Ibudone: Adult Dosing

Dosage forms: 5/200,10/200

pain, acute

1 tab PO q4-6h prn

Max: 5 tab/day; Info: use lowest effective dose, shortest tx duration

renal dosing

see below

advanced renal dz: avoid use

hepatic dosing

see below

severe impairment: caution advised

Ibudone: Peds Dosing

Dosage forms: 5/200,10/200

pain, acute

>16 yo

Dose: 1 tab PO q4-6h prn; Max: 5 tab/day; Info: use lowest effective dose, shortest tx duration

renal dosing

see below

advanced renal dz: avoid use

hepatic dosing

see below

severe impairment: caution advised

Ibudone: Contraindications/Cautions

• hypersens. to drug/class/compon.
• ASA/NSAID-induced asthma or urticaria
• aspirin triad
• respiratory depression
• paralytic ileus
• pregnancy, 3rd trimester
• CABG surgery (periop pain)
• caution if cardiovascular dz
• caution if HTN
• caution if CHF
• caution if fluid retention
• caution if cor pulmonale
• caution if asthma, COPD
• caution if impaired pulm. fxn
• caution if acute abdomen
• caution if biliary dz
• caution if shock
• caution if CNS depression
• caution if head injury
• caution if incr. ICP
• caution if seizure disorder
• caution if PUD/GI bleed hx, risk factors
• caution if coagulopathy
• caution in elderly or debilitated pts
• caution if impaired renal fxn, severe
• caution if impaired liver fxn, severe
• caution if alcohol/drug abuse
• caution if hypothyroidism
• caution if adrenal insufficiency
• caution if urinary tract obstruction

Ibudone: Drug Interactions

Contraindicated

• cidofovir

Avoid/Use Alternative

• acetaminophen/propoxyphene

• amiodarone

• aspirin, buffered/pravastatin

• beta blocker/thiazide combos

• beta blockers, systemic

• COX 2 inhibitors

• cyclosporine

• drotrecogin alfa

• ethanol

• fondaparinux

• heparins

• imatinib

• lansoprazole/naproxen

• lopinavir/ritonavir

• methotrexate

• mycophenolate mofetil

• pentosan polysulfate sodium

• potassium salts

• probenecid

• propafenone

• quinidine

• ritonavir

• sirolimus

• sodium oxybate

• sumatriptan/naproxen sodium

• tacrolimus

• terbinafine

• tipranavir

• warfarin

Monitor/Modify Tx

• A2R blocker/HCTZ combos

• ACE inhibitor/HCTZ combos

• ACE inhibitors

• acetaminophen/butalbital

• acetaminophen/caffeine/CNS depressant combos

• acetaminophen/opiate combos

• acetaminophen/tramadol

• acetaminophens

• adefovir

• amlodipine/A2R blocker combos

• angiotensin II receptor blockers

• dexmedetomidine

• diuretics, potassium-sparing

• diuretics, potassium-sparing/HCTZ

• drospirenone

• enalapril/felodipine

• eplerenone

• hydralazine

• hydralazine/isosorbide dinitrate

• lithium

• metformin/sulfonylurea combos

• pegvisomant

• zoledronic acid

Therapeutic Advantage

• local anesthetics

• local anesthetics/epinephrine

• opiate antagonists

Caution Advised

• anticholinergics

• antidepressants, other

• antihist/decongest/DM combos

• antihist/decongestant combos

• antiplatelets

• aspirin

• aspirin/butalbital/caffeine

• aspirin/butalbital/caffeine/codeine

• aspirin/caffeine/dihydrocodeine

• aspirin/caffeine/orphenadrine

• aspirin/dipyridamole

• aspirin/muscle relaxant combos

• aspirin/opiate combos

• azelastine nasal

• bisphosphonates, oral

• budesonide

• bupropion

• BZDs, all

• cannabinoids

• central alpha 2 agonists

• cetirizine

• chlorpromazine

• cinacalcet

• corticosteroids, systemic

• dantrolene

• darifenacin

• darunavir

• dasatinib

• desvenlafaxine

• diclofenac topical

• disopyramide

• diuretics, loop

• diuretics, thiazide

• donepezil

• doxazosin

• droperidol

• fluphenazine

• fluvoxamine

• gabapentin

• galantamine

• iloprost inhaled

• leflunomide

• levocetirizine

• loperamide

• maraviroc

• meperidine/promethazine

• meprobamate

• methadone

• metoclopramide

• mitotane

• muscle relaxants

• neostigmine

• NSAIDs

• olanzapine/fluoxetine

• omega-3-acid

• opiate agonist/antagonists

• opiates

• oxcarbazepine

• perphenazine

• pimozide

• platelet GP IIb/IIIa inhibitors

• pramipexole

• pregabalin

• prochlorperazine

• promethazine

• promethazine/codeine

• propoxyphene

• pyridostigmine

• quinolones, all

• ranolazine

• rivastigmine

• ropinirole

• rotigotine transdermal

• sedative/hypnotics

• SSRIs 1 (2D6 inhibitors)

