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Components:
Colchicine
Method of action:
Antigout, Anti-Inflammatory
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Medically reviewed by Oliinyk Elizabeth Ivanovna, Pharmacy. Last updated on 2020.01.25

Therapeutic indications

The information provided in Therapeutic indications of Kolsin is based on data of another medicine with exactly the same composition as the Kolsin of the medicine (Colchicine). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Kolsin directly from the package or from the pharmacist at the pharmacy.
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Adults

- Treatment of acute gout

- Prophylaxis of gout attack during initiation of therapy with allopurinol and uricosuric drugs

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of Kolsin is based on data of another medicine with exactly the same composition as the Kolsin of the medicine (Colchicine). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug Kolsin directly from the package or from the pharmacist at the pharmacy.
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Posology

Adults

Treatment of acute gout attack:

1 mg (2 tablets) to start followed by 500 micrograms (1 tablet) after 1 hour.

No further tablets should be taken for 12 hours.

After 12 hours, treatment can resume if necessary with a maximum dose of 500 micrograms (1 tablet) every 8 hours until symptoms are relieved.

The course of treatment should end when symptoms are relieved or when a total of 6 mg (12 tablets) has been taken.

No more than 6 mg (12 tablets) should be taken as a course of treatment.

After completion of a course, another course should not be started for at least 3 days (72 hours).

Prophylaxis of gout attack during initiation of therapy with allopurinol and uricosuric drugs:

500 micrograms twice daily.

The treatment duration should be decided after factors such as flare frequency, gout duration and the presence and size of tophi have been assessed.

Patients with renal impairment:

Use with caution in patients with mild renal impairment.).

Patients with hepatic impairment

Use with caution in patients with mild/moderate hepatic impairment. Such patients should be carefully monitored for adverse effects of Kolsine.

Elderly:

Use with caution.

Method of Administration

For oral administration

Tablets should be swallowed whole with a glass of water

Posology

Adults

Treatment of acute gout attack:

1 mg (2 tablets) to start followed by 500 micrograms (1 tablet) after 1 hour.

No further tablets should be taken for 12 hours.

After 12 hours, treatment can resume if necessary with a maximum dose of 500 micrograms (1 tablet) every 8 hours until symptoms are relieved.

The course of treatment should end when symptoms are relieved or when a total of 6 mg (12 tablets) has been taken.

No more than 6 mg (12 tablets) should be taken as a course of treatment.

After completion of a course, another course should not be started for at least 3 days (72 hours).

Prophylaxis of gout attack during initiation of therapy with allopurinol and uricosuric drugs:

500 micrograms twice daily.

The treatment duration should be decided after factors such as flare frequency, gout duration and the presence and size of tophi have been assessed.

Patients with renal impairment:

Use with caution in patients with mild renal impairment.).

Patients with hepatic impairment

Use with caution in patients with mild/moderate hepatic impairment. Such patients should be carefully monitored for adverse effects of Kolsin.

Elderly:

Use with caution.

Method of Administration

For oral administration

Tablets should be swallowed whole with a glass of water

Contraindications

The information provided in Contraindications of Kolsin is based on data of another medicine with exactly the same composition as the Kolsin of the medicine (Colchicine). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Kolsin directly from the package or from the pharmacist at the pharmacy.
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-

- Patients with blood dyscrasias

- Pregnancy

- Breastfeeding

- Women of childbearing potential unless using effective contraceptive measures

- Patients with severe renal impairment

- Patients with severe hepatic impairment

- Kolsine should not be used in patients undergoing haemodialysis since it cannot be removed by dialysis or exchange transfusion.

- Kolsine is contraindicated in patients with renal or hepatic impairment who are taking a P-glycoprotein (P-gp) inhibitor or a strong CYP3A4 inhibitor

-

- Patients with blood dyscrasias

- Pregnancy

- Breastfeeding

- Women of childbearing potential unless using effective contraceptive measures

- Patients with severe renal impairment

- Patients with severe hepatic impairment

- Kolsin should not be used in patients undergoing haemodialysis since it cannot be removed by dialysis or exchange transfusion.

