United States - English - NLM (National Library of Medicine)

micro labs limited - piroxicam (unii: 13t4o6vmam) (piroxicam - unii:13t4o6vmam) - piroxicam 10 mg - piroxicam capsule is indicated: - for relief of the signs and symptoms of osteoarthritis. - for relief of the signs and symptoms of rheumatoid arthritis. piroxicam is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to piroxicam or any components of the drug product [see warnings and precautions (5.7, 5.9)] - 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 [see  warnings and precautions (5.7,  5.8)] - in the setting of cabg surgery [see warnings and precautions (5.1)] risk summary use of nsaids, including piroxicam, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neo

United States - English - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - piroxicam (unii: 13t4o6vmam) (piroxicam - unii:13t4o6vmam) - piroxicam 20 mg - piroxicam capsules are indicated: - for relief of the signs and symptoms of osteoarthritis. - for relief of the signs and symptoms of rheumatoid arthritis. piroxicam is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to piroxicam or any components of the drug product [see warnings and precautions ( 5.7, 5.9)] - 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 [see warnings and precautions ( 5.7, 5.8)] - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions ( 5.1)] pregnancy category c prior to 30 weeks gestation; category d starting at 30 weeks gestation. risk summary use of nsaids, including piroxicam, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. avoid use of nsaids, including piroxica

United States - English - NLM (National Library of Medicine)

h.j. harkins company, inc. - piroxicam (unii: 13t4o6vmam) (piroxicam - unii:13t4o6vmam) - piroxicam 10 mg - carefully consider the potential benefits and risks of piroxicam capsules and other treatment options before deciding to use piroxicam capsules. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). piroxicam capsules are indicated: - for relief of the signs and symptoms of osteoarthritis. - for relief of the signs and symptoms of rheumatoid arthritis. piroxicam capsules are contraindicated in patients with known hypersensitivity to piroxicam. piroxicam capsules 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 warnings , anaphylactoid reactions and precautions , preexisting asthma ). piroxicam capsules are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (cabg) surgery (see warnings ).

United States - English - NLM (National Library of Medicine)

zydus pharmaceuticals (usa) inc. - piroxicam (unii: 13t4o6vmam) (piroxicam - unii:13t4o6vmam) - piroxicam capsules, usp are indicated: - for relief of the signs and symptoms of osteoarthritis. - for relief of the signs and symptoms of rheumatoid arthritis. piroxicam is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to piroxicam or any components of the drug product [see warnings and precautions (5.7, 5.9)] - 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 [see warnings and precautions (5.7, 5.8)] - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1 )] pregnancy category c prior to 30 weeks gestation; category d starting at 30 weeks gestation. risk summary use of nsaids, including piroxicam, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. avoid use of nsaids, including

Australia - English - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - piroxicam, quantity: 10 mg - tablet, dispersible - excipient ingredients: sodium stearylfumarate; hyprolose; microcrystalline cellulose; lactose monohydrate - symptomatic treatment of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis.

United States - English - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - piroxicam (unii: 13t4o6vmam) (piroxicam - unii:13t4o6vmam) - piroxicam 10 mg - piroxicam capsules are indicated: piroxicam is contraindicated in the following patients: pregnancy category c prior to 30 weeks gestation; category d starting at 30 weeks gestation. risk summary use of nsaids, including piroxicam, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. avoid use of nsaids, including piroxicam, in pregnant women starting at 30 weeks of gestation (third trimester). there are no adequate and well-controlled studies of piroxicam 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 5 and 10 times the mrhd,

United States - English - NLM (National Library of Medicine)

nostrum laboratories, inc. - piroxicam (unii: 13t4o6vmam) (piroxicam - unii:13t4o6vmam) - piroxicam 10 mg - piroxicam capsules are indicated: piroxicam capsules are contraindicated in the following patients: 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 5 and 10 times the maximum recommended human dose (mrhd), respectively. in rat studies with

United States - English - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - piroxicam (unii: 13t4o6vmam) (piroxicam - unii:13t4o6vmam) - piroxicam 10 mg - piroxicam capsules are indicated: piroxicam capsules are contraindicated in the following patients: 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 5 and 10 times the maximum recommended human dose (mrhd), respectively. in rat studies with

Australia - English - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - piroxicam, quantity: 10 mg - capsule, hard - excipient ingredients: lactose monohydrate; maize starch; magnesium stearate; sodium starch glycollate; sodium lauryl sulfate; propylene glycol; ethanol; butan-1-ol; purified water; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide; titanium dioxide; iron oxide yellow; iron oxide red; gelatin - symptomatic treatment of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis.

United States - English - NLM (National Library of Medicine)

avkare - piroxicam (unii: 13t4o6vmam) (piroxicam - unii:13t4o6vmam) - piroxicam 20 mg - piroxicam capsules are indicated: - for relief of the signs and symptoms of osteoarthritis. - for relief of the signs and symptoms of rheumatoid arthritis. piroxicam is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to piroxicam or any components of the drug product [see warnings and precautions (5.7, 5.9)] - 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 [see warnings and precautions (5.7, 5.8)] - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1)] pregnancy category c prior to 30 weeks gestation; category d starting at 30 weeks gestation. risk summary use of nsaids, including piroxicam, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. avoid use of nsaids, including piroxicam, in pregnant women starting at 30 weeks of gestation (third trimester). there are no adequate and well-controlled studies of piroxicam 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 5 and 10 times the 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. clinical considerations labor or delivery there are no studies on the effects of piroxicam during labor or delivery. in animal studies, nsaids, including piroxicam inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth. data animal data pregnant rats administered piroxicam at 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 2 and 5 times the maximum recommended human dose [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 7 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. risk summary limited data from 2 published reports that included a total of 6 breastfeeding women and 2 infants showed piroxicam is excreted in human milk at approximately 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 and any potential adverse effects on the breastfed infant from the piroxicam or from the underlying maternal condition. infertility females based on the mechanism of action, the use of prostaglandin-mediated nsaids, including piroxicam, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin-mediated follicular rupture required for ovulation. small studies in women treated with nsaids have also shown a reversible delay in ovulation. consider withdrawal of nsaids, including piroxicam, in women who have difficulties conceiving or who are undergoing investigation of infertility. piroxicam has not been investigated in pediatric patients. the safety and effectiveness of piroxicam 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 [see warnings and precautions (5.1, 5.2, 5.3, 5.6, 5.13)].