropion
• Buserelin
• Buspirone
• Butabarbital
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Canrenoate
• Canrenone
• Carbamazepine
• Carbinoxamine
• Cariprazine
• Carisoprodol
• Carphenazine
• Cenobamate
• Ceritinib
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chloroquine
• Chlorothiazide
• Chlorpheniramine
• Chlorpromazine
• Chlorthalidone
• Chlorzoxazone
• Cimetidine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clemastine
• Clidinium
• Clobazam
• Clofazimine
• Clomipramine
• Clonazepam
• Clopamide
• Clopidogrel
• Clorazepate
• Clothiapine
• Cloxazolam
• Clozapine
• Cobicistat
• Cocaine
• Codeine
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Cyclopenthiazide
• Cyclopentolate
• Cyclosporine
• Cyclothiazide
• Cyproheptadine
• Dabrafenib
• Dantrolene
• Daridorexant
• Darifenacin
• Darunavir
• Dasatinib
• Degarelix
• Delamanid
• Delavirdine
• Delorazepam
• Desipramine
• Deslorelin
• Desmopressin
• Desvenlafaxine
• Deutetrabenazine
• Dexamethasone
• Dexmedetomidine
• Dextroamphetamine
• Dextromethorphan
• Dezocine
• Diacetylmorphine
• Diazepam
• Diazoxide
• Dibenzepin
• Dichloralphenazone
• Dicyclomine
• Difenoxin
• Diltiazem
• Dimenhydrinate
• Diphenhydramine
• Diphenoxylate
• Dipyrone
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Doxylamine
• Droperidol
• Duloxetine
• Duvelisib
• Ebastine
• Efavirenz
• Elagolix
• Eletriptan
• Encorafenib
• Enflurane
• Entrectinib
• Enzalutamide
• Eplerenone
• Eribulin
• Erythromycin
• Escitalopram
• Esketamine
• Eslicarbazepine Acetate
• Estazolam
• Eszopiclone
• Ethacrynic Acid
• Ethchlorvynol
• Ethopropazine
• Ethylmorphine
• Etozolin
• Etrasimod
• Etravirine
• Famotidine
• Felbamate
• Fenfluramine
• Fentanyl
• Fesoterodine
• Fexinidazole
• Fingolimod
• Flavoxate
• Flecainide
• Flibanserin
• Flunitrazepam
• Fluoxetine
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fluvoxamine
• Formoterol
• Fosamprenavir
• Fosaprepitant
• Foscarnet
• Fosnetupitant
• Fosphenytoin
• Fospropofol
• Fostemsavir
• Frovatriptan
• Furosemide
• Gabapentin
• Gabapentin Enacarbil
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Glycopyrrolate
• Glycopyrronium Tosylate
• Gonadorelin
• Goserelin
• Granisetron
• Halazepam
• Halofantrine
• Haloperidol
• Halothane
• Hexobarbital
• Histrelin
• Homatropine
• Hydrochlorothiazide
• Hydrocodone
• Hydroflumethiazide
• Hydromorphone
• Hydroquinidine
• Hydroxyamphetamine
• Hydroxychloroquine
• Hydroxytryptophan
• Hydroxyzine
• Hyoscyamine
• Ibutilide
• Idelalisib
• Iloperidone
• Imatinib
• Imipramine
• Indapamide
• Indinavir
• Inotuzumab Ozogamicin
• Ipratropium
• Isocarboxazid
• Isoflurane
• Itraconazole
• Ivabradine
• Ivacaftor
• Ivosidenib
• Josamycin
• Ketamine
• Ketazolam
• Ketobemidone
• Lacosamide
• Lapatinib
• Larotrectinib
• Lasmiditan
• Lefamulin
• Lemborexant
• Lenacapavir
• Lenvatinib
• Lesinurad
• Letermovir
• Leuprolide
• Levocetirizine
• Levofloxacin
• Levomilnacipran
• Levorphanol
• Linezolid
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lofexidine
• Lomitapide
• Lonafarnib
• Lopinavir
• Loprazolam
• Lorazepam
• Lorcaserin
• Lorlatinib
• Lormetazepam
• Loxapine
• Lumacaftor
• Lumefantrine
• Lurasidone
• Macimorelin
• Magnesium Oxybate
• Meclizine
• Medazepam
• Mefloquine
• Melitracen
• Melperone
• Mepenzolate
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Metaclazepam
• Metaxalone
• Methadone
• Methamphetamine
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methyclothiazide
• Methylene Blue
• Metoclopramide
• Metolazone
• Metronidazole
• Mibefradil
• Midazolam
• Mifepristone
• Milnacipran
• Mirtazapine
• Mitotane
• Mizolastine
• Mobocertinib
• Modafinil
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nafarelin
• Nafcillin
• Nalbuphine
• Naldemedine
• Naloxegol
• Naratriptan
• Nefazodone
• Nelfinavir
• Netupitant
• Nevirapine
• Nicomorphine
• Nilotinib
• Nitrazepam
• Nitrous Oxide
• Nordazepam
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Orphenadrine
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxazepam
• Oxcarbazepine
• Oxitropium Bromide
• Oxybutynin
• Oxycodone
• Oxymorphone
• Ozanimod
• Pacritinib
• Palbociclib
• Paliperidone
• Palonosetron
• Panobinostat
• Papaveretum
• Papaverine
• Paregoric
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenelzine
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pinazepam
• Pipamperone
• Pipenzolate Bromide
• Piperacetazine
• Pipotiazine
• Pirenzepine
• Piretanide
• Piritramide
• Pitolisant
• Polythiazide
• Ponesimod
• Potassium Oxybate
• Prazepam
• Prednisone
• Pregabalin
• Primidone
• Probucol
• Procainamide
• Procarbazine
• Prochlorperazine
• Procyclidine
• Promazine
• Promethazine
• Propafenone
• Propantheline
• Propiverine
• Propofol
• Protriptyline
• Quazepam
• Quetiapine
• Quinethazone
• Quinidine
• Quinine
• Quizartinib
• Ramelteon
• Ranitidine
• Ranolazine
• Rasagiline
• Relugolix
• Remifentanil
• Remimazolam
• Remoxipride
• Ribociclib
• Rifabutin
• Rifampin
• Rifapentine
• Risperidone
• Ritonavir
• Rizatriptan
• Ropeginterferon Alfa-2b-njft
• Schisandra sphenanthera
• Scopolamine
• Secobarbital
• Selegiline
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Sibutramine
• Siponimod
• Sodium Oxybate
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Spironolactone
• St John’s Wort
• Stramonium
• Sufentanil
• Sulpiride
• Sultopride
• Sumatriptan
• Sunitinib
• Suvorexant
• Tacrolimus
• Tamoxifen
• Tapentadol
• Telaprevir
• Telavancin
• Telithromycin
• Telotristat Ethyl
• Temazepam
• Terodiline
• Tetrabenazine
• Tetrazepam
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Thiothixene
• Tianeptine
• Tilidine
• Tiotropium
• Tizanidine
• Tolonium Chloride
• Tolterodine
• Topiramate
• Toremifene
• Torsemide
• Tramadol
• Tranylcypromine
• Trazodone
• Treosulfan
• Triamterene
• Triazolam
• Trichlormethiazide
• Triclabendazole
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trihexyphenidyl
• Trimeprazine
• Trimipramine
• Triptorelin
• Troleandomycin
• Tropicamide
• Trospium
• Tryptophan
• Tucatinib
• Umeclidinium
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Verapamil
• Vilanterol
• Vilazodone
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Vortioxetine
• Voxelotor
• Xipamide
• Zaleplon
• Ziprasidone
• Zolmitriptan
• Zolpidem
• Zopiclone
• Zotepine
• Zuclopenthixol
• Zuranolone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Clonidine
• 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 this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

