Histamine Phosphate

Dosage form: injection
Drug class:Miscellaneous uncategorized agents

Medically reviewed by Drugs.com. Last updated on Apr 21, 2022.

Directions for Use of

Positive Skin Test Control- Histamine

HISTATROL®

Histamine Base 1 mg/mL

(Histamine Phosphate 2.75 mg/mL)

in Glycerin 50% (v/v)

For Percutaneous Testing

Histamine Base 0.1 mg/mL

(Histamine Phosphate 0.275 mg/mL)

For Intracutaneous (Intradermal) Testing

Port Washington, New York 11050

U.S. Government License No. 1256

Histamine Phosphate Description

The chemical formula for Histamine Phosphate is C5H9N3 · 2H3 PO4; its molecular weight is 307.14. For prick, puncture or scratch testing, the product is a sterile solution that contains 1 mg/mL histamine base (2.75 mg/mL Histamine Phosphate) in Water for Injection; it also contains Glycerin 50% (v/v) as viscosity agent and Phenol 0.4% as preservative. For intracutaneous (intradermal) skin testing, the product is a sterile solution that contains 0.1 mg/mL histamine base (0.275 mg/mL Histamine Phosphate) in Water for Injection and Phenol 0.4% as preservative. The product should be stored refrigerated and protected from light.

Histamine Phosphate - Clinical Pharmacology

Histamine acts as a potent vasodilator when released from mast cells during an allergic reaction. It is largely responsible for the immediate skin test reaction of a sensitive patient when challenged with an offending allergen.

The effect of added Glycerin (50% v/v) to 1 mg/mL histamine base was studied by puncture testing using a bifurcated needle in twelve volunteer subjects. The mean sum of cross-diameters of the wheals was 13.25 mm (range 10-15 mm) for the non-glycerinated, and 12.54 mm (range 9-15 mm) for the glycerinated formulation. Sum of cross-diameters of erythema was 52.88 mm (range 23-92 mm) for the non-glycerinated, and 54.42 mm (range 19-87 mm) for the glycerinated formulation. These differences are not statistically significant.

Indications and Usage for Histamine Phosphate

For use as a positive control in evaluation of allergenic (...