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

prasco laboratories - colchicine (unii: sml2y3j35t) (colchicine - unii:sml2y3j35t) - colchicine 0.6 mg - colchicine tablets, usp are indicated for prophylaxis and the treatment of acute gout flares. colchicine tablets, usp are indicated in adults and children 4 years or older for treatment of familial mediterranean fever (fmf). patients with renal or hepatic impairment should not be given colchicine tablets, usp in conjunction with p-gp or strong cyp3a4 inhibitors (this includes all protease inhibitors except fosamprenavir). in these patients, life-threatening and fatal colchicine toxicity has been reported with colchicine taken in therapeutic doses. pregnancy category c. there are no adequate and well-controlled studies with colchicine in pregnant women. colchicine crosses the human placenta. while not studied in the treatment of gout flares, data from a limited number of published studies found no evidence of an increased risk of miscarriage, stillbirth or teratogenic effects among pregnant women using colchicine to treat familial mediterranean fever (fmf). although animal reproductive and developmental studie

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

hikma pharmaceuticals usa inc. - colchicine (unii: sml2y3j35t) (colchicine - unii:sml2y3j35t) - colchicine 0.6 mg - colchicine capsules are indicated for prophylaxis of gout flares in adults. limitations of use: the safety and effectiveness of colchicine capsules for acute treatment of gout flares during prophylaxis has not been studied. colchicine capsules are not an analgesic medication and should not be used to treat pain from other causes. patients with renal or hepatic impairment should not be given colchicine capsules with drugs that inhibit both p-glycoprotein and cyp3a4 inhibitors [see drug interactions (7)] . combining these dual inhibitors with colchicine in patients with renal or hepatic impairment has resulted in life-threatening or fatal colchicine toxicity. patients with both renal and hepatic impairment should not be given colchicine capsules.  there are no adequate and well-controlled studies with colchicine capsules in pregnant women. colchicine crosses the human placenta. developmental studies in animals were not conducted with colchicine capsules, however published animal reproduction and development studies with colchicine demonstrated embryofetal toxicity, teratogenicity, and altered postnatal development at exposures within or above the clinical therapeutic range. colchicine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. the effect of colchicine on labor and delivery is unknown. colchicine is excreted into human milk. limited information suggests that infants exclusively breastfed receive less than 10 percent of the maternal weight-adjusted dose. while there are no published reports of adverse effects in breast-feeding infants of mothers taking colchicine, colchicine can affect gastrointestinal cell renewal and permeability. caution should be exercised and breastfeeding infants should be observed for adverse effects when colchicine capsules is administered to a nursing woman.   gout is rare in pediatric patients; the safety and effectiveness of colchicine capsules in pediatric patients has not been evaluated in controlled studies. because of the increased incidence of decreased renal function in the elderly population, and the higher incidence of other co-morbid conditions in the elderly population requiring the use of other medications, reducing the dosage of colchicine when elderly patients are treated with colchicine should be carefully considered. no dedicated pharmacokinetic study has been conducted using colchicine capsules in patients with varying degrees of renal impairment.  colchicine is known to be excreted in urine in humans and the presence of severe renal impairment has been associated with colchicine toxicity. urinary clearance of colchicine and its metabolites may be decreased in patients with impaired renal function. dose reduction or alternatives should be considered for the prophylaxis of gout flares in patients with severe renal impairment. colchicine is not effectively removed by hemodialysis. patients who are undergoing hemodialysis should be monitored carefully for colchicine toxicity. no dedicated pharmacokinetic study using colchicine capsules has been conducted in patients with varying degrees of hepatic impairment. colchicine is known to be metabolized in humans and the presence of severe hepatic impairment has been associated with colchicine toxicity. hepatic clearance of colchicine may be significantly reduced and plasma half-life prolonged in patients with chronic hepatic impairment. dose reduction or alternatives should be considered for the prophylaxis of gout flares in patients with severe hepatic impairment. tolerance, abuse, or dependence from colchicine has not been reported.

