Names and pronunciation
(kol′chih-seen) ColciGel, Colcrys, Gloperba, Mitagere
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Drug reference
(kol′chih-seen) ColciGel, Colcrys, Gloperba, Mitagere
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Func. class.: Antigout agent
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Chem. class.: Alkaloid
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Do not confuse: colchicine/Cortrosyn
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ACTION: Inhibits microtubule forma- tion of lactic acid in leukocytes, which decreases phagocytosis and inflamma- tion in joints
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USES: Gout, gouty arthritis (preven- tion, treatment); to arrest the progres- sion of neurologic disability in those with MS, Mediterranean fever
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Unlabeled uses: Bechet syndrome with C arthritis, cutaneous lesions or mucocuta- neous ulcers, acute and recurrent peri- carditis with NSAIDs, or aspirin
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CONTRAINDICATIONS: Serious GI, severe cardiac/renal/hepatic disor- ders, hypersensitivity Precautions: Pregnancy (PO), breast- feeding, children, geriatric patients, blood dyscrasias, hepatic disease
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SIDE EFFECTS GI: Nausea, vomiting, anorexia, cramps HEMA: Agranulocytosis, thrombocytope- nia, aplastic anemia, pancytopenia MISC: Alopecia, peripheral neuritis
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INTERACTIONS Increase: colchicine level/toxicity— moderate/strong CYP3A4 inhibitors (ata- zanavir, clarithromycin, indinavir, itracon- azole, ketoconazole, ritonavir, nefazodone, nelfinavir, saquinavir, telithromycin), P-glycoprotein inhibitors; reduce dose Increase: GI effects—NSAIDs, ethanol Increase: bone marrow depression— radiation, bone marrow depressants, cycloSPORINE Increase: rhabdomyolysis HMG-CoA reductase inhibitors—digoxin Decrease: action of vitamin B12; may cause reversible malabsorption Drug/Food Increase: colchicine level—grapefruit juice, avoid using together Drug/Lab Test Increase: alkaline phosphatase, AST Decrease: platelets, WBC, granulocytes False positive: urine HB Interference: urinary 17-hydroxycorti- costeroids
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TREATMENT OF OVERDOSE: D/C medication; may need opioids to treat diarrhea
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DOSAGE AND ROUTES Gout prevention • Adult: PO 0.6-1.2 mg/day in 1-2 di- vided doses, depending on severity Gout treatment • Adult: PO 1.2 mg initially, then 0.6 mg 1 hr later (1.8 mg); for those on strong CYP3A4 inhibitor (during past 14 days), 0.6 mg initially, then 0.3 mg 1 hr later Mediterranean fever • Adult on no interacting products: PO 1.2-2.4 mg/day in 1-2 divided doses; strong CYP3A4 inhibitors; P-glycopro- tein inhibitors within 14 days: max 0.6 mg/day in 1-2 divided doses; moderate CYP3A4 inhibitors within 14 days: max 1.2 mg/day in 1-2 divided doses • Adolescent: PO 1.2-2.4 mg/day in 1-2 divided doses, titrate by 0.3 mg/day • Child >6-12 yr: PO 0.9-1.8 mg/day in 1-2 divided doses • Child 4-6 yr: PO 0.3-1.8 mg/day in 1-2 divided doses Bechet syndrome (unlabeled) • Adult PO: 1.2-1.8 mg/day in divided doses Pericarditis (unlabeled) • Adult PO: ≥70 kg 0.5-0.6 mg bid; <70 kg 0.5-0.6 mg daily Renal dose • Adult: PO CCr <30 mL/min, for acute gout, do not repeat course for 2 wk; for familial Mediterranean fever, 0.3 mg daily, increase cautiously
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Available forms: Tablets 0.6 mg; oral solution 0.6 mg/5 mL; capsules 0.6 mg; topical gel 4×
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Administer: PO route • Without regard to food • Cumulative doses ≤4 mg, renal pa- tients ≤2 mg
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Assess: • Gout: relief of pain, uric acid levels decreasing; monitor response to treat- ment q1hr • Familial Mediterranean fever: chest pain, fever, joint pain, red lesions base- line and during treatment • I&O ratio; observe for decrease in urinary output • CBC, platelets, reticulocytes before, during therapy (q3mo); may cause aplas- tic anemia, agranulocytosis, decreased platelets in those on long-term therapy • Toxicity: weakness, abdominal pain, nau- sea, vomiting, diarrhea; product should be discontinued, report symptoms immediately • Beers: reduce dose in older adults; monitor for adverse reactions • Pregnancy/breastfeeding: no well- controlled studies; use in pregnancy only if benefits outweigh fetal risk; neonatal codeine withdrawal may occur; don’t use in labor (premature infant); excreted in breast milk, avoid breastfeeding
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Evaluate: • Therapeutic response: decreased stone formation, decreased pain in kid- ney region, absence of hematuria, de- creased pain in joints, reduced familial Mediterranean fever episodes
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • To avoid alcohol, OTC preparations that contain alcohol • To report any pain, redness, hard ar- eas, usually in legs; rash, sore throat, fever, bleeding, bruising, weakness, numbness, tingling, nausea, vomiting, abdominal pain, muscle pain, weakness • To avoid grapefruit and juice, may increase colchicine level • About the importance of complying with medical regimen (diet, weight loss, product therapy); about the possibility of bone marrow depression occurring; not to double or skip doses; during acute attacks other products may be needed • To advise all providers of product use; that surgery may increase the possibility of acute gout symptoms
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PHARMACOKINETICS PO: Peak ½-2 hr, half-life 30 hr, deace tylates in liver, excreted in feces (metabo- lites/active product)
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• Child >6-12 yr: PO 0.9-1.8 mg/day in 1-2 divided doses
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• Child 4-6 yr: PO 0.3-1.8 mg/day in 1-2 divided doses Bechet syndrome (unlabeled)
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