Alti-Piroxicam

In the U.S.

• Feldene

In Canada

• Alti-Piroxicam

Available Dosage Forms:

• Capsule
• Tablet

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Oxicam

Piroxicam is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain and help relieve symptoms of arthritis (eg, osteoarthritis, rheumatoid 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 use it.

This medicine is available only with your doctor's prescription.

Applies to piroxicam: oral capsule, oral tablet

Along with its needed effects, piroxicam 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 while taking piroxicam:

• Bloating
• bloody or black, tarry stools
• burning upper abdominal or stomach pain
• cloudy urine
• constipation
• decrease in urine output or decrease in urine-concentrating ability
• headache
• heartburn
• indigestion
• itching skin or rash
• loss of appetite
• nausea or vomiting
• pale skin
• severe abdominal or stomach pain, cramping, or burning
• severe and continuing nausea
• swelling
• swelling of the face, fingers, feet, or lower legs
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting of blood or material that looks like coffee grounds
• weight changes

• Bleeding gums
• blood in the urine
• bloody nose
• blurred vision
• burning feeling in the 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 with swallowing
• dilated neck veins
• dizziness
• extreme fatigue
• fainting
• fever or chills
• flushing or redness of the skin
• frequent urge to urinate
• increased sensitivity of the 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 the hands, feet, or lips
• pain or burning in the throat
• peeling of the skin
• pinpoint red or purple spots on the skin
• pounding in the ears
• rapid, shallow breathing
• redness or other discoloration of the skin
• redness, swelling, or soreness of the tongue
• severe sunburn
• slow, fast, pounding, or irregular heartbeat or pulse
• sore throat
• sores, ulcers, or white spots on the lips or tongue or inside the mouth
• stomach upset
• swelling or inflammation of the mouth
• swollen glands
• tenderness in the stomach area
• tightness in the chest
• unpleasant breath odor
• unusually warm skin
• weakness or heaviness of the legs
• yellow eyes or skin

• Anxiety
• back or leg pains
• burning, dry, or itching eyes
• cold sweats
• coma
• cracks in the skin
• diarrhea
• discharge or 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 the joints
• irregular, fast or slow, or shallow breathing
• joint pain
• large, hive-like swelling on the 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 the arms, jaw, back, or neck
• pains in the 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 skin lesions, often with a purple center
• red, irritated eyes
• redness, pain, or swelling of the eye, eyelid, or inner lining of the 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 or back
• stomach pain, continuing
• suddenly sweating
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• trouble sleeping

Get emergency help immediately if any of the following symptoms of overdose occur while taking piroxicam:

• Agitation
• depression
• hives
• hostility
• irritability
• muscle twitching
• pain or discomfort in the chest, upper stomach, or throat
• rapid weight gain
• stupor
• swelling of the ankles or hands
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Some side effects of piroxicam 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:

• Acid or sour stomach
• belching
• continuing ringing or buzzing or other unexplained noise in the ears
• excess air or gas in the stomach or intestines
• hearing loss
• passing gas
• stomach discomfort or upset

• Feeling of constant movement of self or surroundings
• hair loss or thinning of the hair
• lack or loss of strength
• sensation of spinning
• shakiness in the legs, arms, hands, or feet
• trembling or shaking of the hands or feet

• Change in hearing
• changes in appetite
• inability to sit still
• mood alterations
• need to keep moving
• restlessness

Recommended dose: 20 mg orally once a day

Comments:
-The lowest effective dose for the shortest duration possible should be used based on individual patient treatment goals.
-Due to the long half-life, there is a progressive response to treatment over several weeks; the effect of therapy should not be assessed for 2 weeks.

Use: For the relief of signs and symptoms of rheumatoid arthritis.

Mild to Moderate Renal Dysfunction: No adjustment recommended
Advanced Renal Disease: Not recommended

If treatment is necessary in patients with renal impairment, close monitoring of renal function is advised.

Mild to Moderate Renal Dysfunction: No adjustment recommended
Advanced Renal Disease: Not recommended

If treatment is necessary in patients with renal impairment, close monitoring of renal function is advised.

In 6 women receiving treatment for up to 52 days, drug concentrations in breast milk were found to be about 1% to 3% of the maternal concentration. A separate study in 4 women receiving 20 mg per day showed nursing infants would be expected to receive an estimated 3.5% to 6.3% of the weight adjusted maternal dose. In separate reporting, 5 older infants remained healthy when nursed by mothers receiving 20 mg once daily for at least 4 months. Due to lack of published clinical experience in newborns, shorter acting agents may be preferred.

UK: Use is not recommended AU and US: Use is not recommended unless potential benefits outweigh any potential risks. Excreted into human milk: Yes Comments: The effects in the nursing infant are unknown.

Summary of Use during Lactation

Low amounts of piroxicam in milk and failure to detect piroxicam or its metabolites in the urine of 2 older infants indicates that it would not be expected to cause adverse effects in older breastfed infants. Because there is no published experience with piroxicam during breastfeeding in the newborn period, shorter-acting agents may be preferred while nursing a newborn or preterm infant.

Drug Levels

Maternal Levels. Peak milk levels of 170 and 220 mcg/L were found in the milk of 2 women who were taking piroxicam 20 and 40 mg daily, respectively. The time of the peak milk levels were 12 and 4 hours after the dose, respectively, in the 2 women.[1]

Maximum milk piroxicam levels averaging 40 mcg/L were found in 3 women during the first week of therapy with oral piroxicam 20 mg daily. After steady-state was attained in these 3 women plus one additional woman, milk levels averaged 102 mcg/L during the first 12 hours after the dose and 73 mcg/L during the period of 13 to 24 hours after the dose. A nursing infant would receive an estimated average 3.5% and maximum 6.3% of the weight-adjusted maternal dosage.[2]

Infant Levels. No piroxicam could be detected in the serum of an 13-month-old infant whose mother had been taking 20 mg daily of piroxicam for 4 months.[1]

Neither piroxicam nor its conjugates could be detected (<15 mcg/L) in the urine of one infant after 52 days of maternal therapy with 20 mg daily.[2]

Effects in Breastfed Infants

No adverse effects were found in the breastfed infant of a patient receiving 20 mg of piroxicam daily for 4 months starting the 9th month postpartum.[1]

Four infants 3 to 4.5 months of age remained healthy during long-term therapy of their mothers with piroxicam 20 mg daily.[2]

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

Acetaminophen, Flurbiprofen, Ibuprofen, Indomethacin, Naproxen

References

1. Ostensen M. Piroxicam in human breast milk. Eur J Clin Pharmacol. 1983;25:829-30. PMID: 6662182

2. Ostensen M, Matheson I, Laufen H. Piroxicam in breast milk after long-term treatment. Eur J Clin Pharmacol. 1988;35:567-9. PMID: 3234465

LactMed Record Number

219

Last Revision Date

20150310

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.