Piroxicam (Capsule)

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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 . 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 to 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.

Pharmacodynamics: Piroxicam is a non-steroidal 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 NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition.<br/>Pharmacokinetics:<br/>Absorption: Piroxicam is well absorbed following oral administration. Drug plasma concentrations are proportional for 10 and 20 mg doses and generally peak within three to five hours after medication. The prolonged half-life (50 hours) results in the maintenance of relatively stable plasma concentrations throughout the day on once daily doses and to significant accumulation upon multiple dosing. A single 20 mg dose generally produces peak piroxicam plasma levels of 1.5 to 2 mcg/mL, while maximum drug plasma concentrations, after repeated daily ingestion of 20 mg piroxicam, usually stabilize at 3 to 8 mcg/mL. Most patients approximate steady-state plasma levels within 7 to 12days. Higher levels, which approximate steady-state at two to three weeks, have been observed in patients in whom longer plasma half-lives of piroxicam occurred. 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.<br/>Distribution: The apparent volume of distribution of piroxicam is approximately 0.14 L/kg. Ninety-nine percent of plasma piroxicam is bound to plasma proteins. Piroxicam is excreted into human milk. The presence in breast milk has been determined during initial and long-term conditions (52 days). Piroxicam appeared in breast milk at about 1% to 3% of the maternal concentration. No accumulation of piroxicam occurred in milk relative to that in plasma during treatment.<br/>Metabolism: Metabolism of piroxicam occurs by hydroxylation at the 5 position of the pyridyl side chain and conjugation of this product; by cyclodehydration; and by a sequence of reactions involving hydrolysis of the amide linkage, decarboxylation, ring contraction and N-demethylation. The biotransformation products of piroxicam metabolism are reported to not have any anti-inflammatory activity.<br/>Excretion: Piroxicam and its biotransformation products are excreted in urine and feces, with about twice as much appearing in the urine as in the feces. Approximately 5% of a piroxicam dose is excreted unchanged. The plasma half-life (T) for piroxicam is approximately 50 hours.<br/>Special Populations:<br/>Pediatric: Piroxicam has not been investigated in pediatric patients.<br/>Race: Pharmacokinetic differences due to race have not been identified.<br/>Hepatic Insufficiency: The effects of hepatic disease on piroxicam pharmacokinetics have not been established. However, a substantial portion of piroxicam elimination occurs by hepatic metabolism. Consequently, patients with hepatic disease may require reduced doses of piroxicam as compared to patients with normal hepatic function.<br/>Renal Insufficiency: Piroxicam pharmacokinetics have been investigated in patients with renal insufficiency. Studies indicate patients with mild to moderate renal impairment may not require dosing adjustments. However, the pharmacokinetic properties of piroxicam in patients with severe renal insufficiency or those receiving hemodialysis are not known.<br/>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 Capsules, USP are available containing 10 mg or 20 mg of piroxicam, USP. The 10 mg capsule is a hard-shell gelatin capsule with a dark green opaque cap and an olive opaque body axially printed with MYLAN over 1010 on both the body and cap. The capsule is filled with a white to off-white powder. They are available as follows: NDC 0378-1010-01bottles of 100 capsules The 20 mg capsule is a hard-shell gelatin capsule with a medium green opaque cap and a medium green opaque body axially printed with MYLAN over 2020 on both the body and cap. The capsule is filled with a white to off-white powder. They are available as follows: NDC 0378-2020-01bottles of 100 capsules NDC 0378-2020-05bottles of 500 capsules Store at 20��to 25��C (68��to 77��F). [See USP for Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined by the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Cardiovascular Risk Gastrointestinal Risk

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Piroxicam

In patients taking piroxicam 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, dyspepsia, elevated liver enzymes, flatulence, gross bleeding/perforation, heartburn, nausea, ulcers (gastric/duodenal), vomiting. Hemic and Lymphatic System: Anemia, increased bleeding time. Nervous System: Dizziness, headache. Skin and Appendages: Pruritus, rash. Special Senses: Tinnitus. Urogenital System: Abnormal renal function. Additional adverse experiences reported occasionally include: Body as a Whole: Fever, infection, sepsis. Cardiovascular System: Congestive heart failure, hypertension, tachycardia, syncope. Digestive System: Dry mouth, esophagitis, gastritis, glossitis, hematemesis, hepatitis, jaundice, melena, rectal bleeding, stomatitis. Hemic and Lymphatic System: Ecchymosis, eosinophilia, epistaxis, leukopenia, purpura, petechial rash, thrombocytopenia. Metabolic and Nutritional: Weight changes. Nervous System: Anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, nervousness, paresthesia, somnolence, tremors, vertigo. Respiratory System: Asthma, dyspnea. Skin and Appendages: Alopecia, bruising, desquamation, erythema, photosensitivity, sweat. Special Senses: Blurred vision. Urogenital System: Cystitis, dysuria, hematuria, hyperkalemia, interstitial nephritis, nephrotic syndrome, oliguria/polyuria, proteinuria, renal failure. Other adverse reactions which occur rarely are: Body as a Whole: Anaphylactic reactions, appetite changes, death, flu-like syndrome, pain (colic), serum sickness. Cardiovascular System: Arrhythmia, exacerbation of angina, hypotension, myocardial infarction, palpitations, vasculitis. Digestive System: Eructation, liver failure, pancreatitis. Hemic and Lymphatic System: Agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, pancytopenia. Hypersensitivity: Positive ANA. Metabolic and Nutritional: Hyperglycemia, hypoglycemia. Nervous System: Akathisia, convulsions, coma, hallucinations, meningitis, mood alterations. Respiratory: Respiratory depression, pneumonia. Skin and Appendages: Angioedema, toxic epidermal necrosis, erythema multiforme, exfoliative dermatitis, onycholysis, Stevens-Johnson syndrome, urticaria, vesiculobullous reaction. Special Senses: Conjunctivitis, hearing impairment, swollen eyes.

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Piroxicam