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

• Addison disease (adrenal gland problem) or
• Alcohol abuse or dependence, or history of or
• Asthma, severe or
• Brain tumor, history of or
• Breathing problems, severe (eg, hypoxia, hypercapnia, sleep apnea) or
• Chronic obstructive pulmonary disease (COPD) or
• Cor pulmonale (serious heart condition) or
• Depression, history of or
• Drug abuse or dependence, especially with narcotics, or history of or
• Enlarged prostate (BPH, prostatic hypertrophy) or
• Gallbladder problems or
• Head injuries, history of or
• Heart disease (eg, angina, congestive heart failure) or
• Heart rhythm problems (eg, atrial fibrillation, slow heartbeat, long QT syndrome) or
• Hepatitis B or C, history of or
• Hypomagnesemia (low magnesium in the blood), severe or
• Hypothyroidism (an underactive thyroid) or
• Hypovolemia (low blood volume) or
• Increased pressure in the head or
• Kyphoscoliosis (curvature of the spine with breathing problems) or
• Mental health problems, history of or
• Problems with passing urine or
• Stomach problems—Use with caution. May increase risk for more serious side effects.

• Hypotension (low blood pressure)—Use with caution. May make this condition worse.
• Liver disease, moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
• Liver disease, severe—Should not be used in patients with this condition.

