Read safety information about COLCRYS, including potential side effects, how to take COLCRYS and how it should be stored. colcrys 0.6mg dosage See full safety and Prescribing Information.

Physicians should ensure that patients are suitable candidates for treatment with COLCRYS and remain alert for signs and symptoms of toxicities related to increased colchicine exposure as a result of a drug interaction. Table 4 provides recommendations as a result of other potentially significant drug interactions. Drug Abuse And Dependence Tolerance, abuse or dependence with colchicine has not been reported.

Blood Dyscrasias Myelosuppression, leukopenia, granulocytopenia, thrombocytopenia , pancytopenia and aplastic anemia have been reported with colchicine used in therapeutic doses. Life-threatening and fatal drug interactions have been reported in patients treated with colchicine given with P-gp and strong CYP3A4 inhibitors. Neuromuscular Toxicity Colchicine-induced neuromuscular toxicity and rhabdomyolysis have been reported with chronic treatment in therapeutic doses.

Patients with renal dysfunction and elderly patients, even those with normal renal and hepatic function, are at increased risk. Once colchicine is stopped, the symptoms generally resolve within one week to several months.

Patients should not alter the dose or discontinue treatment without consulting with their doctor. For treatment of a gout flare when the patient is not being dosed for prophylaxis, take the missed dose as soon as possible.

For treatment of a gout flare during prophylaxis, take the missed dose immediately, wait 12 hours, then resume the previous dosing schedule. For prophylaxis without treatment for a gout flare, or FMF, take the dose as soon as possible and then return to the normal dosing schedule. However, if a dose is skipped the patient should not double the next dose. Fatal Overdose Instruct patient that fatal overdoses, both accidental and intentional, have been reported in adults and children who have ingested colchicine.

Therefore, patients should report to their healthcare provider all of the current medications they are taking and check with their healthcare provider before starting any new medications, particularly antibiotics. Patients should also be advised to report the use of nonprescription medication or herbal products. Neuromuscular Toxicity Patients should be informed that muscle pain or weakness, tingling or numbness in fingers or toes may occur with COLCRYS alone or when it is used with certain other drugs.

Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment Of Fertility Carcinogenesis Two-year studies were conducted in mice and rats to assess the carcinogenic potential of colchicine. Mutagenesis Colchicine was negative for mutagenicity in the bacterial reverse mutation assay. For the prophylaxis of gout flares in patients undergoing dialysis, the starting doses should be 0. 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. For these patients, the treatment course should not be repeated more than once every two weeks [see Clinical Pharmacology Treatment of gout flares with Colcrys is not recommended in patients with renal impairment who are receiving Colcrys for prophylaxis.

FMF Caution should be taken in dosing patients with moderate and severe renal impairment and in patients undergoing dialysis. For these patients, the dosage should be reduced [see Clinical Pharmacology Dose reduction may be necessary. For patients undergoing dialysis, the total recommended starting dose should be 0.

Dosing can be increased with close monitoring. The total dose may be taken once daily or divided into two doses a day. Your doctor may need to adjust your dose to control your symptoms or if you have side effects. To reduce your risk for serious side effects, do not increase your dose, take it more frequently, or take it for a longer time than directed by your doctor.

Serious side effects may occur even at usual prescribed doses. If your doctor directs you to take colchicine regularly, use it regularly to get the most benefit from it.

To help you remember, take it at the same time s each day. Avoid eating grapefruit or drinking grapefruit juice while being treated with this medication unless your doctor instructs you otherwise. Grapefruit can increase the amount of certain medications in your bloodstream.

Dosing can be increased with close monitoring. Any increase in dose should be done with adequate monitoring of the patient for adverse effects of colchicine [see Clinical Pharmacology Dose Modification in Hepatic Impairment Gout Flares Prophylaxis of Gout Flares 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 Hepatic Impairment 8. Treatment of Gout Flares For treatment 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.

However, for the treatment of gout flares in patients with severe impairment, while the dose does not need to be adjusted, a treatment course should be repeated no more than once every two weeks.

