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Colcrys

Colcrys


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Colcrys Drug Description


COLCRYS™
(colchicine, USP) Tablets for Oral Use

DRUG DESCRIPTION

Colchicine is an alkaloid chemically described as (S)N- (5,6,7,9-tetrahydro- 1,2,3, 10-tetramethoxy-9-oxobenzo [alpha] heptalen-7-yl) acetamide with a molecular formula of C22H25NO6 and a molecular weight of 399.4. The structural formula of colchicine is given below.

 

Colcrys (colchicine) structural formula illustration

Colchicine occurs as a pale yellow powder that is soluble in water.

COLCRYS™ (colchicine tablets) (colchicine USP) tablets is supplied for oral administration as purple, film-coated, capsule-shaped tablets (0.1575” × 0.3030”), debossed with ‘AR 374' on one side and scored on the other, containing 0.6 mg of the active ingredient colchicine USP. Inactive ingredients: carnauba wax, FD&C blue #2, FD&C red #40, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, titanium dioxide, and triacetin.

 

What are the possible side effects of colchicine (Colcrys)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • muscle pain or weakness;
  • numbness or tingly feeling in your fingers or toes;
  • pale or gray appearance of your lips, tongue, or hands;
  • severe vomiting or diarrhea;
  • easy bruising or bleeding, feeling weak or tired;
  • fever, chills, body aches, flu...

Read All Potential Side Effects and See Pictures of Colcrys »

 

What are the precautions when taking colchicine tablets (Colcrys)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems (such as cirrhosis).

Alcohol can decrease this drug's effectiveness. Limit alcohol while taking this drug.

This medication can affect how well your body absorbs some foods and nutrients (such as vitamin B12). Consult your doctor or pharmacist for more details.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription...

 

Colcrys


Colcrys Indications & Dosage


INDICATIONS

Gout Flares

COLCRYS® (colchicine, USP) tablets are indicated for prophylaxis and the treatment of acute gout flares.

Prophylaxis of Gout Flares

COLCRYS is indicated for prophylaxis of gout flares.

Treatment of Gout Flares

COLCRYS tablets are indicated for treatment of acute gout flares when taken at the first sign of a flare.

Familial Mediterranean fever (FMF)

COLCRYS® (colchicine, USP) tablets are indicated in adults and children 4 years or older for treatment of familial Mediterranean fever (FMF).

DOSAGE AND ADMINISTRATION

The long term use of colchicine is established for FMF and the prophylaxis of gout flares but the safety and efficacy of repeat treatment for gout flares has not been evaluated. The dosing regimens for COLCRYS are different for each indication and must be individualized.

The recommended dosage of COLCRYS depends on the patient's age, renal function, hepatic function, and use of co-administered drugs [see Dose Modification for Co-administration of Interacting Drugs].

COLCRYS tablets are administered orally, without regard to meals.

COLCRYS is not an analgesic medication and should not be used to treat pain from other causes.

Gout Flares

Prophylaxis of Gout Flares

The recommended dosage of COLCRYS for prophylaxis of gout flares for adults and adolescents older than 16 years of age is 0.6 mg once or twice daily. The maximum recommended dose for prophylaxis of gout flares is 1.2 mg/day.

Treatment of Gout Flares

The recommended dose of COLCRYS for treatment of a gout flare is 1.2 mg (2 tablets) at the first sign of the flare followed by 0.6 mg (1 tablet) one hour later. Higher doses have not been found to be more effective. The maximum recommended dose for treatment of gout flares is 1.8 mg over a 1 hour period. COLCRYS may be administered for treatment of a gout flare during prophylaxis at doses not to exceed 1.2 mg (2 tablets) at the first sign of the flare followed by 0.6 mg (1 tablet) one hour later. Wait 12 hours and then resume the prophylactic dose.

FMF

The recommended dosage of COLCRYS for FMF in adults is 1.2 mg to 2.4 mg daily.

COLCRYS should be increased as needed to control disease and as tolerated in increments of 0.3 mg/day to a maximum recommended daily dose. If intolerable side effects develop, the dose should be decreased in increments of 0.3 mg/day. The total daily COLCRYS dose may be administered in one to two divided doses.

Recommended Pediatric Dosage

Prophylaxis and Treatment of Gout Flares

COLCRYS is not recommended for pediatric use in prophylaxis or treatment of gout flares.

FMF

The recommended dosage of COLCRYS for FMF in pediatric patients 4 years of age and older is based on age. The following daily doses may be given as a single or divided dose twice daily:

  • Children 4 – 6 years: 0.3 mg to 1.8 mg daily
  • Children 6 – 12 years: 0.9 mg to 1.8 mg daily
  • Adolescents older than 12 years: 1.2 mg to 2.4 mg daily

Dose Modification for Co-administration of Interacting Drugs

Concomitant Therapy

Co-administration of COLCRYS with drugs known to inhibit CYP3A4 and/or P-glycoprotein (P-gp) increases the risk of colchicine-induced toxic effects (Table 1). If patients are taking or have recently completed treatment with drugs listed in Table 1 within the prior 14 days, the dose adjustments are as shown on the table below [see DRUG INTERACTIONS].

Table 1 : COLCRYS Dose Adjustment for Co-administration with Interacting Drugs if no Alternative Available1


Table 2 : COLCRYS Dose Adjustment for Co-administration with Protease Inhibitors


Treatment of gout flares with COLCRYS is not recommended in patients receiving prophylactic dose of COLCRYS and CYP3A4 inhibitors.

Dose Modification in Renal Impairment

Colchicine dosing must be individualized according to the patient's renal function [see Renal Impairment].

Clcr in mL/minute may be estimated from serum creatinine (mg/dL) determination using the following formula:

Males: (weight in kg) x (140 – age)
(72) x serum creatinine (mg/100 mL)
Females (0.85) x (above value)
Gout Flares

Prophylaxis of Gout Flares

For prophylaxis of gout flares in patients with mild (estimated creatinine clearance Clcr 50 – 80 mL/min) to moderate (Clcr 30 – 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 CLINICAL PHARMACOLOGY and Renal Impairment].

Treatment of Gout Flares

For treatment of gout flares in patients with mild (Clcr 50 – 80 mL/min) to moderate (Clcr 30 – 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, 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 2 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 (1 tablet). For these patients, the treatment course should not be repeated more than once every 2 weeks [see CLINICAL PHARMACOLOGY and Renal Impairment].

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]. Patients with mild (Clcr 50 – 80 mL/min) and moderate (Clcr 30 – 50 mL/min) renal impairment should be monitored closely for adverse effects of COLCRYS. Dose reduction may be necessary. For patients with severe renal failure (Clcr less than 30 mL/minute), start with 0.3 mg/day; any increase in dose should be done with adequate monitoring of the patient for adverse effects of colchicine [see Renal Impairment]. For patients undergoing dialysis, the total recommended starting dose should be 0.3 mg (half tablet) per day. 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 and Renal Impairment].

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].

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, but a treatment course should be repeated no more than once every 2 weeks. For these patients, requiring repeated courses for the treatment of gout flares, consideration should be given to alternate therapy [see Hepatic Impairment].

Treatment of gout flares with COLCRYS is not recommended in patients with hepatic impairment who are receiving COLCRYS for prophylaxis.