Proper use of buprenorphine/naloxone

Take this medicine exactly 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 medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

If you are using the buccal film:

• Use your tongue to wet the side of your cheek or rinse your mouth with water in the area where you will place the film.
• Do not cut or tear the film. Hold the film on a clean, dry finger. If you are using Bunavail®, hold with the text (BN2, BN4, or BN6) facing up.
• Place the side of the film against the inside of your cheek. If you are using Bunavail®, place with the text (BN2, BN4, or BN6) against the inside of your cheek.
• Press the film and hold it there for 5 seconds.
• Leave the film in place until it dissolves. Do not touch, move, chew, or swallow it.
• If you must use more than one film, place the second film on the other side of your mouth. Do not place more than 2 buccal films to the inside of one cheek at a time.
• Do not eat or drink anything until the film is completely dissolved.
• After the film has completely dissolved, take a sip of water, swish gently around your teeth and gums, and swallow. Wait at least one hour before brushing your teeth.

If you are using the sublingual tablet:

• Do not cut, crush, chew, or swallow it.
• Place the tablet under the tongue until it is dissolved.
• If you take 2 or more tablets at a time, place all of the tablets in different places under the tongue at the same time.
• If this is uncomfortable, place 2 tablets at a time under the tongue and repeat the process until all the tablets have been taken.
• Do not eat or drink anything until the tablets are completely dissolved.
• Rinse your mouth with water and swallow. Wait at least one hour before brushing your teeth.

If you are using the sublingual film:

• Drink water before taking this medicine to help moisten your mouth.
• Place the film under the tongue until it is dissolved.
• If you need to take an additional film, place the new film on the opposite side from the first film.
• Do not eat or drink anything until the film is completely dissolved.
• Do not cut, chew, swallow, or move the film after placing it under the tongue.
• After the film has completely dissolved, take a sip of water, swish gently around your teeth and gums, and swallow. Wait at least one hour before brushing your teeth.

Check with your doctor first before changing dosage forms (eg, films, tablets) or dosage strengths. These forms are very different from each other.

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 buccal dosage form (film):
  • For induction treatment of opioid dependence:
    • Adults—On Day 1, your doctor may give you an induction dosage up to 4.2 milligrams (mg) of buprenorphine and 0.7 mg of naloxone in divided doses. On Day 2, your doctor may give you up to 8.4 mg of buprenorphine and 1.4 mg of naloxone taken as a single dose. If you have been taking methadone, heroin, short-acting, or long-acting opioid medicines, your doctor may recommend you to take buprenorphine alone.
    • Children—Use and dose must be determined by your doctor.
  • For maintenance treatment of opioid dependence:
    • Adults—8.4 milligrams (mg) of buprenorphine and 1.4 mg of naloxone taken as a single dose once a day. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.
• For buccal or sublingual dosage form (film):
  • For induction treatment of opioid dependence:
    • Adults—On Day 1, your doctor may give you an induction dosage up to 8 milligrams (mg) of buprenorphine and 2 mg of naloxone in divided doses. On Day 2, your doctor may give you up to 16 mg of buprenorphine and 4 mg of naloxone taken as a single dose. If you have been taking methadone, heroin, short-acting, or long-acting opioid medicines, your doctor may recommend you to take buprenorphine alone.
    • Children—Use and dose must be determined by your doctor.
  • For maintenance treatment of opioid dependence:
    • Adults—16 milligrams (mg) of buprenorphine and 4 mg of naloxone taken as a single dose once a day. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.
• For sublingual dosage form (tablets):
  • For induction treatment of opioid dependence:
    • Adults—On Day 1, your doctor may give you an induction dosage up to 5.7 milligrams (mg) of buprenorphine and 1.4 mg of naloxone in divided doses. On Day 2, your doctor may give you up to 11.4 mg of buprenorphine and 2.9 mg of naloxone taken as a single dose. If you have been taking methadone, heroin, short-acting or long-acting opioid medicines, your doctor may recommend you take buprenorphine alone.
    • Children—Use and dose must be determined by your doctor.
  • For maintenance treatment of opioid dependence:
    • Suboxone®:
      • Adults—16 milligrams (mg) of buprenorphine and 4 mg of naloxone taken as a single dose once a day. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.
    • Zubsolv®:
      • Adults—11.4 milligrams (mg) of buprenorphine and 2.9 mg of naloxone taken as a single dose once a day. Your doctor may adjust your dose as 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.

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 buprenorphine/naloxone

It is very important that your doctor check your progress while you are using 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. Blood tests may be needed to check for unwanted effects.

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

It is against the law and dangerous for anyone else to use your medicine. Keep your unused films or tablets in a safe and secure place. People who are addicted to drugs might want to steal 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.

Using too much of this medicine may cause an overdose, which can be life-threatening. Symptoms of an overdose include: blurred vision, confusion, difficult or trouble breathing, dizziness, faintness, or lightheadedness when getting up suddenly from a lying position or sitting position, irregular, fast or slow, or shallow breathing, pale or blue lips, fingernails, or skin, pinpoint pupils, sleepiness, sweating, unusual tiredness or weakness. In case of an overdose, call your doctor right away. Your doctor may also give naloxone to treat an overdose.

