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Colchicine
Overview
What is Colcrys?
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 CHNO and a molecular weight of 399.4. The structural formula of colchicine is given below.
Colchicine occurs as a pale yellow powder that is soluble in water.
COLCRYS (colchicine, USP) tablets are 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 does Colcrys look like?
What are the available doses of Colcrys?
0.6 mg tablets — purple capsule-shaped, film-coated with "AR 374" debossed on one side and scored on the other side.
What should I talk to my health care provider before I take Colcrys?
How should I use Colcrys?
COLCRYS (colchicine, USP) tablets are indicated for prophylaxis and the treatment of acute gout flares.
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 coadministered 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.
What interacts with Colcrys?
Sorry No Records found
What are the warnings of Colcrys?
Sorry No Records found
What are the precautions of Colcrys?
Sorry No Records found
What are the side effects of Colcrys?
Sorry No records found
What should I look out for while using Colcrys?
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.
What might happen if I take too much Colcrys?
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 four-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 multiorgan failure and its consequences. Death is usually a result of respiratory depression and cardiovascular collapse. If the patient survives, recovery of multiorgan injury may be accompanied by rebound leukocytosis and alopecia starting about one 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 [.
How should I store and handle Colcrys?
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Protect from light.DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Protect from light.DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Bumetanide Tablets USP are available as light green, flat, round, bevel-edged tablets, debossed “0.5” on one side and bisected on the other side with company logo on the upper half and “4232” on the lower, containing 0.5 mg bumetanide, USP packaged in bottles of 100 tablets. NDC 42291-178-01Bumetanide Tablets USP are available as yellow, flat, round, bevel-edged tablets, debossed “1” on one side and bisected on the other side with company logo on the upper half and “4233” on the lower, containing 1 mg bumetanide, USP packaged in bottles of 100 and 1000 tablets. NDC 42291-179-01 , NDC 42291-179-10 Bumetanide Tablets USP are available as peach, flat, round, bevel-edged tablets, debossed “2” on one side and bisected on the other side with company logo on the upper half and “4234” on the lower, containing 2 mg bumetanide, USP packaged in bottles of 100 and 1000 tablets. NDC 42291-180-01 , NDC 42291-180-10PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. A 03/10AV 04/15 (P)Bumetanide Tablets USP are available as light green, flat, round, bevel-edged tablets, debossed “0.5” on one side and bisected on the other side with company logo on the upper half and “4232” on the lower, containing 0.5 mg bumetanide, USP packaged in bottles of 100 tablets. NDC 42291-178-01Bumetanide Tablets USP are available as yellow, flat, round, bevel-edged tablets, debossed “1” on one side and bisected on the other side with company logo on the upper half and “4233” on the lower, containing 1 mg bumetanide, USP packaged in bottles of 100 and 1000 tablets. NDC 42291-179-01 , NDC 42291-179-10 Bumetanide Tablets USP are available as peach, flat, round, bevel-edged tablets, debossed “2” on one side and bisected on the other side with company logo on the upper half and “4234” on the lower, containing 2 mg bumetanide, USP packaged in bottles of 100 and 1000 tablets. NDC 42291-180-01 , NDC 42291-180-10PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. A 03/10AV 04/15 (P)Bumetanide Tablets USP are available as light green, flat, round, bevel-edged tablets, debossed “0.5” on one side and bisected on the other side with company logo on the upper half and “4232” on the lower, containing 0.5 mg bumetanide, USP packaged in bottles of 100 tablets. NDC 42291-178-01Bumetanide Tablets USP are available as yellow, flat, round, bevel-edged tablets, debossed “1” on one side and bisected on the other side with company logo on the upper half and “4233” on the lower, containing 1 mg bumetanide, USP packaged in bottles of 100 and 1000 tablets. NDC 42291-179-01 , NDC 42291-179-10 Bumetanide Tablets USP are available as peach, flat, round, bevel-edged tablets, debossed “2” on one side and bisected on the other side