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PMS-COLCHICINE ER is a brand name for Colchicine, supplied as a tablet (extended-release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: pms-COLCHICINE ER (colchicine extended-release tablets) is indicated for the reduction of atherothrombotic events in adult patients with existing coronary artery disease, in addition to standard therapies, including LDL-C lowering and antithrombotic drug treatment. 1.1 Pediatrics Pediatrics (<18 years): No data are…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Review of concomitant medications and assessment of renal and hepatic function should be performed prior to initiating pms-COLCHICINE ER (see 7 WARNINGS AND PRECAUTIONS, and 9 DRUG INTERACTIONS). 5 mg tablet once daily.
5 mg daily. pms-COLCHICINE ER (colchicine extended-release tablets) Page 5 of 27 Geriatrics (≥ 65 years): Use with caution in geriatric patients, because of the increased incidence of decreased renal function in this population, and the higher incidence of other co-morbid conditions requiring use of other medications.
Pediatrics (< 18 years):
Health Canada has not authorized an indication for pediatric use. 3 ACTION AND CLINICAL PHARMACOLOGY, Pharmacokinetics, Renal Insufficiency). Patients with any degree of renal impairment should not be given pms-COLCHICINE ER in conjunction with strong P-gp inhibitors or strong CYP3A4 inhibitors (see 2 CONTRAINDICATIONS).
pms-COLCHICINE ER itself is contraindicated in patients with severe renal impairment (see 2 CONTRAINDICATIONS). 3 ACTION AND CLINICAL PHARMACOLOGY, Pharmacokinetics, Hepatic Insufficiency). Patients with any degree of hepatic impairment should not be given pms-COLCHICINE ER in conjunction with strong P-gp inhibitors or strong CYP3A4 inhibitors (see 2 CONTRAINDICATIONS).
pms-COLCHICINE ER itself is contraindicated in patients with severe hepatic impairment (see 2 CONTRAINDICATIONS). 4 Administration pms-COLCHICINE ER may be administered with or without food. Avoid taking grapefruit juice, a moderate CYP3A4 inhibitor, with pms-COLCHICINE ER (see 9 DRUG INTERACTIONS, Drug-Food Interactions).
5 Missed Dose If a dose is missed, patients should take their next dose as soon as possible. However, taking two doses of pms-COLCHICINE ER at the same time should not be undertaken to make up for missed doses.
). , inflammatory bowel diseases, chronic diarrhea, etc. should not be treated with pms-COLCHICINE ER.
Hematologic Blood dyscrasias:
Myelosuppression, leucopenia, granulocytopenia, thrombocytopenia, pancytopenia and aplastic anemia have been reported with colchicine use. Periodic blood tests are recommended since prolonged administration of colchicine may cause blood dyscrasias.
Use of pms-COLCHICINE ER in patients with pre-existing blood dyscrasias is contraindicated (see 2 CONTRAINDICATIONS). Hepatic/Biliary/Pancreatic Colchicine is known to be metabolized by the liver and the presence of severe hepatic impairment has been associated with colchicine toxicity.
Hepatic clearance of colchicine may be significantly reduced, and plasma half-life prolonged in patients with chronic hepatic impairment. Use of pms-COLCHICINE ER is contraindicated in patients with severe hepatic impairment (see 2 CONTRAINDICATIONS).
pms-COLCHICINE ER should not be prescribed in conjunction with strong P-gp inhibitors or strong CYP3A4 inhibitors, including to patients with hepatic impairment (see 2 CONTRAINDICATIONS, and
, Endocrine and Metabolism, and 9 DRUG INTERACTIONS) in severe renal impairment (eGFR < 30 mL/min) in severe hepatic impairment in patients with existing blood dyscrasias, and in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 1 Dosing Considerations Review of concomitant medications and assessment of renal and hepatic function should be performed prior to initiating pms-COLCHICINE ER (see 7 WARNINGS AND PRECAUTIONS, and 9 DRUG INTERACTIONS).
5 mg tablet once daily. 5 mg daily. pms-COLCHICINE ER (colchicine extended-release tablets) Page 5 of 27 Geriatrics (≥ 65 years): Use with caution in geriatric patients, because of the increased incidence of decreased renal function in this population, and the higher incidence of other co-morbid conditions requiring use of other medications.
