Colchicina Seid

Colchicine.

Pink tablets.
Each tablet contains: Colchicine 1 mg.
Excipients/Inactive Ingredients: Erythrosine lacquer, lactose, microcrystalline cellulose, povidone, methylene casein, magnesium stearate.

Pharmacological group: Drugs for the treatment of gout. ATC Code: M04AC01.
Pharmacology: Pharmacodynamics: The exact mechanism of action of colchicine in gout has not been confirmed. It is associated with inhibition of leukocyte migration; reduction of lactic acid production by leukocytes leading to decreased uric acid formation; interference with the formation of kinin and phagocytopenia due to reduced inflammatory responses.
Colchicine exerts its effects by reducing the inflammatory response to the deposited crystals and reducing phagocytosis.
Colchicine reduces the production of lactic acid directly by leukocytes and indirectly by reducing phagocytosis, thereby disrupting the cycle of urate crystal deposition and the inflammatory response that sustains the acute attack.
The oxidation of glucose in white blood cells during phagocytic as well as non-phagocytosis is prevented by colchicine.
Colchicine is not an analgesic even if it does relieve acute pain. Colchicine is not a drug that increases uric acid elimination, so it will not prevent the progression of gout to chronic gout arthritis. Colchicine has a prophylactic and preventive effect, helping to reduce the frequency of exacerbations, relieve frequent pain and reduce discomfort for patients.
Colchicine may cause temporary leukopenia, followed by leukocytosis.
Pharmacokinetics: Children: There are no pharmacokinetic data in children.
Absorption: Colchicine is readily absorbed after oral administration, reaching peak plasma concentrations within 2 hours.
The plasma half-life is approximately 1 hour, 60 hours in leucocytes, which is increased in the renal impairment and decreased in hepatic function impairment.
Distribution: Colchicine is distributed into leukocytes, liver, spleen, and kidneys and undergoes enterohepatic circulation.
Metabolism: Colchicine is deacetylated in the liver.
Elimination: Colchicine is primarily excreted through feces, with 10-20% in the urine. The proportion excreted in the urine increases in patients with liver disease.

Adults: Treatment of acute gout.
Preventive treatment of recurrent gout.
Prophylaxis of gout attack during initiation of therapy with allopurinol and uricosuric drugs.

Method of administration: For oral administration.
Posology: Adult: Treatment of acute gout: Initial dose: 1 mg, followed by 500 mcg every 4 hours until pain relief, or until vomiting, diarrhea occurs, or a total dose of 6 mg is reached.
After completing one treatment course, another course should not be started for at least 3 days.
Prophylaxis: To prevent recurrent gout and acute attacks during the initial phase of treatment with allopurinol or uricosuric drugs: 500 mcg, 2-3 times daily.
Elderly: The same dosage is used for adults, but use with caution in patients with renal impairment. Dose reduction of up to 50% may be necessary.
Hepatic or Renal Impairment: Careful monitoring is required. The initial dose should be reduced by 50% (e.g., ≤1 mg/day).

Colchicine has a narrow therapeutic window and is highly toxic when overdosed. Patients at high risk of toxicity: kidney failure, liver failure, gastrointestinal diseases, heart disease, patients at extremes of age.
Colchicine overdose should be promptly consulted by a doctor. Toxicity can be delayed up to 6 hours to become apparent, some features of toxicity can be delayed by 1 week or longer.
After a colchicine overdose, all patients, even without initial symptoms, should be medically evaluated immediately.
Symptom: Symptoms of acute overdosage may be delayed (3 hours on average): nausea, vomiting, abdominal pain, hemorrhagic gastroenteritis, volume depletion, electrolyte abnormalities, leukocytosis, hypotension in severe cases.
The second phase with life threatening complications develops 24 to 72 hours after drug administration: multisystem organ dysfunction, acute renal failure, confusion, coma, ascending peripheral motor and sensory neuropathy, myocardial depression, pancytopenia, dysrhythmias, respiratory failure, consumption coagulopathy. Death is usually a result of respiratory depression and cardiovascular collapse. If the patient survives, recovery may be accompanied by rebound leukocytosis and reversible alopecia starting about one week after the initial ingestion.
Treatment: No antidote is available. Therefore, the poison can be removed by gastric lavage within 1 hour after acute poisoning.
Consider oral activated charcoal in adults who have ingested more than 0.1 mg/kg bodyweight within 1 hour of presentation and in children who have ingested any amount within 1 hour of presentation.
Haemodialysis has no efficacy.
Close clinical and biological monitoring in hospital environment.
Symptomatic and supportive treatment: control of respiration, maintenance of blood pressure and circulation, correction of fluid and electrolytes imbalance.

