秋水仙碱

秋水仙碱is aprescription drugto treat conditions such as痛风和familial Mediterranean fever。

秋水仙碱is available under the following different brand names:Colcrys， 和Mitigare。

Adult andpediatricdosages:

Tablet

• 0.6mg

Capsule

• 0.6mg

Dosage Considerations – Should be Given as Follows:

Gout

Adults

• 预防（Colcrys，Mitigare）：每天或每12小时口服0.6 mg，每天不超过1.2 mg。痛风之后耀斑, wait 12 hours to continue prophylaxis

Pediatrics

• Children under 16 years old: not recommended
• Children older than 16 years old: Treatment of急性痛风耀斑s (Colcrys): 1.2 mg orally at firstsignof flare, then 0.6 mg 1 hour later, not to exceed 1.8 mgin1 hour period

FamilialMediterranean Fever

Adults

• Colcrys: 1.2-2.4 mg per day orally in a single daily dose or divided every 12 hours, increase in 0.3 mg/day increments as necessary to控制disease，如果发生无法忍受的副作用，每天每天0.3毫克的增量减少，每天不超过2.4 mg

Pediatrics

• Children under 4 years old: Safety and efficacy not established
• 4 - 6年：每天口服0.3-1.8毫克，单剂量或每12小时分裂
• 6-12 years: 0.9-1.8 mg per day orally in a single dose or divided every 12 hours
• Children older than 12 years old: 1.2-2.4 mg per day orally in a single dose or divided every 12 hours

剂量修饰

RenalImpairment

• Mild (creatinineclearance 50-80 ml/minute) and moderate (creatinine clearance 30-50 ml/minute): Dosage adjustment not necessary, monitor patients for adverse effects
• Severe (creatinine clearance under 30 ml/minute): Dosage adjustment not necessary, do not重复more frequently than every 2 weeks
• Hemodialysis: 0.6 orally once, do not repeat more frequently than every 2 weeks

Renal impairment (familial Mediterraneanfever)

• Mild (creatinine clearance 50-80 ml/minute) and moderate (creatinine clearance 30-50 ml/minute): Monitor patients for adverse effects, dosage adjustment may be required
• Severe (creatinine clearance under 30 ml/minute): 0.3 mg per day initially. Dosage increases should be done with adequate monitoring for adverse effects
• Hemodialysis: 0.3 orally once, dosage increases should be done with adequate monitoring for adverse effects

Hepatic损害（痛风）

• Mild to moderate: dosage adjustment not necessary, monitor patients for adverse effects
• 严重：无需剂量调整，不要比每2周重复一次，请考虑替代方案治疗如果重复的场地ses are required

Hepatic impairment (Familial Mediterranean fever)

• Mild to moderate: monitor patients for adverse effects
• 严重：不需要剂量调整，不要比每2周重复一次，如果需要重复的课程，请考虑替代治疗

Strong CYP3A4 inhibitors

• Treatment of acute gout flares: 0.6 mg, then 0.3 mg 1 hour later, to be repeated no earlier than 3 days later
• 预防of acute gout flares: If the original colchicine方案was 0.6 mg twice daily, decrease dose to 0.3 mg each day. If the original colchicine regimen was 0.6 mg per day, decrease dose to 0.3 mg once every other day
• Familial Mediterranean Fever (FMF): Not to exceed 0.6 mg per day, 0.6 mg can be given as 0.3 mg every 12 hours

Moderate CYP3A4 inhibitors

• Gout: 1.2 mg orally once, to be repeated no earlier than 3 days later
• Familial Mediterranean Fever: Not to be exceed 1.2 mg per day, 0.6 mg can be given as 0.6 mg every 12 hours

P-gp inhibitors

• Gout: 0.6 mg orally once, to be repeated no earlier than 3 days later
• Familial Mediterranean fever: Not to exceed 0.6 mg per day, 0.6 mg can be given as 0.3 mg every 12 hours

Administration

• Dosing regimens must be individualized toindication。口服管理，不考虑用餐

Post-STEMI心包炎(off label)

• Treatment of pericarditis after ST-elevationmyocardial infarction（STEMI）
• 0.6mg orally every 12 hours

Pediatric dosing considerations:

• Increased or decreased in 0.3 mg per day increments as necessary, not to exceed maximum recommended daily dose

Side effects associated with use of Colchicine, include the following:

• gastrointestinaleffects (腹泻,lactose intolerance,nausea, cramping,腹痛, vomiting)
• fatigue
• 痛风
• pain在里面throat和vocal cords
• 头痛

Post-marketing side effects of Colchicine reported include:

• disseminated intravascularcoagulation
• cellularinjury(to kidneys, vasculature,liver和central nervous system)
• 骨髓抑制
• neurologic:感官motormalfunction of the nerves (神经病)
• dermatologic:脱发, bruising (purpura), maculopapularrash, rash
• gastrointestinal:lactoseintolerance,abdominalcramping, abdominal pain, vomiting, diarrhea, nausea
• hematologic: lowred blood cellcount (血小板减少症), lowwhite blood cell count, reducedwhite blood cellcount (granulocytopenia), shortage of red, whitebloodcells andplatelets(pancytopenia), failure of thebone marrowto produce red and white blood cells (aplastic anemia)
• hepatobiliary: elevated liver transaminases
• 肌肉骨骼：肌肉disease (myotonia), muscle weakness,肌病, elevated creatinine phosphokinase (CPK), muscle pain, breakdown ofskeletal muscle(rhabdomyolysis)
• reproductive:infertility(精子缺乏), reducedspermcount (oligospermia)

This document does not contain all possible side effects and others may occur. Check with yourphysicianfor additional information about side effects.

If your medical医生is using this medicine to treat your pain, your doctor orpharmacistmay already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor,healthcare provider or pharmacist first.

• 秋水仙碱has no known severe interactions with any drugs.
• 秋水仙碱的严重互动包括：
  • clarithromycin
  • darunavir
  • itraconazole
  • ombitasvir/paritaprevir/ritonavir
  • ombitasvis/paritaprevir/ritonavir and dasabuvir
  • telithromycin
• 秋水仙碱与至少31种不同的药物有严重的相互作用。
• 秋水仙碱has moderate interactions with at least 125 different drugs.
• Mild Interactions of Colchicine include:
  • 蓝葡萄糖
  • efavirenz

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine.

警告

• Must be kept out of reach of children; fatal overdoses have been reported
• This药物contains colchicine. Do not take Colcrys or Mitigare, if you are allergic to colchicine or any ingredients contained in this drug
• Keep out of reach of children. In case of overdose, get medical help or contact aPoison Control Centerimmediately

Contraindications

• Avoid coadministration with P-gp or strong CY3A4 inhibitors in patients with hepatic or renal impairment as life-threatening and fatal colchicinetoxicity据报道therapeuticdosages
• 对秋水仙碱的高敏性

Effects of Drug Abuse

• No information provided

Short-Term Effects

• See "What Are Side Effects Associated with Using Colchicine?"

Long-Term Effects

• Long-term use is established for Familial Mediterranean Fever, but safety and efficacy of repeat treatment in gout flares has not been evaluated
• Muscle injury andneuromusculartoxicity have been reported with long-term treatment at therapeutic dosages; increased risk withkidney(renal)dysfunction, elderly patients, concomitant therapy with myotoxic drugs; symptoms generally resolve within 1 week to few months upon discontinuance
• See "What Are Side Effects Associated with Using Colchicine?"

警告

• Long-term use is established for Familial Mediterranean Fever, but safety and efficacy of repeat treatment in gout flares has not been evaluated
• Not to be used to treat pain from other causes, as colchicine is not ananalgesic
• Must be kept out of reach of children; fatal overdoses have been reported
• 血液心理（减少白细胞，减少红细胞（骨髓抑制），低红血cell(thrombocytopenia), reduction of red and white blood cells, as well as platelets (pancytopenia), reduced white blood cell count (granulocytopenia), failure of thebonemarrow产生红色和白色血细胞（形成性anemia) have been reported at therapeutic dosages
• Coadministration with P-gp and strong CYP3A4 inhibitors may warrant dosage reduction or interruption of therapy
• Muscle injury and neuromuscular toxicity have been reported with long-term treatment at therapeutic dosages; increased risk with renal dysfunction, elderly patients, concomitant therapy with myotoxic drugs; symptoms generally resolve within 1 week to few months upon discontinuance
• Acute gout: Dosages greater than 1.8 mg/day provide no additional efficacy
• Dose reduction recommended in patients who develop gastrointestinal symptoms including loss of appetite (anorexia), diarrhea, vomiting, or nausea due to the therapy
• 肾脏（肾脏）和肝（肝）损害的清除率下降；监测毒性并在必要时调整剂量
• Use with caution in the elderly; consider adjusting dose

Pregnancy和Lactation

• Use colchicine during pregnancy with caution if benefits outweigh risks
• Animal studiesshow风险和人类研究不可用，或者没有进行动物或人类研究
• 秋水仙碱进入breast milk, therefore use with caution. TheAmerican Academy of PediatricsCommittee states that colchicine is "compatible" withbreastfeeding