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

amneal pharmaceuticals llc - colchicine (unii: sml2y3j35t) (colchicine - unii:sml2y3j35t) - colchicine 0.6 mg - colchicine tablets, usp are indicated for prophylaxis and the treatment of acute gout flares. - prophylaxis of gout flares: colchicine tablets, usp are indicated for prophylaxis of gout flares. - treatment of gout flares: colchicine tablets, usp are indicated for treatment of acute gout flares when taken at the first sign of a flare. colchicine tablets, usp are indicated in adults and children four years or older for treatment of familial mediterranean fever (fmf). patients with renal or hepatic impairment should not be given colchicine, usp in conjunction with p-gp or strong cyp3a4 inhibitors (this includes all protease inhibitors except fosamprenavir). in these patients, life-threatening and fatal colchicine, usp toxicity has been reported with colchicine, usp taken in therapeutic doses. risk summary available data from published literature on colchicine use in pregnancy over several decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal or fetal ou

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

american health packaging - colchicine (unii: sml2y3j35t) (colchicine - unii:sml2y3j35t) - colchicine tablets, usp are indicated for prophylaxis and the treatment of acute gout flares. - prophylaxis of gout flares: colchicine tablets, usp are indicated for prophylaxis of gout flares. - treatment of gout flares: colchicine tablets, usp are indicated for treatment of acute gout flares when taken at the first sign of a flare. colchicine tablets, usp are indicated in adults and children four years or older for treatment of familial mediterranean fever (fmf). patients with renal or hepatic impairment should not be given colchicine tablets, usp in conjunction with p-gp or strong cyp3a4 inhibitors (this includes all protease inhibitors except fosamprenavir). in these patients, life-threatening and fatal colchicine toxicity has been reported with colchicine taken in therapeutic doses. risk summary available data from published literature on colchicine use in pregnancy over several decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal

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

american health packaging - colchicine (unii: sml2y3j35t) (colchicine - unii:sml2y3j35t) - colchicine 0.6 mg

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

par pharmaceutical, inc. - colchicine (unii: sml2y3j35t) (colchicine - unii:sml2y3j35t) - colchicine tablets, usp are indicated for prophylaxis and the treatment of acute gout flares. - prophylaxis of gout flares : colchicine tablets, usp are indicated for prophylaxis of gout flares. - treatment of gout flares : colchicine tablets, usp are indicated for treatment of acute gout flares when taken at the first sign of a flare. colchicine tablets, usp are indicated in adults and children four years or older for treatment of familial mediterranean fever (fmf). patients with renal or hepatic impairment should not be given colchicine tablets, usp in conjunction with p-gp or strong cyp3a4 inhibitors (this includes all protease inhibitors except fosamprenavir). in these patients, life-threatening and fatal colchicine toxicity has been reported with colchicine taken in therapeutic doses. risk summary available data from published literature on colchicine use in pregnancy over several decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal or fe

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

mylan pharmaceuticals inc. - colchicine (unii: sml2y3j35t) (colchicine - unii:sml2y3j35t) - colchicine tablets are indicated for prophylaxis and the treatment of acute gout flares. colchicine tablets are indicated in adults and children four years or older for treatment of familial mediterranean fever (fmf). patients with renal or hepatic impairment should not be given colchicine tablets in conjunction with p-gp or strong cyp3a4 inhibitors (this includes all protease inhibitors except fosamprenavir). in these patients, life-threatening and fatal colchicine toxicity has been reported with colchicine taken in therapeutic doses. available data from published literature on colchicine use in pregnancy over several decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data). colchicine crosses the human placenta. although animal reproductive and developmental studies were not conducted with colchicine tablets, published animal reproduction and development studies indicate that colchicine causes embryofetal toxicity, teratoge