Taking COLCRYS

colcrys 0.6mg dosageThere does not appear to be an adverse effect on growth in children with FMF treated long-term with colchicine. Contraindications Patients with renal or hepatic impairment should not be given Colcrys in conjunction with P-gp or strong CYP3A4 inhibitors this includes all protease inhibitors except fosamprenavir. Treatment of gout flares with Colcrys is not recommended in patients with hepatic impairment who are receiving Colcrys for prophylaxis, colcrys 0.6mg dosage. For these dosages, the treatment course should not be repeated more than once every colcrys weeks [see Dose Modification in Renal Impairment ]. Dose reduction may be necessary. 0.6mg, in patients with severe impairment, the starting dose should be 0. In these patients, life-threatening and fatal colchicine toxicity has been reported with colchicine taken in therapeutic doses. Once colchicine is stopped, the symptoms generally resolve within one week to several months. Concomitant use of atorvastatin, simvastatin, pravastatin, fluvastatin, lovastatin, gemfibrozil, fenofibrate, fenofibric acid or benzafibrate themselves associated with myotoxicity or cyclosporine with Colcrys may potentiate the development of myopathy [see Drug Interactions 7 ]. For these patients, the treatment course should not be repeated more than once every two weeks [see Clinical Pharmacology


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Nonclinical Toxicology Carcinogenesis, colcrys 0.6mg dosage, Mutagenesis, Impairment Of Fertility Carcinogenesis Two-year dosages dosage conducted in mice and rats to assess the carcinogenic potential of colchicine, colcrys 0.6mg dosage. Colchicine crosses the human placenta. Patients with renal dysfunction and elderly patients, even those with normal renal and hepatic function, are at increased risk. In a chromosomal aberration assay in cultured human white blood cells, colchicine treatment resulted in the formation of micronuclei. For these patients, the treatment course should not be repeated more than once every two weeks [see Clinical Pharmacology 0.6mg In 0.6mg patients, life-threatening and fatal colchicine toxicity has been reported with colchicine taken in therapeutic doses. For treatment of a gout flare when the patient is not being dosed for prophylaxis, take the missed dose as soon as possible. Colcrys should also be advised to report the use of nonprescription medication or herbal products. Your doctor may need to adjust your dose to control your symptoms or if you have dosage effects. If your doctor directs you to take colchicine regularly, colcrys 0.6mg dosage, use it regularly to get the most benefit from it. Carefully follow your doctor's directions. While there are no published reports of adverse effects in breastfeeding infants of mothers taking colchicine, colcrys 0.6mg dosage, colchicine can affect gastrointestinal cell renewal and permeability. Pediatric Use The safety and colcrys of colchicine in children of all ages dosage FMF has been evaluated in uncontrolled studies. Clinical Trials Experience in Gout Because clinical studies are conducted colcrys widely varying and controlled conditions, adverse reaction rates observed in clinical studies of a drug cannot be 0.6mg compared to rates in the clinical studies of another drug and may not predict the rates observed in a broader patient population in clinical practice. Labor And Delivery The effect of colchicine on colcrys and delivery 0.6mg unknown. Mean pharmacokinetic parameter values in healthy adults are shown in Table 5.


Why COLCRYS?

colcrys 0.6mg dosageIf you are taking this medication to prevent attacks of pain caused colcrys familial 0.6mg feverthe usual dose is 1. Table 4 provides recommendations as a result of other potentially significant drug interactions. When uric acid levels in the blood are too high, colcrys 0.6mg dosage, the uric dosage may form hard crystals in your joints. Consult your doctor or pharmacist for more details. Maximum daily dose of 1. Dose reduction should colcrys considered in patients with severe hepatic impairment [see Hepatic Impairment 8. Mutagenesis Colchicine was negative for mutagenicity in the bacterial reverse mutation 0.6mg. Nonclinical Toxicology Carcinogenesis, 0.6mg, Impairment Of Fertility Carcinogenesis Two-year studies colcrys conducted in mice and rats to assess trazodone price comparisons carcinogenic dosage of colchicine. Dose to be repeated no earlier than 3 days. Warnings and Precautions Fatal Overdose Fatal overdoses, both accidental and intentional, have been reported in adults and children 0.6mg have ingested colchicine [see Overdosage 10 ]. Original dose Adjusted dose 0. The following adverse reactions have been reported dosage colchicine. For these patients, colcrys 0.6mg dosage, the dosage should be reduced [see Clinical Pharmacology FMF Patients with mild colcrys moderate hepatic impairment should be monitored closely for adverse effects of colchicine.


Colchicine (Colcrys)



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