FMF

Patients with mild to moderate hepatic impairment should be monitored closely for adverse effects of colchicine. Dose reduction should be considered in patients with severe hepatic impairment [see Hepatic Impairment].

HOW SUPPLIED

Dosage Forms And Strengths

0.6 mg tablets — purple capsule-shaped, film-coated with AR 374 debossed on one side and scored on the other side.

Storage And Handling

COLCRYS® (colchicine, USP) tablets 0.6 mg, are purple, film-coated, capsule-shaped tablets, debossed with ‘AR 374' on one side and scored on the other side.

Bottles of 30 NDC 13310-119-07
Bottles of 60 NDC 13310-119-06
Bottles of 100 NDC 13310-119-01
Bottles of 250 NDC 13310-119-03
Bottles of 500 NDC 13310-119-05
Bottles of 1000 NDC 13310-119-10

Storage

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] Protect from light.

DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Manufactured for: AR Scientific Inc., Philadelphia, PA 19124 USA by: Mutual Pharmaceutical Company, Inc. Philadelphia, PA 19124 USA. Rev 10, July 2011

 

Colcrys


Colcrys Side Effects & Drug Interactions


SIDE EFFECTS

Prophylaxis of Gout Flares

The most commonly reported adverse reaction in clinical trials of colchicine for the prophylaxis of gout was diarrhea.

Treatment of Gout Flares

The most common adverse reactions reported in the clinical trial with COLCRYS for treatment of gout flares were diarrhea (23%) and pharyngolaryngeal pain (3%).

FMF

Gastrointestinal tract adverse effects are the most frequent side effects in patients initiating COLCRYS, usually presenting within 24 hours, and occurring in up to 20% of patients given therapeutic doses. Typical symptoms include cramping, nausea, diarrhea, abdominal pain, and vomiting. These events should be viewed as dose-limiting if severe as they can herald the onset of more significant toxicity.

Clinical Trials Experience in Gout

Because clinical studies are conducted under widely varying and controlled conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly 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.

In a randomized, double-blind, placebo-controlled trial in patients with a gout flare, gastrointestinal adverse reactions occurred in 26% of patients using the recommended dose (1.8 mg over 1 hour) of COLCRYS compared to 77% of patients taking a non-recommended high-dose (4.8 mg over 6 hours) of colchicine and 20% of patients taking placebo. Diarrhea was the most commonly reported drug-related gastrointestinal adverse event. As shown in Table 3, diarrhea is associated with COLCRYS treatment. Diarrhea was more likely to occur in patients taking the high-dose regimen than the low-dose regimen. Severe diarrhea occurred in 19% and vomiting occurred in 17% of patients taking the non-recommended high-dose colchicine regimen but did not occur in the recommended low-dose COLCRYS regimen.

Table 3 : Number (%) of Patients with at Least One Drug-Related Treatment Emergent Adverse Events with an Incidence of ≥ 2% of Patients in Any Treatment Group

MedDRA System Organ Class
MedDRA Preferred Term
COLCRYS Dose Placebo
(N=59)
n (%)
High
(N=52)
n (%)
Low
(N=74)
n (%)
Number of Patients with at Least One Drug-Related TEAE 40 (77) 27 (37) 16 (27)
Gastrointestinal Disorders 40 (77) 19 (26) 12 (20)
Diarrhea 40 (77) 17 (23) 8 (14)
Nausea 9 (17) 3 (4) 3 (5)
Vomiting 9 (17) 0 0
Abdominal Discomfort 0 0 2 (3)
General Disorders and Administration Site Conditions 4 (8) 1 (1) 1 (2)
Fatigue 2 (4) 1 (1) 1 (2)
Metabolic and Nutrition Disorders 0 3 (4) 2 (3)
Gout 0 3 (4) 1 (2)
Nervous System Disorders 1 (2) 1 (1.4) 2 (3)
Headache 1 (2) 1 (1) 2 (3)
Respiratory Thoracic Mediastinal Disorders 1 (2) 2 (3) 0
Pharyngolaryngeal Pain 1 (2) 2 (3) 0

Postmarketing Experience

Serious toxic manifestations associated with colchicine include myelosuppression, disseminated intravascular coagulation, and injury to cells in the renal, hepatic, circulatory, and central nervous systems.

These most often occur with excessive accumulation or overdosage [see OVERDOSAGE].

The following adverse reactions have been reported with colchicine. These have been generally reversible upon temporarily interrupting treatment or lowering the dose of colchicine.

Neurological: sensory motor neuropathy

Dermatological: alopecia, maculopapular rash, purpura, rash

Digestive: abdominal cramping, abdominal pain, diarrhea, lactose intolerance, nausea, vomiting

Hematological: leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, aplastic anemia

Hepatobiliary: elevated AST, elevated ALT

Musculoskeletal: myopathy, elevated CPK, myotonia, muscle weakness, muscle pain, rhabdomyolysis

Reproductive: azoospermia, oligospermia

DRUG INTERACTIONS

COLCRYS (colchicine) is a substrate of the efflux transporter P-glycoprotein (P-gp). Of the cytochrome P450 enzymes tested, CYP3A4 was mainly involved in the metabolism of colchicine. If COLCRYS is administered with drugs that inhibit P-gp, most of which also inhibit CYP3A4, increased concentrations of colchicine are likely. Fatal drug interactions have been reported.

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. Signs and symptoms of COLCRYS toxicity should be evaluated promptly and, if toxicity is suspected, COLCRYS should be discontinued immediately.

Table 4 provides recommendations as a result of other potentially significant drug interactions. Table 1 provides recommendations for strong and moderate CYP3A4 inhibitors and P-gp inhibitors.

Table 4 : Other Potentially Significant Drug Interactions


Drug Abuse And Dependence

Tolerance, abuse, or dependence with colchicine has not been reported.

 

Colcrys


Colcrys Warnings & Precautions


WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Fatal Overdose

Fatal overdoses, both accidental and intentional, have been reported in adults and children who have ingested colchicine [see OVERDOSAGE]. COLCRYS should be kept out of the reach of children.

Blood Dyscrasias

Myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, and aplastic anemia have been reported with colchicine used in therapeutic doses.

Drug Interactions

Colchicine is a P-gp and CYP3A4 substrate. Life-threatening and fatal drug interactions have been reported in patients treated with colchicine given with P-gp and strong CYP3A4 inhibitors. If treatment with a P-gp or strong CYP3A4 inhibitor is required in patients with normal renal and hepatic function, the patient's dose of colchicine may need to be reduced or interrupted [see DRUG INTERACTIONS]. Use of COLCRYS in conjunction with P-gp or strong CYP3A4 inhibitors (this includes all protease inhibitors, except fosamprenavir) is contraindicated in patients with renal or hepatic impairment [see CONTRAINDICATIONS].

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. Concomitant use of atorvastatin, simvastatin, pravastatin, fluvastatin, gemfibrozil, fenofibrate, fenofibric acid, or benzafibrate (themselves associated with myotoxicity) or cyclosporine with COLCRYS may potentiate the development of myopathy [see DRUG INTERACTIONS]. Once colchicine is stopped, the symptoms generally resolve within 1 week to several months.

Patient Counseling Information

[See Medication Guide]

Dosing Instructions

Patients should be advised to take COLCRYS as prescribed, even if they are feeling better. Patients should not alter the dose or discontinue treatment without consulting with their doctor. If a dose of COLCRYS is missed:

  • 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 twelve 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. COLCRYS should be kept out of the reach of children.

