Ibudone

Name: Ibudone

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What is Ibudone (hydrocodone and ibuprofen)?

Hydrocodone is an opioid pain medication. An opioid is sometimes called a narcotic. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). This medicine works by reducing substances in the body that cause pain, fever, and inflammation.

Hydrocodone and ibuprofen is a combination medicine that is used short-term to relieve severe pain.

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A hydrocodone overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include vomiting, black or bloody stools, coughing up blood, confusion, muscle weakness, cold and clammy skin, slow heart rate, blue lips, noisy or shallow breathing, or fainting.

Before Using Ibudone

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 hydrocodone and ibuprofen combination in children younger than 16 years of age. 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 hydrocodone and ibuprofen combination in the elderly. However, elderly patients are more likely to develop age-related kidney, lung, or stomach problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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.

Ketorolac
Nalmefene
Naltrexone
Safinamide

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.

Abciximab
Aceclofenac
Acemetacin
Acenocoumarol
Acepromazine
Alfentanil
Almotriptan
Alprazolam
Amiloride
Amineptine
Amisulpride
Amitriptyline
Amitriptylinoxide
Amobarbital
Amoxapine
Amphetamine
Amtolmetin Guacil
Anagrelide
Anileridine
Apixaban
Aprepitant
Ardeparin
Argatroban
Aripiprazole
Asenapine
Aspirin
Atazanavir
Baclofen
Balsalazide
Bemiparin
Bendroflumethiazide
Benperidol
Benzphetamine
Benzthiazide
Betamethasone
Betrixaban
Bismuth Subsalicylate
Bivalirudin
Boceprevir
Bromazepam
Bromfenac
Bromopride
Brompheniramine
Budesonide
Bufexamac
Bumetanide
Buprenorphine
Buspirone
Butabarbital
Butorphanol
Cangrelor
Carbinoxamine
Carisoprodol
Carphenazine
Celecoxib
Ceritinib
Certoparin
Chloral Hydrate
Chlordiazepoxide
Chlorothiazide
Chlorpheniramine
Chlorpromazine
Chlorthalidone
Chlorzoxazone
Choline Magnesium Trisalicylate
Choline Salicylate
Cilostazol
Citalopram
Clarithromycin
Clobazam
Clomipramine
Clonazepam
Clonixin
Clopamide
Clopidogrel
Clorazepate
Clozapine
Cocaine
Codeine
Conivaptan
Cortisone
Cyclobenzaprine
Cyclopenthiazide
Cyclosporine
Dabigatran Etexilate
Dalteparin
Danaparoid
Dasabuvir
Deflazacort
Desipramine
Desirudin
Desmopressin
Desvenlafaxine
Dexamethasone
Dexibuprofen
Dexketoprofen
Dexmedetomidine
Dextroamphetamine
Dextromethorphan
Dezocine
Diazepam
Diazoxide
Dibenzepin
Dichloralphenazone
Diclofenac
Difenoxin
Diflunisal
Digoxin
Dihydrocodeine
Diltiazem
Diphenhydramine
Diphenoxylate
Dipyridamole
Dipyrone
Dolasetron
Donepezil
Dothiepin
Doxepin
Doxylamine
Dronedarone
Droperidol
Droxicam
Duloxetine
Edoxaban
Eletriptan
Enflurane
Enoxaparin
Eplerenone
Epoprostenol
Eptifibatide
Erythromycin
Escitalopram
Estazolam
Eszopiclone
Ethacrynic Acid
Ethchlorvynol
Ethopropazine
Ethylmorphine
Etodolac
Etofenamate
Etoricoxib
Felbinac
Fenoprofen
Fentanyl
Fepradinol
Feprazone
Feverfew
