Analgesia was assessed over 8 hours. Mean pain intensity difference PID scores were similar for hydrocodone with ibuprofen and oxycodone with acetaminophen at 0. The sum of the PID scores was similar for hydrocodone with ibuprofen and oxycodone with acetaminophen for the 0- to 3-, 0- to 4-, 0- to 6-, and 0- to 8-hour intervals. The median estimated time to onset of analgesia, mean peak PR score, median time to remedication, and mean global assessment score were similar for hydrocodone with ibuprofen and oxycodone with acetaminophen.
Though it helps many people, this medication may sometimes cause addiction. Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details. Upset stomach, nausea, vomiting, constipation, dizziness, lightheadedness, or drowsiness may occur.
If any of these effects persist or worsen, tell your doctor or pharmacist promptly. To prevent constipation, eat dietary fiber, drink enough water, and exercise. You may also need to take a laxative. Ask your pharmacist which type of laxative is right for you. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Stop taking this medication and get medical help right away if any of these very serious side effects occur:.
This drug may rarely cause serious, possibly fatal, liver disease. Stop taking this medication and get medical help right away if you have any symptoms of liver damage, including:. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
Call your doctor for medical advice about side effects. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at Before taking this medication, tell your doctor or pharmacist if you are allergic to ibuprofen or hydrocodone; or to aspirin or other NSAIDs such as naproxen, celecoxib ; or to other opioids such as benzhydrocodone, codeine, morphine, hydromorphone ; or if you have any other allergies.
This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of:. Problems are more likely to occur if you are dehydrated, have heart failure or kidney disease, are an older adult, or if you take certain medications see also Drug Interactions section. Drink plenty of fluids as directed by your doctor to prevent dehydration and tell your doctor right away if you have a change in the amount of urine.
This drug may make you dizzy or drowsy. Alcohol or marijuana cannabis can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana cannabis. Before having surgery, tell your doctor or dentist about all the products you use including prescription drugs, nonprescription drugs, and herbal products.
This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Avoid alcohol and stop smoking.
Consult your doctor or pharmacist for more information. During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor. See also Warning section.
This drug passes into breast milk and may have undesirable effects on a nursing infant. Tell the doctor right away if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breast-feeding.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions.
Do not start, stop, or change the dosage of any medicines without your doctor's approval. This medication may increase the risk of bleeding when taken with other drugs that also may cause bleeding. Examples include azole antifungals such as ketoconazole , macrolide antibiotics such as erythromycin , mifepristone, HIV medications such as ritonavir , rifamycins such as rifabutin, rifampin , certain drugs used to treat seizures such as carbamazepine, phenytoin , among others.
These drugs are similar to ibuprofen, so taking one of these drugs while also taking ibuprofen may increase your risk of side effects. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention usually at dosages of milligrams a day , you should continue taking the aspirin unless your doctor instructs you otherwise. Talk to your doctor about using a different medication such as acetaminophen to treat pain. Take this product at least 8 hours before or at least 2 hours after your aspirin dose.
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.
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.
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.
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. 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. 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. 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. 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.
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.
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:. 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. 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. If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
Keep from freezing. Store the medicine in a safe and secure place. Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.
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.
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