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Carbinoxamine maleate molecule was developed as a state-of-the-art antihistamine at a time when histamine activity was only first being understood. Patients with allergic rhinitis often faced a difficult choice between symptoms that interfered with routine activities or medications that provided relief; but rendered heavy sedation as well. Carbinoxamine maleate was one of the very first products to offer relief with no serious side effects. The primary side effect is a sedation rate of 15-20%.
Launch Study by Dr. H.D. Beale, et al
The initial study was conducted in 1954 by three allergy specialists in Toledo, OH. The clinical study included two strengths of carbinoxamine maleate: 4mg and 6mg. 126 patients (90% suffered from allergic rhinitis) were treated with each of the three options: 4mg, 6mg and placebo.
Researchers made several key observations:
- action began in about 30 minutes
- 4mg dose was more effective (87% of patients noted relief) than the 6mg tablet (80% of patients noted relief).
- 1% (1 patient) reported severe sedation /drowsiness
- 3% (4 patients) reported moderate sedation / drowsiness
- 11% (14 patients) reported mild sedation / drowsiness
- 85% of the patients reported no sedation or drowsiness
- in those patients reporting drowsiness, the condition disappeared after a few days continued use.
- There was no significant report (less than 1%) of any other side effects: nausea, dizziness, insomnia, or headache.
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The study was published in the Journal of Allergy 25:521-524, November, 1954.
Clistin® Product Line
McNeil introduced carbinoxamine maleate under this brand name in 1954. The product was very successfully used for more than thirty years in the following forms:
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- Clistin® Tablets were available as 4mg (scored, round, pink tablet)
- Clistin® Elixir was a dark red syrup containing 5cc per teaspoonful. (7% alcohol).
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PALGIC® Product Line
Pan American Laboratories, (Pamlab, L.L.C.), launched the carbinoxamine maleate as a single-ingredient antihistamine product in 2003. PALGIC® product line includes both liquid (4mg per 5mL) and tablets (4mg). These products are dosed PRN as most patients require only one dose per day to maintain allergy relief.
PALGIC® 4mg
NDC 0525-6748-01 |
PALGIC® 4mg/5mL
NDC 0525-6752-04 |
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McNeil Laboratories, Inc.® and Clistin® are registered trademarks of
McNeil Laboratories, Inc., Fort Washington, PA 19034.
PALGIC® is a registered trademark of Pamlab LLC, Covington, LA, 70433
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