Flibanserin
Floctafenine
Fluconazole
Flufenamic Acid
Fluocortolone
Fluoxetine
Fluphenazine
Flurazepam
Flurbiprofen
Fluspirilene
Fluvoxamine
Fondaparinux
Fosaprepitant
Fospropofol
Frovatriptan
Furazolidone
Furosemide
Ginkgo
Gossypol
Granisetron
Halazepam
Haloperidol
Halothane
Heparin
Hexobarbital
Hydrochlorothiazide
Hydrocortisone
Hydroflumethiazide
Hydromorphone
Hydroxytryptophan
Hydroxyzine
Ibuprofen
Idelalisib
Iloprost
Imatinib
Imipramine
Indapamide
Indinavir
Indomethacin
Iproniazid
Isocarboxazid
Isoflurane
Itraconazole
Ketamine
Ketazolam
Ketobemidone
Ketoconazole
Ketoprofen
Lepirudin
Levomilnacipran
Levorphanol
Linezolid
Lisdexamfetamine
Lithium
Lofepramine
Lopinavir
Lorazepam
Lorcaserin
Lornoxicam
Loxapine
Loxoprofen
Lumiracoxib
Magnesium Salicylate
Meadowsweet
Meclizine
Meclofenamate
Mefenamic Acid
Melitracen
Meloxicam
Melperone
Meperidine
Mephobarbital
Meprobamate
Meptazinol
Mesalamine
Mesoridazine
Metaxalone
Methadone
Methamphetamine
Methdilazine
Methocarbamol
Methohexital
Methotrexate
Methotrimeprazine
Methyclothiazide
Methylene Blue
Methylprednisolone
Metolazone
Midazolam
Milnacipran
Mirtazapine
Moclobemide
Molindone
Moricizine
Morniflumate
Morphine
Morphine Sulfate Liposome
Nabumetone
Nadroparin
Nalbuphine
Naproxen
Naratriptan
Nefazodone
Nelfinavir
Nepafenac
Netupitant
Nialamide
Nicomorphine
Niflumic Acid
Nimesulide
Nimesulide Beta Cyclodextrin
Nitrazepam
Nitrous Oxide
Nortriptyline
Olanzapine
Olsalazine
Ombitasvir
Ondansetron
Opipramol
Opium
Opium Alkaloids
Orphenadrine
Oxaprozin
Oxazepam
Oxycodone
Oxymorphone
Oxyphenbutazone
Palonosetron
Papaveretum
Paramethasone
Parecoxib
Paregoric
Paritaprevir
Parnaparin
Paroxetine
Pemetrexed
Pentazocine
Pentobarbital
Pentosan Polysulfate Sodium
Pentoxifylline
Perampanel
Perazine
Periciazine
Perphenazine
Phenelzine
Phenindione
Phenobarbital
Phenprocoumon
Phenylbutazone
Phenyl Salicylate
Piketoprofen
Piperacetazine
Pipotiazine
Piritramide
Piroxicam
Polythiazide
Posaconazole
Pralatrexate
Prasugrel
Prazepam
Prednisolone
Prednisone
Primidone
Procarbazine
Prochlorperazine
Proglumetacin
Promazine
Promethazine
Propofol
Propyphenazone
Proquazone
Protein C
Protriptyline
Quazepam
Quetiapine
Ramelteon
Rasagiline
Reboxetine
Remifentanil
Remoxipride
Reviparin
Ritonavir
Rivaroxaban
Rizatriptan
Rofecoxib
Salicylamide
Salicylic Acid
Salsalate
Saquinavir
Secobarbital
Selegiline
Sertindole
Sertraline
Sibutramine
Sodium Oxybate
Sodium Salicylate
Spironolactone
Sufentanil
Sulfasalazine
Sulindac
Sulpiride
Sumatriptan
Suvorexant
Tacrolimus
Tapentadol
Telaprevir
Telithromycin
Temazepam
Tenoxicam
Thiethylperazine
Thiopental
Thiopropazate
Thioridazine
Tianeptine
Tiaprofenic Acid
Ticagrelor
Ticlopidine
Tilidine
Tinzaparin
Tirofiban
Tizanidine
Tolfenamic Acid
Tolmetin
Tolonium Chloride
Topiramate
Torsemide
Tramadol
Tranylcypromine
Trazodone
Treprostinil
Triamterene
Triazolam
Trichlormethiazide
Trifluoperazine
Trifluperidol
Triflupromazine
Trimeprazine
Trimipramine
Trolamine Salicylate
Tryptophan
Valdecoxib
Venlafaxine
Verapamil
Vilazodone
Vorapaxar
Voriconazole
Vortioxetine
Warfarin
Xipamide
Zaleplon
Ziprasidone
Zolmitriptan
Zolpidem
Zopiclone
Zotepine

