In the U.S.—

• Analgesic

Hydrocodone and ibuprofen ( hye-droe-KOE-done and eye-byoo-PROE-fen) combination is used to relieve pain.

The hydrocodone is a narcotic analgesic that acts in 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). Physical dependence may lead to withdrawal side effects 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) used in this combination to relieve inflammation, swelling, and pain.

This medicine is available only with your doctor's prescription, in the following dosage form(s):

Oral
• Tablets (U.S.)

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 hydrocodone and ibuprofen combination, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to aspirin, hydrocodone or other narcotic analgesics, or ibuprofen or other nonsteroidal anti-inflammatory drugs (NSAIDs). Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies on birth defects with hydrocodone and ibuprofen combination have not been done in pregnant women. However, there is a chance that the ibuprofen in this combination may cause unwanted effects on the heart or blood flow of the fetus or newborn baby if they are taken during the last few months of pregnancy. Also, too much use during pregnancy of a narcotic analgesic like the hydrocodone in the combination may cause the baby to become dependent on the medicine. This may lead to withdrawal side effects after birth. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether hydrocodone and ibuprofen combination passes into breast milk. However, hydrocodone and ibuprofen combination is not recommended for use during breast-feeding because it may cause unwanted effects in nursing babies.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of hydrocodone and ibuprofen combination in children with its use in other age groups.

Older adults—Elderly people are especially sensitive to the effects of hydrocodone and ibuprofen combination. This may increase the chance of side effects during treatment. Constipation may be especially likely to occur in elderly patients.

Other 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 hydrocodone and ibuprofen combination, it is especially important that your health care professional know if you are taking any of the following:

• Alcohol or
• Central nervous system (CNS) depressants (medicine that causes drowsiness) or
• Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate]) or
• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Pertofrane], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil]—The chance of side effects may be increased

• Anticoagulants (blood thinners)—The chance of bleeding may be increased

• Angiotensin-converting enzyme (ACE) inhibitors (benazepril [e.g., Lotensin], captopril [e.g., Capoten], enalapril [e.g., Vasotec], fosinopril [e.g., Monopril], lisinopril [e.g., Prinivil, Zestril], quinapril [e.g., Accupril], ramipril [e.g., Altace] or
• Diuretics (water pills)—Hydrocodone and ibuprofen combination may decrease the effects of these medicines; the chance of kidney problems also may be increased

• Lithium (e.g., Lithane) or
• Methotrexate (e.g., Mexate)—Higher blood levels of these medicines and an increased chance of side effects may occur

• Asthma or other chronic lung disease or
• Brain disease or head injury or
• Enlarged prostate or problems with urination—Side effects of hydrocodone and ibuprofen combination may be dangerous with these conditions
• Abdominal conditions or
• Anemia or
• Alcohol abuse, or history of, or
• Bleeding problems or
• Dehydration or
• Drug dependence, especially narcotic abuse, or history of or
• Heart disease or
• Kidney disease or
• Liver disease or
• Stomach ulcer or
• Tobacco use or
• Underactive thyroid—The chance of side effects may be increased

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 health care professional. Taking too much of this medicine may increase the chance of unwanted effects.

Dosing—

The dose of hydrocodone and ibuprofen combination 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 hydrocodone and ibuprofen combination. If your dose is different, do not change it unless your doctor tells you to do so.

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 taking hydrocodone and ibuprofen combination .

• For oral dosage form (tablets):
  • For pain:
    • Adults—1 tablet of Vicoprofen every four to six hours as needed.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Hydrocodone and ibuprofen combination will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, sleeping medicine, or other prescription pain medication. 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.

This medicine may cause some people to become drowsy, dizzy, or lightheaded, or to feel a false sense of well-being. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert and clearheaded. If these reactions are especially bothersome, check with your doctor.

Dizziness, lightheadedness, or fainting may occur, especially when getting up suddenly from a lying or sitting position. Getting up slowly may lessen this problem.

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 dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if 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.

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 as soon as possible if any of the following side effects occur:

• Less common or rare
  • Bloody stools;  burning feeling in chest or stomach;  congestion in chest;  changes in facial skin color;  cough;  diarrhea;  difficulty in 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;  ringing or buzzing in the ears;  shortness of breath, troubled breathing, tightness in chest and/or wheezing;  skin rash, hives, and/or itching;  stomach pain;  tenderness in stomach 
  
  

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

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Anxiety;  constipation;  dry mouth;  gas;  increased sweating;  nausea and/or vomiting;  nervousness;  pounding heartbeat;  sleepiness;  swelling of feet or lower legs;  trouble in sleeping;  unusual tiredness or weakness 
  
  

• Less common or rare
  • Confusion;  decreased appetite;  decrease in sexual ability;  depression ;  headache;  heartburn;  increased thirst;  irritability;  mood or mental changes;  mouth ulcers ;  pain or burning in throat;  runny nose;  sensation of burning, warmth, heat, numbness, tightness, or tingling;  slurred speech;  stomach upset;  thinking abnormalities ;  trembling or shaking of hands or feet;  unexplained weight loss;  unusual feeling of well-being;  visual disturbances 
  
  

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