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

leading pharma, llc - diclofenac potassium (unii: l4d5ua6cb4) (diclofenac - unii:144o8ql0l1) - diclofenac potassium is indicated for relief of mild to moderate acute pain in adult and pediatric patients 12 years of age and older. diclofenac potassium 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)] - diclofenac potassium contains gelatin and is contraindicated in patients with known hypersensitivity to bovine protein. risk summary use of nsaids, including diclofenac potassium, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in s

New Zealand - English - Medsafe (Medicines Safety Authority)

dr reddy's new zealand limited - diclofenac potassium 25mg - film coated tablet - 25 mg - active: diclofenac potassium 25mg excipient: crospovidone macrogol 6000 magnesium stearate mannitol opadry clear potassium bicarbonate sodium laurilsulfate - diclofenac 25 tablets are indicated for the short-term treatment of the following acute conditions: · post-traumatic pain, inflammation and swelling, e.g. due to sprains · post-operative pain, inflammation and swelling, e.g. following dental or orthopaedic surgery · painful and/or inflammatory conditions in gynaecology, e.g. primary dysmenorrhoea or adnexitis · migraine attacks · painful syndromes of the vetebral column · non-articular rheumatism · as an adjuvant in severe painful inflammatory infections of the ear, nose or throat, e.g. pharyngotonsillitis, otitis. in keeping with general therapeutic principles, the underlying disease should be treated with basic therapy, as appropriate. fever alone is not an indication. diclofenac should only be prescribed when the benefits are considered to outweigh the potential risks.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

a a h pharmaceuticals ltd - diclofenac potassium - oral tablet - 25mg

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

archis pharma llc - diclofenac potassium (unii: l4d5ua6cb4) (diclofenac - unii:144o8ql0l1) - 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 potassium tablets are 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 to nsaids have been repo

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

nucare pharmaceuticals,inc. - diclofenac potassium (unii: l4d5ua6cb4) (diclofenac - unii:144o8ql0l1) - 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 potassium tablets are 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 t

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

accord-uk ltd - diclofenac potassium - oral tablet - 50mg

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

carilion materials management - 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: diclofenac is contraindicated in the following patients:

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

a-s medication solutions - 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 to nsaids have been reported in

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

ascend laboratories, llc - diclofenac potassium (unii: l4d5ua6cb4) (diclofenac - unii:144o8ql0l1) - diclofenac potassium for oral solution is indicated for the acute treatment of migraine attacks with or without aura in adults (18 years of age or older). limitations of use - diclofenac potassium for oral solution is not indicated for the prophylactic therapy of migraine. - the safety and effectiveness of diclofenac potassium for oral solution have not been established for cluster headache, which is present in an older, predominantly male population. diclofenac potassium for oral 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 [

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

leading pharma, llc - diclofenac potassium (unii: l4d5ua6cb4) (diclofenac - unii:144o8ql0l1) - diclofenac potassium is indicated for the acute treatment of migraine attacks with or without aura in adults (18 years of age or older). limitations of use: - diclofenac potassium is not indicated for the prophylactic therapy of migraine. - the safety and effectiveness of diclofenac potassium have not been established for cluster headache, which is present in an older, predominantly male population. diclofenac potassium 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 potassium, 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 potassium use between about 20 and 30 weeks of gestation, and avoid diclofenac potassium 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 potassium, 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 studies, oral administration of diclofenac sodium to pregnant mice, rats, and rabbits resulted in adverse effects on development (embryofetal mortality, reduced fetal growth) at doses similar to those used clinically. 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 potassium, 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. all pregnancies have a background risk of birth defects, 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 2-4% and 15-20%, respectively. the reported rate of major birth defects among deliveries to women with migraine ranged from 2.2% to 2.9% and the reported rate of miscarriage was 17%, which were similar to rates reported in women without migraine. clinical considerations disease-associated maternal and/or embryo/fetal risk several studies have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy. fetal/neonatal adverse reactions premature closure of fetal ductus arteriosus: avoid use of nsaids in women at about 30 weeks gestation and later in pregnancy, because nsaids, including diclofenac potassium, 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 potassium treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios. if oligohydramnios occurs, discontinue diclofenac potassium and follow up according to clinical practice (see data). labor or delivery the effects of diclofenac potassium on labor and delivery in pregnant women are unknown. in rat studies, maternal exposure to nsaids, as with other drugs known to inhibit prostaglandin synthesis, increased the incidence of dystocia, delayed parturition, and decreased pup survival. 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 oral administration of diclofenac sodium to pregnant mice and rabbits during organogenesis resulted in embryofetal toxicity at oral doses of up to 20 and 10 mg/kg/day (up to approximately 2 and 4 times, respectively, the recommended human dose [rhd] of 50 mg/day, based on body surface area [mg/m2 ]). in rats, oral administration of diclofenac at doses of up to 10 mg/kg/day (up to approximately 2 times the rhd on a mg/m2 basis) during organogenesis resulted in increased embryofetal mortality and reduced fetal body weights. risk summary data from published literature reports with oral preparations of diclofenac indicate the presence of small amounts of diclofenac in human milk. there are no data on the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for diclofenac potassium and any potential adverse effects on the breastfed infant from diclofenac potassium or from the underlying maternal condition. infertility females based on the mechanism of action, the use of prostaglandin-mediated nsaids, including diclofenac potassium, 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 potassium, in women who have difficulties conceiving or who are undergoing investigation of infertility. 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, monitor patients for adverse effects [see warnings and precautions (5.1, 5.2, 5.3, 5.6, 5.15) ]. clinical studies of diclofenac potassium did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. because hepatic metabolism accounts for almost 100% of diclofenac elimination, patients with hepatic impairment should be considered for treatment with diclofenac potassium only if the benefits outweigh the risks. there is insufficient information available to support dosing recommendations for diclofenac potassium in patients with hepatic insufficiency [see clinical pharmacology (12.3) ]. no information is available from controlled clinical studies regarding the use of diclofenac potassium in patients with advanced renal disease. therefore, treatment with diclofenac potassium is not recommended in patients with advanced renal disease. if diclofenac potassium therapy must be initiated, close monitoring of the patient’s renal function is advisable.