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.

Acebutolol
Alacepril
Amikacin
Atenolol
Azilsartan
Azilsartan Medoxomil
Benazepril
Betaxolol
Bisoprolol
Candesartan
Captopril
Carteolol
Carvedilol
Celiprolol
Cilazapril
Delapril
Enalapril
Enalaprilat
Eprosartan
Esmolol
Fosinopril
Imidapril
Irbesartan
Labetalol
Levobunolol
Lisinopril
Losartan
Metipranolol
Metoprolol
Moexipril
Nadolol
Nebivolol
Olmesartan
Oxprenolol
Penbutolol
Pentopril
Perindopril
Pindolol
Practolol
Propranolol
Quinapril
Ramipril
Sotalol
Spirapril
Telmisartan
Temocapril
Timolol
Trandolapril
Valsartan
Zofenopril

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
Grapefruit Juice

Proper Use of hydrocodone and ibuprofen

This section provides information on the proper use of a number of products that contain hydrocodone and ibuprofen. It may not be specific to Ibudone. Please read with care.

For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of this medicine may increase the chance of unwanted effects.

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

Swallow the tablet whole. Do not crush, break, or chew it.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):
- For pain:
  - Adults and children 16 years of age and older—1 tablet every 4 to 6 hours as needed. However, the dose is usually not more than 5 tablets per day.
  - Children younger than 16 years of age—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.

Store the medicine in a safe and secure place. Do not throw unused medicine in the trash. Ask your pharmacist about the best way to dispose of medicine you do not use.

Uses of Ibudone

It is used to ease pain.

What are some other side effects of Ibudone?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

Anxiety.
Feeling sleepy.
Dry mouth.
Sweating a lot.
Feeling nervous and excitable.
Hard stools (constipation).
Upset stomach or throwing up.
Dizziness.
Belly pain or heartburn.
Feeling tired or weak.
Not able to sleep.
Loose stools (diarrhea).
Gas.
Headache.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

How do I store and/or throw out Ibudone?

Store at room temperature.
Protect from light.
Store in a dry place. Do not store in a bathroom.
Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
Check with your pharmacist about how to throw out unused drugs.

Clinical Studies

In single-dose studies of post surgical pain (abdominal, gynecological, orthopedic), 940 patients were studied at doses of one or two tablets. Ibudone® produced greater efficacy than placebo and each of its individual components given at the same dose. No advantage was demonstrated for the two-tablet dose.

Precautions

Masking of Inflammation and Fever

The pharmacological activity of Ibudone® in reducing inflammation, and possibly fever, may diminish the utility of diagnostic signs in detecting infections.

Ophthalmological Effects

Blurred or diminished vision, scotomata, and changes in color vision have been reported with oral ibuprofen. Discontinue ibuprofen if a patient develops such complaints, and refer the patient for an ophthalmologic examination that includes central visual fields and color vision testing.

Information for Patients

Advise the patient to read the FDA-approved patient labeling (Medication Guide) that accompanies each prescription dispensed. Patients, families, or their caregivers should be informed of the following information before initiating therapy with Ibudone® and periodically during the course of ongoing therapy.

Addiction, Abuse, and Misuse
Inform patients that the use of Ibudone®, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death (see WARNINGS: Addiction, Abuse, and Misuse). Instruct patients not to share Ibudone® with others and to take steps to protect Ibudone® from theft or misuse.
Life-Threatening Respiratory Depression
Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting Ibudone® or when the dosage is increased, and that it can occur even at recommended dosages (see WARNINGS: Life-Threatening Respiratory Depression). Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop.
Accidental Ingestion
Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death (see WARNINGS: Life-Threatening Respiratory Depression). Instruct patients to take steps to store Ibudone® securely and to dispose of unused Ibudone® appropriately as described below.
Interactions with Benzodiazepines and Other CNS Depressants
Inform patients and caregivers that potentially fatal additive effects may occur if Ibudone® is used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider (see WARNINGS: Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants, PRECAUTIONS: Drug Interactions).
Serotonin Syndrome
Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their healthcare providers if they are taking, or plan to take serotonergic medications (see PRECAUTIONS: Drug Interactions).
MAOI Interaction
Inform patients to avoid taking Ibudone® while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking Ibudone® (see PRECAUTIONS: Drug Interactions).
Adrenal Insufficiency
Inform patients that opioids could cause adrenal insufficiency, a potentially life-threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms (see WARNINGS: Adrenal Insufficiency).
Important Administration Instructions
Instruct patients how to properly take Ibudone®. For the short-term (generally less than 10 days) management of acute pain, the recommended dose of Ibudone® is one tablet every 4 to 6 hours, as necessary. Inform patients that the dosage should not exceed 5 tablets in a 24-hour period (see DOSAGE AND ADMINISTRATION).
Hypotension
Inform patients that Ibudone® may cause orthostatic hypotension and syncope. Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from a sitting or lying position) (see WARNINGS: Severe Hypotension).
Anaphylaxis
Inform patients that anaphylaxis has been reported with ingredients contained in Ibudone®. Advise patients how to recognize such a reaction and when to seek medical attention (see CONTRAINDICATIONS, WARNINGS: Anaphylactic Reactions).
Pregnancy
Neonatal Opioid Withdrawal Syndrome
Inform female patients of reproductive potential that prolonged use of Ibudone® during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated (see Boxed Warning, WARNINGS: Neonatal Opioid Withdrawal Syndrome, PRECAUTIONS: Pregnancy).