Blood Dyscrasias

Patients should be informed that bone marrow depression with agranulocytosis, aplastic anemia, and thrombocytopenia may occur with COLCRYS.

Drug and Food Interactions

Patients should be advised that many drugs or other substances may interact with COLCRYS and some interactions could be fatal. 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 non-prescription medication or herbal products. Grapefruit and grapefruit juice may also interact and should not be consumed during COLCRYS treatment.

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. Patients developing any of these signs or symptoms must discontinue COLCRYS and seek medical evaluation immediately.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Carcinogenicity studies of colchicine have not been conducted. Due to the potential for colchicine to produce aneuploid cells (cells with an unequal number of chromosomes), there is theoretically an increased risk of malignancy.

Mutagenesis

Colchicine was negative for mutagenicity in the bacterial reverse mutation assay. In a chromosomal aberration assay in cultured human white blood cells, colchicine treatment resulted in the formation of micronuclei. Since published studies demonstrated that colchicine induces aneuploidy from the process of mitotic nondisjunction without structural DNA changes, colchicine is not considered clastogenic, although micronuclei are formed.

Impairment of Fertility

No studies of colchicine effects on fertility were conducted with COLCRYS. However, published nonclinical studies demonstrated that colchicine-induced disruption of microtubule formation affects meiosis and mitosis. Reproductive studies also reported abnormal sperm morphology and reduced sperm counts in males, and interference with sperm penetration, second meiotic division, and normal cleavage in females when exposed to colchicine. Colchicine administered to pregnant animals resulted in fetal death and teratogenicity. These effects were dose dependent, with the timing of exposure critical for the effects on embryofetal development. The nonclinical doses evaluated were generally higher than an equivalent human therapeutic dose, but safety margins for reproductive and developmental toxicity could not be determined.

Case reports and epidemiology studies in human male subjects on colchicine therapy indicated that infertility from colchicine is rare. 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.

Use In Specific Populations

Pregnancy

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 studies were not conducted with COLCRYS, 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. COLCRYS should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Labor and Delivery

The effect of colchicine on labor and delivery is unknown.

Nursing Mothers

Colchicine is excreted into human milk. Limited information suggests that exclusively breast-fed infants 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 breast-feeding infants should be observed for adverse effects when COLCRYS is administered to a nursing woman.

Pediatric Use

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. Gout is rare in pediatric patients, safety and effectiveness of colchicine in pediatric patients has not been established.

Geriatric Use

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 Dose Modification for Co-administration of Interacting Drugs].

Renal Impairment

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.

Prophylaxis of Gout Flares

For prophylaxis of gout flares in patients with mild (estimated creatinine clearance Clcr 50 – 80 mL/min) to moderate (Clcr 30 – 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 Dose Modification in Renal Impairment].

Treatment of Gout Flares

For treatment of gout flares in patients with mild (Clcr 50 – 80 mL/min) to moderate (Clcr 30 – 50 mL/min) renal function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of COLCRYS. 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 2 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 (1 tablet). For these patients, the treatment course should not be repeated more than once every 2 weeks [see Dose Modification in Renal Impairment].

FMF

Although, pharmacokinetics of colchicine in patients with mild (Clcr 50 – 80 mL/min) and moderate (Clcr 30 – 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 (Clcr less than 30 mL/minute) and end-stage renal disease requiring dialysis, COLCRYS 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 COLCRYS [see Pharmacokinetics and Dose Modification in Renal Impairment].

Hepatic Impairment

The clearance of colchicine may be significantly reduced and plasma half-life prolonged in patients with chronic hepatic impairment, compared to healthy subjects [see Pharmacokinetics].

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 Dose Modification in Hepatic Impairment].

Treatment of Gout Flares

For treatment of gout flares in patients with mild to moderate hepatic function impairment, adjustment of the recommended COLCRYS dose is not required, but patients should be monitored closely for adverse effects of COLCRYS. 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 2 weeks. For these patients, requiring repeated courses for the treatment of gout flares, consideration should be given to alternate therapy [see Dose Modification in Hepatic Impairment].

FMF

In patients with severe hepatic disease, dose reduction should be considered with careful monitoring [see Pharmacokinetics and Dose Modification in Hepatic Impairment].

 

Colcrys


Colcrys Overdosage & Contraindications


OVERDOSE

The exact dose of colchicine that produces significant toxicity is unknown. Fatalities have occurred after ingestion of a dose as low as 7 mg over a 4-day period, while other patients have survived after ingesting more than 60 mg. A review of 150 patients who overdosed on colchicine found that those who ingested less than 0.5 mg/kg survived and tended to have milder toxicities, such as gastrointestinal symptoms, whereas those who took 0.5 to 0.8 mg/kg had more severe reactions, such as myelosuppression. There was 100% mortality in those who ingested more than 0.8 mg/kg.

The first stage of acute colchicine toxicity typically begins within 24 hours of ingestion and includes gastrointestinal symptoms, such as abdominal pain, nausea, vomiting, diarrhea, and significant fluid loss, leading to volume depletion. Peripheral leukocytosis may also be seen. Life-threatening complications occur during the second stage, which occurs 24 to 72 hours after drug administration, attributed to multi-organ failure and its consequences. Death is usually a result of respiratory depression and cardiovascular collapse. If the patient survives, recovery of multi-organ injury may be accompanied by rebound leukocytosis and alopecia starting about 1 week after the initial ingestion.

Treatment of colchicine poisoning should begin with gastric lavage and measures to prevent shock. Otherwise, treatment is symptomatic and supportive. No specific antidote is known. Colchicine is not effectively removed by dialysis [see Pharmacokinetics].

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). In these patients, life-threatening and fatal colchicine toxicity has been reported with colchicine taken in therapeutic doses.

 

Colcrys


 

Colcrys Clinical Pharmacology


CLINICAL PHARMACOLOGY

Mechanism of Action

The mechanism by which COLCRYS exerts its beneficial effect in patients with FMF has not been fully elucidated; however, evidence suggests that colchicine may interfere with the intracellular assembly of the inflammasome complex present in neutrophils and monocytes that mediates activation of interleukin-1β. Additionally, colchicine disrupts cytoskeletal functions through inhibition of β-tubulin polymerization into microtubules, and consequently prevents the activation, degranulation, and migration of neutrophils thought to mediate some gout symptoms.

Pharmacokinetics

Absorption

In healthy adults, COLCRYS is absorbed when given orally, reaching a mean Cmax of 2.5 ng/mL (range 1.1 to 4.4 ng/mL) in 1 to 2 hours (range 0.5 to 3 hours) after a single dose administered under fasting conditions.

Following oral administration of COLCRYS given as 1.8 mg colchicine over 1 hour to healthy, young adults under fasting conditions, colchicine appears to be readily absorbed, reaching mean maximum plasma concentrations of 6.2 ng/mL at a median 1.81 hours (range: 1.0 to 2.5 hours). Following administration of the non-recommended high-dose regimen (4.8 mg over 6 hours), mean maximal plasma concentrations were 6.8 ng/mL, at a median 4.47 hours (range: 3.1 to 7.5 hours).