with company logo on the upper half and “4234” on the lower, containing 2 mg bumetanide, USP packaged in bottles of 100 and 1000 tablets. NDC 42291-180-01 , NDC 42291-180-10PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. A 03/10AV 04/15 (P)Bumetanide Tablets USP are available as light green, flat, round, bevel-edged tablets, debossed “0.5” on one side and bisected on the other side with company logo on the upper half and “4232” on the lower, containing 0.5 mg bumetanide, USP packaged in bottles of 100 tablets. NDC 42291-178-01Bumetanide Tablets USP are available as yellow, flat, round, bevel-edged tablets, debossed “1” on one side and bisected on the other side with company logo on the upper half and “4233” on the lower, containing 1 mg bumetanide, USP packaged in bottles of 100 and 1000 tablets. NDC 42291-179-01 , NDC 42291-179-10 Bumetanide Tablets USP are available as peach, flat, round, bevel-edged tablets, debossed “2” on one side and bisected on the other side with company logo on the upper half and “4234” on the lower, containing 2 mg bumetanide, USP packaged in bottles of 100 and 1000 tablets. NDC 42291-180-01 , NDC 42291-180-10PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. A 03/10AV 04/15 (P)Bumetanide Tablets USP are available as light green, flat, round, bevel-edged tablets, debossed “0.5” on one side and bisected on the other side with company logo on the upper half and “4232” on the lower, containing 0.5 mg bumetanide, USP packaged in bottles of 100 tablets. NDC 42291-178-01Bumetanide Tablets USP are available as yellow, flat, round, bevel-edged tablets, debossed “1” on one side and bisected on the other side with company logo on the upper half and “4233” on the lower, containing 1 mg bumetanide, USP packaged in bottles of 100 and 1000 tablets. NDC 42291-179-01 , NDC 42291-179-10 Bumetanide Tablets USP are available as peach, flat, round, bevel-edged tablets, debossed “2” on one side and bisected on the other side with company logo on the upper half and “4234” on the lower, containing 2 mg bumetanide, USP packaged in bottles of 100 and 1000 tablets. NDC 42291-180-01 , NDC 42291-180-10PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. A 03/10AV 04/15 (P)Bumetanide Tablets USP are available as light green, flat, round, bevel-edged tablets, debossed “0.5” on one side and bisected on the other side with company logo on the upper half and “4232” on the lower, containing 0.5 mg bumetanide, USP packaged in bottles of 100 tablets. NDC 42291-178-01Bumetanide Tablets USP are available as yellow, flat, round, bevel-edged tablets, debossed “1” on one side and bisected on the other side with company logo on the upper half and “4233” on the lower, containing 1 mg bumetanide, USP packaged in bottles of 100 and 1000 tablets. NDC 42291-179-01 , NDC 42291-179-10 Bumetanide Tablets USP are available as peach, flat, round, bevel-edged tablets, debossed “2” on one side and bisected on the other side with company logo on the upper half and “4234” on the lower, containing 2 mg bumetanide, USP packaged in bottles of 100 and 1000 tablets. NDC 42291-180-01 , NDC 42291-180-10PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. A 03/10AV 04/15 (P)Bumetanide Tablets USP are available as light green, flat, round, bevel-edged tablets, debossed “0.5” on one side and bisected on the other side with company logo on the upper half and “4232” on the lower, containing 0.5 mg bumetanide, USP packaged in bottles of 100 tablets. NDC 42291-178-01Bumetanide Tablets USP are available as yellow, flat, round, bevel-edged tablets, debossed “1” on one side and bisected on the other side with company logo on the upper half and “4233” on the lower, containing 1 mg bumetanide, USP packaged in bottles of 100 and 1000 tablets. NDC 42291-179-01 , NDC 42291-179-10 Bumetanide Tablets USP are available as peach, flat, round, bevel-edged tablets, debossed “2” on one side and bisected on the other side with company logo on the upper half and “4234” on the lower, containing 2 mg bumetanide, USP packaged in bottles of 100 and 1000 tablets. NDC 42291-180-01 , NDC 42291-180-10PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. A 03/10AV 04/15 (P)Bumetanide Tablets USP are available as light green, flat, round, bevel-edged tablets, debossed “0.5” on one side and bisected on the other side with company logo on the upper half and “4232” on the lower, containing 0.5 mg bumetanide, USP packaged in bottles of 100 tablets. NDC 42291-178-01Bumetanide Tablets USP are available as yellow, flat, round, bevel-edged tablets, debossed “1” on one side and bisected on the other side with company logo