Embryo-Fetal Toxicity
Inform female patients of reproductive potential that Ibudone® can cause fetal harm and to inform the prescriber of a known or suspected pregnancy. Inform pregnant women to avoid use of Ibudone® and other NSAIDs starting at 30 weeks gestation because of the risk of premature closing of the fetal ductus arteriosus (see WARNINGS: Premature Closure of Fetal Ductus Arteriosis, PRECAUTIONS: Pregnancy).
Lactation
Advise nursing mothers to monitor infants for increased sleepiness (more than usual), breathing difficulties, or limpness. Instruct nursing mothers to seek immediate medical care if they notice these signs (see PRECAUTIONS: Nursing Mothers).
Infertility
Inform patients that chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible. Advise female patients of reproductive potential who desire pregnancy that NSAIDs, including Ibudone®, may be associated with a reversible delay in ovulation (see PRECAUTIONS: Carcinogenicity, Mutagenicity, Impairment of Fertility).
Driving or Operating Heavy Machinery
Inform patients that Ibudone® may impair the ability to perform potentially hazardous activities such as driving a car or operating heavy machinery. Advise patients not to perform such tasks until they know how they will react to the medication (see WARNINGS: Risks of Driving and Operating Machinery).
Constipation
Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention (see ADVERSE REACTIONS: Clinical Trials Experience).
Cardiovascular Thrombotic Events
Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their healthcare provider immediately (see WARNINGS: Cardiovascular Thrombotic Events).
Gastrointestinal Bleeding, Ulceration, and Perforation
Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their healthcare provider. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for and the signs and symptoms of GI bleeding (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation).
Hepatotoxicity
Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, diarrhea, jaundice, right upper quadrant tenderness, and "flu-like" symptoms). If these occur, instruct patients to stop Ibudone® and seek immediate medical therapy (see WARNINGS: Hepatotoxicity).
Heart Failure and Edema
Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur (see WARNINGS: Heart Failure and Edema).
Serious Skin Reactions
Advise patients to stop Ibudone® immediately if they develop any type of rash and to contact their healthcare provider as soon as possible (see WARNINGS: Serious Skin Reactions).
Avoid Concomitant use of NSAIDs
Inform patients that the concomitant use of Ibudone® with other NSAIDs or salicylates (e.g., diflunisal, salsalate) is not recommended due to the increased risk of gastrointestinal toxicity, and little or no increase in efficacy (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation, PRECAUTIONS: Drug Interactions). Alert patients that NSAIDs may be present in “over the counter” medications for treatment of colds, fever, or insomnia.
Use of NSAIDS and Low-Dose Aspirin
Inform patients not to use low-dose aspirin concomitantly with Ibudone® until they talk to their healthcare provider (see PRECAUTIONS: Drug Interactions).
Ophthalmological Effects
Instruct patients to report any signs of blurred vision or other eye symptoms (see PRECAUTIONS: Ophthalmological Effects).
Disposal of Unused Ibudone®
Advise patients to flush the unused tablets down the toilet when Ibudone® is no longer needed or to contact the Drug Enforcement Agency (DEA) to find the location of an authorized collector (1-800-882-9539).

Laboratory Monitoring

Because serious GI bleeding, hepatotoxicity, and renal injury can occur without warning symptoms or signs, consider monitoring patients with a CBC and a chemistry profile periodically (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation, Renal Toxicity and Hyperkalemia, Hepatotoxicity).

Drug Interactions

Inhibitors of CYP3A4 and CYP2D6
The concomitant use of Ibudone® and CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), protease inhibitors (e.g., ritonavir), can increase the plasma concentration of hydrocodone, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of Ibudone® and CYP2D6 and CYP3A4 inhibitors, particularly when an inhibitor is added after a stable dose of Ibudone® is achieved (see WARNINGS: Risks of Concomitant Use or Discontinuation of Cytochrome P450 3A4 Inhibitors and Inducers).

After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the hydrocodone plasma concentration will decrease (see CLINICAL PHARMACOLOGY: Pharmacokinetics), resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to Ibudone®.

If concomitant use is necessary, consider dosage reduction of Ibudone® until stable drug effects are achieved. Monitor patients for respiratory depression and sedation at frequent intervals. If a CYP3A4 inhibitor is discontinued, consider a dosage increase of Ibudone® until stable drug effects are achieved. Monitor for signs of opioid withdrawal.

CYP3A4 Inducers
The concomitant use of Ibudone® and CYP3A4 inducers, such as rifampin, carbamazepine, and phenytoin, can decrease the plasma concentration of hydrocodone (see CLINICAL PHARMACOLOGY: Pharmacokinetics), resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to hydrocodone (see WARNINGS: Withdrawal).

After stopping a CYP3A4 inducer, as the effects of the inducer decline, the hydrocodone plasma concentration will increase (see CLINICAL PHARMACOLOGY: Pharmacokinetics), which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression.