• succinylcholine

• sulfinpyrazone

• tacrine

• thalidomide

• thioridazine

• thrombin inhibitors

• thrombolytics

• tiagabine

• tramadol

• tricyclic antidepressants

• trifluoperazine

• valproic acid derivatives

• ziconotide intrathecal

Ibudone: Adverse Reactions

Serious Reactions

• CNS depression
• respiratory depression
• dependency, abuse
• GI bleed
• GI ulceration/perforation
• paralytic ileus
• biliary spasm
• cholestatic jaundice
• nephrotoxicity
• renal papillary necrosis
• hepatotoxicity, incl. fatal (rare)
• anaphylactoid rxns
• bronchospasm
• incr. ICP
• aseptic meningitis (rare)
• seizures (rare)
• anemia
• prolonged bleeding time
• thrombocytopenia
• agranulocytosis
• hypotension, severe
• HTN
• MI
• CHF
• stroke
• thromboembolism
• exfoliative dermatitis
• Stevens-Johnson syndrome
• toxic epidermal necrolysis

Common Reactions

• headache
• somnolence
• constipation
• nausea
• dizziness
• dyspepsia
• abdominal pain
• xerostomia
• vomiting
• asthenia
• diarrhea
• flatulence
• diaphoresis
• edema/fluid retention
• pruritus
• nervousness
• anxiety
• insomnia
• gastritis
• vasodilation
• confusion
• anorexia
• urinary frequency
• abnormal thinking
• euphoria
• tinnitus
• urinary retention
• elevated liver transaminases
• hypertonia
• ecchymosis

Ibudone: Safety Monitoring

Pregnancy: C, see Contraind/Caut.

Lactation: Safety Unknown

Monitoring Parameters: Cr at baseline, then if severe renal dz cont. periodically; LFTs if severe hepatic dz; BP

Avoid Abrupt Cessation: taper dose gradually to D/C if at risk for physical dependence (abrupt cessation of opioids may cause a withdrawal syndrome including restlessness, irritability, anxiety, insomnia, mydriasis, lacrimation, rhinorrhea, sneezing, yawning, perspiration, incr. body temp., chills, piloerection, myalgia, backache, arthralgia, weakness, abdominal and muscle cramps, muscle twitching, anorexia, nausea, vomiting, diarrhea, incr. BP, respiratory rate, heart rate)

Ibudone: Pharmacology

Metabolism: see individual drugs (ibuprofen); for hydrocodone: liver extensively; CYP450: 2D6, 3A4 substrate; Info: active metabolite

Excretion: see individual drugs (ibuprofen); for hydrocodone: renal; Half-life: 3.8h

Class: Narcotics, combos

Mechanism Of Action
hydrocodone binds to various opioid receptors, producing analgesia and sedation; ibuprofen exact mechanism of action unknown, inhibits cyclooxygenase and lipoxygenase and reduces prostaglandin synthesis

Ibudone: Manufacturer/Pricing

Manufacturer: ProEthic Pharmaceuticals, Inc. DEA/FDA: Schedule III

Ibudone: Patient Education

• Generic Name: hydrocodone and ibuprofen

• Pronounced: hye dro KOE done and eye byoo PRO fen

• Brand Names: Reprexain, Vicoprofen

What is the most important information I should know about hydrocodone and ibuprofen?

Ibuprofen can increase your risk of heart attack or stroke. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG). Seek emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

Ibuprofen can also increase your risk of serious effects on the stomach or intestines. These conditions can be fatal and can occur without warning at any time while you are taking ibuprofen. Call your doctor at once if you have black, bloody, or tarry stools, or if you cough up blood or vomit that looks like coffee grounds.

Hydrocodone may be habit-forming and should be used only by the person this medicine was prescribed for. Keep the medication in a secure place where others cannot get to it.

Avoid drinking alcohol while taking hydrocodone and ibuprofen. Alcohol may increase your risk of stomach bleeding while taking ibuprofen.

Tell your doctor if the medicine seems to stop working as well in relieving your pain.

What is hydrocodone and ibuprofen?

Hydrocodone is in a group of drugs called narcotic pain relievers.

Ibuprofen is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Ibuprofen works by reducing hormones that cause inflammation and pain in the body.

The combination of hydrocodone and ibuprofen is used short-term to relieve severe pain. This medication is not for treating arthritis pain.

Hydrocodone and ibuprofen may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking hydrocodone and ibuprofen?