This medicine may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.

This medicine may cause serious tooth problems. Tell your doctor right away if you have cavities, tooth decay, tooth pain, tooth infection, tooth erosion, tooth fracture, or tooth loss. Schedule regular dental checkups while taking this medicine.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine. Serious unwanted effects can occur if certain medicines are given together with buprenorphine and naloxone combination.

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, 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 the medicines listed above while you are using this medicine.

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. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Using this medicine while you are pregnant may cause neonatal opioid withdrawal syndrome in your newborn baby. Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or fails to gain weight.

This medicine may cause adrenal insufficiency. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

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

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.

Do not suddenly stop using it without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help reduce the possibility of withdrawal symptoms, including anxiety, fever, nausea, runny nose, stomach cramps, sweating, tremors, or trouble with sleeping.

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 this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine 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.

Side Effects of buprenorphine/naloxone

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:

More common

• Chills
• cough
• feeling faint, dizzy, or lightheaded
• feeling of warmth or heat
• fever
• flushing or redness of the skin, especially on the face and neck
• headache
• hoarseness
• lower back or side pain
• painful or difficult urination
• sweating

Incidence not known

• Agitation
• bloating or swelling of the face, arms, hands, lower legs, or feet
• chest tightness
• darkening of the skin
• diarrhea
• difficulty swallowing
• dizziness
• fainting
• fast heartbeat
• hives, itching, skin rash
• loss of appetite
• mental depression
• nausea
• overactive reflexes
• poor coordination
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• restlessness shivering talking or acting with excitement you cannot control
• tingling of the hands or feet
• toothache
• trembling or shaking twitching
• unusual weight gain or loss
• vomiting

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

Symptoms of overdose

• Blurred vision
• confusion
• difficult or trouble breathing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness
• irregular, fast, slow, or shallow breathing
• pale or blue lips, fingernails, or skin
• pinpoint pupils
• relaxed and calm feeling
• sleepiness
• unusual tiredness or weakness

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

More common

• Difficulty having a bowel movement
• lack or loss of strength
• stomach pain
• trouble sleeping

Less common

• Back pain
• diarrhea
• runny or stuffy nose
• sneezing

Incidence not known

• Burning or sore mouth
• burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings inside the mouth
• decline or loss of libido or sexual desire
• irritability
• mood swings
• poor concentration
• redness, swelling, or soreness of the tongue
• reduced muscle strength
• swelling, inflammation, or redness of the mouth

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

Commonly used brand name(s)

In the U.S.

• Cassipa
• Suboxone
• Zubsolv

Available Dosage Forms:

• Tablet
• Film

Bunavail buccal films contains a combination of buprenorphine and naloxone. Buprenorphine is an opioid medication, sometimes called a narcotic. Naloxone blocks the effects of opioid medication, including pain relief or feelings of well-being that can lead to opioid abuse.

Bunavail buccal films are used to treat opioid addiction.

Bunavail is not for use as a pain medication.

Warnings

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Using Bunavail during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use Bunavail with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Before taking this medicine

You should not use Bunavail if you are allergic to buprenorphine or naloxone (Narcan).

To make sure Bunavail is safe for you, tell your doctor if you have ever had:

• tooth problems, including a history of cavities;
• breathing problems, sleep apnea;
• enlarged prostate, urination problems;
• liver or kidney disease;
• abnormal curvature of the spine that affects breathing;
• problems with your gallbladder, adrenal gland, or thyroid;
• a head injury, brain tumor, or seizures; or
• alcoholism or drug addiction.

If you use Bunavail while you are pregnant, your baby could become dependent on this medicine. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.

Ask a doctor before using Bunavail if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

How should I take Bunavail?

Use Bunavail buccal films exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides. Never use Bunavail in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of this medicine.

Never share Bunavail with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine in a place where others cannot get to it. Selling or giving away Bunavail is against the law.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Rinse your mouth with water after the Bunavail film dissolves. Wait one hour after the medicine dissolves to brush your teeth to prevent damage to the teeth and gums. You should receive regular dental checkups while using Bunavail.

If you switch between medicines containing buprenorphine, you may not use the same dose for each one. Follow all directions carefully.

Do not stop using Bunavail suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

You will need frequent blood tests to check your liver function.

All your medical care providers should know that you are being treated for opioid addiction, and that you take Bunavail. Make sure your family members know how to provide this information in case they need to speak for you during an emergency.

Never crush or break a Bunavail pill to inhale the powder or mix it into a liquid to inject the drug into your vein. This practice has resulted in death.

Store Bunavail films in the foil pouch at room temperature, away from moisture and heat. Discard an empty pouch in a place children and pets cannot get to. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using Bunavail accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, remove any unused films from the foil pack and flush the films down the toilet. Throw the empty foil pack into the trash.