If concomitant use is necessary, consider a dosage increase of Ibudone® until stable drug effects are achieved. Monitor for signs of opioid withdrawal. If a CYP3A4 inducer is discontinued, consider Ibudone® dosage reduction and monitor for signs of respiratory depression.

Benzodiazepines and Other Central Nervous System (CNS) Depressants
Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants such as benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, and other opioids, including alcohol, increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.

Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients closely for signs of respiratory depression and sedation (see WARNINGS: Life- Threatening Respiratory Depression).

Serotonergic Drugs
The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), and monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue), has resulted in serotonin syndrome (see PRECAUTIONS: Information for Patients).

If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue Ibudone® if serotonin syndrome is suspected.

Monoamine Oxidase Inhibitors (MAOIs)
MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma).

If urgent use of an opioid is necessary with MAOIs such as phenelzine, tranylcypromine, linezolid, use test doses and frequent titration of small doses to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression.

The use of Ibudone® is not recommended for patients taking MAOIs or within 14 days of stopping such treatment.

Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics
Agonist/antagonist analgesics such as pentazocine, nalbuphine, butorphanol and buprenorphine may reduce the analgesic effect of Ibudone® and/or precipitate withdrawal symptoms in these patients.

Avoid concomitant use of these drugs.

Muscle Relaxants
Hydrocodone, as well as other opioid analgesics, may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.

Monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of Ibudone® and/or the muscle relaxant as necessary.

Anticholinergics
The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.

Monitor patients for signs of urinary retention or reduced gastric motility when Ibudone® is used concomitantly with anticholinergic drugs.

Drugs That Interfere With Hemostasis
Ibuprofen and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of ibuprofen and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone.

Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone.

Monitor patients with concomitant use of Ibudone® with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), SSRIs, and SNRIs for signs of bleeding (see WARNINGS: Hematologic Toxicity).

Aspirin
Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation).

Concomitant use of Ibudone® and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding (see WARNINGS: Hematologic Toxicity).

ACE-Inhibitors, Angiotensin Receptor Blockers, and Beta-blockers
NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol).

During concomitant use of Ibudone® and ACE-inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained.

In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. Monitor for signs of worsening renal function (see WARNINGS: Renal Toxicity and Hyperkalemia). These effects are usually reversible.

When these drugs are administered concomitantly, patients should be adequately hydrated. Assess renal function at the beginning of the concomitant treatment and periodically thereafter.

Diuretics
Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis.

During concomitant use of Ibudone® with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects (see WARNINGS: Renal Toxicity and Hyperkalemia).

Digoxin
The concomitant use of ibuprofen with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin.

During concomitant use of Ibudone® and digoxin, monitor serum digoxin levels.

Lithium
NSAIDs have produced elevations in plasma lithium concentration and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis.

During concomitant use of Ibudone® and lithium, monitor patients for signs of lithium toxicity.

Methotrexate
Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction).

During concomitant use of Ibudone® and methotrexate, monitor patients for methotrexate toxicity.

Cyclosporine
Concomitant use of Ibudone® and cyclosporine may increase cyclosporine’s nephrotoxicity.

During concomitant use of Ibudone® and cyclosporine, monitor patients for signs of worsening renal function.

NSAIDs and Salicylates
Concomitant use of ibuprofen with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation).

The concomitant use of ibuprofen with other NSAIDs or salicylates is not recommended.

Pemetrexed
Concomitant use of Ibudone® and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information).

During concomitant use of Ibudone® and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity.

NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed.

In the absence of data regarding potential interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following pemetrexed administration.

Carcinogenicity, Mutagenicity, Impairment of Fertility

Carcinogenesis
Long-term animal studies to evaluate the carcinogenic potential of the combination of hydrocodone and ibuprofen, ibuprofen alone, or hydrocodone alone have not been conducted.

Mutagenesis
The mutagenic potential of the combination of hydrocodone and ibuprofen or hydrocodone alone has not been investigated.

In published studies, ibuprofen was not mutagenic in the in vitro bacterial reverse mutation assay (Ames assay).

Impairment of Fertility
Animal studies evaluating the impact of the combination of hydrocodone and ibuprofen or hydrocodone alone on fertility have not been conducted.

In a published study, dietary administration of ibuprofen to male and female rats 8-weeks prior to and during mating at dose levels of 20 mg/kg (0.2-times the MRHD of 1000 mg ibuprofen based on body surface area comparison) did not impact male or female fertility or litter size.

In other studies, adult mice were administered ibuprofen intraperitoneally at a dose of 5.6 mg/kg/day (0.03-times the MRHD based on body surface area comparison) for 35 or 60 days in males and 35 days in females. There was no effect on sperm motility or viability in males but decreased ovulation was reported in females.