- Kolsin is contraindicated in patients with renal or hepatic impairment who are taking a P-glycoprotein (P-gp) inhibitor or a strong CYP3A4 inhibitor

Special warnings and precautions for use

The information provided in Special warnings and precautions for use of Kolsin is based on data of another medicine with exactly the same composition as the Kolsin of the medicine (Colchicine). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Kolsin directly from the package or from the pharmacist at the pharmacy.
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Kolsine is potentially toxic so it is important not to exceed the dose prescribed by a physician with the necessary knowledge and experience.

Kolsine has a narrow therapeutic window. The administration should be discontinued if toxic symptoms such as nausea, vomiting, abdominal pain, diarrhoea occur.

Kolsine may cause severe bone marrow depression (agranulocytosis, aplastic anaemia, thrombocytopenia). The change in blood counts may be gradual or very sudden. Aplastic anaemia in particular has a high mortality rate. Periodic checks of the blood picture are essential.

If patients develop signs or symptoms that could indicate a blood cell dyscrasia, such as fever, stomatitis, sore throat, prolonged bleeding, bruising or skin disorders, treatment with Kolsine should be immediately discontinued and a full haematological investigation should be conducted straight away.

Caution is advised in case of:

- liver or renal impairment

- cardiovascular disease

- gastrointestinal disorders

- elderly and debilitated patients

- patients with abnormalities in blood counts

Patients with liver or renal impairment should be carefully monitored for adverse effects of Kolsine.

Co-administration with P-gp inhibitors and/or moderate or strong CYP3A4 inhibitors will increase the exposure to Kolsine, which may lead to Kolsine induced toxicity including fatalities. If treatment with a P-gp inhibitor or a moderate or strong CYP3A4 inhibitor is required in patients with normal renal and hepatic function, a reduction in Kolsine dosage or interruption of Kolsine treatment is recommended.

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.

Kolsin is potentially toxic so it is important not to exceed the dose prescribed by a physician with the necessary knowledge and experience.

Kolsin has a narrow therapeutic window. The administration should be discontinued if toxic symptoms such as nausea, vomiting, abdominal pain, diarrhoea occur.

Kolsin may cause severe bone marrow depression (agranulocytosis, aplastic anaemia, thrombocytopenia). The change in blood counts may be gradual or very sudden. Aplastic anaemia in particular has a high mortality rate. Periodic checks of the blood picture are essential.

If patients develop signs or symptoms that could indicate a blood cell dyscrasia, such as fever, stomatitis, sore throat, prolonged bleeding, bruising or skin disorders, treatment with Kolsin should be immediately discontinued and a full haematological investigation should be conducted straight away.

Caution is advised in case of:

- liver or renal impairment

- cardiovascular disease

- gastrointestinal disorders

- elderly and debilitated patients

- patients with abnormalities in blood counts

Patients with liver or renal impairment should be carefully monitored for adverse effects of Kolsin.

Co-administration with P-gp inhibitors and/or moderate or strong CYP3A4 inhibitors will increase the exposure to Kolsin, which may lead to Kolsin induced toxicity including fatalities. If treatment with a P-gp inhibitor or a moderate or strong CYP3A4 inhibitor is required in patients with normal renal and hepatic function, a reduction in Kolsin dosage or interruption of Kolsin treatment is recommended.

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

The information provided in Effects on ability to drive and use machines of Kolsin is based on data of another medicine with exactly the same composition as the Kolsin of the medicine (Colchicine). Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug Kolsin directly from the package or from the pharmacist at the pharmacy.
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No details are available regarding the influence of Kolsine on the ability to drive and use machines. However, the possibility of drowsiness and dizziness should be taken into account.

No details are available regarding the influence of Kolsin on the ability to drive and use machines. However, the possibility of drowsiness and dizziness should be taken into account.

Undesirable effects

The information provided in Undesirable effects of Kolsin is based on data of another medicine with exactly the same composition as the Kolsin of the medicine (Colchicine). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Kolsin directly from the package or from the pharmacist at the pharmacy.
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The following adverse reactions have been observed.

