Stany Zjednoczone - angielski - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - diclofenac potassium (unii: l4d5ua6cb4) (diclofenac - unii:144o8ql0l1) - diclofenac potassium 50 mg - carefully consider the potential benefits and risks of diclofenac potassium tablets and other treatment options before deciding to use diclofenac potassium tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ; gastrointestinal bleeding, ulceration, and perforation ). diclofenac potassium tablets are indicated: - for treatment of primary dysmenorrhea - for relief of mild to moderate pain - for relief of the signs and symptoms of osteoarthritis - for relief of the signs and symptoms of rheumatoid arthritis diclofenac is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product (see warnings ; anaphylactic reactions, serious skin reactions ). - history of asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions t

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium 100 mg - carefully consider the potential benefits and risks of diclofenac sodium extended-release tablets, usp and other treatment options before deciding to use diclofenac sodium extended-release tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). diclofenac sodium extended-release tablets are indicated: - for relief of the signs and symptoms of osteoarthritis - for relief of the signs and symptoms of rheumatoid arthritis diclofenac sodium extended-release tablets, usp are contraindicated in patients with known hypersensitivity to diclofenac. diclofenac sodium extended-release tablets 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, anaphylactic reactions , and precautions, general: preexisting asthma ). diclofenac sodium extended-release ta

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium topical solution, 1.5% w/w is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1). diclofenac sodium topical solution, 1.5% w/w is contraindicated in the following patients: pregnancy category c prior to 30 weeks gestation; category d starting 30 weeks gestation. risk summary use of nsaids, including diclofenac sodium topical solution, 1.5% w/w, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. avoid use of nsaids, including diclofenac sodium topical solution, 1.5% w/w, in pregnant women starting at 30 weeks of gestation (third trimester). there are no adequate and well-controlled studies of diclofenac sodium topical solution, 1.5% w/w 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

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium gel is indicated for the topical treatment of actinic keratoses (ak). diclofenac sodium gel is contraindicated in the following patients: risk summary use of nsaids, including diclofenac sodium gel, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. because of these risks, limit dose and duration of diclofenac sodium gel use between about 20 and 30 weeks of gestation and avoid diclofenac sodium gel use at about 30 weeks of gestation and later in pregnancy. oligohydramnios/neonatal renal impairment use of nsaids at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. premature closure of fetal ductus arteriosus use of nsaids, including diclofenac sodium gel, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal d

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

zydus pharmaceuticals (usa) inc. - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium topical solution is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1). diclofenac sodium topical solution is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac 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 30 weeks gestation. risk summary use of nsaids, including diclofenac sodium topical solution, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. avoid use of nsaids,

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium topical gel is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. diclofenac sodium is contraindicated in the following patients: pregnancy category c prior to 30 weeks gestation; category d starting 30 weeks gestation risk summary use of nsaids, including diclofenac sodium, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. avoid use of nsaids, including diclofenac sodium, in pregnant women starting at 30 weeks of gestation (third trimester). there are no adequate and well-controlled studies of diclofenac sodium in pregnant women. human and animal studies indicate that diclofenac crosses the placenta. 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 e

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

alembic pharmaceuticals inc. - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium topical gel is indicated for the topical treatment of actinic keratoses (ak). diclofenac sodium topical gel is contraindicated in the following patients:  - with known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product [see warnings and precautions (5.1, 5.3, 5.10) and description (11)]     - with the 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 (5.1, 5.2)] - application on damaged skin resulting from any etiology, including exudative dermatitis, eczema, infected lesions, burns or wounds [see warnings and precautions (5.3)] - in the setting of coronary bypass graft (cabg) surgery [see warnings and precautions (5.4)] risk summary use of nsaids, including diclofenac sodium topical gel, can cause premature closure of the fetal ductus arteriosu

