Piroxicam (piroxicam 10 mg) Dailymed

In late pregnancy, as with other NSAIDs, Piroxicam Capsules, USP should be avoided because it may cause premature closure of the ductus arteriosus.

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. Piroxicam Capsules, USP, 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 WARNINGS, CARDIOVASCULAR EFFECTS ). Piroxicam Capsules, USP, 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 WARNINGS: Gastrointestinal Effects: Risk of Ulceration, Bleeding and Perforation ). Piroxicam Capsules, USP, like other NSAIDs, can cause serious skin side effects such as exfoliative dermatitis, SJS and TEN, which may result in hospitalizations and even death. Although serious skin reactions may occur without warning, patients should be alert for the signs and symptoms of skin rash and bulers, 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. Patients should promptly report signs or symptoms of unexplained weight gain or edema to their physicians. 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. 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 WARNINGS ). In late pregnancy, as with other NSAIDs, Piroxicam Capsules, USP should be avoided because it may cause premature closure of the ductus arteriosus. Advise females of reproductive potential who desire pregnancy that NSAIDs, including Piroxicam Capsules USP, may be associated with a reversible delay in ovulation. For women who have difficulties conceiving, or who are undergoing investigation of infertility, use of piroxicam is not recommended (see PRECAUTIONS-Reversible Delayed Ovulation ).



There are no adequate and well-controlled studies of Piroxicam Capsules, USP in pregnant women. Use of NSAIDs, including Piroxicam Capsules, USP, during the third trimester of pregnancy increases the risk of premature closure of the ductus arteriosus. All pregnancies, regardless of drug exposure, have a background rate of 2-4% for major malformations, and 15-20% for pregnancy loss. During the first and second trimesters of pregnancy, use Piroxicam Capsules, USP only if the potential benefit justifies the potential risk to the fetus. During the third trimester of pregnancy, the patient should be apprised of the potential hazard to a fetus.

There are no adequate and well-controlled studies of Piroxicam Capsules, USP in pregnant women. Use of NSAIDs, including Piroxicam Capsules, USP, during the third trimester of pregnancy increases the risk of premature closure of the ductus arteriosus. All pregnancies, regardless of drug exposure, have a background rate of 2-4% for major malformations, and 15-20% for pregnancy loss. During the first and second trimesters of pregnancy, use Piroxicam Capsules, USP only if the potential benefit justifies the potential risk to the fetus. During the third trimester of pregnancy, the patient should be apprised of the potential hazard to a fetus. Pregnant rats administered piroxicam 2, 5, or 10 mg/kg/day during the period of organogenesis (gestation days 6 to 15) demonstrated increased post-implantation losses with 5 and 10 mg/kg/day of piroxicam (equivalent to 3 and 5 times the maximum recommended human dose [MRHD], of 20 mg respectively, based on a mg/m2 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 2, 5, or 10 mg/kg/day during the period of organogenesis (gestation days 7 to 18) demonstrated no drug-related developmental abnormalities in offspring (up to 11 times the MRHD based on a mg/m2 BSA). Based on animal data, prostaglandins have shown an important role in endometrial vascular permeability, blastocyst implantation and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as piroxicam, have been shown to result in increased pre- and post-implantation loss. In a pre- and post-natal developement study in which pregnant rats were administered piroxicam 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 starting gestation day 20 (5 times the MRHD based on a mg/m2 BSA). Treated dams revealed peritonitis, adhesions, gastric bleeding, hemorrhagic enteritis and dead fetuses in utero. Parturition was delayed in all piroxicam-treated groups, and there was an increased incidence of stillbirth. Postnatal development could not be reliably assessed due to the absence of maternal care secondary to severe maternal toxicity.

The effects of Piroxicam Capsules, USP on labor and delivery in pregnant women are unknown. In rat studies with piroxicam, as with other drugs known to inhibit prostaglandin synthesis, delayed parturition and an increased incidence of stillbirth were noted at doses equivalent to the MRHD of piroxicam.

Piroxicam is present in human milk at about 1% to 3% of the maternal concentration. No accumulation of piroxicam occurred in milk relative to that in maternal plasma during treatment.The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Piroxicam Capsules, USP and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition. Excercise caution when Piroxicam Capsules, USP is administered to a nursing woman.