The frequencies are listed under one of the following classifications:

Very common > 1/10

Common > 1/100 and < 1/10

Uncommon > 1/1000 and < 1/100

Rare > 1/10 000 and < 1/1000

Very rare < 1/10 000

Not known (cannot be estimated from the available data)

Blood and lymphatic system disorders

Not known: bone marrow depression with agranulocytosis, aplastic anaemia and thrombocytopenia.

Nervous system disorders

Not known: peripheral neuritis, neuropathy.

Gastrointestinal system disorders

Common: abdominal pain, nausea, vomiting and diarrhoea.

Not known: gastrointestinal haemorrhage.

Hepatobiliary disorders

Not known: hepatic damage.

Skin and subcutaneous tissue disorders

Not known: alopecia, rash.

Musculoskeletal and connective tissue disorders

Not known: myopathy and rhabdomyolysis.

Renal and urinary disorders

Not known: renal damage.

Reproductive system and breast disorders

Not known: amenorrhoea, dysmenorrhoea, oligospermia, azoospermia.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

Overdose

The information provided in Overdose of Kolsin is based on data of another medicine with exactly the same composition as the Kolsin of the medicine (Colchicine). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Kolsin directly from the package or from the pharmacist at the pharmacy.
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Kolsine has a narrow therapeutic window and is extremely toxic in overdose. Patients at particular risk of toxicity are those with renal or hepatic impairment, gastrointestinal or cardiac disease, and patients at extremes of age.

Following Kolsine overdose, all patients, even in the absence of early symptoms, should be referred for immediate medical assessment.

Clinical:

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.

Elimination of toxins by gastric lavage within one hour of acute poisoning.

Consider oral activated charcoal in adults who have ingested more than 0.1mg/kg bodyweight within 1 hour of presentation and in children who have ingested any amount within 1 hour of presentation.

Haemodialysis has no efficacy (high apparent distribution volume).

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.

The lethal dose varies widely (7-65 mg single dose) for adults but is generally about 20 mg.

Kolsin has a narrow therapeutic window and is extremely toxic in overdose. Patients at particular risk of toxicity are those with renal or hepatic impairment, gastrointestinal or cardiac disease, and patients at extremes of age.

Following Kolsin overdose, all patients, even in the absence of early symptoms, should be referred for immediate medical assessment.

Clinical:

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.

Elimination of toxins by gastric lavage within one hour of acute poisoning.

Consider oral activated charcoal in adults who have ingested more than 0.1mg/kg bodyweight within 1 hour of presentation and in children who have ingested any amount within 1 hour of presentation.

Haemodialysis has no efficacy (high apparent distribution volume).

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.

The lethal dose varies widely (7-65 mg single dose) for adults but is generally about 20 mg.

Pharmacodynamic properties

The information provided in Pharmacodynamic properties of Kolsin is based on data of another medicine with exactly the same composition as the Kolsin of the medicine (Colchicine). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug Kolsin directly from the package or from the pharmacist at the pharmacy.
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Pharmacotherapeutic group: drugs for gout, with no effect on uric acid metabolism. ATC code: M04AC01

In the AGREE (Acute Gout Flare Receiving Kolsine Evaluation) study low- and high-dose Kolsine were compared using a randomized, placebo controlled design. The high-dose prolonged Kolsine regimen (4.8 mg total over 6 hours) was compared with a placebo and a low-dose abbreviated regimen (1.8 mg total over 1 hour, i.e. 1.2 mg followed by 0.6 mg in 1 hour). Both Kolsine regimens were significantly more effective than placebo, with 32.7% responders in the high dose group, 37.8% responders in the low-dose group, and 15.5% responders in the placebo group (P = 0.034 and P = 0.005, respectively, versus placebo). The results at the primary 24hour end point demonstrate superior safety of low dose Kolsine, without loss of efficacy, relative to high dose Kolsine for early acute gout flare (self-administered within 12 hours of flare onset). The pharmacokinetic analysis performed in this study showed that the Kolsine plasma concentration was decreased substantially from about 12 hours after administration in healthy volunteers.

