Hydrocodone and ibuprofen (oral route)


    Brand Name

    US Brand Name

    Ibudone

    Reprexain

    Vicoprofen

    Canadian Brand Name

    Codofen

    Ibucodone


    Description

    Hydrocodone and ibuprofen combination is used to relieve short-term pain severe enough to require opioid treatment and when other pain medicines did not work well enough or cannot be tolerated. This medicine should only be used for short periods of time, usually for a total of less than 10 days. This combination is not used for osteoarthritis or rheumatoid arthritis.

    Hydrocodone is an opioid analgesic that acts on the central nervous system to relieve pain. If hydrocodone is used for a long time, it may become habit-forming (causing mental or physical dependence). However, people who have continuing pain should not let the fear of dependence keep them from using opioids to relieve their pain. Mental dependence (addiction) is less likely to occur when opioids are used for this purpose. Physical dependence may lead to withdrawal symptoms when you stop taking the medicine. Since hydrocodone and ibuprofen combination is only used for short-term (10 days or less) relief of pain, physical dependence will probably not occur.

    Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that is used in this combination to relieve inflammation, swelling, and pain.

    This medicine is available only under a restricted distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.

    This product is available in the following dosage forms:

    • Tablet

    Before Using

    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, heart, lung, or stomach problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

    Breastfeeding

    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.

    Drug Interactions

    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
    • Naltrexone
    • Safinamide
    • Samidorphan

    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.

    • Abametapir
    • Abciximab
    • Aceclofenac
    • Acemetacin
    • Acenocoumarol
    • Acepromazine
    • Aclidinium
    • Alfentanil
    • Almotriptan
    • Alprazolam
    • Amantadine
    • Amifampridine
    • Amiloride
    • Amineptine
    • Amiodarone
    • Amitriptyline
    • Amitriptylinoxide
    • Amobarbital
    • Amoxapine
    • Amphetamine
    • Amprenavir
    • Amtolmetin Guacil
    • Anagrelide
    • Anileridine
    • Apalutamide
    • Apixaban
    • Aprepitant
    • Ardeparin
    • Argatroban
    • Aripiprazole
    • Aripiprazole Lauroxil
    • Armodafinil
    • Asciminib
    • Asenapine
    • Aspirin
    • Atazanavir
    • Atropine
    • Avacopan
    • Baclofen
    • Balsalazide

    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
    • Amikacin
    • Atenolol
    • Azilsartan
    • Azilsartan Medoxomil
    • Benazepril
    • Betaxolol
    • Bisoprolol
    • Candesartan
    • Captopril
    • Carteolol
    • Carvedilol
    • Celiprolol
    • Enalapril
    • Enalaprilat
    • Eprosartan
    • Esmolol
    • Fosinopril
    • Irbesartan
    • Labetalol
    • Levobunolol
    • Lisinopril
    • Losartan
    • Metipranolol
    • Metoprolol
    • Moexipril
    • Nadolol
    • Nebivolol
    • Olmesartan
    • Oxprenolol
    • Penbutolol
    • Perindopril
    • Pindolol
    • Propranolol
    • Quinapril
    • Ramipril
    • Sotalol
    • Spirapril
    • Telmisartan
    • Timolol

    Other Interactions

    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
    • Tobacco

    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's disease (adrenal gland problem) or
    • Alcohol use disorder, or history of or
    • Brain tumor or
    • Breathing problems (eg, COPD, cor pulmonale, hypercapnia, hypoxia) or
    • Dehydration or
    • Depression, or history of or
    • Drug use disorder or dependence, especially opioids, or history of or
    • Enlarged prostate (BPH, prostatic hypertrophy) or
    • Head injury, history of or
    • Hypothyroidism (underactive thyroid) or
    • Hypovolemia (low blood volume) or
    • Kidney disease, severe or
    • Liver disease, severe or
    • Problems with urination or
    • Systemic lupus erythematosus (SLE) or
    • Weakened physical condition—Use with caution. May increase risk for more serious side effects.
    • Anemia or
    • Bleeding problems or
    • Edema (fluid retention) or
    • Gallbladder problems or
    • Heart attack, history of or
    • Heart disease (eg, congestive heart failure) or
    • Hypertension (high blood pressure) or
    • Hypotension (low blood pressure) or
    • Kidney disease or
    • Liver disease or
    • Pancreatitis (swelling of the pancreas) or
    • Seizures, history of or
    • Stomach or bowel problems (eg, peptic ulcer disease, bleeding), history of or
    • Stroke, history of—Use with caution. May make these conditions worse.
    • Aspirin-sensitive asthma or
    • Aspirin sensitivity, history of or
    • Asthma, acute or severe or
    • Lung breathing problems (eg, respiratory depression) or
    • Stomach or bowel blockage (eg, paralytic ileus)—Should not be used in patients with these conditions.
    • Coagulopathy (bleeding disorder) or
    • Liver disease, advanced—May increase risk of stomach or bowel bleeding.
    • Dehydration or
    • Hypovolemia—Must be corrected first before using this medicine.
    • Heart surgery (eg, coronary artery bypass graft [CABG])—Should not be used to relieve pain right before or after the surgery.

    Proper Use

    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. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. Taking too much of this medicine may increase the chance of unwanted effects, it may become habit-forming (causing mental or physical dependence) or cause an overdose.

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

    Swallow the 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. Your doctor may adjust your dose 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, 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.