After 10 days on a regimen of 0.6 mg twice daily, peak concentrations are 3.1 to 3.6 ng/mL (range 1.6 to 6.0 ng/mL), occurring 1.3 to 1.4 hours post-dose (range 0.5 to 3.0 hours). Mean pharmacokinetic parameter values in healthy adults are shown in Table 5 below.

Table 5 : Mean (%CV) Pharmacokinetic Parameters in Healthy Adults Given COLCRYS

Cmax (colchicine ng/mL) Tmax1 (h) Vd/F (L) CL/F (L/hr) t½ (h)
COLCRYS 0.6 mg Single Dose (N=13)
2.5 (28.7) 1.5 (1.0 – 3.0) 341.5 (54.4) 54.1 (31.0) --
COLCRYS 0.6 mg b.i.d. x 10 days (N =13)
3.6 (23.7) 1.3 (0.5 – 3.0) 1150 (18.7) 30.3 (19.0) 26.6 (16.3)
1 Tmax mean (range)
CL= Dose/AUC0-t (Calculated from mean values)
Vd = CL/Ke (Calculated from mean values)

In some subjects, secondary colchicine peaks are seen, occurring between 3 and 36 hours post-dose and ranging from 39% to 155% of the height of the initial peak. These observations are attributed to intestinal secretion and reabsorption and/or biliary recirculation.

Absolute bioavailability is reported to be approximately 45%.

Administration of COLCRYS with food has no effect on the rate of colchicine absorption, but did decrease the extent of colchicine by approximately 15%. This is without clinical significance.

Distribution

The mean apparent volume of distribution in healthy young volunteers was approximately 5 to 8 L/kg.

Colchicine binding to serum protein is low, 39 ± 5%, primarily to albumin regardless of concentration.

Colchicine crosses the placenta (plasma levels in the fetus are reported to be approximately 15% of the maternal concentration). Colchicine also distributes into breast milk at concentrations similar to those found in the maternal serum [see Pregnancy and Nursing Mothers].

Metabolism

Colchicine is demethylated to two primary metabolites, 2-O-demethylcolchicine and 3-O-demethylcolchicine (2- and 3-DMC, respectively), and one minor metabolite, 10-O-demethylcolchicine (also known as colchiceine). In vitro studies using human liver microsomes have shown that CYP3A4 is involved in the metabolism of colchicine to 2- and 3-DMC. Plasma levels of these metabolites are minimal (less than 5% of parent drug).

Elimination/Excretion

In healthy volunteers (n=12) 40 – 65% of 1 mg orally administered colchicine was recovered unchanged in urine. Enterohepatic recirculation and biliary excretion are also postulated to play a role in colchicine elimination. Following multiple oral doses (0.6 mg twice daily), the mean elimination half-lives in young healthy volunteers (mean age 25 to 28 years of age) is 26.6 to 31.2 hours. Colchicine is a substrate of P-gp.

Extracorporeal Elimination: Colchicine is not removed by hemodialysis.

Special Populations

There is no difference between men and women in the pharmacokinetic disposition of colchicine.

Pediatric Patients: Pharmacokinetics of colchicine was not evaluated in pediatric patients.

Elderly: Pharmacokinetics of colchicine has not been determined in elderly patients. A published report described the pharmacokinetics of 1 mg oral colchicine tablet in four elderly women compared to six young healthy males. The mean age of the four elderly women was 83 years (range 75 – 93), mean weight was 47 kg (38 – 61 kg) and mean creatinine clearance was 46 mL/min (range 25 – 75 mL/min). Mean peak plasma levels and AUC of colchicine were two times higher in elderly subjects compared to young healthy males. However, it is possible that the higher exposure in the elderly subjects was due to decreased renal function.

Renal impairment: Pharmacokinetics of colchicine in patients with mild and moderate renal impairment is not known. A published report described the disposition of colchicine (1 mg) in young adult men and women with FMF who had normal renal function or end-stage renal disease requiring dialysis. Patients with end-stage renal disease had 75% lower colchicine clearance (0.17 vs 0.73 L/hr/kg) and prolonged plasma elimination half-life (18.8 hrs vs 4.4 hrs) as compared to subjects with FMF and normal renal function [see Dose Modification in Renal Impairment and Renal Impairment].

Hepatic impairment: Published reports on the pharmacokinetics of IV colchicine in patients with severe chronic liver disease, as well as those with alcoholic or primary biliary cirrhosis, and normal renal function suggest wide inter-patient variability. In some subjects with mild to moderate cirrhosis, the clearance of colchicine is significantly reduced and plasma half-life prolonged compared to healthy subjects. In subjects with primary biliary cirrhosis, no consistent trends were noted [see Dose Modification in Hepatic Impairment and Hepatic Impairment]. No pharmacokinetic data are available for patients with severe hepatic impairment (Child-Pugh C).

Drug interactions

In vitro drug interactions: In vitro studies in human liver microsomes have shown that colchicine is not an inhibitor or inducer of CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A4 activity.

In vivo drug interactions: The effects of co-administration of other drugs with COLCRYS on Cmax, AUC, and Cmin are summarized in Table 6 (effect of other drugs on colchicine) and Table 7 (effect of colchicine on other drugs). For information regarding clinical recommendations, see Table 1 in Dose Modification for Co-administration of Interacting Drugs [see Dose Modification for Co-administration of Interacting Drugs].

Table 6 : Drug Interactions: Pharmacokinetic Parameters for COLCRYS (colchicine, USP) tablets in the Presence of the Co-Administered Drug


Estrogen-containing oral contraceptives: In healthy female volunteers given ethinyl estradiol and norethindrone (Ortho-Novum® 1/35) co-administered with COLCRYS (0.6 mg b.i.d. × 14 days), hormone concentrations are not affected.

In healthy volunteers given theophylline co-administered with COLCRYS (0.6 mg b.i.d. × 14 days), theophylline concentrations were not affected.

Table 7 : Drug Interactions: Pharmacokinetic Parameters for Co-Administration of Drug in the Presence of COLCRYS (colchicine, USP) tablets


Clinical Studies

The evidence for the efficacy of colchicine in patients with chronic gout is derived from the published literature. Two randomized clinical trials assessed the efficacy of colchicine 0.6 mg twice a day for the prophylaxis of gout flares in patients with gout initiating treatment with urate lowering therapy. In both trials, treatment with colchicine decreased the frequency of gout flares.

The efficacy of a low dosage regimen of oral colchicine (COLCRYS total dose 1.8 mg over 1 hour) for treatment of gout flares was assessed in a multicenter, randomized, double-blind, placebo-controlled, parallel group, 1 week, dose comparison study. Patients meeting American College of Rheumatology criteria for gout were randomly assigned to three groups: high-dose colchicine (1.2 mg, then 0.6 mg hourly × 6 hours [4.8 mg total]); low-dose colchicine (1.2 mg, then 0.6 mg in 1 hour [1.8 mg total] followed by 5 placebo doses hourly); or placebo (2 capsules, then 1 capsule hourly × 6 hours). Patients took the first dose within 12 hours of the onset of the flare and recorded pain intensity (11-point Likert scale) and adverse events over 72 hours. The efficacy of colchicine was measured based on response to treatment in the target joint, using patient self assessment of pain at 24 hours following the time of first dose as recorded in the diary. A responder was one who achieved at least a 50% reduction in pain score at the 24-hour post-dose assessment relative to the pre-treatment score and did not use rescue medication prior to the actual time of 24-hour post-dose assessment.

