Pronunciation:

hye-droe-KOE-done bye-tar-trate, eye-byoo-PROE-fen

Brand Names:

• Ibudone
• Reprexain
• Vicoprofen

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Opioid/NSAID Combination

Pharmacologic—

NSAID

Chemical—

Hydrocodone

Uses of This Medicine:

Hydrocodone and ibuprofen 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.

Before Using This Medicine:

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.

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.

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.

Other medicines—

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

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or 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:

• 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

Proper Use of This Medicine:

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 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—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—

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.

Precautions While Using This Medicine:

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.

Serious side effects can occur during treatment with this medicine. Sometimes serious side effects can occur without any warning. However, possible warning signs often occur, including swelling of the face, fingers, feet, and/or lower legs; severe stomach pain, black, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; unusual weight gain; and/or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in chest, fast or irregular heartbeat, or unusual flushing or warmth of skin. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs.

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.

Side Effects of This Medicine:

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

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

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 may also occur in some patients. If you notice any other effects, check with your healthcare professional.