Colchicine

Colchicine is an oral, plant-based prescription alkaloid derived from the dried seeds of the autumn crocus or meadow saffron ( Colchicum autumnale ) that, depending on the brand or generic, may be used to: treat and prevent gout flares in adults (Colcrys, generics) prevent gout flares in adults and children aged 16 years and older (Colcrys, Gloperba, Mitigare, generics) treat symptoms of Behçet disease (BD), such as redness, swelling, or pain) (generics) treat familial Mediterranean fever (FMF) in adults and children 4 years of age or older (Colcrys) reduce the risk of heart attack, stroke, and cardiovascular death in adults with heart disease or at high risk of developing it (Lodoco tablets). Colchicine is not an analgesic medication and should not be used to treat pain from other causes. How colchicine works is not fully understood. However, it's believed the mechanism of action (MOA) of colchicine is to reduce the inflammatory reaction to urate crystals by interfering with a process in white blood cells that triggers inflammation and prevents their migration to areas of inflammation. Colchicine does not affect uric acid production or excretion. Colchicine was initially approved in 1961 and developed before federal regulations requiring FDA review of all marketed drug products. Colchicine may also be used for purposes not listed here.

Colchicine is an oral, plant-based prescription alkaloid derived from the dried seeds of the autumn crocus or meadow saffron ( Colchicum autumnale ) that, depending on the brand or generic, may be used to: treat and prevent gout flares in adults (Colcrys, generics) prevent gout flares in adults and children aged 16 years and older (Colcrys, Gloperba, Mitigare, generics) treat symptoms of Behçet disease (BD), such as redness, swelling, or pain) (generics) treat familial Mediterranean fever (FMF) in adults and children 4 years of age or older (Colcrys) reduce the risk of heart attack, stroke, and cardiovascular death in adults with heart disease or at high risk of developing it (Lodoco tablets). Colchicine is not an analgesic medication and should not be used to treat pain from other causes. How colchicine works is not fully understood. However, it's believed the mechanism of action (MOA) of colchicine is to reduce the inflammatory reaction to urate crystals by interfering with a process in white blood cells that triggers inflammation and prevents their migration to areas of inflammation. Colchicine does not affect uric acid production or excretion. Colchicine was initially approved in 1961 and developed before federal regulations requiring FDA review of all marketed drug products. Colchicine may also be used for purposes not listed here.

Do not take colchicine 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. Before you take colchicine, tell your healthcare provider about all your medical conditions, including if you: have liver or kidney problems take other medications, including ones that are only taken for a short time, such as antibiotics, because they may interact with colchicine are pregnant or plan to become pregnant are breastfeeding or plan to breastfeed. Your dose of colchicine may need to be changed. Colchicine may rarely and transiently impair fertility in males who can father children.

The most common side effects of colchicine are gastrointestinal symptoms, including diarrhea, nausea, vomiting, and abdominal (stomach) pain

Do not take colchicine 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. Blood problems (such as myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, and aplastic anemia) have been reported (have happened in some people taking colchicine. Get medical help right away if you have a pale or gray color to your lips, tongue, or palms of your hands; feel weak or tired; unusual bleeding or bruising; or increased infections Muscle weakness has happened in some people taking colchicine. Get medical help right away if you have any of these symptoms muscle weakness or pain, numbness, or tingling in your fingers or toes. Colchicine can cause serious side effects or death if levels of colchicine are too high in your body. 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. These are not all of the possible side effects of colchicine For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Do not take colchicine 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. Blood problems (such as myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, and aplastic anemia) have been reported (have happened in some people taking colchicine. Get medical help right away if you have a pale or gray color to your lips, tongue, or palms of your hands; feel weak or tired; unusual bleeding or bruising; or increased infections Muscle weakness has happened in some people taking colchicine. Get medical help right away if you have any of these symptoms muscle weakness or pain, numbness, or tingling in your fingers or toes. Colchicine can cause serious side effects or death if levels of colchicine are too high in your body. 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. These are not all of the possible side effects of colchicine For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

300 ug (300 (300)) 12 hourly PO — Maintenance, As Required 600 to 900 ug (750 (750)) 24 hourly PO — Loading Scraped Dose — Take colchicine exactly as your healthcare provider tells you to take it. If you are not sure about your dosing, call your healthcare provider. Colchicine tablets, capsules, or the solution can be taken with or without food . Measure Gloperba liquid with an accurate milliliter measuring device. A household teaspoon is not an accurate measuring device. Ask your pharmacist to recommend a measuring device and for instructions on how to measure the correct dose. Gastrointestinal symptoms, such as diarrhea , are often the first sign of colchicine toxicity. Contact your healthcare provider immediately if new symptoms develop. If you have a gout flare while taking colchicine daily, report this to your healthcare provider. Do not stop taking colchicine even if you start to feel better unless your healthcare provider tells you.

Safety not established ( ) —

Safety not established ( ) —

Colchicine is known to interact with other drugs, the details of drug interactions is as follows:DrugDetailsSeverityOnsetManagementCyanocobalaminCyanocobalamincolchicine reduce GI absorptionCyclosporin AErythromycinHydroxocobalaminMecobalaminColchicine impairs cobalamin absorption.PitavastatinCases of myopathy, including rhabdomyolysis, have been reported when coadministered with colchicinecaution should be exercised when prescribing PITAVASTATIN with colchicineVORICONAZOLEVoriconazole may increase the serum concentration of colchicine by decreasing its metabolism. A dose reduction of colchicine is recommended along with increased monitoring for colchicine toxicity. These interactions are sometimes beneficial and sometimes may pose threats to life. Always consult your physician for the change of dose regimen or an alternative drug of choice that may strictly be required.

Inj Store at room temperature. Do not Freeze. Protect from Sunlight. Tab Store in a well closed container, Below 40°C. Protect from Sunlight.