Based on the mechanism of action, the use of prostaglandin-mediated NSAIDs, including ibuprofen, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. Small studies in women treated with NSAIDs have also shown a reversible delay in ovulation. Consider withdrawal of NSAID-containing products, including Ibudone®, in women who have difficulties conceiving or who are undergoing investigation of infertility.

Chronic use of opioids may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible (see ADVERSE REACTIONS: Postmarketing Experience).

Pregnancy

Risk Summary
Use of drug products containing NSAIDs, including Ibudone®, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including Ibudone®, in pregnant women starting at 30 weeks gestation (third trimester). Prolonged use of opioid analgesics during pregnancy can cause neonatal opioid withdrawal syndrome (see WARNINGS: Neonatal Opioid Withdrawal Syndrome). There are no available data with Ibudone® in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive.

In animal reproduction studies, an increase in the percentage of litters and fetuses with any major abnormality and an increase in the number of litters and fetuses with one or more nonossified metacarpals was observed when the combination of hydrocodone and ibuprofen was administered orally to pregnant rabbits during organogenesis at 1.8 times the maximum daily dose. There are no animal reproductive and developmental toxicology studies with hydrocodone alone.

In published animal reproduction studies testing ibuprofen alone, there were no clear developmental effects at doses up to 1.2 times the maximum recommended human dose (MRHD) in the rabbit and 1.8 times in the MRHD rat when dosed throughout gestation. In contrast, an increase in membranous ventricular septal defects was reported in rats treated on Gestation Days 9 & 10 with 3 times the MRHD. Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as ibuprofen, resulted in increased pre- and post-implantation loss (see Data). Based on animal data, advise pregnant women of the potential risk to a fetus.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Clinical Considerations

Fetal/neonatal adverse reactions
Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth.

Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high-pitched cry, tremor, vomiting, diarrhea, and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly (see WARNINGS: Neonatal Opioid Withdrawal Syndrome).

Labor and Delivery
Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. An opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression.

There are no studies on the effects of Ibudone® during labor or delivery. In animal studies, NSAIDs, including ibuprofen, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth.

Ibudone® is not recommended for use in women during and immediately prior to labor, when use of shorter-acting analgesics or other analgesic techniques are more appropriate. Opioid analgesics, including Ibudone®, can prolong labor through actions that temporarily reduce the strength, duration, and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilatation, which tends to shorten labor. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression.

Data

Animal Data
Pregnant rabbits were treated with 10, 33, or 95 mg/kg of 1:27 ratio of hydrocodone:ibuprofen (the high dose is 1.8 times the maximum daily dose of both compounds based on surface area) from Gestation Day 5 to 18. The dose of 95 mg/kg of the combination, which also produced maternal toxicity (44% decrease in body weight gain compared to control), resulted in an increase in the percentage of litters and fetuses with any major abnormality and an increase in the number of litters and fetuses with one or more nonossified metacarpals (a minor abnormality).

Pregnant rats were treated with 50, 100, or 166 mg/kg of a 1:27 ratio of hydrocodone:ibuprofen (the high dose is 1.6 times the maximum daily dose of both compounds based on body surface area) from Gestation Day 5 to 15. No reproductive toxicity was noted despite the presence of maternal toxicity in the 100 and 166 mg/kg groups (21% and 60% decrease in body weight gain compared to control).

In a published study, female rabbits given 7.5, 20, or 60 mg/kg ibuprofen (0.15, 0.39, or 1.2 times the maximum recommended human daily dose of 1000 mg of ibuprofen based on body surface area) from Gestation Days 1 to 29, no clear treatment-related adverse developmental effects were noted. This dose was associated with significant maternal toxicity (stomach ulcers, gastric lesions). In the same publication, female rats were administered 7.5, 20, 60, 180 mg/kg ibuprofen (0.07, 0.2, 0.6, 1.8 times the maximum daily dose) did not result in clear adverse developmental effects. Maternal toxicity (gastrointestinal lesions) was noted at 20 mg/kg and above.

In a published study, rats were orally dosed with 300 mg/kg ibuprofen (3 times the maximum human daily dose of 1000 mg based on body surface area) during Gestation Days 9 and 10 (critical time points for heart development in rats). Ibuprofen treatment resulted in an increase in the incidence of membranous ventricular septal defects. This dose was associated with significant maternal toxicity including gastrointestinal toxicity (1 out of 20 animals). In the same study/publication rabbits were dosed on Gestation Day 9, 10 and 11 with 500 mg/kg (9.7 times the maximum human daily dose), and only one incidence each of a membranous ventricular septal defect and gastroschisis was noted in the rabbit fetuses. This dose was also associated with maternal toxicity.

