PIROXENE

A cyclooxygenase inhibiting, non-steroidal anti-inflammatory agent (NSAID) that is well established in treating rheumatoid arthritis and osteoarthritis and used for musculoskeletal disorders, dysmenorrhea, and postoperative pain.

Its long half-life enables it to be administered once daily.

For treatment of osteoarthritis and rheumatoid arthritis.

Piroxicam is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs).

Piroxicam works by reducing hormones that cause inflammation and pain in the body.

Piroxicam is used to reduce the pain, inflammation, and stiffness caused by rheumatoid arthritis and osteoarthritis.

G/H synthase 2 Inhibitor Prostaglandin G/H synthase 1 Inhibitor.

Well absorbed following oral administration.

Renal Hover over products below to view reaction partners Piroxicam 5'-Hydroxypiroxicam.

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.

However, a substantial portion of piroxicam elimination occurs by hepatic metabolism.

Piroxicam is excreted into human milk.

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Symptoms of overdose include drowsiness, nausea, stomach pain, and/or vomiting.

• 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.

• Known hypersensitivity to piroxicam or any components of the drug product.

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 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.

• Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals.

• OA and RA: 20 mg once daily.

Capsules, USP are available containing 20 mg of piroxicam, USP.

The 20 mg capsules are hard gelatin capsules with a swedish orange opaque cap and swedish orange opaque body containing white to off-white powder.

The capsules are imprinted with

NP above in black ink on the cap.

They are available as follows

NDC 63629-9149-1 bottles of 100 capsules Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). .

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.

Risk Summary Use of

NSAIDs, including piroxicam capsules, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus.

Avoid use of

NSAIDs, including piroxicam capsules, in pregnant women starting at 30 weeks of gestation (third trimester).

There are no adequate and well-controlled studies of piroxicam capsules in pregnant women.

Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive.

In the general

U.S. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2% to 4% for major malformations, and 15% to 20% for pregnancy loss.

In animal reproduction studies in rats and rabbits, there was no evidence of teratogenicity at exposures up to and 10 times the maximum recommended human dose (MRHD), respectively.

In rat studies with piroxicam, fetotoxicity (postimplantation loss) was observed at exposures 2 times the MRHD, and delayed parturition and an increased incidence of stillbirth were noted at doses equivalent to the MRHD of piroxicam.

Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization.

In animal studies, administration of prostaglandin synthesis inhibitors such as piroxicam, resulted in increased pre.

• and post-implantation loss.

There are no studies on the effects of piroxicam capsules during labor or delivery.

In animal studies, NSAIDs, including piroxicam inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth.

Pregnant rats administered piroxicam at 2, 5, or 10 mg/kg/day during the period of organogenesis (Gestation Days to 15) demonstrated increased post-implantation losses with and 10 mg/kg/day of piroxicam (equivalent to and 5 times the MRHD, of 20 mg respectively, based on a mg/m 2 body surface area [BSA]).

There were no drug-related developmental abnormalities noted in offspring.

Gastrointestinal tract toxicity was increased in pregnant rats in the last trimester of pregnancy compared to non-pregnant rats or rats in earlier trimesters of pregnancy.

Pregnant rabbits administered piroxicam at 2, 5, or 10 mg/kg/day during the period of organogenesis (Gestation Days to 18) demonstrated no drug-related developmental abnormalities in offspring (up to 10 times the MRHD based on a mg/m 2 BSA).

In a pre.

• and post-natal development study in which pregnant rats were administered piroxicam at 2, 5, or 10 mg/kg/day on Gestation Day 15 through delivery and weaning of offspring, reduced weight gain and death were observed in dams at 10 mg/kg/day (5 times the MRHD based on a mg/m 2 BSA) starting on Gestation Day 20.

Treated dams revealed peritonitis, adhesions, gastric bleeding, hemorrhagic enteritis and dead fetuses in utero.

Parturition was delayed and there was an increased incidence of stillbirth in all piroxicam-treated groups (at doses equivalent to the MRHD).

Postnatal development could not be reliably assessed due to the absence of maternal care secondary to severe maternal toxicity.

Piroxicam capsules has not been investigated in pediatric patients.

The safety and effectiveness of piroxicam capsules have not been established.

Elderly patients, compared to younger patients, are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions.

If the anticipated benefit for the elderly patient outweighs these potential risks, start dosing at the low end of the dosing range, and monitor patients for adverse effects.