Ephedrine/Pseudoephedrine

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Labelling Standard

I) Description:

Single ingredient non-modified release formulations containing ephedrine or pseudoephedrine in solid or liquid form and intended to be taken orally for use as a nasal decongestant.

For single ingredient Ephedra (MaHuang) products, please consult the Ephedra Labelling Standard.

Combination products are not included in this standard.

II) Pharmaceutical Quality:

1. All ingredient (medicinal and nonmedicinal) and finished product specifications should as a minimum meet the standards described in the publications referred to in Schedule B to the Food and Drugs Act, or equivalent standards. Where no Schedule B monograph exists for the dosage form, specifications should be similar to those of a comparable compendial dosage form. In the absence of a Schedule B standard for any dosage form, testing must be adequate to demonstrate the product's identity, potency, purity and quality.
   
   
2. Special Notes:

   Finished product specifications should include tests for identification and an assay with suitable limits for the medicinal ingredient(s). The specifications for all dosage forms should include a description of the dosage form including organoleptic properties as well as physico-chemical testing e.g., pH, specific gravity, viscosity, appropriate to the dosage form. Where antimicrobial preservatives are added, an assay with suitable limits should be included. Antimicrobial preservative effectiveness should be determined in order to establish that the product is capable of resisting microbial contamination.

III) Ingredients:

1. Single Medicinal ingredients:

   • Ephedrine

     (sources l-ephedrine hydrochloride, dl-ephedrine hydrochloride, l-ephedrine sulphate, dl-ephedrine sulphate)

   • Pseudoephedrine

     (D-pseudoephedrine hydrochloride, D-pseudoephedrine sulfate)

2. Nonmedicinal Ingredients:

   Nonmedicinal ingredients must be restricted to those substances, necessary for the formulation of the dosage form. Their concentration must not exceed the minimum required to provide their intended effect. They must be harmless in the amounts used, their presence must not affect the therapeutic efficacy or safety of the medicinal ingredients and they must not interfere with assays and tests for the medicinal ingredients and, if present, antimicrobial preservatives.

IV) Labelling:

1. This labelling standard describes those requirements that are specific to this class of drugs. Other requirements described in the Regulations to the Food and Drugs Actand in the Guide for the Labelling of Drugs for Human Use must also be met.
   
   
2. Directions for Use:
   
   
   1. Indications

      relief of nasal congestion (cold, hayfever)

      Unacceptable Indications

      stimulant

      weight loss (diet aid)

   2. Dosage
      
      

      Ingredient	Adult & 12yr		6-12 yr		2-6 yr
      	Single Frequ.	Daily	Single Frequ.	Daily	Single Frequ.	Daily
      Ephedrine HCl Ephedrine Sulphate	8mg q 6-8h	32mg	--		--
      Pseudoephedrine HCl and Sulphate	60mg q 4-6h	240mg	30mg q4-6h	120mg	15mg q 4-6h	60mg

      Note: Products exceeding the recommended dosage will be reviewed outside the labelling standard. In addition, higher dose ephedrine products may be subject to sections C.01.025* and C.01.027* of the Food and Drug Regulations.

      *Where the amount of ephedrine in a single dose exceeds 11 mg or where the daily dose exceeds 32.5 mg, a warning must be added to the inner and outer labels that the product should be used only on the advice of a physician (C.01.025) and advertising for these products shall be limited to brand name, proper name, common name, price and quantity of the drug (C.01.027).

3. Warnings
   
   
   1. Do not exceed recommended dosage or take for more than 7 days except on the advice of a physician.
   2. Consult a physician prior to use if you have heart or thyroid disease, high blood pressure, diabetes, glaucoma, difficulty in urination due to an enlargement of the prostate gland or if you are taking any prescription drugs.
   3. Do not take if you are currently taking or have recently taken Monoamine Oxidase (MAO) inhibitor drugs.

Bureau of Pharmaceutical Assessment
19 July 1996

V) References

1. First Report of the Expert Advisory Committee on Nonprescription Cough and Cold Remedies to the Health Protection Branch, Health and Welfare Canada, August 1988.
2. United States Department of Health and Human Services, Food and Drug Administration, Federal Register, Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Amendment of Final Monograph for OTC Bronchodilator Drug Products, Vol. 58, No. 201, 1993, pp. 54238-54242.
3. Canadian Food and Drugs Act and Regulations.