Nursing Mothers

Risk Summary
Hydrocodone is present in human milk. A published lactation study reports variable concentrations of hydrocodone and hydromorphone (an active metabolite) in breast milk with administration of immediate-release hydrocodone to nursing mothers in the early post-partum period. This lactation study did not assess breastfed infants for potential adverse drug reactions.

Limited published literature reports that, following oral administration, ibuprofen is present in human milk at relative infant doses of 0.06% to 0.6% of the maternal weight-adjusted daily dose.

Lactation studies have not been conducted with Ibudone®, and no information is available on the effects of the drug on the breastfed infant or the effects of the drug on milk production.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Ibudone® and any potential adverse effects on the breastfed infant from Ibudone® or from the underlying maternal condition.

Clinical Considerations
Monitor infants exposed to Ibudone® through breast milk for excess sedation and respiratory depression. Withdrawal symptoms can occur in breastfed infants when maternal administration of hydrocodone is stopped, or when breastfeeding is stopped.

Pediatric Use

The safety and effectiveness of Ibudone® in pediatric patients below the age of 16 have not been established.

Geriatric Use

In controlled clinical trials there was no difference in tolerability between patients < 65 years of age and those ≥ 65, apart from an increased tendency of the elderly to develop constipation. However, elderly patients are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and renal adverse reactions as well as possible increased risk of respiratory depression with opioids. In general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy (see WARNINGS: Cardiovascular Thrombotic Events, Gastrointestinal Bleeding, Ulceration, and Perforation, Renal Toxicity and Hyperkalemia).

Respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. Titrate the dosage of Ibudone® slowly in geriatric patients and monitor closely for signs of central nervous system and respiratory depression (see WARNINGS: Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients).

Both hydrocodone and ibuprofen are known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Hepatic Impairment

Patients with hepatic impairment may have higher hydrocodone plasma concentrations than those with normal function. In patients with severe hepatic impairment, use a low initial dose. Monitor these patients closely for adverse events such as respiratory depression, sedation, and hypotension.

Renal Impairment

Patients with renal impairment may have higher hydrocodone plasma concentrations than those with normal function. Use a low initial dose in patients with renal impairment and monitor closely for adverse events such as respiratory depression, sedation, and hypotension.

Drug Abuse and Dependence

Controlled Substance

Ibudone® contains hydrocodone, a Schedule II controlled substance.

Abuse

Ibudone® contains hydrocodone, a substance with a high potential for abuse similar to other opioids including fentanyl, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol. Ibudone® can be abused and is subject to misuse, addiction, and criminal diversion (see WARNINGS: Addiction, Abuse, and Misuse).

All patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use.

Prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects.

Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal.

“Drug seeking” behavior is very common with substance use disorders. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated “loss” of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating healthcare provider(s). “Doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among drug abusers and people suffering from untreated addiction.

Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control.

Abuse and addiction are separate and distinct from physical dependence and tolerance. Healthcare providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true addiction.

Ibudone®, like other opioids, can be diverted for non-medical use into illicit channels of distribution. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised.

Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.

Risks Specific to Abuse of Ibudone®
Abuse of Ibudone® poses a risk of overdose and death. The risk is increased with concurrent abuse of Ibudone® with alcohol and other central nervous system depressants (see WARNINGS: Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants).

Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.

Dependence

Both tolerance and physical dependence can develop during chronic opioid therapy. Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects.

Physical dependence results in withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug. Withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone, nalmefene), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage.

Ibudone® should not be abruptly discontinued in a physically-dependent patient (see DOSAGE AND ADMINISTRATION: Discontinuation of Ibudone®). If Ibudone® is abruptly discontinued in a physically-dependent patient, a withdrawal syndrome may occur. Some or all of the following can characterize this syndrome: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.

Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs (see PRECAUTIONS: Pregnancy).

Medication Guide

Ibudone® (eye" bue done)
(hydrocodone bitartrate and ibuprofen tablets), CII

Ibudone® is:

A strong prescription pain medicine that contains an opioid (narcotic) and a non-steroidal anti- inflammatory drug (NSAID), that is used to manage short-term (acute) pain, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
An opioid pain medicine can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
NSAIDs are used to treat pain, redness, swelling, and inflammation.

Important information about Ibudone®:

Get emergency help right away if you take too much Ibudone® (overdose). When you first start taking Ibudone®, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
Taking Ibudone® with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
Never give anyone else your Ibudone®. They could die from taking it. Store Ibudone® away from children and in a safe place to prevent stealing or abuse. Selling or giving away Ibudone® is against the law.