Kolsine prophylaxis (0.6 mg twice daily) during initiation of allopurinol for chronic gouty arthritis reduced the frequency and severity of acute flares, and reduced the likelihood of recurrent flares. Treatment may be continued for up to 6 months, based on clinical data. Prospective randomized controlled trials are needed to further evaluate flare prophylaxis for up to 6 months, after 6 months, and over time.

The mechanism of action of Kolsine in the treatment of gout is not clearly understood. Kolsine is considered to act against the inflammatory response to urate crystals, by possibly inhibiting the migration of granulocytes into the inflamed area. Other properties of Kolsine, such as interaction with the microtubules, could also contribute to the operation. Onset of action is approximately 12 hours after oral administration and is maximal after 1 to 2 days.

Pharmacotherapeutic group: drugs for gout, with no effect on uric acid metabolism. ATC code: M04AC01

In the AGREE (Acute Gout Flare Receiving Kolsin Evaluation) study low- and high-dose Kolsin were compared using a randomized, placebo controlled design. The high-dose prolonged Kolsin regimen (4.8 mg total over 6 hours) was compared with a placebo and a low-dose abbreviated regimen (1.8 mg total over 1 hour, i.e. 1.2 mg followed by 0.6 mg in 1 hour). Both Kolsin regimens were significantly more effective than placebo, with 32.7% responders in the high dose group, 37.8% responders in the low-dose group, and 15.5% responders in the placebo group (P = 0.034 and P = 0.005, respectively, versus placebo). The results at the primary 24hour end point demonstrate superior safety of low dose Kolsin, without loss of efficacy, relative to high dose Kolsin for early acute gout flare (self-administered within 12 hours of flare onset). The pharmacokinetic analysis performed in this study showed that the Kolsin plasma concentration was decreased substantially from about 12 hours after administration in healthy volunteers.

Kolsin prophylaxis (0.6 mg twice daily) during initiation of allopurinol for chronic gouty arthritis reduced the frequency and severity of acute flares, and reduced the likelihood of recurrent flares. Treatment may be continued for up to 6 months, based on clinical data. Prospective randomized controlled trials are needed to further evaluate flare prophylaxis for up to 6 months, after 6 months, and over time.

The mechanism of action of Kolsin in the treatment of gout is not clearly understood. Kolsin is considered to act against the inflammatory response to urate crystals, by possibly inhibiting the migration of granulocytes into the inflamed area. Other properties of Kolsin, such as interaction with the microtubules, could also contribute to the operation. Onset of action is approximately 12 hours after oral administration and is maximal after 1 to 2 days.

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of Kolsin is based on data of another medicine with exactly the same composition as the Kolsin of the medicine (Colchicine). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Kolsin directly from the package or from the pharmacist at the pharmacy.
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Kolsine is rapidly and almost completely absorbed after oral administration. Maximum plasma concentrations are met usually after 30 to 120 minutes. The terminal half-life is 3 to 10 hours. Plasma protein binding is approximately 30%. Kolsine is partially metabolised in the liver and then in part via the bile. It accumulates in leucocytes. Kolsine is largely excreted (80%) in unchanged form and as metabolites in the faeces. 10-20% is excreted in the urine.

Renal impairment

Kolsine is significantly excreted in urine in healthy subjects. Clearance of Kolsine is decreased in patients with impaired renal function. Total body clearance of Kolsine was reduced by 75% in patients with end-stage renal disease undergoing dialysis.

The influence of renal impairment on the pharmacokinetics of Kolsine was assessed in a study in patients with familial Mediterranean fever (FMF), 5 women and 4 men, with (n=4) and without (n=5) renal impairment. The mean age was 30 years (range 19-42 years). All 5 patients with renal impairment had biopsy-proven amyloidosis; 4 were on routine haemodialysis and 1 had a serum creatinine CL of 15 ml/min. They could therefore be classified as having severe renal impairment. Subjects received 1 mg Kolsine except for 1 subject with cirrhosis who received 500 micrograms. A 4-fold decrease in Kolsine CL was observed in subjects with renal impairment compared to those with normal renal function (0.168 ± 0.063 l/h/kg vs. 0.727 ± 0.110 l/h/kg). The terminal half-life was 18.8 ± 1.2 h for subjects with severe renal impairment and 4.4 ± 1.0 h for those with normal renal function. The volume of distribution was similar between groups. The patient with cirrhosis had a 10-fold lower CL compared to the subjects with normal renal function.