Rates of response were similar for the recommended low-dose treatment group (38%) and the non-recommended high-dose group (33%) but were higher as compared to the placebo group (16%) as shown in Table 8.

Table 8 : Number (%) of Responders Based on Target Joint Pain Score at 24 Hours Post First Dose

COLCRYS Dose Responders n (%) Placebo n (%)
(n=58)
% Differences in Proportion
Low-dose
(n=74)
High-dose
(n=52)
Low-dose vs Placebo (95% CI) High-dose vs Placebo (95% CI)
28 (38%) 17 (33%) 9 (16%) 22 (8, 37) 17 (1, 33)

Figure 1 below shows the percentage of patients achieving varying degrees of improvement in pain from baseline at 24 hours.

Figure 1 : Pain Relief on Low and High Doses of COLCRYS and Placebo (Cumulative)

Pain Relief on Low and High Doses of COLCRYS and Placebo - Illustration

The evidence for the efficacy of colchicine in patients with FMF is derived from the published literature. Three randomized, placebo-controlled studies were identified. The three placebo-controlled studies randomized a total of 48 adult patients diagnosed with FMF and reported similar efficacy endpoints as well as inclusion and exclusion criteria.

One of the studies randomized 15 patients with FMF to a 6-month crossover study during which 5 patients discontinued due to study non-compliance. The 10 patients completing the study experienced 5 attacks over the course of 90 days while treated with colchicine compared to 59 attacks over the course of 90 days while treated with placebo. Similarly, the second study randomized 22 patients with FMF to a 4-month crossover study during which 9 patients discontinued due to lack of efficacy while receiving placebo or study non-compliance. The 13 patients completing the study experienced 18 attacks over the course of 60 days while treated with colchicine compared to 68 attacks over the course of 60 days while treated with placebo. The third study was discontinued after an interim analysis of 6 of the 11 patients enrolled had completed the study; results could not be confirmed.

Open-label experience with colchicine in adults and children with FMF is consistent with the randomized, controlled trial experience, and was utilized to support information on the safety profile of colchicine and for dosing recommendations.

 

Colcrys


Colcrys Medication Guide


PATIENT INFORMATION

MEDICATION GUIDE

COLCRYS
(KOL-kris)
(colchicine) tablets

Read the Medication Guide that comes with COLCRYS before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. You and your healthcare provider should talk about COLCRYS when you start taking it and at regular checkups.

What is the most important information I should know about COLCRYS?

COLCRYS can cause serious side effects or death if levels of COLCRYS are too high in your body.

  • Taking certain medicines with COLCRYS can cause your level of COLCRYS to be too high, especially if you have kidney or liver problems.
  • Tell your healthcare provider about all your medical conditions, including if you have kidney or liver problems. Your dose of COLCRYS may need to be changed.
  • Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.
  • Even medicines that you take for a short period of time, such as antibiotics, can interact with COLCRYS and cause serious side effects or death.
  • Talk to your healthcare provider or pharmacist before taking any new medicine.
  • Especially tell your healthcare provider if you take:

 

  • atazanavir sulfate (Reyataz®)
  • cyclosporine (Neoral®, Gengraf®, Sandimmune®)
  • fosamprenavir (Lexiva®) with ritonavir
  • indinavir (Crixivan®)
  • ketoconazole (Nizoral®)
  • nefazodone (Serzone®)
  • ritonavir (Norvir®)
  • telithromycin (Ketek®)
  • clarithromycin (Biaxin ®)
  • darunavir (Prezista ®)
  • fosamprenavir (Lexiva ®)
  • itraconazole (Sporanox ®)
  • lopinavir/ritonavir (Kaletra ®)
  • nelfinavir mesylate (Viracept ®)
  • saquinavir mesylate (Invirase ®)
  • tipranavir (Aptivus ®)

Ask your healthcare provider or pharmacist if you are not sure if you take any of the medicines listed above. This is not a complete list of all the medicines that can interact with COLCRYS.

  • Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
  • Keep COLCRYS out of the reach of children.

What is COLCRYS?

COLCRYS is a prescription medicine used to:

  • prevent and treat gout flares in adults
  • treat familial Mediterranean fever (FMF) in adults and children age four or older

COLCRYS is not a pain medicine and it should not be taken to treat pain related to other conditions unless specifically for those conditions.

Who should not take COLCRYS?

Do not take COLCRYS if you have liver or kidney problems and you take certain other medicines. Serious side effects, including death, have been reported in these patients even when taken as directed. See “What is the most important information I should know about COLCRYS?”

What should I tell my healthcare provider before starting COLCRYS?

See “What is the most important information I should know about COLCRYS?”

Before you take COLCRYS tell your healthcare provider about all your medical conditions including if you:

  • have liver or kidney problems
  • are pregnant or plan to become pregnant. It is not known if COLCRYS will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
  • are breast-feeding or plan to breast-feed. COLCRYS passes into your breast milk. You and your healthcare provider should decide if you will take COLCRYS or breast-feed. If you take COLCRYS and breast-feed, you should talk to your child's healthcare provider about how to watch for side effects in your child.

Tell your healthcare provider about all the medicines you take, including ones that you may only be taking for a short time, such as antibiotics. See “What is the most important information I should know about COLCRYS?” Do not start a new medicine without talking to your healthcare provider.

Using COLCRYS with certain other medicines, such as cholesterol-lowering medications and digoxin, can affect each other causing serious side effects. Your healthcare provider may need to change your dose of COLCRYS. Talk to your healthcare provider about whether the medications you are taking might interact with COLCRYS, and what side effects to look for.

How should I take COLCRYS?

  • Take COLCRYS exactly as your healthcare provider tells you to take it. If you are not sure about your dosing, call your healthcare provider.
  • COLCRYS can be taken with or without food.
  • If you take too much COLCRYS go to the nearest hospital emergency room right away.
  • Do not stop taking COLCRYS even if you start to feel better, unless your healthcare provider tells you.
  • Your healthcare provider may do blood tests while you take COLCRYS.
  • If you take COLCRYS daily and you miss a dose, then take it as soon as you remember. If it is almost time for your next dose, just skip the missed dose. Take the next dose at your regular time. Do not take 2 doses at the same time.
  • If you have a gout flare while taking COLCRYS daily, report this to your healthcare provider.

What should I avoid while taking COLCRYS?

  • Avoid eating grapefruit or drinking grapefruit juice while taking COLCRYS. It can increase your chances of getting serious side effects.

What are the possible side effects of COLCRYS?

COLCRYS can cause serious side effects or even cause death. See “What is the most important information I should know about COLCRYS?”

Get medical help right away, if you have:

  • Muscle weakness or pain
  • Numbness or tingling in your fingers or toes
  • Unusual bleeding or bruising
  • Increased infections
  • Feel weak or tired
  • Pale or gray color to your lips, tongue, or palms of your hands
  • Severe diarrhea or vomiting

Gout Flares: The most common side effect of COLCRYS in people who have gout flares is diarrhea.

FMF: The most common side effects of COLCRYS in people who have FMF are abdominal pain, diarrhea, nausea and vomiting.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of COLCRYS. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store COLCRYS?

  • Store COLCRYS at room temperature between 68° and 77°F (20° to 25°C).
  • Keep COLCRYS in a tightly closed container.
  • Keep COLCRYS out of the light.

