Piroxicam Information
Piroxicam ()
Piroxicam () Description
Piroxicam () is a member of the oxicam group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for Piroxicam () is 4-Hydroxy-2-methyl-N-2-pyridinyl-2H-1,2-benzothiazine-3-carboxamide 1,1-dioxide. Piroxicam () occurs as a white crystalline solid, sparingly soluble in water, dilute acid and most organic solvents. It is slightly soluble in alcohols and in aqueous alkaline solution. It exhibits a weakly acidic 4-hydroxy proton (pKa 5.1) and a weakly basic pyridyl nitrogen (pKa 1.8). It has the following structural formula:
Molecular Formula: N3O4S
Molecular Weight: 331.35
Each capsule, for oral administration, contains 10 mg or 20 mg Piroxicam () . In addition each capsule contains the following inactive ingredients: black iron oxide, corn starch, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Green #3, FD&C Red #40, gelatin, lactose, magnesium stearate, methylparaben, propylparaben, sodium lauryl sulfate, titanium dioxide and other ingredients. In addition to these ingredients, the 10 mg capsules contain yellow iron oxide.
Piroxicam () Pharmacodynamics
Piroxicam () is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic and antipyretic activities in animal models. The mechanism of action of Piroxicam () , like that of other NSAID, is not completely understood but may be related to prostaglandin synthetase inhibition.
Piroxicam () Pharmacokinetics
With food there is a slight delay in the rate but not the extent of absorption following oral administration. The concomitant administration of antacids (aluminum hydroxide or aluminum hydroxide with magnesium hydroxide) have been shown to have no effect on the plasma levels of orally administered Piroxicam () .
Piroxicam () Other Information
In controlled clinical trials, the effectiveness of Piroxicam () has been established for both acute exacerbations and long-term management of rheumatoid arthritis and osteoarthritis.
The therapeutic effects of Piroxicam () are evident early in the treatment of both diseases with a progressive increase in response over several (8 to 12) weeks. Efficacy is seen in terms of pain relief and, when present, subsidence of inflammation.
Doses of 20 mg/day Piroxicam () display a therapeutic effect comparable to therapeutic doses of aspirin, with a lower incidence of minor gastrointestinal effects and tinnitus.
Piroxicam () has been administered concomitantly with fixed doses of gold and corticosteroids. The existence of a “steroid-sparing” effect has not been adequately studied to date.
Piroxicam () Indications And Usage
Carefully consider the potential benefits and risks of Piroxicam () and other treatment options before deciding to use Piroxicam () . Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see ).
Piroxicam () is indicated:
1. For relief of the signs and symptoms of rheumatoid arthritis
2. For relief of the signs and symptoms of osteoarthritis
Piroxicam () Contraindications
Piroxicam () is contraindicated in patients with known hypersensitivity to Piroxicam () .
Piroxicam () should not be given to patients who have experienced asthma, urticaria or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see and ).
Piroxicam () is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see ).
Piroxicam () Warnings
Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of a nonsteroidal anti-inflammatory drug may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greater risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.
Advanced Renal Disease
No information is available from controlled clinical studies regarding the use of Piroxicam () in patients with advanced renal disease. Therefore, treatment with Piroxicam () is not recommended in these patients with advanced renal disease. If Piroxicam () therapy must be initiated, close monitoring of the patient’s renal function is advisable.
Anaphylactoid Reactions
As with other NSAIDs, anaphylactoid reactions may occur in patients without known prior exposure to Piroxicam () . Piroxicam () should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs (see and ). Emergency help should be sought in cases where an anaphylactoid reaction occurs.
Piroxicam () Precautions
Piroxicam () cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids.
The pharmacological activity of Piroxicam () in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions.
Borderline elevations of one or more liver tests may occur in up to 15% of patients taking NSAIDs including Piroxicam () . These laboratory abnormalities may progress, may remain unchanged, or may be transient with continuing therapy. Notable elevations of ALT or AST (approximately three or more times the upper limit of normal) have been reported in approximately 1% of patients in clinical trials with NSAIDs. In addition, rare cases of severe hepatic reactions, including jaundice and fatal fulminant hepatitis, liver necrosis and hepatic failure, some of them with fatal outcomes have been reported.
A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver test has occurred, should be evaluated for evidence of the development of more severe hepatic reaction while on therapy with Piroxicam () . If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), Piroxicam () should be discontinued (see ).
Anemia is sometimes seen in patients receiving NSAIDs, including Piroxicam () . This may be due to fluid retention, occult or gross GI blood loss, or an incompletely described effect upon erythropoiesis. Patients on long-term treatment with NSAIDs, including Piroxicam () , should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia.
NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Unlike aspirin, their effect on platelet function is quantitatively less, of shorter duration, and reversible. Patients receiving Piroxicam () who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants, should be carefully monitored.
Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy. Patients should also be encouraged to read the NSAID Medication Guide that accompanies each prescription dispensed.
1. Piroxicam () , like other NSAIDS, may cause CV side effects, such as MI or stroke, which may result in hospitalization and even death. Although serious CV events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and should ask for medical advice when observing any indicative sign or symptoms. Patients should be apprised of the importance of this follow-up (see ).
2. Piroxicam () , like other NSAIDs, can cause GI discomfort and, rarely, serious GI side effects, such as ulcers and bleeding, which may result in hospitalization and even death. Although serious GI tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for the signs and symptoms of ulcerations and bleeding, and should ask for medical advice when observing any indicative sign or symptoms including epigastric pain, dyspepsia, melena, and hematemesis. Patients should be apprised of the importance of this follow-up (see ).