Dosing information

Usual Adult Dose for Opiate Dependence: Buprenorphine monotherapy is generally used for induction. Bunavail may be used for induction in patients dependent on heroin or short-acting opioid products. Note – one Bunavail 4.2 mg/0.7 mg buccal film provides the equivalent buprenorphine exposure to one Suboxone 8 mg/2 mg sublingual tablet.

INDUCTION dose: Day 1: Initial dose: 2.1 mg/0.3 mg buccally; followed in intervals of approximately 2 hours with additional doses to a total dose of 4.2 mg/0.7 mg to control acute withdrawal symptoms
Day 2: a single dose up to 8.4 mg/1.4 mg buccally.

MAINTENANCE Treatment: Doses should be adjusted to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms; doses should be titrated to clinical effectiveness as rapidly as possible as gradual titration may lead to higher drop-out rates.
-Progressively adjust in increments/decrements of 2.1 mg/0.3 mg to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms.
-Recommended target dose: 8.4 mg/1.4 mg buccally once a day; range 2.1 mg/0.3 mg to 12.6 mg/2.1 mg
Maximum dose: 12.6 mg/ 2.1 mg buccally once a day.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . An opioid overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

What should I avoid while taking Bunavail?

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or operating machinery until you know how Bunavail will affect you. Dizziness or severe drowsiness can cause falls, accidents, or severe injuries.

Buprenorphine and naloxone side effects

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

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once or seek emergency medical attention if you have:

• any problems with your teeth or gums;
• weak or shallow breathing, breathing that stops during sleep;
• a light-headed feeling, like you might pass out;
• confusion, loss of coordination, extreme weakness;
• blurred vision, slurred speech;
• liver problems – upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• high levels of serotonin in the body – agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea;
• low cortisol levels – nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
• opioid withdrawal symptoms – shivering, goose bumps, increased sweating, feeling hot or cold, runny nose, watery eyes, diarrhea, muscle pain.

Serious breathing problems may be more likely in older adults and those who are debilitated or have wasting syndrome or chronic breathing disorders.

Common Bunavail side effects may include:

• dizziness, drowsiness, blurred vision, feeling drunk, trouble concentrating;
• withdrawal symptoms;
• tongue pain, redness or numbness inside your mouth;
• nausea, vomiting, constipation;
• headache, back pain;
• fast or pounding heartbeats, increased sweating; or
• sleep problems (insomnia).

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

What other drugs will affect Bunavail?

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic (“water pill”);
• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
• other opioids – opioid pain medicine or prescription cough medicine;
• a sedative like Valium – diazepam, alprazolam, lorazepam, Xanax, Klonopin, Ativan, and others;
• drugs that make you sleepy or slow your breathing – a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or
• drugs that affect serotonin levels in your body – a stimulant, or medicine for depression, Parkinson’s disease, migraine headaches, serious infections, or nausea and vomiting.

What is hydrocodone and acetaminophen?

Hydrocodone and acetaminophen is a combination medicine used to relieve moderate to severe pain. Hydrocodone is an opioid pain reliever and cough suppressant that belongs to the group of medicines called narcotic analgesics, that work on the central nervous system. Acetaminophen is a non-opioid analgesic used for pain relief and to reduce fever. Acetaminophen is a less potent pain reliever that increases the effects of hydrocodone.

Hydrocodone and acetaminophen tablets have been marketed under the brand names Norco (discontinued), Vicodin  (discontinued), Lortab (discontinued), Hycet (discontinued), Lorcet (discontinued), Verdrocet (discontinued), Xodol (discontinued), Zamicet (discontinued) and now generic hydrocodone and acetaminophen products are available.

Is hydrocodone with acetaminophen a controlled substance?

Yes, hydrocodone with acetaminophen is a controlled substance. Under the Controlled Substances Act (CSA) hydrocodone (which includes hydrocodone with acetaminophen) is a schedule 2 controlled substance.  This means hydrocodone has a high potential for abuse, it currently has an accepted medical use which may include severe restrictions. Abuse may lead to severe psychological or physical dependence.

What strength is hydrocodone and acetaminophen tablets available as?

Examples of hydrocodone and acetaminophen tablets are:

• hydrocodone and acetaminophen 2.5mg/325mg tablets
• hydrocodone and acetaminophen 5mg/325mg tablets
• hydrocodone and acetaminophen 7.5mg/325mg tablets
• hydrocodone and acetaminophen 10mg/325mg tablets

Sometimes hydrocodone and acetaminophen strengths get abbreviated to hydrocodone acetaminophen 5-325 or hydrocodone acetaminophen 5 325, but is better to use the correct names and strengths (hydrocodone and acetaminophen 5mg/325mg tablets or hydrocodone 5mg and acetaminophen 325mg) to avoid confusion and dosing errors.