Pediatrics (< 18 years):
Health Canada has not authorized an indication for pediatric use. 3 ACTION AND CLINICAL PHARMACOLOGY, Pharmacokinetics, Renal Insufficiency). Patients with any degree of renal impairment should not be given pms-COLCHICINE ER in conjunction with strong P-gp inhibitors or strong CYP3A4 inhibitors (see 2 CONTRAINDICATIONS).
pms-COLCHICINE ER itself is contraindicated in patients with severe renal impairment (see 2 CONTRAINDICATIONS). 3 ACTION AND CLINICAL PHARMACOLOGY, Pharmacokinetics, Hepatic Insufficiency). Patients with any degree of hepatic impairment should not be given pms-COLCHICINE ER in conjunction with strong P-gp inhibitors or strong CYP3A4 inhibitors (see 2 CONTRAINDICATIONS).
pms-COLCHICINE ER itself is contraindicated in patients with severe hepatic impairment (see 2 CONTRAINDICATIONS). 4 Administration pms-COLCHICINE ER may be administered with or without food. Avoid taking grapefruit juice, a moderate CYP3A4 inhibitor, with pms-COLCHICINE ER (see 9 DRUG INTERACTIONS, Drug-Food Interactions).
pms-COLCHICINE ER is contraindicated with strong P-glycoprotein (P-gp) inhibitors or strong CYP3A4 inhibitors (see 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism, and 9 DRUG INTERACTIONS) in severe renal impairment (eGFR < 30 mL/min) in severe hepatic impairment in patients with existing blood dyscrasias, and in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Colchicine in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
5 Missed Dose If a dose is missed, patients should take their next dose as soon as possible. However, taking two doses of pms-COLCHICINE ER at the same time should not be undertaken to make up for missed doses. 5 OVERDOSAGE Colchicine has a narrow therapeutic window and is highly toxic in overdose.
Fatal overdoses, whether accidental and intentional, have been reported in adults and children who have ingested colchicine. pms-COLCHICINE ER should be kept out of the reach of children. There is usually a latent period of 2 to 12 hours between overdosage and the onset of symptoms, regardless of the route of administration.
Deaths have been reported with as little as 7 mg, although higher doses have been taken without fatal results. The exact dose of colchicine that produces significant toxicity is unknown. Following colchicine overdose, all patients, even in the absence of early symptoms, should be referred for immediate medical assessment.
Symptoms:
The first stage of acute colchicine toxicity typically begins within 24 hours of ingestion and includes gastrointestinal symptoms such as abdominal pain, nausea, vomiting, diarrhea and significant fluid loss, leading to volume depletion.
Peripheral leukocytosis may also be seen. The second phase with life threatening complications develops 24 to 72 hours after drug administration: multisystem organ dysfunction, acute renal failure, confusion, coma, ascending pms-COLCHICINE ER (colchicine extended-release tablets) Page 6 of 27 peripheral motor and sensory neuropathy, myocardial depression, pancytopenia, dysrhythmias, respiratory failure, and 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 specific antidote exists. Discontinue therapy immediately. Elimination of toxins by gastric lavage within one hour of acute poisoning. 1 mg/kg bodyweight within 1 hour of presentation and in children who have ingested any amount within 1 hour of presentation.
Hemodialysis has no efficacy (high apparent distribution volume). Close clinical and biological monitoring in hospital environment is required.
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. For management of a suspected drug overdose, contact your regional poison control centre.
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging pms-COLCHICINE ER extended-release tablets are blue-green, with a translucent to white finish, round, biconvex coated tablets, debossed with ‘’P‘’ on one side and ‘’05‘’ on the other side.
pms-COLCHICINE ER is supplied in bottles of 100 tablets. 7 WARNINGS AND PRECAUTIONS Endocrine and Metabolism Co-administration of pms-COLCHICINE ER with strong P-gp inhibitors and/or strong CYP3A4 inhibitors will increase exposure to colchicine, which may lead to colchicine-induced toxicity including fatalities.
Such concomitant use is contraindicated (see 2 CONTRAINDICATIONS). pms-COLCHICINE ER should be […]