3. Piroxicam () , like other NSAIDs, can cause serious skin side effects such as exfoliative dermatitis, SJS, and TEN, which may result in hospitalization and even death. Although serious skin reactions may occur without warning, patients should be alert for the signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching, and should ask for medical advice when observing any indicative signs or symptoms. Patients should be advised to stop the drug immediately if they develop any type of rash and contact their physicians as soon as possible.
4. Patients should promptly report signs or symptoms of unexplained weight gain or edema to their physicians.
5. Patients should be informed of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and “flu-like” symptoms). If these occur, patients should be instructed to stop therapy and seek immediate medical therapy.
6. Patients should be informed of the signs of an anaphylactoid reaction (e.g. difficulty breathing, swelling of the face or throat). If these occur, patients should be instructed to seek immediate emergency help (see ).
7. In late pregnancy, as with other NSAIDs, Piroxicam () should be avoided because it may cause premature closure of the ductus arteriosus.
Subacute, acute and chronic toxicity studies have been carried out in rats, mice, dogs, and monkeys. The pathology most often seen was that characteristically associated with the animal toxicology of anti-inflammatory agents: renal papillary necrosis (see ) and gastrointestinal lesions.
Reproductive studies revealed no impairment of fertility in animals.
As with any NSAID, caution should be exercised in treating the elderly (65 years and older). Most spontaneous reports of fatal GI events with NSAIDs are in the elderly or debilitated patients and, therefore, care should be taken in treating this population. In addition to a past history of ulcer disease, older age and poor general health status ( among other factors) may increase the risk for GI bleeding. To minimize the potential risk of an adverse GI event, the lowest effective dose should be used for the shortest possible duration (see ).
As with all other NSAIDs, there is a risk of developing renal toxicity in patients in which renal prostaglandins have a compensatory role in maintenance of renal perfusion. Discontinuation of nonsteroidal anti-inflammatory drug therapy is usually followed by recovery to the pretreatment state (see ).
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting a greater frequency of impaired drug elimination and of concomitant disease or other drug therapy.
Piroxicam () Adverse Reactions
In patients taking Piroxicam () or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1-10% of patients are:
Additional adverse experiences reported occasionally include:
Other adverse reactions which occur rarely are:
Piroxicam () Overdosage
Symptoms following acute NSAID overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur, Hypertension, acute renal failure, respiratory depression and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose.
Patients should be managed by symptomatic and supportive care following an NSAID overdose. There are no specific antidotes, Emesis and/or activated charcoal (60-100 g in adults, 1-2 g/kg in children) and /or osmotic cathartic may be indicated. The long plasma half-life of Piroxicam () should be considered when treating an overdose with Piroxicam () . Experiments in dogs have demonstrated that the use of multiple-dose treatments with activated charcoal could reduce the half-life of Piroxicam () by more than 50% and systemic bioavailability by as much as 37% when activated charcoal is given as late as 6 hours after ingestion of Piroxicam () . Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.
Piroxicam () Dosage And Administration
Carefully consider the potential benefits and risks of Piroxicam () and other treatment options before deciding to use Piroxicam () . Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see ).
After observing the response to initial therapy with Piroxicam () , the dose and frequency should be adjusted to suit an individual patient’s needs.
For the relief of rheumatoid arthritis and osteoarthritis, the recommended dose is 20 mg given orally once per day. If desired, the daily dose may be divided. Because of the long half-life of Piroxicam () , steady-state blood levels are not reached for 7-12 days. Therefore, although the therapeutic effects of Piroxicam () are evident early in treatment, there is a progressive increase in response over several weeks and the effect of therapy should not be assessed for two weeks.
Piroxicam () How Supplied
Piroxicam () Capsules, USP 10 mg and 20 mg for oral administration are available as:
10 mg capsules
Olive Opaque/Dark Green Opaque (imprinted in black “026” and “G”) Bottles of 1000 NDC #55567-026-35
20 mg capsules
Dark Green Opaque/Dark Green Opaque (imprinted in black “027” and “G”) Bottles of 1000 NDC #55567-027-35
Keep bottles tightly closed. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.
• with longer use of NSAID medicines
• in people who have heart disease
• can happen without warning symptoms
• may cause death
The chance of a person getting an ulcer or bleeding increases with:
• taking medicines called “corticosteroids” and “anticoagulants”
• longer use
• smoking
• drinking alcohol
• older age
• having poor health
• exactly as prescribed
• at the lowest dose possible for your treatment
• for the shortest time needed
NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:
• different types of arthritis
• menstrual cramps and other types of short-term pain
Do not take an NSAID medicine:
• if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
• for pain right before or after heart bypass surgery
• about all of your medical conditions.
• about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects.
• if you are pregnant.
• if you are breastfeeding.
• shortness of breath or trouble breathing
• chest pain
• weakness in one part or side of your body
• slurred speech
• swelling of the face or throat
• nausea
• more tired or weaker than usual
• itching
• your skin or eyes look yellow
• stomach pain
• flu-like symptoms
• vomit blood
• there is blood in your bowel movement or it is black and sticky like tar
• unusual weight gain
• skin rash or blisters with fever
• swelling of the arms and legs, hands and feet
These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines.
• Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
• Some of these NSAID medicines are sold in lower doses without a prescription (over –the –counter). Talk to your healthcare provider before using over –the –counter NSAIDs for more than 10 days.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured by
Toronto, ON
M8Z 2S6 Canada
1-800-661-7134
000-150 Rev. #13 March 2007