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium topical solution is indicated for the treatment of the pain of osteoarthritis of the knee(s). diclofenac sodium topical solution is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac 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)] risk summary use of nsaids, including diclofenac sodium topical solution, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. because of these risks, limit dose and duration of diclofenac sodium topical solution use between about 20 and 30 weeks of gestation, and avoid diclofenac sodium topical solution use at about 30 weeks of gestation and later in pregnancy (see clinical considerations, data). premature closure of fetal ductus arteriosus use of nsaids, including diclofenac sodium topical solution, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus. oligohydramnios/neonatal renal impairment use of nsaids at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. data from observational studies regarding other potential embryofetal risks of nsaid use in women in the first or second trimesters of pregnancy are inconclusive. in animal reproduction studies, no evidence of malformations were observed in mice, rats, or rabbits given diclofenac during the period of organogenesis at doses up to approximately 0.6, 0.6, and 1.3 times, respectively, the maximum recommended human dose (mrhd) of 162 mg diclofenac sodium via diclofenac sodium topical solution, despite the presence of maternal and fetal toxicity at these doses [see data]. 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 diclofenac, resulted in increased pre- and post-implantation loss. prostaglandins also have been shown to have an important role in fetal kidney development. in published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses. the estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations fetal/neonatal adverse reactions premature closure of the fetal ductus arteriosus: avoid use of nsaids in women at about 30 weeks gestation and later in pregnancy, because nsaids, including diclofenac sodium topical solution, can cause premature closure of the fetal ductus arteriosus (see data) . oligohydramnios/neonatal renal impairment: if an nsaid is necessary at about 20 weeks gestation or later in pregnancy, limit the use to the lowest effective dose and shortest duration possible. if diclofenac sodium topical solution treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios. if oligohydramnios occurs, discontinue diclofenac sodium topical solution and follow up according to clinical practice (see data) . labor or delivery: there are no studies on the effects of diclofenac sodium topical solution during labor or delivery. in animal studies, nsaids, including diclofenac inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth. data human data      premature closure of fetal ductus arteriosus: published literature reports that the use of nsaids at about 30 weeks of gestation and later in pregnancy may cause premature closure of the fetal ductus arteriosus. oligohydramnios/neonatal renal impairment: published studies and postmarketing reports describe maternal nsaid use at about 20 weeks gestation or later in pregnancy associated with fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. these adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after nsaid initiation. in many cases, but not all, the decrease in amniotic fluid was transient and reversible with cessation of the drug. there have been a limited number of case reports of maternal nsaid use and neonatal renal dysfunction without oligohydramnios, some of which were irreversible. some cases of neonatal renal dysfunction required treatment with invasive procedures, such as exchange transfusion or dialysis. methodological limitations of these postmarketing studies and reports include lack of a control group; limited information regarding dose, duration, and timing of drug exposure; and concomitant use of other medications. these limitations preclude establishing a reliable estimate of the risk of adverse fetal and neonatal outcomes with maternal nsaid use. because the published safety data on neonatal outcomes involved mostly preterm infants, the generalizability of certain reported risks to the full-term infant exposed to nsaids through maternal use is uncertain. animal data: reproductive and developmental studies in animals demonstrated that diclofenac sodium administration during organogenesis did not produce malformations despite the induction of maternal toxicity and fetal toxicity in mice at oral doses up to 20 mg/kg/day (approximately 0.6 times the maximum recommended human dose [mrhd] of diclofenac sodium topical solution, 162 mg diclofenac sodium/day, based on body surface area (bsa) comparison), and in rats and rabbits at oral doses up to 10 mg/kg/day (approximately 0.6 and 1.3-times, respectively, the mrhd based on bsa comparison). published reproductive and developmental studies of dimethyl sulfoxide (dmso, the solvent used in diclofenac sodium topical solution) are equivocal as to potential teratogenicity. in a study in which pregnant rats were orally administered 2 or 4 mg/kg diclofenac (0.12 and 0.24 times the mrhd, respectively, based on bsa comparison) from gestation day 15 through lactation day 21, significant maternal toxicity (peritonitis, mortality) was noted. these maternally toxic doses were associated with dystocia, prolonged gestation, reduced fetal weights and growth, and reduced fetal survival. diclofenac has been shown to cross the placental barrier in mice and rats. in published studies, diclofenac administration to pregnant rats prolonged gestation and produced liver toxicity and neuronal loss in offspring (1 mg/kg, ip; 0.06 times the mrhd based on bsa comparison), impaired nephrogenesis in the kidney (3.6 mg/kg, ip; 0.2 times the mrhd based on bsa comparison), and caused adverse effects on the developing testes (6.1 mg/kg, oral; 0.4 times the mrhd based on bsa comparison). risk summary based on available data, diclofenac may be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for diclofenac sodium topical solution and any potential adverse effects on the breastfed infant from the diclofenac sodium topical solution or from the underlying maternal condition. data one woman treated orally with a diclofenac salt, 150 mg/day, had a milk diclofenac level of 100 mcg/l, equivalent to an infant dose of about 0.03 mg/kg/day. diclofenac was not detectable in breast milk in 12 women using diclofenac (after either 100 mg/day orally for 7 days or a single 50 mg intramuscular dose administered in the immediate postpartum period). infertility females: based on the mechanism of action, the use of prostaglandin-mediated nsaids, including diclofenac sodium topical solution, 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 diclofenac sodium topical solution, in women who have difficulties conceiving or who are undergoing investigation of infertility. males: published studies in adult male rodents report that diclofenac, at clinically relevant doses, can produce adverse effects on male reproductive tissues. the impact of these findings on male fertility is not clear [see nonclinical toxicology (13.1) ]. safety and effectiveness in pediatric patients 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, 5.14)]. of the 911 patients treated with diclofenac sodium topical solution 1.5% in seven controlled, phase 3 clinical trials, 444 subjects were 65 years of age and over. there was no age-related difference in the incidence of adverse events. of the 793 patients treated with diclofenac sodium topical solution 1.5% in one open-labeled safety trial, 334 subjects were 65 years of age and over including 107 subjects 75 and over. there was no difference in the incidence of adverse events with long-term exposure to diclofenac sodium topical solution 1.5% for this elderly population.