Ibudone® contains an NSAID. NSAIDs can cause serious side effects, including:

Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase:
◦ with increasing doses of medicine containing NSAIDs
◦ with longer use of medicine containing NSAIDs
Do not take NSAIDS right before or after a heart surgery called a “coronary artery bypass graft (CABG)."
Avoid taking NSAIDS after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.
Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines:
◦ any time during use
◦ without warning symptoms
◦ that may cause death
The risk of getting an ulcer or bleeding increases with:
◦ past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs
◦ taking medicines called “corticosteroids,” “anticoagulants,” “SSRIs,” or “SNRIs”
◦ increasing doses of NSAIDS
◦ older age
◦ longer use of NSAIDS
◦ poor health
◦ smoking
◦ advanced liver disease
◦ drinking alcohol
◦ bleeding problems

Do not take Ibudone®:

if you have severe asthma, trouble breathing, or other lung problems.
if you have a bowel blockage or have narrowing of the stomach or intestines.
if you have had an asthma attack, hives, or other allergic reaction with aspirin, other NSAIDs, or opioid medicine.
right before or after heart bypass surgery.

Before taking Ibudone®, tell your healthcare provider if you have a history of:

head injury or seizures
liver, kidney, or thyroid problems
problems urinating
pancreas or gallbladder problems
high blood pressure
asthma
abuse of street or prescription drugs, alcohol addiction, or mental health problems.

Tell your healthcare provider if you are:

pregnant or planning to become pregnant. Talk to your healthcare provider if you are considering taking Ibudone® during pregnancy. Prolonged use of Ibudone® during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. You should not take NSAIDs after 29 weeks of pregnancy.
breastfeeding or planning to breastfeed. Ibudone® passes into breast milk and may harm your baby.
taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Ibudone® with certain other medicines can cause serious side effects that could lead to death.

When taking Ibudone®:

Do not change your dose. Take Ibudone® exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
Take your prescribed dose every 4 to 6 hours, as needed. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
Call your healthcare provider if the dose you are taking does not control your pain.
If you have been taking Ibudone® regularly, do not stop taking it without talking to your healthcare provider.
After you stop taking Ibudone®, flush any unused tablets down the toilet or contact the Drug Enforcement Agency (DEA) to find the location of an authorized collector (1-800-882-9539) after you stop taking Ibudone®.

While taking Ibudone® DO NOT:

drive or operate heavy machinery, until you know how it affects you. Ibudone® can make you sleepy, dizzy, or lightheaded.
drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with Ibudone® may cause you to overdose and die.

The possible side effects of Ibudone®:

constipation, diarrhea, gas, heartburn, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain, heart attack, stroke, new or worse high blood pressure, heart failure, liver problems including liver failure, kidney problems including kidney failure, bleeding and ulcers in the stomach and intestine, low red blood cells (anemia), life-threatening skin reactions, life- threatening allergic reactions, asthma attacks in people who have asthma. Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help if you have:

trouble breathing or shortness of breath
agitation
fast heartbeat
high body temperature
chest pain
trouble walking
swelling of your face, tongue, or throat
stiff muscles
extreme drowsiness
mental changes such as confusion
lightheadedness when changing positions
weakness in one part or side of your body
a fainting spell
slurred speech

Stop Ibudone® and call your healthcare provider right away if you have any of the following symptoms:

nausea
flu-like symptoms
more tired or weaker than usual
vomit blood
diarrhea
there is blood in your bowel movement or it is black and sticky like tar
itching
unusual weight gain
your skin or eyes look yellow
skin rash or blisters with fever
indigestion or stomach pain
swelling of the arms and legs, hands and feet

These are not all the possible side effects of Ibudone®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov.

Other information:

Aspirin is an NSAID medicine, but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
Do not take other NSAID medicines, even those sold in lower doses without a prescription (over-the-counter) while taking Ibudone®. NSAIDs may be present in over-the-counter medications for treatment of colds, fever, or insomnia.

Manufactured for: Poly Pharmaceuticals, Inc. Huntsville, AL 35741

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Rev 5/17 8183126 R2

Ibudone

What is Ibudone (hydrocodone and ibuprofen)?

What happens if I overdose?

Before Using Ibudone

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of hydrocodone and ibuprofen

Dosing

Missed Dose

Storage

Uses of Ibudone

What are some other side effects of Ibudone?

How do I store and/or throw out Ibudone?

Clinical Studies

Precautions

Masking of Inflammation and Fever

Ophthalmological Effects

Information for Patients

Laboratory Monitoring

Drug Interactions

Carcinogenicity, Mutagenicity, Impairment of Fertility

Pregnancy

Nursing Mothers

Pediatric Use

Geriatric Use

Hepatic Impairment

Renal Impairment

Drug Abuse and Dependence

Controlled Substance

Abuse

Dependence

Medication Guide

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