Warnings

MISUSE OF HYDROCODONE AND ACETAMINOPHEN CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in secure a place where others cannot get to it.

Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Acetaminophen and hydrocodone can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Taking opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing. See interactions section below for more information on drug interactions.

Tell your doctor if you drink more than three alcoholic beverages per day or if you have ever had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen.

Stop taking acetaminophen and hydrocodone and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Before taking this medicine

You should not use this medicine if you are allergic to acetaminophen or hydrocodone, or if you have:

• severe asthma or breathing problems; or
• a blockage in your stomach or intestines.

To make sure acetaminophen and hydrocodone is safe for you, tell your doctor if you have ever had:

• breathing problems, sleep apnea;
• liver disease;
• a drug or alcohol addiction;
• kidney disease;
• a head injury or seizures;
• urination problems; or
• problems with your thyroid, pancreas, or gallbladder.

Pregnancy

If you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.

Breastfeeding

Do not breastfeed. Acetaminophen and hydrocodone can pass into breast milk and cause drowsiness, breathing problems, or death in a nursing baby.

How should I take hydrocodone and acetaminophen?

Take hydrocodone and acetaminophen exactly as it was prescribed for you. Follow all directions on your prescription label. Never take hydrocodone and acetaminophen in larger amounts, or for longer than prescribed. An overdose can damage your liver or cause death. Tell your doctor if you feel an increased urge to use more of this medicine.

Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine in a place where others cannot get to it. Selling or giving away hydrocodone and acetaminophen is against the law.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

If you need surgery or medical tests, tell the doctor ahead of time that you are using this medicine.

You should not stop using this medicine suddenly. Follow your doctor’s instructions about tapering your dose.

Store acetaminophen and hydrocodone at room temperature away from moisture and heat. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

Dosage

Use: For the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Usual Adult Dose for Pain:

Hydrocodone 2.5 mg-acetaminophen 325 mg per tablet, Hydrocodone 5 mg-acetaminophen 325 mg per tablet

• Initial dose: 1 to 2 tablets every 4 to 6 hours as needed for pain
• Maximum dose: 8 tablets/24 hours

Hydrocodone 7.5 mg-acetaminophen 325 mg, Hydrocodone 10 mg-acetaminophen 325 mg per tablet:

• Initial dose: 1 tablet every 4 to 6 hours as needed for pain
• Maximum dose: 6 tablets/24 hours

Hydrocodone 7.5 mg-acetaminophen 325 mg per 15 mL oral solution:

• Initial dose: 15 mL every 4 to 6 hours as needed for pain
• Maximum dose: 90 mL/24 hours

Hydrocodone 10 mg-acetaminophen 300 mg per 15 mL oral solution:

• Initial dose: 11.25 mL every 4 to 6 hours as needed for pain
• Maximum dose: 67.5 mL/24 hours

Comments:

• Doses should be individually titrated to provide adequate analgesia while minimizing adverse reactions.
• Because of the risks of addiction, abuse and misuse, the lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.
• Monitor patients closely for respiratory depression within the first 24 to 72 hours of initiating therapy and following any increase in dose.

For more information on hydocodone/acetminophen doses for adults or children, or dosage adjustments required for medical conditions click on the link below.

What happens if I miss a dose?

Since this medicine is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . An overdose of acetaminophen and hydrocodone can be fatal.

Acute overdosage with hydrocodone and acetaminophen tablets can cause respiratory depression, sleepiness progressing to near-unconsciousness or coma, floppy muscles, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, slow heartbeat, low blood pressure, partial or complete airway obstruction, unusual snoring, and death. If the patient who has overdosed becomes very low in oxygen pupils may become very dilated instead of constricted pupils. 

Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don’t wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

What to avoid

• Avoid driving or operating machinery until you know how hydrocodone and acetaminophen will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.
• Do not drink alcohol. Dangerous side effects or death could occur.
• Ask a doctor or pharmacist before using any other medicine that may contain acetaminophen which is sometimes abbreviated as APAP and also known as paracetamol. Taking certain medications together with acetaminophen and hydrocodone can lead to a fatal overdose. 

Side effects of hydrocodone and acetaminophen

Common side effects of hydrocodone acetaminophen include:

• dizziness, drowsiness, feeling tired;
• nausea, vomiting, stomach pain;
• constipation; or headache.

Serious side effects of hydrocodone acetaminophen include:

Get emergency medical help if you have signs of an allergic reaction to acetaminophen and hydrocodone: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
• a light-headed feeling, like you might pass out;
• liver problems – nausea, upper stomach pain, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• low cortisol levels – nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
• high levels of serotonin in the body – agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea.

Serious breathing problems may be more likely in older adults and in those who are debilitated or have wasting syndrome or chronic breathing disorders.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

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 .