Paediatric population

No pharmacokinetics data are available in children.

Kolsin is rapidly and almost completely absorbed after oral administration. Maximum plasma concentrations are met usually after 30 to 120 minutes. The terminal half-life is 3 to 10 hours. Plasma protein binding is approximately 30%. Kolsin is partially metabolised in the liver and then in part via the bile. It accumulates in leucocytes. Kolsin is largely excreted (80%) in unchanged form and as metabolites in the faeces. 10-20% is excreted in the urine.

Renal impairment

Kolsin is significantly excreted in urine in healthy subjects. Clearance of Kolsin is decreased in patients with impaired renal function. Total body clearance of Kolsin was reduced by 75% in patients with end-stage renal disease undergoing dialysis.

The influence of renal impairment on the pharmacokinetics of Kolsin was assessed in a study in patients with familial Mediterranean fever (FMF), 5 women and 4 men, with (n=4) and without (n=5) renal impairment. The mean age was 30 years (range 19-42 years). All 5 patients with renal impairment had biopsy-proven amyloidosis; 4 were on routine haemodialysis and 1 had a serum creatinine CL of 15 ml/min. They could therefore be classified as having severe renal impairment. Subjects received 1 mg Kolsin except for 1 subject with cirrhosis who received 500 micrograms. A 4-fold decrease in Kolsin CL was observed in subjects with renal impairment compared to those with normal renal function (0.168 ± 0.063 l/h/kg vs. 0.727 ± 0.110 l/h/kg). The terminal half-life was 18.8 ± 1.2 h for subjects with severe renal impairment and 4.4 ± 1.0 h for those with normal renal function. The volume of distribution was similar between groups. The patient with cirrhosis had a 10-fold lower CL compared to the subjects with normal renal function.

Paediatric population

No pharmacokinetics data are available in children.

Pharmacotherapeutic group

The information provided in Pharmacotherapeutic group of Kolsin is based on data of another medicine with exactly the same composition as the Kolsin of the medicine (Colchicine). Be careful and be sure to specify the information on the section Pharmacotherapeutic group in the instructions to the drug Kolsin directly from the package or from the pharmacist at the pharmacy.
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drugs for gout, with no effect on uric acid metabolism. ATC code: M04AC01

Preclinical safety data

The information provided in Preclinical safety data of Kolsin is based on data of another medicine with exactly the same composition as the Kolsin of the medicine (Colchicine). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Kolsin directly from the package or from the pharmacist at the pharmacy.
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Genotoxicity

In one study, a bacterial test indicated that Kolsine has a slight mutagenic effect.

However, two other bacterial tests and a test in Drosophila melanogaster found that Kolsine was not mutagenic.

Tests have shown that Kolsine induces chromosomal aberrations and micronuclei, and causes some DNA damage.

Teratogenicity

Tests in animals have shown that Kolsine is teratogenic.

Genotoxicity

In one study, a bacterial test indicated that Kolsin has a slight mutagenic effect.

However, two other bacterial tests and a test in Drosophila melanogaster found that Kolsin was not mutagenic.

Tests have shown that Kolsin induces chromosomal aberrations and micronuclei, and causes some DNA damage.

Teratogenicity

Tests in animals have shown that Kolsin is teratogenic.

Incompatibilities

The information provided in Incompatibilities of Kolsin is based on data of another medicine with exactly the same composition as the Kolsin of the medicine (Colchicine). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Kolsin directly from the package or from the pharmacist at the pharmacy.
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None known.

Special precautions for disposal and other handling

The information provided in Special precautions for disposal and other handling of Kolsin is based on data of another medicine with exactly the same composition as the Kolsin of the medicine (Colchicine). Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Kolsin directly from the package or from the pharmacist at the pharmacy.
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None

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