BROMPHENIRAMINE AND ITS SALTS AS A SINGLE ENTITY FOR THE TREATMENT OF ALLERGIES

Recommended by NDSAC:             Schedule III – January 18, 2003

Recommended by CDAC:            Schedule III – September, 1998

AVAILABILITY

·          At this time, there is no single entity brompheniramine product that is marketed for the management of allergic symptoms.

USES/ADMINISTRATION

·          For the symptomatic relief of allergic symptoms.

PHARMACOLOGICAL CONSIDERATIONS

CONTRAINDICATIONS

·          Hypersensitivity reactions to brompheniramine maleate

·          Uncontrolled hypertension

·          Concurrent use of a monoamine oxidase inhibitor (phenelzine sulfate, tranylcypromine sulfate)

PRECAUTIONS/COMMENTS

·          May cause drowsiness.  Avoid alcoholic beverages while taking brompheniramine.  Use caution when operating a motorized vehicle.

·          Do not take with other antihistamines, tranquilizers or any other sedating drugs without first consulting a physician.

·          May cause excitability in children.

·          Use of brompheniramine in patients with glaucoma, chronic lung disease, benign prostatic hyperplasia, pregnant or breast feeding women, should only be under the advice of a physician after evaluating the risk benefit ratio.

ADVERSE EFFECTS

·          Generally well tolerated.  As with other first generation antihistamines brompheniramine can cause drowsiness, insomnia, nervousness, and irritability.

·          Brompheniramine can cause excitability in children.  Rare case of urinary retention in children have been reported.

APPLICABLE SCHEDULING FACTORS

FACTORS

SCH III # 1 The initial need for the drug can be identified by the patient, physician, or pharmacist, but chronic, recurrent or subsequent therapy can be monitored by the pharmacist.

SCH III # 2 The maximum recommended duration of use of the drug is limited and specified on the product label. Factor # 2 is a positive factor and does not apply against brompheniramine for keeping it in Schedule III. 

SCH III # 4 The drug is used to treat a persistent, chronic or recurring condition and the availability of the pharmacist to provide advice can promote appropriate use.

SCH III #5 The drug is used for self-treatment of self-limiting ailments; however, where product selection has been identified as likely to cause patient confusion and to result in adverse outcomes, the availability of the pharmacist to provide advice can promote appropriate use.

SCH III #6 The drug demonstrates adverse effects, including allergies, or interacts with other drugs, foods, or disease states that can be identified in product labeling, but appropriate product selection and explanation of risk may require the advice of the pharmacist.

NDSAC reviewed the submission prepared by Whitehall-Robins Inc. and listened to a presentation by the company.  The submission and presentation focused on the postmarketing safety data of brompheniramine.  Brompheniramine has been available in Canada since the 1950’s.  Whitehall-Robins has not received any unexpected serious side effect reports concerning brompheniramine.  Canadian safety data reports on Whitehall-Robins products from 1997 to 2002 failed to produce any reported adverse reactions with brompheniramine.  NDSAC was asked to schedule brompheniramine as it pertained to the existing products in Canada (i.e., in combination products for the treatment of cough and cold symptoms).  As such, the information contained in the submission and presentation focused on data of the combination product.  Although no brompheniramine single entity product exists for the treatment of allergies, the committee decided to apply the scheduling factors in the anticipation that a company might elect to market such a product.  After the presentation and an extensive question and answer session, NDSAC reviewed the scheduling factors for Schedules I and II.  None of the factors from Schedules I and II were felt to be applicable, hence, the committee proceeded to review the scheduling factors for Schedule III and identified factors # 1, 2, 4, 5, and 6 as applicable.  The committee voted in favour of a motion that brompheniramine and its salts as a single entity for the treatment of allergies be kept in Schedule III.

BIBLIOGRAPHY:

1.       McEvoy GK (Ed). 2002 American Hospital Formulary Service - Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 10-12.

2.       Anon. First report of the expert advisory committee on nonprescription cough and cold remedies to the Health Protection Branch, Health and Welfare Canada.  Ottawa, August 1988.

3.       Anon. Antihistamines. Drugdex Drug Evaluations. Micromedex, Denver, Colorado. Expires Dec 31, 2002.