Notice: Prescription Drug List (PDL): Hyoscine butylbromide

October 16, 2015
Our file number: 15-111222-135

The purpose of this Notice of Consultation is to provide an opportunity to comment on the proposal to switch injectable Hyoscine butylbromide to prescription status from ethical status for human use by adding it to the Human Prescription Drug List (PDL). Injectable Hyoscine butylbromide is already listed on the Veterinary Prescription Drug List.

The proposed wording of the new listing on the Human List is:

Drugs containing the following: Hyoscine butylbromide

Qualifier:

when recommended for parenteral use

Effective Date:

to be determined

Rationale

Hyoscine butylbromide is an antispasmodic agent that may be administered orally or parenterally (via injection) that relaxes the smooth muscle of the gastrointestinal, biliary and urinary tracts.

Four products containing Hyoscine butylbromide have been marketed in Canada for many years. Three products are for human use: 2 products are for injection, marketed by Boehringer Ingelheim Canada Ltd (DIN 00363839) and Sandoz Canada (DIN 02229868), one is for oral use, marketed by Boehringer Ingelheim Canada Ltd (DIN 00363812). The remaining product is a parenteral prescription drug for use in horses, also sold by Boehringer Ingelheim Canada Ltd (DIN 02282089).

Health Canada has conducted a scientific assessment of this switch against a set of established and publicly available criteria outlined in section C.01.040.3 of the Food and Drug Regulations. Practitioner supervision is required for parenteral use of Hyoscine butylbromide as there is the potential of side effects due to the anticholinergic properties of the drug as well as a narrow margin of safety between the therapeutic and toxic doses in high risk groups such as the elderly, children, pregnant and nursing women. The injectable forms meet the considerations of prescription status as do most ethical status drugs. Prescription status would also be consistent with the veterinary use of Hyoscine butylbromide.

Additional information on how Health Canada determines prescription status (or non-prescription status) is available in the Guidance Document: Determining Prescription Status for Human and Veterinary Drugs.

Comments on this proposed change to the Prescription Drug List should be provided to Health Canada in writing, preferably in electronic format, within 75 days from the date of this notice.

Please send your comments to:

• Health Canada
  Prescription Drug Status Committee
  Address Locator 3102C3
  Holland Cross, Tower B
  1600 Scott Street
  Ottawa, Ontario
  K1A 0K9
• Telephone: 613-957-1058
  Facsimile: 613-941-5035
  E-mail: drug_prescription_status-statut_d'ordonnance_des_drogues@hc-sc.gc.ca

If all comments not in favour of this switch can be addressed, a Notice of Intent to Amend will be posted on the Health Canada website. This Notice will address these comments and inform stakeholders of Health Canada's intention to revise the PDL. The actual revision to the PDL would be made six months from the date of the Notice of Intent to Amend and communicated to stakeholders through a Notice of Amendment.