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)

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)

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)

direct rx - colchicine (unii: sml2y3j35t) (colchicine - unii:sml2y3j35t) - 1.1 gout flares 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. 1.2 familial mediterranean fever (fmf) 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.

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

american health packaging - colchicine (unii: sml2y3j35t) (colchicine - unii:sml2y3j35t) - 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. pregnancy category c . 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

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

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

golden state medical supply, 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 t

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)

redpharm drug, 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. 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 n

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

aphena pharma solutions - tennessee, llc - 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