Brand Name
Piroxicam
View Brand InformationFDA approval date: January 26, 1994
Classification: Nonsteroidal Anti-inflammatory Drug
Form: Capsule
What is Piroxicam?
Piroxicam Capsules are indicated: For relief of the signs and symptoms of osteoarthritis. For relief of the signs and symptoms of rheumatoid arthritis.
Approved To Treat
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Brand Information
Piroxicam (piroxicam)
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
Cardiovascular Thrombotic Events
- Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use
- Piroxicam capsules are contraindicated in the setting of coronary artery bypass graft (CABG) surgery
Gastrointestinal Bleeding, Ulceration, and Perforation
- NSAIDs cause an increased risk of serious gastrointestinal (GI) 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events
1INDICATIONS AND USAGE
Piroxicam capsules are indicated:
- For relief of the signs and symptoms of osteoarthritis.
- For relief of the signs and symptoms of rheumatoid arthritis.
2DOSAGE AND ADMINISTRATION
Carefully consider the potential benefits and risks of piroxicam capsules and other treatment options before deciding to use piroxicam capsules. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals
After observing the response to initial therapy with piroxicam capsules, the dose and frequency should be adjusted to suit an individual patient’s needs.
For the relief of rheumatoid arthritis and osteoarthritis, the dosage is 20 mg given orally once per day. If desired, the daily dose may be divided. Because of the long half-life of piroxicam capsules, steady-state blood levels are not reached for 7 to 12 days. Therefore, although the therapeutic effects of piroxicam capsules 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.
3DOSAGE FORMS AND STRENGTHS
Piroxicam Capsules, USP are available containing 10 mg or 20 mg of piroxicam, USP.
- The 10 mg capsule is a hard gelatin capsule with a swedish orange opaque cap and ivory opaque body containing white to off-white powder. The capsule is imprinted with
- The 20 mg capsule is a hard gelatin capsule with a swedish orange opaque cap and swedish orange opaque body containing white to off-white powder. The capsule is imprinted with
4CONTRAINDICATIONS
Piroxicam capsules are contraindicated in the following patients:
- Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to piroxicam or any components of the drug product
- History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients
- In the setting of CABG surgery
5ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Cardiovascular Thrombotic Events
- GI Bleeding, Ulceration and Perforation
- Hepatotoxicity
- Hypertension
- Heart Failure and Edema
- Renal Toxicity and Hyperkalemia
- Anaphylactic Reactions
- Serious Skin Reactions
- Hematologic Toxicity
5.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In patients taking piroxicam capsules or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1% to 10% of patients are:
Cardiovascular System:Edema
Digestive System:Anorexia, abdominal pain, constipation, diarrhea, flatulence, nausea, vomiting
Nervous System:Dizziness, headache, vertigo
Skin and Appendages:Pruritus, rash
Special Senses:Tinnitus
Additional adverse experiences reported occasionally include:
Cardiovascular System:Palpitations
Digestive System:Stomatitis
Nervous System:Drowsiness
Special Senses:Blurred vision
5.2Postmarketing Experience
The following adverse reactions have been identified during post approval use of piroxicam capsules. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Body As a Whole:Fever, infection, sepsis, anaphylactic reactions, appetite changes, death, flu-like syndrome, pain (colic), serum sickness
Cardiovascular System:Congestive heart failure, hypertension, tachycardia, syncope, arrhythmia, exacerbation of angina, hypotension, myocardial infarction, vasculitis
Digestive System:Dyspepsia, elevated liver enzymes, gross bleeding/perforation, heartburn, ulcers (gastric/duodenal), dry mouth, esophagitis, gastritis, glossitis, hematemesis, hepatitis, jaundice, melena, rectal bleeding, eructation, liver failure, pancreatitis
Hemic and Lymphatic System:Anemia, increased bleeding time, ecchymosis, eosinophilia, epistaxis, leukopenia, purpura, petechial rash, thrombocytopenia, agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, pancytopenia
Hypersensitivity: Positive ANA
Metabolic and Nutritional:Weight changes, Fluid retention, hyperglycemia, hypoglycemia
Nervous System:Anxiety, asthenia, confusion, depression, dream abnormalities, insomnia, malaise, nervousness, paresthesia, somnolence, tremors, akathisia, convulsions, coma, hallucinations, meningitis, mood alterations
Respiratory System:Asthma, dyspnea, respiratory depression, pneumonia
Skin and Appendages:Alopecia, bruising, desquamation, erythema, photosensitivity, sweat, angioedema, toxic epidermal necrosis, erythema multiforme, exfoliative dermatitis, onycholysis, Stevens Johnson Syndrome, urticaria, vesiculobullous reaction
Special Senses:Conjunctivitis, hearing impairment, swollen eyes
Urogenital System:Abnormal renal function, cystitis, dysuria, hematuria, hyperkalemia, interstitial nephritis, nephrotic syndrome, oliguria/polyuria, proteinuria, renal failure, glomerulonephritis
Reproductive System and Breast Disorders:Female fertility decreased
6DRUG INTERACTIONS
See Table 1 for clinically significant drug interactions with piroxicam.