Keep COLCRYS and all medicines out of the reach of children.

General Information about COLCRYS

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use COLCRYS for a condition for which it was not prescribed. Do not give COLCRYS to other people, even if they have the same symptoms that you have. It may harm them. This Medication Guide summarizes the most important information about COLCRYS. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about COLCRYS that is written for healthcare professionals.

For more information, go to www.COLCRYS.com or call 1-888-351-3786.

What are the ingredients in COLCRYS?

Active Ingredient: Colchicine

Inactive Ingredients: carnauba wax, FD&C blue #2, FD&C red #40, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, titanium dioxide, and triacetin.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

 

Colcrys


Colcrys Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

COLCHICINE - ORAL

 

(KOL-chi-seen)

 

USES: This medication is used to prevent or treat gout attacks (flares). Usually gout symptoms develop suddenly and involve only one or a few joints. The big toe, knee, or ankle joints are most often affected. Gout is caused by too much uric acid in the blood. When uric acid levels in the blood are too high, the uric acid may form hard crystals in your joints. Colchicine works by decreasing swelling and lessening the build up of uric acid crystals that cause pain in the affected joint(s).

This medication is also used to prevent attacks of pain in the abdomen, chest, or joints caused by a certain inherited disease (familial Mediterranean fever). It is thought to work by decreasing your body's production of a certain protein (amyloid A) that builds up in people with familial Mediterranean fever.

Colchicine is not a pain medication and should not be used to relieve other causes of pain.

 

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking colchicine and each time you get a refill. If you have any questions regarding the information, ask your doctor or pharmacist.

Take this medication by mouth with or without food, exactly as directed by your doctor. Dosing recommendations vary widely and may be different from the following recommendations. Taking more than the recommended dose may not increase this drug's effectiveness and may increase your risk for side effects. Ask your doctor or pharmacist for more details.

If you are taking this medication to treat a gout attack, carefully follow the directions given by your doctor. This medication works best if you take it at the first sign of an attack. The recommended dose is 1.2 milligrams at the first sign of an attack, followed by 0.6 milligrams one hour later. The maximum recommended dose is 1.8 milligrams taken over a 1-hour period. Ask your doctor ahead of time about how soon you can repeat treatment with this medication if you have another gout attack.

If you are taking this medication to prevent gout attacks, ask your doctor about the dose and schedule you should follow. Carefully follow your doctor's directions.

If you are taking this medication to prevent attacks of pain caused by familial Mediterranean fever, the usual dose is 1.2 to 2.4 milligrams daily. 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.

The dosage is based on your medical condition, other drugs/foods you may be taking, and response to treatment. 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. Consult your doctor or pharmacist for more details.

If you are taking this medication to treat symptoms due to familial Mediterranean fever, tell your doctor if your condition does not improve or if it worsens.

 

Colcrys


Colcrys Consumer (continued)

SIDE EFFECTS: Diarrhea, nausea, cramping, abdominal pain, and vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Stop taking this medication and seek immediate medical attention if any of these rare but serious side effects occur: unusual bleeding/bruising, severe diarrhea or vomiting, muscle weakness or pain, numbness/tingling in your fingers or toes, pale or gray color of the lips/tongue/palms of hands, signs of infection (such as fever, persistent sore throat), unusual weakness/tiredness.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems (such as cirrhosis).

Alcohol can decrease this drug's effectiveness. Limit alcohol while taking this drug.

This medication can affect how well your body absorbs some foods and nutrients (such as vitamin B12). Consult your doctor or pharmacist for more details.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Colchicine can decrease sperm production, which may affect the ability of a male to father a child. Consult your doctor for more information.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding. Your doctor may recommend that you separate the time(s) you take your medication apart from breast-feeding.

 

Colcrys


Colcrys Medication Guide


PATIENT INFORMATION

MEDICATION GUIDE

COLCRYS
(KOL-kris)
(colchicine) tablets

Read the Medication Guide that comes with COLCRYS before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. You and your healthcare provider should talk about COLCRYS when you start taking it and at regular checkups.

What is the most important information I should know about COLCRYS?

COLCRYS can cause serious side effects or death if levels of COLCRYS are too high in your body.

  • Taking certain medicines with COLCRYS can cause your level of COLCRYS to be too high, especially if you have kidney or liver problems.
  • Tell your healthcare provider about all your medical conditions, including if you have kidney or liver problems. Your dose of COLCRYS may need to be changed.
  • Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.
  • Even medicines that you take for a short period of time, such as antibiotics, can interact with COLCRYS and cause serious side effects or death.
  • Talk to your healthcare provider or pharmacist before taking any new medicine.
  • Especially tell your healthcare provider if you take:

 

  • atazanavir sulfate (Reyataz®)
  • cyclosporine (Neoral®, Gengraf®, Sandimmune®)
  • fosamprenavir (Lexiva®) with ritonavir
  • indinavir (Crixivan®)
  • ketoconazole (Nizoral®)
  • nefazodone (Serzone®)
  • ritonavir (Norvir®)
  • telithromycin (Ketek®)
  • clarithromycin (Biaxin ®)
  • darunavir (Prezista ®)
  • fosamprenavir (Lexiva ®)
  • itraconazole (Sporanox ®)
  • lopinavir/ritonavir (Kaletra ®)
  • nelfinavir mesylate (Viracept ®)
  • saquinavir mesylate (Invirase ®)
  • tipranavir (Aptivus ®)

Ask your healthcare provider or pharmacist if you are not sure if you take any of the medicines listed above. This is not a complete list of all the medicines that can interact with COLCRYS.

  • Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
  • Keep COLCRYS out of the reach of children.

What is COLCRYS?

COLCRYS is a prescription medicine used to:

  • prevent and treat gout flares in adults
  • treat familial Mediterranean fever (FMF) in adults and children age four or older

COLCRYS is not a pain medicine and it should not be taken to treat pain related to other conditions unless specifically for those conditions.

Who should not take COLCRYS?

Do not take COLCRYS if you have liver or kidney problems and you take certain other medicines. Serious side effects, including death, have been reported in these patients even when taken as directed. See “What is the most important information I should know about COLCRYS?”

What should I tell my healthcare provider before starting COLCRYS?

See “What is the most important information I should know about COLCRYS?”

Before you take COLCRYS tell your healthcare provider about all your medical conditions including if you:

  • have liver or kidney problems
  • are pregnant or plan to become pregnant. It is not known if COLCRYS will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
  • are breast-feeding or plan to breast-feed. COLCRYS passes into your breast milk. You and your healthcare provider should decide if you will take COLCRYS or breast-feed. If you take COLCRYS and breast-feed, you should talk to your child's healthcare provider about how to watch for side effects in your child.

Tell your healthcare provider about all the medicines you take, including ones that you may only be taking for a short time, such as antibiotics. See “What is the most important information I should know about COLCRYS?” Do not start a new medicine without talking to your healthcare provider.

Using COLCRYS with certain other medicines, such as cholesterol-lowering medications and digoxin, can affect each other causing serious side effects. Your healthcare provider may need to change your dose of COLCRYS. Talk to your healthcare provider about whether the medications you are taking might interact with COLCRYS, and what side effects to look for.

How should I take COLCRYS?

