Accelera Pharma Canada Inc. (APCI), in partnership with Halewood Chemicals Ltd., is pleased to announce HALYCIL TM (propylthiouracil 50mg Tablets) 56 tablets in Blister Pack format approved by Health Canada is now available.
HALYCIL TM is indicated for Adults (≥18 years of age):
- For the medical management of hyperthyroidism.
- In conjunction with radioiodine to hasten recovery while awaiting the effects of radiation.
- For the control of thyrotoxicosis prior to surgery.
- In the management of a thyroid storm in addition to other therapeutic measures.
The DIN number is: 02521059
The recommended dose and dose adjustment is as follows:
Adults (≥18 years of age): The recommended initial dose is 50-100 mg (1 to 2 tablets of HALYCIL) every 8 hours, with increases as necessary up to a maximum of 500 mg/day.
In some cases, initial doses as high as 900 mg/day may be required.
When doses larger than 300 mg/day of HALYCIL are needed, the drug should be administered every 4 to 6 hours.The patient should be examined regularly by the physician and the dose of HALYCIL adjusted until the patient is euthyroid (usually after 6-8 weeks). At this stage, the dose should be reduced by 1/3 every 4-6 weeks to a maintenance dosage of one tablet of HALYCIL 2 or 3 times daily, administered at regular intervals.
Geriatric (65 years of age): Evidence from clinical studies and experience suggests that use in the geriatric population is associated with no differences in safety or effectiveness. Dose selection for an elderly patient should be cautious reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Pediatric (18 years of age): Health Canada has not authorized an indication for pediatric use.
Hepatic impairment: No clinical studies have been performed with HALYCIL in patients with hepatic insufficiency. Since liver toxicity is associated with the use of propylthiouracil, caution is warranted in these patients. The dose should be kept as low as possible.
Renal impairment: No clinical studies have been performed with HALYCIL in patients with renal impairment. The following schedule is recommended by W.M. Bennett et al[1]:
| Glomerular Filtration Rate (creatinine clearance) | 10-50 mL/min | 10 mL/min |
| Reduce dose by | 50% of the usual maintenance dose | 25% of the usual maintenance dose |
HALYCIL™ is available in Blister Packs of 50mg tablets containing 56 tablets per pack.
Bennett WM et al. Guidelines for drug therapy in renal failure. Ann Intern Med 1977; 86:754-83.
* HALYCIL™ (propylthiouracil 50mg Tablets) 56 tablets in Blister Pack format, will replace the UK product, Propylthiouracil (PTU) 50 mg Tablets manufactured by Halewood Chemicals (previously available under an interim order) and no longer available. Prescriptions for HALYCIL™ (propylthiouracil 50mg Tablets), should be written as “ HALYCIL™ (propylthiouracil 50mg Tablets)”, to ensure patients receive the prescribed branded product.
For further information about the product, including the product monograph please refer to the link below:
Accelera Pharma Canada Inc. (APCI), in partnership with Halewood Chemicals Ltd., is pleased to announce HALYCIL TM (propylthiouracil 50mg Tablets) 56 tablets in Blister Pack format approved by Health Canada is now available.
HALYCIL TM is indicated for Adults (≥18 years of age):
- For the medical management of hyperthyroidism.
- In conjunction with radioiodine to hasten recovery while awaiting the effects of radiation.
- For the control of thyrotoxicosis prior to surgery.
- In the management of a thyroid storm in addition to other therapeutic measures.
The DIN number is: 02521059
The recommended dose and dose adjustment is as follows:
Adults (≥18 years of age): The recommended initial dose is 50-100 mg (1 to 2 tablets of HALYCIL) every 8 hours, with increases as necessary up to a maximum of 500 mg/day.
In some cases, initial doses as high as 900 mg/day may be required.
When doses larger than 300 mg/day of HALYCIL are needed, the drug should be administered every 4 to 6 hours.The patient should be examined regularly by the physician and the dose of HALYCIL adjusted until the patient is euthyroid (usually after 6-8 weeks). At this stage, the dose should be reduced by 1/3 every 4-6 weeks to a maintenance dosage of one tablet of HALYCIL 2 or 3 times daily, administered at regular intervals.
Geriatric (65 years of age): Evidence from clinical studies and experience suggests that use in the geriatric population is associated with no differences in safety or effectiveness. Dose selection for an elderly patient should be cautious reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Pediatric (18 years of age): Health Canada has not authorized an indication for pediatric use.
Hepatic impairment: No clinical studies have been performed with HALYCIL in patients with hepatic insufficiency. Since liver toxicity is associated with the use of propylthiouracil, caution is warranted in these patients. The dose should be kept as low as possible.
Renal impairment: No clinical studies have been performed with HALYCIL in patients with renal impairment. The following schedule is recommended by W.M. Bennett et al[1]:
Glomerular Filtration Rate (creatinine clearance)
| 10-50 mL/min | Reduce dose by 50% of the usual maintenance dose |
| 10 mL/min | Reduce dose by 25% of the usual maintenance dose |
HALYCIL™ is available in Blister Packs of 50mg tablets containing 56 tablets per pack.
| Product Description | HALYCIL 50MG BP 56 TAB (PROPYLTHIOURACIL) |
| Product Strength | 50 mg |
| DIN | 2521059 |
| APCI Product code | ARX-30463 |
| UPC | 5060306430463 |
- Bennett WM et al. Guidelines for drug therapy in renal failure. Ann Intern Med 1977; 86:754-83.
* HALYCIL™ (propylthiouracil 50mg Tablets) 56 tablets in Blister Pack format, will replace the UK product, Propylthiouracil (PTU) 50 mg Tablets manufactured by Halewood Chemicals (previously available under an interim order) and no longer available. Prescriptions for HALYCIL™ (propylthiouracil 50mg Tablets), should be written as “ HALYCIL™ (propylthiouracil 50mg Tablets)”, to ensure patients receive the prescribed branded product.
For further information about the product, including the product monograph please refer to the link below:
| Product Description | Product Strength | DIN | APCI Product code | UPC |
| HALYCIL 50 MG BP 56 TAB (PROPYLTHIOURACIL) | 50MG | 2521059 | ARX-30463 | 5060306430463 |
Please contact the Accelera Pharma Canada Inc. (“APCI”) Customer Service Team to place your order at:
Toll Free: 1-855-611-2724 Ext 2202
e-FAX: 647-660-0279 H
Email: orders@apcipharma.com
For adverse events or product complaints, please call 1-855-611-2724