(Lodoco) Avoid use Grapefruit juice increases exposure to colchicine Pregnancy Available human data from published literature on colchicine use in pregnancy over several decades have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes Animal data Published animal reproduction and development studies indicate that colchicine causes embryofetal toxicity and altered postnatal development at exposures within or above the clinical therapeutic range Infertility Males: Case reports and epidemiology studies in human male subjects indicated that infertility from colchicine is rare and a case report showed that azoospermia was reversed when therapy was stopped Females: 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 Lactation Colchicine is present in human milk No adverse events in breastfed infants in the published literature after administration of colchicine to lactating women No data available on the effects of colchicine on milk production Consider developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal conditionPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Gout: Disruption of cytoskeletal functions through inhibition of β-tubulin polymerization into microtubules, which prevents activation, degranulation, and migration of neutrophils FMF: Mechanism not established; may interfere with intracellular assembly of inflammasome complex present in neutrophils and monocytes, which mediates activation of interleukin-1β Absorption Bioavailability: ~45% Onset: 18-24 hr Time to peak effect: 48-72 hr Fasted Peak plasma concentration: 3 ng/mL (Mitigare); 2.16 ng/mL (Gloperba); 2.5-3.6 ng/mL (Colcrys) Peak plasma time: 1 hr (Gloperba); 1.3-1.5 hr (Colcrys) AUC: 19.9 hr·ng/mL (Gloperba) Fed Peak plasma concentration: 1.68 ng/mL (Gloperba) Peak plasma time: 2 hr (Gloperba) AUC: 18.47 hr·ng/mL (Gloperba) Distribution Vd: ~1420L (Colcrys); ~5-8L/kg (Mitigare); 341-1150 L (Colcrys) Protein bound: 39% Colchicine crosses the placenta (plasma levels in the fetus reported to be ~15% of the maternal concentration) Metabolism Metabolized by P-gp and CYP3A4 May also be metabolized by glucuronidation Metabolites: Demethylated to 2 primary metabolites and 1 minor metabolite Elimination Half-life: 31 hr (Mitigare and Gloperba); 26.6-31.2 hr (Colcrys) Dialyzable: No (hemodialysis) Excretion: Urine (40-65%) Oral Administration Administered orally, without regard to meals Missed dose Colcrys Treatment of gout flare: Take missed dose as soon as possible Treatment of gout flare during prophylaxis: Take missed dose immediately, wait 12 hr, then resume previous dosing schedule Prophylaxis without treatment for gout flare or FMF: Take dose as soon as possible and then return to normal dosing schedule; however, if a dose is skipped, do NOT double next dose Mitigare, Gloperba Take missed dose as soon as possible If it is almost time for next dose, skip the missed dose and take at regularly scheduled time Do NOT take 2 doses at the same time Lodoco Taken as soon as possible, and then return to normal dosing schedule If dose is skipped, do NOT double next dose Storage All formulations: Store at 20-25°C (68-77°F) Tablets or capsules: Protect from light BRAND FORM. UNIT PRICE PILL IMAGE colchicine oral- 0.6 mg tabletcolchicine oral- 0.6 mg capsulecolchicine oral- 0.6 mg tabletcolchicine oral- 0.6 mg tabletcolchicine oral- 0.6 mg tabletcolchicine oral- 0.6 mg tabletcolchicine oral- 0.6 mg tabletcolchicine oral- 0.6 mg tabletGloperba oral- 0.6 mg/5 mL solutionMitigare oral- 0.6 mg capsuleColcrys oral- 0.6 mg tabletCopyright © 2010 First DataBank, Inc.Print Patient Educationcolchicine oral COLCHICINE SOLUTION - ORAL (KOL-chi-seen) COMMON BRAND NAME(S): Gloperba USES: This medication is used to prevent gout attacks (flares). Gout symptoms usually 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 buildup of uric acid crystals that cause pain in the affected joint(s).Colchicine is not a pain medication. Do not use it 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, ask your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually once or twice a day. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.The dosage is based on your medical condition, other drugs/foods you may be taking, and response to treatment. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). To decrease your risk for serious side effects, do not increase your dose, take it more often, 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, take 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 using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details. SIDE EFFECTS: Diarrhea, nausea, cramping, abdominal pain, and vomiting may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor 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 get medical help right away if any of these very serious side effects occur: unusual bleeding/bruising, 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 sore throat that doesn't go away, fever, chills), unusual weakness/tiredness, fast heartbeat, signs of kidney problems (such as change in the amount of urine).A very serious allergic reaction to this drug is rare. However, get medical help right away 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 or at www.fda.gov/medwatch.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 colchicine, 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.Alcohol can make this drug work less well. Limit alcohol while taking this drug.This medication may contain sugar or aspartame. Caution is advised if you have diabetes, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.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).Older adults may be more sensitive to the side effects of this drug, especially muscle weakness/pain and numbness/tingling in their fingers or toes.Colchicine can decrease sperm production, an effect that may lower male fertility. Consult your doctor for more details.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 from the times you breast-feed. DRUG INTERACTIONS: See also How to Use and Precautions sections.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines 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 atazanavir, certain azole antifungals (such as itraconazole, ketoconazole), diltiazem, macrolide antibiotics (such as clarithromycin, erythromycin), ritonavir, telithromycin, verapamil, among others.Colchicine may rarely cause a certain kind of 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: digoxin, gemfibrozil, pravastatin, simvastatin, among others.This medication may interfere with certain lab tests, possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug. OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center 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).Lab and/or medical tests (such as complete blood count, kidney/liver function) may be done while you are taking this medication. Keep all medical and lab appointments. MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up. STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications 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. Information last revised August 2022. Copyright(c) 2023 First Databank, Inc. 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. FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be