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

mylan institutional inc. - colchicine (unii: sml2y3j35t) (colchicine - unii:sml2y3j35t) - colchicine tablets are indicated for prophylaxis and the treatment of acute gout flares. - prophylaxis of gout flares:   colchicine tablets are indicated for prophylaxis of gout flares. - treatment of gout flares:   colchicine tablets are indicated for treatment of acute gout flares when taken at the first sign of a flare. colchicine tablets are indicated in adults and children four years or older for treatment of familial mediterranean fever (fmf). patients with renal or hepatic impairment should not be given colchicine tablets in conjunction with p-gp or strong cyp3a4 inhibitors (this includes all protease inhibitors except fosamprenavir). in these patients, life-threatening and fatal colchicine toxicity has been reported with colchicine taken in therapeutic doses. available data from published literature on colchicine use in pregnancy over several decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data). colchicine crosses the human placenta. although animal reproductive and developmental studies were not conducted with colchicine tablets, published animal reproduction and development studies indicate that colchicine causes embryofetal toxicity, teratogenicity and altered postnatal development at exposures within or above the clinical therapeutic range. the estimated background risk of major birth defects and miscarriage for the indicated population 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. available data from published observational studies, case series, and case reports over several decades do not suggest an increased risk for major birth defects or miscarriage in pregnant women with rheumatic diseases (such as rheumatoid arthritis, behcet’s disease, or familial mediterranean fever (fmf) treated with colchicine at therapeutic doses during pregnancy. limitations of these data include the lack of randomization and inability to control for confounders such as underlying maternal disease and maternal use of concomitant medications. colchicine is present in human milk (see data) . adverse events in breastfed infants have not been reported in the published literature after administration of colchicine to lactating women. there are no data on the effects of colchicine on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for colchicine tablets and any potential adverse effects on the breastfed child from colchicine tablets or from the underlying maternal condition. limited published data from case reports and a small lactation study demonstrate that colchicine is present in breastmilk. a systematic review of literature reported no adverse effects in 149 breastfed children. in a prospective observational cohort study, no gastrointestinal or other symptoms were reported in 38 colchicine-exposed breastfed infants. case reports and epidemiology studies in human male subjects on colchicine therapy indicated that infertility from colchicine is rare and may be reversible. a case report indicated that azoospermia was reversed when therapy was stopped. case reports and epidemiology studies in female subjects on colchicine therapy have not established a clear relationship between colchicine use and female infertility. however, since the progression of fmf without treatment may result in infertility, the use of colchicine needs to be weighed against the potential risks [see nonclinical toxicology (13.1)] . the safety and efficacy of colchicine in children of all ages with fmf has been evaluated in uncontrolled studies. there does not appear to be an adverse effect on growth in children with fmf treated long-term with colchicine. safety and effectiveness of colchicine in pediatric patients with gout has not been established. clinical studies with colchicine for prophylaxis and treatment of gout flares and for treatment of fmf did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients. in general, dose selection for an elderly patient with gout should be cautious, reflecting the greater frequency of decreased renal function, concomitant disease or other drug therapy [see dosage and administration (2.4), clinical pharmacology (12.3)] . colchicine is significantly excreted in urine in healthy subjects. clearance of colchicine is decreased in patients with impaired renal function. total body clearance of colchicine was reduced by 75% in patients with end-stage renal disease undergoing dialysis. for prophylaxis of gout flares in patients with mild (estimated creatinine clearance cl cr 50 to 80 ml/min) to moderate (cl cr 30 to 50 ml/min) renal function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of colchicine. however, in patients with severe impairment, the starting dose should be 0.3 mg per day and any increase in dose should be done with close monitoring. for the prophylaxis of gout flares in patients undergoing dialysis, the starting doses should be 0.3 mg given twice a week with close monitoring [see dosage and administration (2.5)] . for treatment of gout flares in patients with mild (cl cr 50 to 80 ml/min) to moderate (cl cr 30 to 50 ml/min) renal function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of colchicine tablets. however, in patients with severe impairment, while the dose does not need to be adjusted for the treatment of gout flares, a treatment course should be repeated no more than once every two weeks. for patients with gout flares requiring repeated courses, consideration should be given to alternate therapy. for patients undergoing dialysis, the total recommended dose for the treatment of gout flares should be reduced to a single dose of 0.6 mg (one tablet). for these patients, the treatment course should not be repeated more than once every two weeks [see dosage and administration (2.5)] . although pharmacokinetics of colchicine in patients with mild (cl cr 50 to 80 ml/min) and moderate (cl cr 30 to 50 ml/min) renal impairment is not known, these patients should be monitored closely for adverse effects of colchicine. dose reduction may be necessary. in patients with severe renal failure (cl cr less than 30 ml/min) and end-stage renal disease requiring dialysis, colchicine tablets may be started at the dose of 0.3 mg/day. any increase in dose should be done with adequate monitoring of the patient for adverse effects of colchicine tablets [see clinical pharmacology (12.3), dosage and administration (2.5)] . the clearance of colchicine may be significantly reduced and plasma half-life prolonged in patients with chronic hepatic impairment compared to healthy subjects [see clinical pharmacology (12.3)] . for prophylaxis of gout flares in patients with mild to moderate hepatic function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of colchicine. dose reduction should be considered for the prophylaxis of gout flares in patients with severe hepatic impairment [see dosage and administration (2.6)] . for treatment of gout flares in patients with mild to moderate hepatic function impairment, adjustment of the recommended colchicine tablets dose is not required, but patients should be monitored closely for adverse effects of colchicine tablets. however, for the treatment of gout flares in patients with severe impairment, while the dose does not need to be adjusted, the treatment course should be repeated no more than once every two weeks. for these patients, requiring repeated courses for the treatment of gout flares, consideration should be given to alternate therapy [see dosage and administration (2.6)] . in patients with severe hepatic disease, dose reduction should be considered with careful monitoring [see clinical pharmacology (12.3), dosage and administration (2.6)] . tolerance, abuse or dependence with colchicine has not been reported.