What other drugs will affect hydrocodone and acetaminophen?

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic (“water pill”);
• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
• other opioids – opioid pain medicine or prescription cough medicine;
• a sedative like Valium – diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;
• drugs that make you sleepy or slow your breathing – a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness;
• drugs that affect serotonin levels in your body – a stimulant, or medicine for depression, Parkinson’s disease, migraine headaches, serious infections, or nausea and vomiting.

What is hydrocodone and ibuprofen?

Hydrocodone is an opioid pain medicine. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). This combination medicine is used short-term to relieve severe pain.

Hydrocodone and ibuprofen may also be used for purposes not listed in this medication guide.

Hydrocodone and ibuprofen side effects

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Hydrocodone and ibuprofen may cause serious side effects. Call your doctor at once if you have:

• weak or shallow breathing, sighing, slow heartbeat, breathing that stops during sleep;
• swelling, rapid weight gain;
• a skin rash, no matter how mild;
• signs of stomach bleeding–bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems–loss of appetite, diarrhea, upper stomach pain, tiredness, flu-like symptoms, dark urine, jaundice (yellowing of the skin or eyes);
• kidney problems–little or no urination, swelling in your feet or ankles, feeling tired or short of breath;
• low cortisol levels–vomiting, dizziness, worsening tiredness or weakness; or
• high levels of serotonin in the body–agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea.

Serious breathing problems may be more likely in older adults and in those who are debilitated or have wasting syndrome or chronic breathing disorders.

Common side effects of hydrocodone and ibuprofen may include:

• dizziness, drowsiness;
• stomach pain, nausea, vomiting, heartburn, gas;
• constipation, diarrhea; or
• headache.

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 .

Warnings

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Taking hydrocodone and ibuprofen during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Before taking this medicine

You should not use this medicine if you are allergic to hydrocodone or ibuprofen, or if you have:

• severe asthma or breathing problems; or
• a blockage in your stomach or intestines.

Ibuprofen can increase your risk of fatal heart attack or stroke. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG). Ibuprofen may also cause stomach or intestinal bleeding, which can be fatal.

Tell your doctor if you have ever had:

• breathing problems, sleep apnea;
• a head injury, brain tumor, or seizure;
• liver or kidney disease;
• high blood pressure, heart problems, or a heart attack;
• problems with your gallbladder, pancreas, or thyroid;
• urination problems; or
• drug or alcohol addiction, or mental illness.

If you are pregnant, you should not take this medicine unless your doctor tells you to. Taking an NSAID during the last 20 weeks of pregnancy can cause serious problems in the unborn baby and possible complications with your pregnancy. If you take opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks.

Ask a doctor before using this medicine if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

How should I take hydrocodone and ibuprofen?

Follow the directions on your prescription label and read all medication guides. Never use hydrocodone and ibuprofen in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to take more of this medicine.

Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

Store at room temperature away from moisture and heat.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

Hydrocodone and ibuprofen dosing information

Usual Adult Dose for Pain:

1 tablet orally every 4 to 6 hours as needed
Maximum dose: 5 tablets in 24 hours
Duration of therapy: Generally less than 10 days

Comments:
-The lowest effective dose or the longest dosing interval should be sought for each patient.
-Each tablet provides a combination of ibuprofen 200 mg and either hydrocodone 2.5, 5, 7.5, or 10 mg.
-Because of the risks of addiction and abuse, this drug should be reserved for use in patients for whom alternative treatment options have not been tolerated, or are not expected to be tolerated; or have not provided adequate analgesia, or are not expected to provide adequate analgesia.

Use: For the short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Usual Pediatric Dose for Pain:

16 years or older:

1 tablet orally every 4 to 6 hours as needed
Maximum dose: 5 tablets in 24 hours
Duration of therapy: Generally less than 10 days

Comments:
-The lowest effective dose or the longest dosing interval should be sought for each patient.
-Each tablet provides a combination of ibuprofen 200 mg and either hydrocodone 2.5, 5, 7.5, or 10 mg.
-Because of the risks of addiction and abuse, this drug should be reserved for use in patients for whom alternative treatment options have not been tolerated, or are not expected to be tolerated; or have not provided adequate analgesia, or are not expected to provide adequate analgesia.

Use: For the short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

What happens if I miss a dose?

Since hydrocodone and ibuprofen is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include black or bloody stools, coughing up blood, severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don’t wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

What should I avoid while taking hydrocodone and ibuprofen?

Avoid driving or hazardous activity until you know how hydrocodone and ibuprofen will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Do not drink alcohol. Dangerous side effects or death could occur.

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to ibuprofen (such as aspirin, ketoprofen, or naproxen).

What other drugs will affect hydrocodone and ibuprofen?