  • Take COLCRYS exactly as your healthcare provider tells you to take it. If you are not sure about your dosing, call your healthcare provider.
  • COLCRYS can be taken with or without food.
  • If you take too much COLCRYS go to the nearest hospital emergency room right away.
  • Do not stop taking COLCRYS even if you start to feel better, unless your healthcare provider tells you.
  • Your healthcare provider may do blood tests while you take COLCRYS.
  • If you take COLCRYS daily and you miss a dose, then take it as soon as you remember. If it is almost time for your next dose, just skip the missed dose. Take the next dose at your regular time. Do not take 2 doses at the same time.
  • If you have a gout flare while taking COLCRYS daily, report this to your healthcare provider.

What should I avoid while taking COLCRYS?

  • Avoid eating grapefruit or drinking grapefruit juice while taking COLCRYS. It can increase your chances of getting serious side effects.

What are the possible side effects of COLCRYS?

COLCRYS can cause serious side effects or even cause death. See “What is the most important information I should know about COLCRYS?”

Get medical help right away, if you have:

  • Muscle weakness or pain
  • Numbness or tingling in your fingers or toes
  • Unusual bleeding or bruising
  • Increased infections
  • Feel weak or tired
  • Pale or gray color to your lips, tongue, or palms of your hands
  • Severe diarrhea or vomiting

Gout Flares: The most common side effect of COLCRYS in people who have gout flares is diarrhea.

FMF: The most common side effects of COLCRYS in people who have FMF are abdominal pain, diarrhea, nausea and vomiting.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of COLCRYS. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store COLCRYS?

  • Store COLCRYS at room temperature between 68° and 77°F (20° to 25°C).
  • Keep COLCRYS in a tightly closed container.
  • Keep COLCRYS out of the light.

Keep COLCRYS and all medicines out of the reach of children.

General Information about COLCRYS

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use COLCRYS for a condition for which it was not prescribed. Do not give COLCRYS to other people, even if they have the same symptoms that you have. It may harm them. This Medication Guide summarizes the most important information about COLCRYS. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about COLCRYS that is written for healthcare professionals.

For more information, go to www.COLCRYS.com or call 1-888-351-3786.

What are the ingredients in COLCRYS?

Active Ingredient: Colchicine

Inactive Ingredients: carnauba wax, FD&C blue #2, FD&C red #40, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, titanium dioxide, and triacetin.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

 

 

Colcrys


Colcrys Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

COLCHICINE - ORAL

 

(KOL-chi-seen)

 

USES: This medication is used to prevent or treat gout attacks (flares). Usually gout symptoms develop suddenly and involve only one or a few joints. The big toe, knee, or ankle joints are most often affected. Gout is caused by too much uric acid in the blood. When uric acid levels in the blood are too high, the uric acid may form hard crystals in your joints. Colchicine works by decreasing swelling and lessening the build up of uric acid crystals that cause pain in the affected joint(s).

This medication is also used to prevent attacks of pain in the abdomen, chest, or joints caused by a certain inherited disease (familial Mediterranean fever). It is thought to work by decreasing your body's production of a certain protein (amyloid A) that builds up in people with familial Mediterranean fever.

Colchicine is not a pain medication and should not be used to relieve other causes of pain.

 

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking colchicine and each time you get a refill. If you have any questions regarding the information, ask your doctor or pharmacist.

Take this medication by mouth with or without food, exactly as directed by your doctor. Dosing recommendations vary widely and may be different from the following recommendations. Taking more than the recommended dose may not increase this drug's effectiveness and may increase your risk for side effects. Ask your doctor or pharmacist for more details.

If you are taking this medication to treat a gout attack, carefully follow the directions given by your doctor. This medication works best if you take it at the first sign of an attack. The recommended dose is 1.2 milligrams at the first sign of an attack, followed by 0.6 milligrams one hour later. The maximum recommended dose is 1.8 milligrams taken over a 1-hour period. Ask your doctor ahead of time about how soon you can repeat treatment with this medication if you have another gout attack.

If you are taking this medication to prevent gout attacks, ask your doctor about the dose and schedule you should follow. Carefully follow your doctor's directions.

If you are taking this medication to prevent attacks of pain caused by familial Mediterranean fever, the usual dose is 1.2 to 2.4 milligrams daily. 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.

The dosage is based on your medical condition, other drugs/foods you may be taking, and response to treatment. 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. Consult your doctor or pharmacist for more details.

If you are taking this medication to treat symptoms due to familial Mediterranean fever, tell your doctor if your condition does not improve or if it worsens.

 

Colcrys


Colcrys Consumer (continued)

SIDE EFFECTS: Diarrhea, nausea, cramping, abdominal pain, and vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Stop taking this medication and seek immediate medical attention if any of these rare but serious side effects occur: unusual bleeding/bruising, severe diarrhea or vomiting, muscle weakness or pain, numbness/tingling in your fingers or toes, pale or gray color of the lips/tongue/palms of hands, signs of infection (such as fever, persistent sore throat), unusual weakness/tiredness.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems (such as cirrhosis).

Alcohol can decrease this drug's effectiveness. Limit alcohol while taking this drug.

This medication can affect how well your body absorbs some foods and nutrients (such as vitamin B12). Consult your doctor or pharmacist for more details.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Colchicine can decrease sperm production, which may affect the ability of a male to father a child. Consult your doctor for more information.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding. Your doctor may recommend that you separate the time(s) you take your medication apart from breast-feeding.

 

Colcrys


Colcrys Consumer (continued)

DRUG INTERACTIONS: See also How to Use and Precautions sections.

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Other medications can affect the removal of colchicine from your body, which may affect how colchicine works or increase the risk of serious side effects. Examples include azole antifungals (such as itraconazole, ketoconazole), cyclosporine, HIV medications (such as ritonavir), macrolide antibiotics (such as clarithromycin, erythromycin), telithromycin, verapamil, among others.

Colchicine may rarely cause a certain serious (even fatal) muscle damage (rhabdomyolysis). This muscle damage releases substances that can lead to serious kidney problems. The risk may be increased if other drugs that may also cause rhabdomyolysis are taken along with colchicine. Some affected drugs include: atorvastatin, digoxin, gemfibrozil, fenofibrate, pravastatin, simvastatin, among others.

This medication may interfere with certain laboratory tests, possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe nausea/vomiting/diarrhea, abdominal pain, trouble breathing, weakness.

 

NOTES: Do not share this medication with others.

Being overweight, drinking too much alcohol, and eating certain foods may worsen gout symptoms. Limit alcohol and ask your doctor, pharmacist, or dietitian about avoiding foods high in purines that may worsen gout (such as anchovies, bacon, beer, sardines, organ meats including liver/kidneys).

Laboratory and/or medical tests (such as blood tests, kidney function, liver function) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

 

MISSED DOSE: If you are taking colchicine regularly and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Colcrys


Colcrys Patient Information Including Side Effects

Brand Names: Colcrys

Generic Name: colchicine (Pronunciation: KOL chi seen)

 

  • What is colchicine (Colcrys)?
  • What are the possible side effects of colchicine (Colcrys)?
  • What is the most important information I should know about colchicine (Colcrys)?
  • What should I discuss with my healthcare provider before taking colchicine (Colcrys)?
  • How should I take colchicine (Colcrys)?
  • What happens if I miss a dose (Colcrys)?
  • What happens if I overdose (Colcrys)?
  • What should I avoid while taking colchicine (Colcrys)?
  • What other drugs will affect colchicine (Colcrys)?
  • Where can I get more information?