Table 1: Clinically Significant Drug Interactions with Piroxicam
7OVERDOSAGE
Symptoms following acute NSAID overdoses have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare
Manage patients with symptomatic and supportive care following an NSAID overdose. There are no specific antidotes. Consider emesis and/or activated charcoal (60 grams to 100 grams in adults, 1 gram to 2 grams per kg of body weight in pediatric patients) and/or osmotic cathartic in symptomatic patients seen within four hours of ingestion or in patients with a large overdosage (5 to 10 times the recommended dosage).
The long plasma half-life of piroxicam should be considered when treating an overdose with piroxicam. Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.
For additional information about overdosage treatment contact a poison control center (1-800-222-1222).
8DESCRIPTION
Piroxicam Capsules, USP is a nonsteroidal anti-inflammatory drug, available as Ivory opaque/Swedish orange opaque 10 mg capsules and Swedish orange opaque/Swedish orange opaque 20 mg capsules for oral administration. The chemical name is 4-hydroxyl-2-methyl-
Piroxicam occurs as a white crystalline solid, sparingly soluble in water, dilute acid, and most organic solvents. It is slightly soluble in alcohol and in aqueous solutions. It exhibits a weakly acidic 4-hydroxy proton (pKa 5.1) and a weakly basic pyridyl nitrogen (pKa 1.8).
The inactive ingredients in piroxicam capsules include: Hard gelatin capsules (which may contain FD&C Blue 1, FD&C Red 40, D&C Yellow 10, titanium dioxide and gelatin inactive ingredients), corn starch, lactose, magnesium stearate and sodium lauryl sulfate.
9CLINICAL STUDIES
In controlled clinical trials, the effectiveness of piroxicam capsules has been established for both acute exacerbations and long term management of rheumatoid arthritis and osteoarthritis.
The therapeutic effects of piroxicam capsules are evident early in the treatment of both diseases with a progressive increase in response over several (8-12) weeks. Efficacy is seen in terms of pain relief and, when present, subsidence of inflammation.
Doses of 20 mg/day piroxicam capsules display a therapeutic effect comparable to therapeutic doses of aspirin, with a lower incidence of minor gastrointestinal effects and tinnitus.
Piroxicam capsules have been administered concomitantly with fixed doses of gold and corticosteroids. The existence of a “steroid sparing” effect has not been adequately studied to date.
10HOW SUPPLIED/STORAGE AND HANDLING
Piroxicam Capsules, USP
The 10 mg capsules are hard gelatin capsules with a swedish orange opaque cap and ivory opaque body containing white to off-white powder.
NDC: 72162-1290-1: 100 Capsules in a BOTTLE, PLASTIC
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [see USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504
11PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
Cardiovascular Thrombotic Events Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their health care provider immediately [see .
Gastrointestinal Bleeding, Ulceration, and Perforation Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their healthcare provider. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for and the signs and symptoms of GI bleeding [see .
HepatotoxicityInform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, diarrhea, jaundice, right upper quadrant tenderness, and “flu-like” symptoms). If these occur, instruct patients to stop piroxicam capsules and seek immediate medical therapy [see .
Heart Failure and EdemaAdvise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur [see .
Anaphylactic ReactionsInform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat). Instruct patients to seek immediate emergency help if these occur [see .
Serious Skin ReactionsAdvise patients to stop piroxicam capsules immediately if they develop any type of rash and to contact their healthcare provider as soon as possible [see .
Female FertilityAdvise females of reproductive potential who desire pregnancy that NSAIDs, including piroxicam capsules, may be associated with a reversible delay in ovulation [see .
Fetal ToxicityInform pregnant women to avoid use of piroxicam capsules and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closing of the fetal ductus arteriosus [see .
Avoid Concomitant Use of NSAIDsInform patients that the concomitant use of piroxicam capsules with other NSAIDs or salicylates (e.g., diflunisal, salsalate) is not recommended due to the increased risk of gastrointestinal toxicity, and little or no increase in efficacy [see Alert patients that NSAIDs may be present in “over the counter” medications for treatment of colds, fever, or insomnia.
Use of NSAIDs and Low-Dose AspirinInform patients not to use low-dose aspirin concomitantly with piroxicam capsules until they talk to their healthcare provider [see .
Manufactured by:
Rev: November 2019
12Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
Manufactured by:
Rev: November 2019