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium topical gel is indicated for the topical treatment of actinic keratoses (ak). diclofenac sodium topical gel is contraindicated in the following patients:  risk summary use of nsaids, including diclofenac sodium topical gel, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.  because of these risks, limit dose and duration of diclofenac sodium topical gel use between about 20 and 30 weeks of gestation and avoid diclofenac sodium topical gel use at about 30 weeks of gestation and later in pregnancy.  oligohydramnios/neonatal renal impairment use of nsaids at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. premature closure of fetal ductus arteriosus use of nsaids, including diclofenac sodium topical gel, at about 30 weeks gestation or later in pregnancy inc

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium topical solution is indicated for the treatment of the pain of osteoarthritis of the knee(s). diclofenac sodium topical solution is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac 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)] risk summary use of nsaids, including diclofenac sodium topical solution, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. because of these risks, limit dose and duration of diclofenac sodium topical solution use between about 20 and 30 weeks of gestation, and avoid diclofenac sodium topical solution use at about 30 weeks of gestation and later in pregnancy (see clinical considerations, data). premature closure of fetal ductus arteriosus use of nsaids, including diclofenac sodium topical solution, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus. oligohydramnios/neonatal renal impairment use of nsaids at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. data from observational studies regarding other potential embryofetal risks of nsaid use in women in the first or second trimesters of pregnancy are inconclusive. in animal reproduction studies, no evidence of malformations were observed in mice, rats, or rabbits given diclofenac during the period of organogenesis at doses up to approximately 0.6, 0.6, and 1.3 times, respectively, the maximum recommended human dose (mrhd) of 162 mg diclofenac sodium via diclofenac sodium topical solution, despite the presence of maternal and fetal toxicity at these doses [see data]. 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 diclofenac, resulted in increased pre- and post-implantation loss. prostaglandins also have been shown to have an important role in fetal kidney development. in published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses. the estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations fetal/neonatal adverse reactions premature closure of the fetal ductus arteriosus: avoid use of nsaids in women at about 30 weeks gestation and later in pregnancy, because nsaids, including diclofenac sodium topical solution, can cause premature closure of the fetal ductus arteriosus (see data) . oligohydramnios/neonatal renal impairment: if an nsaid is necessary at about 20 weeks gestation or later in pregnancy, limit the use to the lowest effective dose and shortest duration possible. if diclofenac sodium topical solution treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios. if oligohydramnios occurs, discontinue diclofenac sodium topical solution and follow up according to clinical practice (see data) . labor or delivery: there are no studies on the effects of diclofenac sodium topical solution during labor or delivery. in animal studies, nsaids, including diclofenac inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth. data human data      premature closure of fetal ductus arteriosus: published literature reports that the use of nsaids at about 30 weeks of gestation and later in pregnancy may cause premature closure of the fetal ductus arteriosus. oligohydramnios/neonatal renal impairment: published studies and postmarketing reports describe maternal nsaid use at about 20 weeks gestation or later in pregnancy associated with fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. these adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after nsaid initiation. in many cases, but not all, the decrease in amniotic fluid was transient and reversible with cessation of the drug. there have been a limited number of case reports of