on the upper half and “4233” on the lower, containing 1 mg bumetanide, USP packaged in bottles of 100 and 1000 tablets. NDC 42291-179-01 , NDC 42291-179-10 Bumetanide Tablets USP are available as peach, flat, round, bevel-edged tablets, debossed “2” on one side and bisected on the other side with company logo on the upper half and “4234” on the lower, containing 2 mg bumetanide, USP packaged in bottles of 100 and 1000 tablets. NDC 42291-180-01 , NDC 42291-180-10PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. A 03/10AV 04/15 (P)Bumetanide Tablets USP are available as light green, flat, round, bevel-edged tablets, debossed “0.5” on one side and bisected on the other side with company logo on the upper half and “4232” on the lower, containing 0.5 mg bumetanide, USP packaged in bottles of 100 tablets. NDC 42291-178-01Bumetanide Tablets USP are available as yellow, flat, round, bevel-edged tablets, debossed “1” on one side and bisected on the other side with company logo on the upper half and “4233” on the lower, containing 1 mg bumetanide, USP packaged in bottles of 100 and 1000 tablets. NDC 42291-179-01 , NDC 42291-179-10 Bumetanide Tablets USP are available as peach, flat, round, bevel-edged tablets, debossed “2” on one side and bisected on the other side with company logo on the upper half and “4234” on the lower, containing 2 mg bumetanide, USP packaged in bottles of 100 and 1000 tablets. NDC 42291-180-01 , NDC 42291-180-10PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. A 03/10AV 04/15 (P)Bumetanide Tablets USP are available as light green, flat, round, bevel-edged tablets, debossed “0.5” on one side and bisected on the other side with company logo on the upper half and “4232” on the lower, containing 0.5 mg bumetanide, USP packaged in bottles of 100 tablets. NDC 42291-178-01Bumetanide Tablets USP are available as yellow, flat, round, bevel-edged tablets, debossed “1” on one side and bisected on the other side with company logo on the upper half and “4233” on the lower, containing 1 mg bumetanide, USP packaged in bottles of 100 and 1000 tablets. NDC 42291-179-01 , NDC 42291-179-10 Bumetanide Tablets USP are available as peach, flat, round, bevel-edged tablets, debossed “2” on one side and bisected on the other side with company logo on the upper half and “4234” on the lower, containing 2 mg bumetanide, USP packaged in bottles of 100 and 1000 tablets. NDC 42291-180-01 , NDC 42291-180-10PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. A 03/10AV 04/15 (P)
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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.
Non-Clinical Toxicology
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.Drugs With Ototoxic Potential (see )
Especially in the presence of impaired renal function, the use of parenterally administered bumetanide in patients to whom aminoglycoside antibiotics are also being given should be avoided, except in life-threatening conditions.
Drugs With Nephrotoxic Potential
There has been no experience with the concurrent use of bumetanide with drugs known to have a nephrotoxic potential. Therefore, the simultaneous administration of these drugs should be avoided.
Lithium
Lithium should generally not be given with diuretics (such as bumetanide) because they reduce its renal clearance and add a high risk of lithium toxicity.
Probenecid
Pretreatment with probenecid reduces both the natriuresis and hyperreninemia produced by bumetanide. This antagonistic effect of probenecid on bumetanide natriuresis is not due to a direct action on sodium excretion but is probably secondary to its inhibitory effect on renal tubular secretion of bumetanide. Thus, probenecid should not be administered concurrently with bumetanide.
Indomethacin
Indomethacin blunts the increases in urine volume and sodium excretion seen during bumetanide treatment and inhibits the bumetanide-induced increase in plasma renin activity. Concurrent therapy with bumetanide is thus not recommended.
Antihypertensives
Bumetanide may potentiate the effect of various antihypertensive drugs, necessitating a reduction in the dosage of these drugs.
Digoxin
Interaction studies in humans have shown no effect on digoxin blood levels.
Anticoagulants
Interaction studies in humans have shown bumetanide to have no effect on warfarin metabolism or on plasma prothrombin activity.
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.
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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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. 315.72Tips
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