 

What is colchicine (Colcrys)?

Colchicine affects the way the body responds to uric acid crystals, which reduces swelling and pain.

Because colchicine was developed prior to federal regulations requiring FDA review of all marketed drug products, not all uses for colchicine have been approved by the FDA. As of 2009, Colcrys is the only brand of colchicine that has been approved by the FDA.

The Colcrys brand of colchicine is FDA-approved to treat gout in adults, and to treat a genetic condition called Familial Mediterranean Fever in adults and children who are at least 4 years old.

Generic forms of colchicine have been used to treat or prevent attacks of gout, or to treat symptoms of Behcets syndrome (such as swelling, redness, warmth, and pain).

Colchicine is not a cure for gouty arthritis or Behcets syndrome, and it will not prevent these diseases from progressing. Colchicine should not be used as a routine pain medication for other conditions.

Colchicine may also be used for other purposes not listed in this medication guide.

Colchicine 0.6 mg-WES

round, white, imprinted with west-ward 201

What are the possible side effects of colchicine (Colcrys)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • muscle pain or weakness;
  • numbness or tingly feeling in your fingers or toes;
  • pale or gray appearance of your lips, tongue, or hands;
  • severe vomiting or diarrhea;
  • easy bruising or bleeding, feeling weak or tired;
  • fever, chills, body aches, flu symptoms;
  • blood in your urine; or
  • urinating less than usual or not at all.

Less serious side effects may include:

  • mild nausea or stomach pain; or
  • mild diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about colchicine (Colcrys)?

Because colchicine was developed prior to federal regulations requiring FDA review of all marketed drug products, not all uses for colchicine have been approved by the FDA. As of 2009, Colcrys is the only brand of colchicine that has been approved by the FDA.

You should not use this medication if you are allergic to colchicine. Do not take colchicine if you have liver or kidney disease and are also taking any of the medications listed below under "What other drugs can affect colchicine."

Before taking colchicine, tell your doctor if yo have liver or kidney disease, heart disease, a stomach ulcer, ulcerative colitis, Crohn's disease, intestinal bleeding, or any other severe gastrointestinal disorder.

If you take colchicine over a long period of time, your blood may need to be tested on a regular basis. Do not miss any scheduled appointments.

Call your doctor at once if you have a serious side effect such as muscle pain or weakness, numbness or tingly feeling in your fingers or toes, severe vomiting or diarrhea, easy bruising or bleeding, feeling weak or tired, flu symptoms, blood in your urine, urinating less than usual or not at all, or a pale or gray appearance of your lips, tongue, or hands.

Related Drug Centers
  • Colcrys

 

Colcrys


Colcrys Patient Information including How Should I Take

In this Article

  • What is colchicine (Colcrys)?
  • What are the possible side effects of colchicine (Colcrys)?
  • What is the most important information I should know about colchicine (Colcrys)?
  • What should I discuss with my healthcare provider before taking colchicine (Colcrys)?
  • How should I take colchicine (Colcrys)?
  • What happens if I miss a dose (Colcrys)?
  • What happens if I overdose (Colcrys)?
  • What should I avoid while taking colchicine (Colcrys)?
  • What other drugs will affect colchicine (Colcrys)?
  • Where can I get more information?

What should I discuss with my healthcare provider before taking colchicine (Colcrys)?

You should not use this medication if you are allergic to colchicine. Do not take colchicine if you have liver or kidney disease and are also taking any of the medications listed below under "What other drugs can affect colchicine."

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take colchicine:

  • liver disease;
  • kidney disease;
  • heart disease;
  • a stomach ulcer or severe gastrointestinal disorder;
  • ulcerative colitis;
  • Crohn's disease; or
  • intestinal bleeding or other disorder.

It is not known whether colchicine is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether colchicine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take colchicine (Colcrys)?

If your doctor has prescribed the Colcrys brand of colchicine, do not use any other type or brand of the medication. Colcrys is the only brand of colchicine that has been approved by the FDA. If you use a generic brand of colchicine, you may be using an unapproved dose of this medication, which could be dangerous. Do not purchase colchicine on the Internet or from vendors outside of the United States. Using this medication improperly or without the advice of a doctor can result in serious side effects or death.

Take colchicine exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Colchicine can be taken with or without food.

Your dose will depend on the reason you are taking this medication. Colchicine doses for gout and Mediterranean fever are different.

To treat a gout attack, for best results take colchicine at the first sign of the attack. The longer you wait to start taking the medication, the less effective it may be.

You may need to take a second lower dose of colchicine 1 hour after the first dose if you still have gout pain. Follow your doctor's instructions.

If you use this medication over a long period of time, your blood may need to be tested on a regular basis. Do not miss any scheduled appointments.

Store colchicine at room temperature away from moisture, heat, and light.

Related Drug Centers
  • Colcrys

Colcrys


Colcrys Patient Information including If I Miss a Dose

In this Article

  • What is colchicine (Colcrys)?
  • What are the possible side effects of colchicine (Colcrys)?
  • What is the most important information I should know about colchicine (Colcrys)?
  • What should I discuss with my healthcare provider before taking colchicine (Colcrys)?
  • How should I take colchicine (Colcrys)?
  • What happens if I miss a dose (Colcrys)?
  • What happens if I overdose (Colcrys)?
  • What should I avoid while taking colchicine (Colcrys)?
  • What other drugs will affect colchicine (Colcrys)?
  • Where can I get more information?

What happens if I miss a dose (Colcrys)?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Colcrys)?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of colchicine can be fatal.

Overdose symptoms may include diarrhea (may be bloody and severe), nausea, vomiting, stomach pain, heartburn, a burning feeling in your throat or stomach, muscle weakness, urinating less than usual, numbness or tingling, fainting, or seizure (convulsions).

What should I avoid while taking colchicine (Colcrys)?

Grapefruit and grapefruit juice may interact with colchicine and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

What other drugs will affect colchicine (Colcrys)?

Colchicine can interact with certain other drugs. A colchicine drug interaction can be fatal. Tell your doctor about all other medications you use, especially:

  • conivaptan (Vaprisol);
  • digoxin (Lanoxin, digitalis);
  • diclofenac (Arthrotec, Cataflam, Voltaren, Flector Patch, Solareze);
  • imatinib (Gleevec);
  • isoniazid (for treating tuberculosis);
  • quinidine (Quinaglute, Quinidex, Quin-Release);
  • an antidepressant such as nefazodone;
  • an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), or telithromycin (Ketek);
  • an antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);
  • cholesterol-lowering medicines such as atorvastatin (Lipitor), fenofibrate (Antara, Lipofen, TriCor), gemfibrozil (Lopid), simvastatin (Zocor), lovastatin (Mevacor), pravastatin (Pravachol), and others;
  • heart or blood pressure medication such as amiodarone (Cordarone, Pacerone), diltiazem (Cartia, Cardizem), felodipine (Plendil), nicardipine (Cardene), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;
  • HIV or AIDS medication such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Kaletra, Norvir); or
  • medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), or tacrolimus (Prograf).

This list is not complete and there may be other drugs that can interact with colchicine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about colchicine.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2010 Cerner Multum, Inc. Version: 4.02. Revision date: 08/21/2009.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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  • Colcrys
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