    Store the medicine in a safe and secure place. Drop off any unused opioid medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused opioid 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

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

    Using this medicine during the later part of pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

    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.

    If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Your doctor may also give naloxone to treat an overdose. Naloxone is a medicine that temporarily reverses the effects of an overdose. If you have been prescribed naloxone, make sure household members know how to use this on you in the event of an overdose or suspected overdose. Emergency medical attention is still needed after naloxone is used because the reversal effects are only temporary. Signs of an overdose include: trouble breathing, irregular, fast or slow, or shallow breathing, nausea or vomiting, pain in the upper stomach, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, or yellow eyes or skin.

    Do not use this medicine and an MAO inhibitor (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within 14 days of each other.

    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 adrenal gland problems. 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.

    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 dizziness or lightheadedness.

    This medicine may increase your risk of having a heart attack, heart failure, or stroke. This is more likely to occur in people who already have heart disease. People who use this medicine for a long time might also have a higher risk. Some signs of serious heart problems are chest pain, tightness in the chest, fast or irregular heartbeat, or unusual flushing or warmth of the skin. Check with your doctor right away if you notice any of these warning signs.

    This medicine may cause bleeding in your stomach or bowels. These problems can happen without warning signs. This is more likely to occur if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or are using certain other medicines (eg, steroids or a blood thinner). Call your doctor right away if you have severe stomach pain, black, tarry stools, or are vomiting blood or material that looks like coffee grounds.

    Check with your doctor right away if you or your child 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.

    Your blood pressure might get too high while you are using this medicine. This may cause headaches, dizziness, or blurred vision. You might need to measure your blood pressure at home. If you think your blood pressure is too high, call your doctor right away.

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

    This medicine may cause serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.

    This medicine may cause a delay in ovulation for women and may affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.

    Using this medicine while you are pregnant may cause neonatal 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.

    Call your doctor right away if you have worsening of pain, increased sensitivity to pain, or new pain after taking this medicine. These may be symptoms of opioid-induced hyperalgesia and allodynia.

    This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, sleeping medicine, or other prescription pain medicine or opioids, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Do not drink alcoholic beverages, and check with your medical doctor or dentist before taking any of the medicines listed above while you are using this medicine.

    Do not change your dose or suddenly stop using this medicine 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 prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as anxiety, fever, nausea, runny nose, stomach cramps, sweating, tremors, or trouble with sleeping.

    This medicine may cause some people to become drowsy, dizzy, or lightheaded, or to feel a false sense of well-being. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

    Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

    Hydrocodone and ibuprofen combination may cause dry mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if you take this medicine for a long time and dry mouth continues for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

    Call your doctor right away if you have confusion, drowsiness, fever, a general feeling of illness, a headache, loss of appetite, nausea, a stiff neck or back, or vomiting. These could be symptoms of a serious condition called aseptic meningitis.

    Check with your doctor immediately if blurred vision, difficulty with reading, or any other change in vision occurs during or after your treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

    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.

    This medicine may cause constipation. This is more common if you use it for a long time. Ask your doctor if you should also use a laxative to prevent and treat constipation.

    Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

    This medicine may cause hyperkalemia (high potassium in the blood). Check with your doctor right away if you have confusion, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, stomach pain, difficult breathing, or weakness or heaviness of the legs.

    Using too much of this medicine may cause infertility (unable to have children) and may cause a delay in ovulation for women and may affect their ability 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

    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:

    Rare

    • Bloody stools
    • burning feeling in the chest or stomach
    • changes in facial skin color
    • chest tightness
    • cough
    • diarrhea
    • difficulty with swallowing
    • fast or irregular breathing
    • fever
    • frequent urge to urinate
    • heartburn
    • inability to urinate
    • irregular heartbeat
    • lightheadedness or dizziness
    • loss of bladder control
    • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    • ringing or buzzing in the ears
    • trouble breathing
    • skin rash, hives, or itching
    • stomach pain or tenderness
    • visual disturbances
    • yellow eyes or skin

    Incidence not known

    • Agitation
    • confusion
    • darkening of the skin
    • difficulty swallowing
    • dizziness
    • fainting
    • fever
    • increased sensitivity to pain
    • loss of appetite
    • mental depression
    • nausea
    • overactive reflexes
    • poor coordination
    • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    • restlessness
    • shivering
    • talking or acting with excitement you cannot control
    • trembling or shaking
    • twitching
    • unusual tiredness or weakness
    • vomiting
    • worsening of pain

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

    Symptoms of overdose

    • Blurred vision
    • cold or clammy skin
    • confusion
    • difficulty hearing or ringing or buzzing in the ears
    • dizziness
    • general feeling of illness
    • headache
    • mood or mental changes
    • nausea
    • severe drowsiness
    • severe stomach pain
    • skin rash
    • slow heartbeat
    • stiff neck or back
    • swelling of the face, fingers, feet, or lower legs
    • vomiting

    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

    • Anxiety
    • constipation
    • dry mouth
    • gas
    • increased sweating
    • nervousness
    • pounding heartbeat
    • sleepiness
    • trouble in sleeping

    Rare

    • Decreased appetite
    • decrease in sexual ability
    • headache
    • heartburn
    • increased thirst
    • irritability
    • mood or mental changes
    • mouth ulcers
    • pain or burning in the throat
    • runny nose
    • sensation of burning, warmth, heat, numbness, tightness, or tingling
    • slurred speech
    • stomach upset
    • thinking abnormalities
    • unexplained weight loss
    • unusual feeling of well-being

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

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.






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