maternal nsaid use and neonatal renal dysfunction without oligohydramnios, some of which were irreversible. some cases of neonatal renal dysfunction required treatment with invasive procedures, such as exchange transfusion or dialysis. methodological limitations of these postmarketing studies and reports include lack of a control group; limited information regarding dose, duration, and timing of drug exposure; and concomitant use of other medications. these limitations preclude establishing a reliable estimate of the risk of adverse fetal and neonatal outcomes with maternal nsaid use. because the published safety data on neonatal outcomes involved mostly preterm infants, the generalizability of certain reported risks to the full-term infant exposed to nsaids through maternal use is uncertain. animal data: reproductive and developmental studies in animals demonstrated that diclofenac sodium administration during organogenesis did not produce malformations despite the induction of maternal toxicity and fetal toxicity in mice at oral doses up to 20 mg/kg/day (approximately 0.6 times the maximum recommended human dose [mrhd] of diclofenac sodium topical solution, 162 mg diclofenac sodium/day, based on body surface area (bsa) comparison), and in rats and rabbits at oral doses up to 10 mg/kg/day (approximately 0.6 and 1.3-times, respectively, the mrhd based on bsa comparison). published reproductive and developmental studies of dimethyl sulfoxide (dmso, the solvent used in diclofenac sodium topical solution) are equivocal as to potential teratogenicity. in a study in which pregnant rats were orally administered 2 or 4 mg/kg diclofenac (0.12 and 0.24 times the mrhd, respectively, based on bsa comparison) from gestation day 15 through lactation day 21, significant maternal toxicity (peritonitis, mortality) was noted. these maternally toxic doses were associated with dystocia, prolonged gestation, reduced fetal weights and growth, and reduced fetal survival. diclofenac has been shown to cross the placental barrier in mice and rats. in published studies, diclofenac administration to pregnant rats prolonged gestation and produced liver toxicity and neuronal loss in offspring (1 mg/kg, ip; 0.06 times the mrhd based on bsa comparison), impaired nephrogenesis in the kidney (3.6 mg/kg, ip; 0.2 times the mrhd based on bsa comparison), and caused adverse effects on the developing testes (6.1 mg/kg, oral; 0.4 times the mrhd based on bsa comparison). risk summary based on available data, diclofenac may be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for diclofenac sodium topical solution and any potential adverse effects on the breastfed infant from the diclofenac sodium topical solution or from the underlying maternal condition. data one woman treated orally with a diclofenac salt, 150 mg/day, had a milk diclofenac level of 100 mcg/l, equivalent to an infant dose of about 0.03 mg/kg/day. diclofenac was not detectable in breast milk in 12 women using diclofenac (after either 100 mg/day orally for 7 days or a single 50 mg intramuscular dose administered in the immediate postpartum period). infertility females: based on the mechanism of action, the use of prostaglandin-mediated nsaids, including diclofenac sodium topical solution, 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 diclofenac sodium topical solution, in women who have difficulties conceiving or who are undergoing investigation of infertility. males: published studies in adult male rodents report that diclofenac, at clinically relevant doses, can produce adverse effects on male reproductive tissues. the impact of these findings on male fertility is not clear [see nonclinical toxicology (13.1) ]. safety and effectiveness in pediatric patients 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, 5.14)]. of the 911 patients treated with diclofenac sodium topical solution, 1.5% in seven controlled, phase 3 clinical trials, 444 subjects were 65 years of age and over. there was no age-related difference in the incidence of adverse events. of the 793 patients treated with diclofenac sodium topical solution, 1.5% in one open-labeled safety trial, 334 subjects were 65 years of age and over including 107 subjects 75 and over. there was no difference in the incidence of adverse events with long-term exposure to diclofenac sodium topical solution, 1.5% for this elderly population.