Kolchin 0.6 Tablet
Colchicine
0.6mg
Incepta Pharmaceuticals Ltd.
| Pack size | 30's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 5.00 AED |
Available as:
Indications
Kolchin 0.6 Tablet is used for:
Acute gout, Familial Mediterranean Fever, Behcet's disease, Gouty arthritis
Adult Dose
Gout
Treatment of acute gout flares: 1.2 mg PO at first sign of flare, then 0.6 mg 1 hr later; not to exceed 1.8 mg in 1-hr period
Prophylaxis: 0.6 mg PO once daily or 12 hourly; not to exceed 1.2 mg/day; after gout flare, wait 12 hr to continue prophylaxis
Familial Mediterranean Fever
1.2-2.4 mg/day PO in single daily dose or divided twice daily; increased in 0.3 mg/day increments as necessary to control disease; decreased in 0.3 mg/day increments if intolerable side effects develop; not to exceed 2.4 mg/day
Child Dose
Gout
<16 years
Not recommended
>16 years
Treatment of acute gout flares: 1.2 mg PO at first sign of flare, then 0.6 mg 1 hr later; not to exceed 1.8 mg in 1-hr period
Prophylaxis: 0.6 mg PO once daily or 12 hourly; not to exceed 1.2 mg/day; after gout flare, wait 12 hr to continue prophylaxis
Familial Mediterranean Fever
<4 years: Safety and efficacy not established
4-6 years: 0.3-1.8 mg/day PO in single daily dose or divided 12 hourly
6-12 years: 0.9-1.8 mg/day PO in single daily dose or divided 12 hourly
>12 years: 1.2-2.4 mg/day PO in single daily dose or divided 12 hourly
Renal Dose
Renal impairment (gout)
Mild (CrCl 50-80 mL/min) and moderate (CrCl 30-50 mL/min): Dosage adjustment not necessary; monitor patients for adverse effects
Severe (CrCl <30 mL/min): Dosage adjustment not necessary; do not repeat more frequently than every 2 weeks
Hemodialysis: 0.6 mg once; do not repeat more frequently than every 2 weeks
Renal impairment (familial Mediterranean fever)
Mild (CrCl 50-80 mL/min) and moderate (CrCl 30-50 mL/min): Monitor patients for adverse effects; dosage adjustment may be required
Severe (CrCl <30 mL/min): 0.3 mg/day initially; dosage increases should be done with adequate monitoring for adverse effects
Hemodialysis: 0.3 mg PO once; dosage increases should be done with adequate monitoring for adverse effects
Administration
Should be taken with food.
Contra Indications
Hypersensitivity; blood dyscrasias, severe renal impairment, pregnancy, debilitated patients; SC/IM admin.
Precautions
Long-term use is established for FMF, but safety and efficacy of repeat treatment in gout flares has not been evaluated
Not to be used to treat pain from other causes; drug is not analgesic
Must be kept out of reach of children; fatal overdoses reported in both adults and children
Blood dyscrasias (eg, leukopenia, myelosuppression, thrombocytopenia, pancytopenia, granulocytopenia, aplastic anemia) reported at therapeutic dosages
Rhabdomyolysis and neuromuscular toxicity reported with long-term treatment at therapeutic dosages; increased risk in renal dysfunction, elderly patients, and concomitant therapy with myotoxic drugs; symptoms generally resolve within 1 week to few months upon discontinuance
Pregnancy-Lactation
Pregnancy
Available human data from published literature on colchicine use in pregnancy over several decades have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes
Animal data
Published animal reproduction and development studies indicate that colchicine causes embryofetal toxicity and altered postnatal development at exposures within or above the clinical therapeutic range
Infertility
Males: Case reports and epidemiology studies in human male subjects indicated that infertility from colchicine is rare and a case report showed that azoospermia was reversed when therapy was stopped
Females: Case reports and epidemiology studies in female subjects on colchicine therapy have not established a clear relationship between colchicine use and female infertility; however, since the progression of FMF without treatment may result in infertility, the use of colchicine needs to be weighed against the potential risks
Lactation
Colchicine is present in human milk
No adverse events in breastfed infants in the published literature after administration of colchicine to lactating women
No data available on the effects of colchicine on milk production
Consider developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition
Interactions
CYP3A4 and P-gp substrate
Dual CYP3A4 and P-gp inhibitors
Consider dosage reduction or interruption of therapy
Inhibition of both CYP3A4 and P-gp by dual inhibitors (ie, clarithromycin) reported to produce life-threatening or fatal colchicine toxicity due to significant increases in systemic colchicine levels
HMG-CoA reductase inhibitors and fibrates
Monitor serum creatinine kinase levels if muscle pain or weakness reported
HMG-CoA reductase inhibitors and fibrates may increase the risk of myopathy when combined with colchicine
Digoxin
Monitor for signs or symptoms muscle pain toxicity
Digoxin (a P-gp substrate) may increase the risk of rhabdomyolysis
Oral contraceptives
Use with caution
In healthy females given coadministered with colchicine 0.6 mg BID, hormone concentrations are not affected
Colchicine can interact with oral contraceptives like norethindrone/ethinyl estradiol and can cause adverse events(eg, diarrhea, nausea, upper abdominal pain, cold sweat)
Contraindicated (2)
nirmatrelvir/ritonavir
xanomeline/trospium
Potentially Fatal: With ciclosporin, increased risk of nephrotoxicity and myotoxicity. Risk of colchicine toxicity when used with macrolides.
Adverse Effects
Side effects of Colchicine :
>10%
Gastrointestinal (GI) effects (eg, diarrhea, nausea, cramping, abdominal pain, vomiting) (26-77%)
1-10%
Fatigue (1-4%),Gout (0-4%),Pharyngolaryngeal pain (2-3%),Headache (1-2%)
Mechanism of Action
Colchicine, a phenanthrene derivative, exerts its effect by reducing the inflammatory response to the deposited urate crystals and also by diminishing phagocytosis in joints. It inhibits lactic acid production by leucocytes, thereby interrupting urate deposition and inflammatory response that sustains the acute gout attack.
Note
Kolchin 0.6 0.6mg Tablet manufactured by Incepta Pharmaceuticals Ltd.. Its generic name is Colchicine. Kolchin 0.6 is availble in Bangladesh.
Farmaco BD drug index information on Kolchin 0.6 Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.