Hypersensitivity to colchicine, gastrointestinal disorders, patients with renal or hepatic impairment, cardiovascular disease, and severe blood disorders.

Colchicine is potentially toxic and should not be used exceeding the dosage prescribed by a medical specialist.
Colchicine should be used with caution in elderly, debilitated patients and those with heart, liver, kidney, and gastro-intestinal diseases.
Colchicine has adversely affected spermatogenesis in humans under certain treatment conditions. Patients on long-term treatment should undergo regular blood tests.
Inform a doctor if the patient experience skin rash, sore throat, fever, unusual bleeding, bruising, fatigue or weakness, numbness, or tingling sensations.
Stop the drug as soon as the gout pain subsides or when the first sign is nausea, vomiting, stomach pain, or diarrhea. If symptoms persist, inform a doctor.
This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Effects on Ability to Drive and Use Machines: Colchicine does not affect the ability to drive and operate machinery.

Pregnancy: Colchicine has been shown to cause teratogens in animals and poses a risk of teratogenicity or fetal chromosomal damage in humans. Colchicine should not be used in the first trimester of pregnancy and only in the late stages of pregnancy when considering the risks/benefits because colchicine can be excreted through breast milk.
Lactation: It should not be used by women who are breastfeeding because of the risk of cytotoxicity.

Colchicine may increase alkaline phosphatase (ALP) and SGOT activity and reduce platelet count.
Bone marrow suppression, with aplastic anemia, agranulocytosis, leukopenia, or thrombocytopenia, may occur in patients receiving long-term treatment. Loss of hair, rashes, bullous dermatitis, peripheral neuritis or neuropathy, myopathy, anuria, kidney damage, hematuria, and purpura have been reported with prolonged administration of colchicine.
Vomiting, diarrhea, abdominal pain, and nausea may occur especially when maximum doses are required for therapeutic effect. These symptoms are particularly concerning for patients with peptic ulcer disease or colonic spasm.
At toxic doses, colchicine can cause severe diarrhea, systemic vascular damage, and kidney injury with hematuria and oliguria. To prevent severe toxicity, discontinue colchicine immediately if these symptoms appear, regardless of joint pain relief.
Skin lesions have been reported, and hypersensitivity reactions may occur, though they are uncommon.
Hepatobiliary disorders: Liver toxicity has been observed, but the exact frequency is unknown.
Report any adverse effects to a doctor or pharmacist immediately.

Colchicine has been shown to cause reversible malabsorption of vitamin B12 by altering the function of the ileal mucosa. Colchicine can reduce the absorption of fats, sodium, potassium, nitrogen, xylose, and other actively transported sugars. This can lead to decreased serum cholesterol and carotene levels.
Colchicine is inhibited by acidifying agents but enhanced by alkalizing agents.
Colchicine may increase sensitivity to central nervous system depressants and enhance responses to sympathetic-like substances.
Colchicine can cause false-positive results when testing for RBC or hemoglobin in the urine.
Colchicine can react with cyclosporin, resulting in an increased risk of kidney toxicity and increased plasma levels of cyclosporin.
Colchicine has been reported to interfere with the determination of 17-hydroxycorticoids in urine using the Reddy, Jenkins, and Thorn procedure. Concomitant use with clarithromycin can lead to colchicine poisoning. Colchicine is a CYP3A transmetabolite and P-glycoprotein (Pgp) flow transporter. Clarithromycin and other macrolides inhibit CYP3A and Pgp. When clarithromycin and colchicine are used concomitantly, inhibition of Pgp and/or CYP3A by clarithromycin can lead to an overdose of colchicine. Patients should be monitored for clinical symptoms of colchicine poisoning.
Concomitant use with erythromycin can also lead to colchicine poisoning.

Store in sealed packaging at room temperature below 30°C. Protect from light and moisture.
Shelf Life: 60 months from the date of manufacture.

Hyperuricemia & Gout Preparations

M04AC01 - colchicine ; Belongs to the class of preparations with no effect on uric acid metabolism. Used in the treatment of gout.