Pronunciation:

roe-fe-KOX-ib

Brand Names:

• Vioxx

Dosage Forms:

• Suspension
• Tablet

Classifications:

Therapeutic

Analgesic

Pharmacologic

Cyclooxygenase-2 Inhibitor

Uses of This Medicine:

Rofecoxib is used to relieve some symptoms caused by arthritis, such as inflammation, swelling, stiffness, and joint pain. However, this medicine does not cure arthritis and will help you only as long as you continue to take it.

Rofecoxib is also used to relieve other kinds of pain, such as menstrual cramps, and pain following surgery.

This medicine was available with your doctor's prescription.

Rofecoxib was voluntarily withdrawn from the U.S. and worldwide market September 30, 2004 due to safety concerns of an increased risk for heart problems .

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 the use of rofecoxib in children with use in older age groups.

Older adults

This medicine has been tested in a limited number of elderly patients 65 years of age and older and has not been shown to cause different side effects or problems in older people than it does in younger adults.

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

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 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.

• Pemetrexed
• Theophylline
• Tizanidine

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.

• Aspirin
• Bemetizide
• Bendroflumethiazide
• Benzthiazide
• Buthiazide
• Candesartan Cilexetil
• Chlorothiazide
• Chlorthalidone
• Clopamide
• Cyclopenthiazide
• Cyclothiazide
• Desvenlafaxine
• Duloxetine
• Eprosartan
• Hydrochlorothiazide
• Hydroflumethiazide
• Indapamide
• Irbesartan
• Lithium
• Losartan
• Methotrexate
• Methyclothiazide
• Metolazone
• Milnacipran
• Olmesartan Medoxomil
• Polythiazide
• Quinethazone
• Rifampin
• Tasosartan
• Telmisartan
• Trichlormethiazide
• Valsartan
• Venlafaxine
• Warfarin
• Xipamide

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:

• Alcohol abuse or
• Bleeding problems or
• Stomach ulcer or other stomach or intestinal problems
• Tobacco use (or recent history of) The chance of side effects may be increased.

• Anemia or
• Asthma or
• Dehydration or
• Fluid retention (swelling of feet or lower legs) or
• Heart disease or
• High blood pressure or
• Kidney disease or
• Liver disease Rofecoxib may make these conditions worse.

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.

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:

If you will be taking this medicine for a long time, your doctor should check your progress at regular visits.

Stomach problems may be more likely to occur if you drink alcoholic beverages while being treated with this medicine. Therefore, do not regularly drink alcoholic beverages while taking this medicine, unless otherwise directed by your doctor.

Taking two or more of the nonsteroidal anti-inflammatory drugs together on a regular basis may increase the chance of unwanted effects. Also, taking acetaminophen, aspirin or other salicylates, or ketorolac (e.g., Toradol) regularly while you are taking a nonsteroidal anti-inflammatory drug may increase the chance of unwanted effects. The risk will depend on how much of each medicine you take every day, and on how long you take the medicines together. If your health care professional directs you to take these medicines together on a regular basis, follow his or her directions carefully. However, do not take acetaminophen or aspirin or other salicylates together with this medicine for more than a few days, and do not take any ketorolac (e.g., Toradol) while taking this medicine, unless your doctor has directed you to do so and is following your progress.

Serious side effects can occur during treatment with this medicine. Sometimes serious side effects can occur without warning. However, possible warning signs often occur, including severe stomach pain, black tarry stools, and/or vomiting of blood or material that looks like coffee grounds; skin rash; swelling of the face, fingers, feet, and/or lower legs. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs.

Rofecoxib may cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur often in patients who are allergic to aspirin or other nonsteroidal anti-inflammatory drugs. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in skin color of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once. Ask someone to drive you to the nearest hospital emergency room. Call an ambulance, lie down, cover yourself to keep warm, and prop your feet higher than your head. Stay in that position until help arrives.

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:

More common

Congestion in chest

cough

fever

sneezing

sore throat

Less common or rare

Bloody or black, tarry stools

burning feeling in chest or stomach

chills

hives

loss of appetite

muscle aches and pain

prolonged or severe vomiting

shortness of breath

skin rash

tenderness in the stomach area

unusual weight gain

vomiting of blood or material that looks like coffee grounds

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

Back pain

diarrhea

dizziness

headache

heartburn

loss of energy or weakness

nausea

stuffy or runny nose

swelling of legs and feet

Less common or rare

Blurred vision

constipation

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.