Do not use this medication if you are allergic to hydrocodone or ibuprofen (Advil, Motrin).

Hydrocodone may be habit-forming and should be used only by the person this medicine was prescribed for. Never give this medication to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Taking ibuprofen can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Ibuprofen can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning at any time while you are taking ibuprofen.

Do not use this medication if you are allergic to ibuprofen (Advil, Motrin) or other NSAIDs such as Aleve, Orudis, Indocin, Lodine, Voltaren, Toradol, Mobic, Relafen, Feldene, and others.

Before using hydrocodone and ibuprofen, tell your doctor if you have:

• heart disease, congestive heart failure, high blood pressure, or a history of heart attack, stroke, or blood clot;
• asthma or other breathing disorders;
• liver or kidney disease;
• a history of head injury or brain tumor;
• stomach or intestinal disorder, history of stomach ulcer or bleeding;
• underactive thyroid, Addison's disease or other adrenal gland disorder;
• curvature of the spine;
• an enlarged prostate or problems with urination; or
• mental illness or a history of drug or alcohol addiction.

If you have any of these conditions, you may not be able to use hydrocodone and ibuprofen, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby, and could cause breathing problems or addiction/withdrawal symptoms in a newborn. Taking ibuprofen during the last 3 months of pregnancy may result in birth defects. Do not take hydrocodone and ibuprofen during pregnancy unless your doctor has told you to.

Hydrocodone and ibuprofen may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may be more sensitive to the effects of this medicine.

How should I take hydrocodone and ibuprofen?

Take this medication exactly as it was prescribed for you. Do not take it in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Drink 6 to 8 full glasses of water daily to help prevent constipation while you are taking hydrocodone and ibuprofen. Ask your doctor about ways to increase the fiber in your diet. Do not use a stool softener (laxative) without first asking your doctor.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using hydrocodone and ibuprofen.

Store hydrocodone and ibuprofen at room temperature away from moisture and heat.

Keep track of how many tablets have been used from each new bottle of this medicine. Hydrocodone is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

What happens if I miss a dose?

Since hydrocodone and ibuprofen is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of hydrocodone and ibuprofen can be fatal.

Overdose symptoms may include extreme drowsiness, pinpoint pupils, nausea, vomiting, dark urine, jaundice (yellowing of the skin or eyes), black or bloody stools, coughing up blood, urinating less than usual or not at all, confusion, ringing in your ears, fainting, weak pulse, slow heart rate, coma, blue lips, shallow breathing, or no breathing.

What should I avoid while taking hydrocodone and ibuprofen?

This medication 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.

Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain ibuprofen or similar medicines. Read the label of any other medicine you are using to see if it contains ibuprofen, ketoprofen, or naproxen.

Avoid drinking alcohol while taking hydrocodone and ibuprofen. Alcohol can increase the risk of stomach bleeding caused by ibuprofen.

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, antidepressants, or seizure medication can add to sleepiness caused by hydrocodone, or could slow your breathing. Tell your doctor if you need to use any of these other medicines while you are taking hydrocodone and ibuprofen.

What are the possible side effects of hydrocodone and ibuprofen?

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

Call your doctor at once if you have any of these serious side effects:

• chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
• black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee ground;
• swelling or rapid weight gain;
• shallow breathing, slow heartbeat;
• confusion, feeling light-headed, fainting;
• easy bruising or bleeding;
• nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• severe blistering, peeling, and red skin rash; or
• fever, headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions).

Less serious side effects include:

• headache, dizziness, drowsiness;
• mild nausea, vomiting, upset stomach, constipation, diarrhea;
• blurred vision; or
• dry mouth.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect hydrocodone and ibuprofen?

Before taking this medication, tell your doctor if you are using any of the following drugs:

• antidepressants such as amitriptyline (Elavil, Etrafon) or imipramine (Janimine, Tofranil);
• an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate);
• aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as diclofenac (Voltaren), etodolac (Lodine), indomethacin (Indocin), naproxen (Aleve, Naprosyn), and others;
• an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), and others;
• lithium (Eskalith, Lithobid);
• a bronchodilator (such as Atrovent, Spiriva), diuretics (water pills), steroid medicines, or blood thinners;
• methotrexate (Rheumatrex, Trexall);
• atropine (Donnatal), dimenhydrinate (Dramamine), or scopolamine (Transderm-Scop);
• bowel or bladder medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin), tolterodine (Detrol) and others;

If you are using any of these drugs, you may not be able to use hydrocodone and ibuprofen, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect hydrocodone and ibuprofen. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist has information about hydrocodone and ibuprofen written for health professionals that you may read.

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Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise.

Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides.

The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Ibudone: Pill Pictures

This information is currently unavailable or not applicable for this drug.