Pronunciation:

peer-OX-i-kam

Brand Names:

• Feldene
• Alti-Piroxicam

Dosage Forms:

• Capsule
• Tablet

Warnings:

• CARDIOVASCULAR RISK
  • NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk

• Piroxicam is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery .

• GASTROINTESTINAL RISK
  • NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events .

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Piroxicam is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal .

Classifications:

Therapeutic—

Analgesic

Pharmacologic—

NSAID

Chemical—

Oxicam

Uses of This Medicine:

Piroxicam is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain and help relieve symptoms of arthritis (osteoarthritis and rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain. This medicine does not cure arthritis and will help you only as long as you continue to take it .

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—

Appropriate studies have not been performed on the relationship of age to the effects of piroxicam in the pediatric population. Safety and efficacy have not been established .

Older adults—

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of piroxicam in the elderly. However, elderly patients may be more sensitive to the effects of piroxicam than younger adults, and are more likely to have age-related kidney problems, which may require adjustment of dosage in patients receiving piroxicam .

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—

Studies in women suggest that this medication poses minimal risk to the infant when used during 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

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:

• Anemia or
• Asthma or
• Bleeding problems or
• Blood clots or
• Edema (fluid retention or body swelling) or
• Heart attack, history of or
• Heart disease (e.g., congestive heart failure) or
• High blood pressure or
• Kidney disease or
• Liver disease (e.g., hepatitis) or
• Stomach or intestinal ulcers or bleeding or
• Stroke, history of—Use with caution. This medicine may make these conditions worse .

• Aspirin sensitivity, history of—This medicine should NOT be used in patients with this condition .

• Heart surgery (e.g., coronary artery bypass graft [CABG] surgery)—This medicine should NOT be used to relieve pain right before or after the surgery .

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 doctor. Taking too much of this medicine may increase the chance of unwanted effects, especially in elderly patients .

When used for severe or continuing arthritis, this medicine must be taken regularly as ordered by your doctor in order for it to help you. This medicine usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of this medicine.

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 (capsules):
  • For osteoarthritis and rheumatoid arthritis:
    • Adults—20 milligrams (mg) once a day or 10 mg twice a day.
    • 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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. 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 .

This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk .

This medicine may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years old, if you are in poor health, or if you are using certain other medicines (a steroid or a blood thinner) .

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, loosening of skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores, ulcers, white spots in mouth or on lips, or unusual tiredness or weakness .

Possible warning signs of some serious side effects that can occur during treatment with this medicine may include 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; yellow skin or eyes; decreased urination; unusual bleeding or bruising; and/or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in chest, fast or irregular heartbeat, unusual flushing or warmth of skin, weakness, or slurring of speech. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs .

This medicine may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or to any of the 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 color of the skin of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once .

Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away .

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

Before having any kind of surgery or medical tests, tell your doctor that you are taking this medicine. It may be necessary for you to stop treatment for a while, or to change to a different nonsteroidal anti-inflammatory drug before your procedure .

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 immediately if any of the following side effects occur:

More common

Bloating

bloody or black, tarry stools

burning upper abdominal pain

cloudy urine

constipation

decrease in urine output or decrease in urine-concentrating ability

headache

heartburn

indigestion

itching skin

loss of appetite

nausea or vomiting

pale skin

severe abdominal pain, cramping, or burning

severe and continuing nausea

skin rash

swelling

troubled breathing with exertion

unusual bleeding or bruising

unusual tiredness or weakness

vomiting of blood or material that looks like coffee grounds

weight loss

Less common

Bleeding gums

blood in urine

bloody nose

blurred vision

burning feeling in chest or stomach

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest pain

clay-colored stools

confusion

cough or hoarseness

dark urine

difficult or labored breathing

difficult, burning, or painful urination

difficulty swallowing

dilated neck veins

dizziness

extreme fatigue

fainting

fever or chills

flushing, redness of skin

frequent urge to urinate

increased sensitivity of skin to sunlight

increased thirst

increased volume of pale, dilute urine

large, flat, blue or purplish patches in the skin

lightheadedness

lower back or side pain

nervousness

noisy breathing

numbness or tingling in hands, feet, or lips

pain or burning in throat

peeling of skin

pinpoint red or purple spots on skin

pounding in the ears

rapid, shallow breathing

redness or other discoloration of skin

redness, swelling, or soreness of tongue

severe sunburn

shortness of breath

slow, fast, pounding, or irregular heartbeat or pulse

sore throat

sores, ulcers, or white spots on lips or tongue or inside the mouth

stomach upset

swelling of face, fingers, feet, or lower legs

swelling or inflammation of the mouth

swollen glands

tenderness in stomach area

tightness in chest

unpleasant breath odor

unusually warm skin

weakness or heaviness of legs

weight gain

wheezing

yellow eyes or skin

Rare

Anxiety

back or leg pains

burning, dry, or itching eyes

cold sweats

coma

cracks in the skin

diarrhea

discharge, excessive tearing

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position

dry mouth

flushed, dry skin

fruit-like breath odor

general body swelling

general feeling of discomfort or illness

high fever

increased hunger

increased urination

inflammation of joints

irregular, fast or slow, or shallow breathing

joint pain

large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

light-colored stools

loss of heat from the body

muscle aches and pains

nightmares

no blood pressure

no breathing

no pulse

pain or discomfort in arms, jaw, back or neck

pains in stomach, side, or abdomen, possibly radiating to the back

pale or blue lips, fingernails, or skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red irritated eyes

red skin lesions, often with a purple center

redness, pain, swelling of eye, eyelid, or inner lining of eyelid

runny nose

scaly skin

seeing, hearing, or feeling things that are not there

seizures

severe headache

shakiness

shivering

sleepiness

slurred speech

sneezing

sores, welting, or blisters

stiff neck and/or back

stomach pain, continuing

suddenly sweating

swollen, painful, or tender lymph glands in neck, armpit, or groin

trouble sleeping

Symptoms of overdose

Agitation

depression

hives

hostility

irritability

muscle twitching

pain or discomfort in chest, upper stomach, or throat

rapid weight gain

stupor

swelling of ankles or hands

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

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

Acid or sour stomach

belching

continuing ringing or buzzing or other unexplained noise in ears

excess air or gas in stomach or intestines

hearing loss

passing gas

stomach discomfort or upset

Less common

Feeling of constant movement of self or surroundings

hair loss, thinning of hair

lack or loss of strength

sensation of spinning

shakiness in legs, arms, hands, or feet

sleeplessness

trembling or shaking of hands or feet

unable to sleep

Rare

Change in hearing

changes in appetite

inability to sit still

mood alterations

need to keep moving

restlessness

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