Colchicine

From Drugs Prescribing Information
(Redirected from Colcrys)
Jump to: navigation, search
Click on "►" to expand:

Contents

[edit] BRAND NAMES

[edit] STRUCTURE

Colchicine.jpg

[edit] MECHANISM OF ACTION

Colchicine is a highly poisonous alkaloid, originally extracted from plants of the genus Colchicum (Autumn crocus, also known as the "Meadow saffron"). Colchicine is an effective treatment for the reduction of pain and clinical symptoms in patients experiencing acute attacks of gout. It apparently interrupts the cycle of monosodium urate crystal deposition in joint tissues and the resultant inflammatory response that initiates and sustains an acute attack.

[edit] INDICATIONS

  • Prophylaxis and Treatment of Gout Flares in adults. Colchicine has a low benefit-toxicity ratio and should be used as a second line therapy when NSAIDs or corticosteroids are contraindicated or ineffective.[1]
  • Familial Mediterranean fever (FMF) in adults and children 4 years or older.

[edit] DOSAGE

  • Gout Flares:
    • Prophylaxis of Gout Flares: 0.6 mg once or twice daily in adults and adolescents older than 16 years of age. Maximum dose 1.2 mg/day.
    • Treatment of Gout Flares: 1.2 mg at the first sign of a gout flare followed by 0.6 mg one hour later.
  • Familial Mediterranean fever (FMF): Adults and Children older than 12 years 1.2 – 2.4 mg; Children 6 to 12 years 0.9 – 1.8 mg; Children 4 to 6 years 0.3 – 1.8 mg.
    • Give total daily dose in one or two divided doses.
    • Increase or decrease the dose as indicated and as tolerated in increments of 0.3 mg/day, not to exceed the maximum recommended daily dose.

Colchicine tablets are administered orally, without regard to meals.

See full prescribing information PI for dose adjustment regarding patients with impaired renal function, impaired hepatic function, the patient’s age, or use of co-administered drugs

[edit] DOSAGE FORMS AND STRENGTHS

  • 0.6 mg tablets

[edit] CONTRAINDICATIONS

Patients with renal or hepatic impairment should not be given Colchicine in conjunction with P-gp or strong CYP3A4 inhibitors. In these patients, life-threatening and fatal colchicine toxicity has been reported with colchicine taken in therapeutic doses

[edit] WARNINGS AND PRECAUTIONS

  • Fatal overdoses have been reported with colchicine in adults and children. Keep Colchicine out of the reach of children.
  • Blood dyscrasias: myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, and aplastic anemia have been reported.
  • Monitor for toxicity and if present consider temporary interruption or discontinuation of colchicine.
  • Drug interaction P-gp and/or CYP3A4 inhibitors: Colchicine is a P-gp and CYP3A4 substrate. Co-administration of colchicine with P-gp and/or strong CYP3A4 inhibitors has resulted in life-threatening interactions and death
  • Neuromuscular toxicity: Myotoxicity including rhabdomyolysis may occur, especially in combination with other myopathic drugs (e.g.,statins) or in those with renal insufficiency.

[edit] INTERACTIONS

Co-administration of P-gp and/or CYP3A4 inhibitors (e.g., clarithromycin or cyclosporine) may lead to increased plasma colchicine levels and agranulocytosis.

The potential for drug-drug interactions must be considered prior to and during therapy.

[edit] PREGNANCY AND LACTATION

  • Pregnancy Category C (US) Use only if the potential benefit justifies the potential risk to the fetus.
  • Nursing Mothers: Caution should be exercised when administered to a nursing woman

[edit] SIDE EFFECTS

Prophylaxis of Gout Flares: The most commonly reported adverse reaction in clinical trials for the prophylaxis of gout was diarrhea.

Treatment of Gout Flares: The most common adverse reactions reported in the clinical trial for gout were diarrhea (23%) and pharyngolaryngeal pain (3%).

FMF: Most common adverse reactions (up to 20%) are abdominal pain, diarrhea, nausea, and vomiting. These effects are usually mild, transient, and reversible upon lowering the dose.

[edit] RELATED LINKS

Gout: Diet, Symptoms and Medication

[edit] REFERENCES

  1. http://www.ncbi.nlm.nih.gov/pubmed/17054279