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Colchicine

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Overview

What is MITIGARE?

Colchicine is an alkaloid obtained from the plant .

The chemical name for colchicine is ((5,6,7,9- tetrahydro-1,2,3,10-tetramethoxy-9 oxobenzol[a]heptalen-7-yl) acetamide. The structural formula is represented below:

Colchicine consists of pale yellow scales or powder; it darkens on exposure to light. Colchicine is soluble in water, freely soluble in alcohol, and slightly soluble in ether.

MITIGARE (colchicine) capsules are supplied for oral administration. Each capsule contains 0.6 mg Colchicine and the following inactive ingredients:  colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The capsule shell contains gelatin, purified water, titanium dioxide, erythrosine, Brilliant Blue FCF and Quinoline Yellow.



What does MITIGARE look like?



What are the available doses of MITIGARE?

0.6 mg capsules No. 4 Dark Blue/Light Blue Hard Gelatin Capsules printed “West-ward 118” in white ink.

What should I talk to my health care provider before I take MITIGARE?

How should I use MITIGARE?

MITIGARE (colchicine) capsules are indicated for prophylaxis of gout flares in adults.

Limitations of use: The safety and effectiveness of MITIGARE for acute treatment of gout flares during prophylaxis has not been studied.

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

0.6 mg (one capsule) once or twice daily ().Maximum dose 1.2 mg/day.


What interacts with MITIGARE?

Sorry No Records found


What are the warnings of MITIGARE?

Sorry No Records found


What are the precautions of MITIGARE?

Sorry No Records found


What are the side effects of MITIGARE?

Sorry No records found


What should I look out for while using MITIGARE?

Patients with renal or hepatic impairment should not be given MITIGARE with drugs that inhibit both P-glycoprotein and CYP3A4 inhibitors [See  ()]. Combining these dual inhibitors with colchicine in patients with renal or hepatic impairment has resulted in life-threatening or fatal colchicine toxicity.

Patients with both renal and hepatic impairment should not be given MITIGARE.


What might happen if I take too much MITIGARE?

The dose of colchicine that would induce significant toxicity for an individual is unknown. Fatalities have been reported in patients after ingesting a dose as low as 7 mg over a 4-day period, while other patients have reportedly 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 adverse reactions, such as gastrointestinal symptoms, whereas those who ingested from 0.5 to 0.8 mg/kg had more severe adverse reactions, including myelosuppression. There was 100% mortality among patients who ingested more than 0.8 mg/kg.


How should I store and handle MITIGARE?

Sorry No Records found


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Colchicine’s effectiveness as a treatment for gout has been postulated to be due to its ability to block neutrophil-mediated inflammatory responses induced by monosodium urate crystals in synovial fluid. Colchicine disrupts the polymerization of β-tubulin into microtubules, thereby preventing the activation, degranulation, and migration of neutrophils to sites of inflammation. Colchicine also interferes with the inflammasome complex found in neutrophils and monocytes that mediates interleukin-1β (IL-1β) activation.

Non-Clinical Toxicology
Patients with renal or hepatic impairment should not be given MITIGARE with drugs that inhibit both P-glycoprotein and CYP3A4 inhibitors [See  ()]. Combining these dual inhibitors with colchicine in patients with renal or hepatic impairment has resulted in life-threatening or fatal colchicine toxicity.

Patients with both renal and hepatic impairment should not be given MITIGARE.

Fatal overdoses, both accidental and intentional, have been reported in adults and children who have ingested colchicine [See ()].  MITIGARE should be kept out of the reach of children.

Gastrointestinal disorders are the most common adverse reactions with colchicine.  They are often the first signs of toxicity and may indicate that the colchicine dose needs to be reduced or therapy stopped.  These include diarrhea, nausea, vomiting, and abdominal pain.

Colchicine has been reported to cause neuromuscular toxicity, which may present as muscle pain or weakness. [see ]

Toxic manifestations associated with colchicine include myelosuppression, disseminated intravascular coagulation, and injury to cells in the renal, hepatic, circulatory, and central nervous system. These most often occur with excessive accumulation or overdosage [see ].

The following reactions have been reported with colchicine. These have been generally reversible by interrupting treatment or lowering the dose of colchicine:

Digestive

Neurological

Dermatological

Hematological

Hepatobiliary

Musculoskeletal

Reproductive

To report SUSPECTED ADVERSE REACTIONS, contact Hikma Americas, Inc. at 1-877-233-2001 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.    

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

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