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

proficient rx lp - colchicine (unii: sml2y3j35t) (colchicine - unii:sml2y3j35t) - colchicine tablets, usp are indicated for prophylaxis and the treatment of acute gout flares. colchicine tablets, usp are indicated in adults and children four years or older for treatment of familial mediterranean fever (fmf). patients with renal or hepatic impairment should not be given colchicine tablets, usp in conjunction with p-gp or strong cyp3a4 inhibitors (this includes all protease inhibitors except fosamprenavir). in these patients, life-threatening and fatal colchicine toxicity has been reported with colchicine taken in therapeutic doses. pregnancy category c there are no adequate and well-controlled studies with colchicine in pregnant women. colchicine crosses the human placenta. while not studied in the treatment of gout flares, data from a limited number of published studies found no evidence of an increased risk of miscarriage, stillbirth or teratogenic effects among pregnant women using colchicine to treat familial mediterranean fever (fmf). although animal reproductive and developmental stud

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

granules pharmaceuticals inc. - colchicine (unii: sml2y3j35t) (colchicine - unii:sml2y3j35t) - colchicine tablets are indicated in adults and children four years or older for treatment of familial mediterranean fever (fmf). patients with renal or hepatic impairment should not be given colchicine in conjunction with p-gp or strong cyp3a4 inhibitors (this includes all protease inhibitors except fosamprenavir). in these patients, life-threatening and fatal colchicine toxicity has been reported with colchicine taken in therapeutic doses. risk summary available data from published literature on colchicine use in pregnancy over several decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data). colchicine crosses the human placenta. although animal reproductive and developmental studies were not conducted with colchicine, published animal reproduction and development studies indicate that colchicine causes embryofetal toxicity, teratogenicity and altered postnatal development at exposures within or above the clinical th