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic (“water pill”);
• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
• other opioids–opioid pain medicine or prescription cough medicine;
• a sedative like Valium–diazepam, alprazolam, lorazepam, Xanax, Klonopin, Ativan, and others;
• drugs that make you sleepy or slow your breathing–a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or
• drugs that affect serotonin levels in your body–a stimulant, or medicine for depression, Parkinson’s disease, migraine headaches, serious infections, or nausea and vomiting.

What is Percocet?

Percocet contains a combination of acetaminophen and oxycodone. Oxycodone is an opioid pain medication. An opioid is sometimes called a narcotic. Acetaminophen is a less potent pain reliever that increases the effects of oxycodone.

Percocet is used to relieve moderate to severe pain.

Due of the risks of addiction, abuse, and misuse, even at recommended doses, Percocet is only prescribed when treatment with non-opioid pain relieving medication has not been tolerated or has not provided adequate pain relief.

Warnings

You should not use Percocet if you have recently used alcohol, sedatives, tranquilizers, or other opioid medications. Do not use Percocet if you have used a MAO Inhibiter in the past 14 days, such as isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, or tranylcypromine, or have received a methylene blue injection.

Oxycodone can slow or stop your breathing, and may be habit-forming. Use only your prescribed dose, and swallow the pill whole to avoid a potentially fatal dose. Never share Percocet with another person.

MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Do not take more Percocet than is recommended. An overdose of oxycodone or acetaminophen (both present in Percocet) can cause death. Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

Oxycodone (present in Percocet) may cause life-threatening withdrawal symptoms in a newborn if the mother has taken Percocet during pregnancy.

Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Fatal side effects can occur if you use Percocet with alcohol, or with other drugs that cause drowsiness or slow your breathing.

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

Before taking this medicine

You should not use Percocet if you are allergic to any of its components including acetaminophen or oxycodone, or if you have:

• severe asthma or breathing problems; or
• a blockage in your stomach or intestines.

To make sure Percocet is safe for you, tell your doctor if you have ever had:

• breathing problems, sleep apnea;
• liver disease;
• a drug or alcohol addiction;
• kidney disease;
• a head injury or seizures;
• urination problems; or
• problems with your thyroid, pancreas, or gallbladder.

If you use Percocet while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.

If you become pregnant while taking oxycodone, do not stop your medication suddenly without talking to your doctor. You may need to decrease your medicine gradually.

Do not breastfeed. Oxycodone can pass into breast milk and cause drowsiness, breathing problems, or death in a nursing baby. Tell your doctor if you are breastfeeding before using oxycodone.

How should I take Percocet?

Take Percocet exactly as prescribed by your doctor. Follow all directions on your prescription label. Never take this medicine in larger amounts, or for longer than prescribed. An overdose can damage your liver or cause death. Tell your doctor if you feel an increased urge to use more of this medicine.

Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine in a place where others cannot get to it. Selling or giving away Percocet is against the law.

If you need surgery or medical tests, tell the doctor ahead of time that you are using Percocet.

You should not stop using Percocet suddenly. Follow your doctor’s instructions about tapering your dose.

Store at room temperature away from moisture and heat. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

What happens if I miss a dose?

Since Percocet is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . An overdose of this medicine can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include nausea, vomiting, sweating, severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don’t wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

What to avoid

Avoid driving or operating machinery until you know how Percocet will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Do not drink alcohol. Dangerous side effects or death could occur.

Ask a doctor or pharmacist before using any other medicine that may contain acetaminophen (sometimes abbreviated as APAP). Taking certain medications together can lead to a fatal overdose.

Percocet side effects

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

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen or Tylenol in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Oxycodone can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
• slow heartbeat or week pulse;
• cold, clammy skin;
• a light-headed feeling, like you might pass out;
• weakness, tiredness, fever, unusual bruising or bleeding;
• confusion, unusual thoughts or behavior;
• seizure (convulsions);
• problems with urination;
• signs of liver problems including nausea, upper stomach pain, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
• high levels of serotonin in the body – agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea.

Serious breathing problems may be more likely in older adults and in those who are debilitated or have wasting syndrome or chronic breathing disorders.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common Percocet side effects include:

• dizziness, drowsiness, feeling tired;
• headache;
• constipation, nausea, vomiting, stomach pain;
• blurred vision;
• itching, red eyes, or flushing;
• feelings of extreme happiness or sadness; or
• dry mouth

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

What other drugs will affect Percocet?

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic (“water pill”);
• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
• other opioids – opioid pain medicine or prescription cough medicine;
• a sedative like Valium – diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;
• drugs that make you sleepy or slow your breathing – a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness;
• drugs that affect serotonin levels in your body – a stimulant, or medicine for depression, Parkinson’s disease, migraine headaches, serious infections, or nausea and vomiting.