Away from light and moisture, keep items at room temperature. Keep out of the bathroom. Keep any drugs away from children and pets. Unless specifically instructed to do so, avoid flushing drugs down the toilet or pouring them into drains. When the product is no longer needed or has expired, dispose of it properly. Contact your pharmacist or the neighborhood waste management firm.
Adjusting the recommended dose for treating gout flares in patients with mild (Clcr 50 to 80 mL/min) to moderate (Clcr 30 to 50 mL/min) renal function impairment is not necessary, although patients should be closely watched for colchicine side effects. A treatment course should only be repeated once every two weeks in patients with significant impairment, even though the dose does not need to be changed for the treatment of gout flares. Consideration should be given to an alternative form of treatment for patients whose gout flares necessitate repeated courses. The total recommended dose for treating gout flares should be decreased for dialysis patients to a single dose of 0.6 mg (one tablet). The therapy regimen for these patients shouldn't be repeated more frequently than once every two weeks. Those using COLCRYS for prophylaxis who have renal impairment should not use COLCRYS to treat gout flare-ups.
SIDE EFFECTS Gout flare-up prevention
Diarrhea was the most often reported adverse effect in clinical studies with colchicine for the prevention of gout.
Care For Gout Flares
In the clinical trial using COLCRYS to treat gout flares, diarrhea (23%) and pharyngolaryngeal discomfort (3%), respectively, were the most frequently reported side events.
The most frequent side effects in individuals starting COLCRYS are gastrointestinal tract adverse effects, which can occur in up to 20% of patients given therapeutic doses and often manifest within 24 hours. Cramps, nauseousness, diarrhea, abdominal pain, and vomiting are typical symptoms. If these events are severe, they should be considered dose-limiting since they may signal the beginning of more serious toxicity.
Experience With Clinical Trials For Gout
The adverse reaction rates seen in clinical studies of one drug cannot be directly compared to those seen in clinical studies of another drug because clinical studies are conducted under highly controlled and variable conditions, and they may not be a good indicator of the rates seen in a larger patient population in clinical practice.
In a randomized, double-blind, placebo-controlled study, 26% of patients who took COLCRYS at the recommended dose (1.8 mg over an hour) experienced gastrointestinal side effects, compared to 77% of patients who took colchicine at a non-recommended high dose (4.8 mg over six hours), and 20% of patients who took a placebo. The most typical drug-related gastrointestinal side event recorded was diarrhea. Diarrhea is connected to COLCRYS therapy, as demonstrated in Table 3. Those on the high-dose regimen had a higher chance of developing diarrhea than those on the low-dose treatment. Among patients using the unrecommended high-dose colchicine regimen, severe diarrhea occurred in 19% of cases, and vomiting struck 17% of patients, but not in patients taking the advised low-dose COLCRYS regimen.
Experience with Postmarketing
Colchicine has serious toxic side effects, including myelosuppression, disseminated intravascular coagulation, and damage to cells in the renal, hepatic, circulatory, and central neurological systems. They most frequently happen as a result of excessive accumulation or overdosage. Colchicine has been linked to the following side effects. When the medication is briefly stopped or the colchicine dose is decreased, they have often been reversible. It is not always possible to accurately measure these reactions' frequency or establish a causal link to drug exposure because the reports of these reactions come voluntarily from a population whose number is unknown.
neurological condition: sensory-motor neuropathy
Dermatological symptoms include baldness, rash, and maculopapular rash.
digestive: diarrhea, lactose intolerance, nausea, vomiting, stomach pain, cramps, and abdominal pain
Leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, and aplastic anemia are hematological conditions.
increased ALT and AST in the liver
Musculoskeletal: rhabdomyolysis, myopathy, increased CPK, myotonia, muscle weakness, and discomfort.
reproductive disorders: oligospermia and azoospermia
Colchicine, or COLCRYS, is a substrate of the P-glycoprotein efflux transporter (P-gp). The cytochrome P450 enzyme CYP3A4 played a major role in the metabolism of colchicine among the examined enzymes. While most P-gp inhibitors also inhibit CYP3A4, higher colchicine concentrations are likely if COLCRYS is taken along with them. Drug interactions have been reported to be fatal.