Treatment Set TS335061 (Page 3 of 4)


Systemic reactions may range from mild exaggeration of the patient’s allergic symptoms to anaphylactic reactions. Very sensitive patients may show a rapid response. In some instances a severe systemic reaction with blood pressure fall and/or shock may occur. Quantitation of patient’s sensitivity combined with careful early observation is essential for safe skin testing and treatment.

Other reactions include, but are not necessarily limited to urticaria, itching, edema of the extremities, respiratory wheezing or asthma, dyspnea, cyanosis, tachycardia, lacrimation, marked perspiration, flushing of the face, neck or upper chest, mild persistent clearing of the throat, hacking cough, or persistent sneezing.

1) Local Reactions

Small amounts of erythema and swelling at the site of injection are common, the extent varying with the patient. Such reactions should not be considered significant unless they persist for at least 24 hours or exceed 50 mm. in diameter.

Larger local reactions are not only uncomfortable, but also indicate the possibility of a systemic reaction if dosage is increased. In such cases the dosage should be reduced to the last level not causing the reaction and maintained at this level for two or three treatments before cautiously increasing again.

Large, persistent local reactions or minor exacerbations of the patient’s allergic symptoms may be treated by local cold applications and/or the use of oral antihistamines, but they should be considered a warning of possible severe systemic reactions and the need for temporarily reduced dosages.

A mild burning immediately after the injection is to be expected; this usually leaves in 10 to 20 seconds. Prolonged pain, or pain radiating up the arm, is usually the result of intramuscular injection, making this injection route undesirable. Subcutaneous injection is the recommended route.

2) Systemic Reactions

With careful attention to dosage and administration, such reactions occur infrequentIy, but it must be remembered that allergenic extracts are highly potent to sensitive individuals and OVERDOSE could result in anaphylactic symptoms. Therefore, it is imperative that physicians administering allergenic extracts understand and be prepared for the treatment of severe reactions.

Adverse reaction frequency data for allergenic extract administration is not available. Inherent difficulties in establishing such data are the wide variations in clinical allergy types, patient sensitivity, treatment schedules used by allergists, potency of extracts from various sources, etc.

It cannot be overemphasized that, under certain unpredictable combinations of circumstances, anaphylactic shock is always a possibility. Other possible systemic reaction symptoms are, in varying degrees of severity, fainting, pallor, bradycardia, hypotension, angioedema, cough, wheezing, conjunctivitis, rhinitis, and urticaria.17,18


If a systemic or anaphylactic reaction does occur, apply a tourniquet above the site of injection and inject intramuscularly or subcutaneously 0.3 to 0.5 ml of 1:1000 epinephrine-hydrochloride into the opposite arm. The dose may be repeated in 5-10 minutes if necessary. Loosen the tourniquet at least every 10 minutes.

The epinephrine HCL 1: 1000 dose for infants to 2 years is 0.05 to 0.1 ml; for children 2 to 6 years it is 0.15 ml; for children 6 to 12 years it is 0.2 ml.

Patients unresponsive to epinephrine may be treated with theophylline. Studies on asthmatic subjects reveal that plasma concentrations of theophylline of 5 to 20 ug/ml are associated with therapeutic effects. Toxicity is particularly apparent at concentrations greater than 20 ug/ml. A loading dose of aminophylline of 5.6 mg/kg intravenously followed by 0.9 mg/kg per hour results in plasma concentrations of approximately 10 ug/ml. (Mitenko and Ogilive 1973b; Nicholoson and Chick 1973).

Other beta-adrenergic drugs such as isoproterenol, isoetharine, or albuterol may be used by inhalation. The usual dose to relieve broncho-constriction in asthma is 0.5 ml or the 0.5% solution for isoproterenol HCL; albuterol is longer acting than isoproterenol by any route of administration. The albuterol inhaler delivers approximately 90 mcg of albuterol from the mouthpiece. The usual dosage for adults and children would be two inhalations repeated every 4 to 6 hours. Isoetharine supplied in the Bronkometer unit delivers approximately 340 mcg isoetharine. The average adult dose is one to two inhalations.

Patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodilators. Respiratory obstruction not responding to parenteral or inhaled bronchodilators may require Theophylline, low-flow oxygen, intubation and the use of life support systems. Parenteral fluid and/or plasma expanders may be utilized for treatment of shock and low flow (two liters per minute) oxygen may be utilized if indicated. Adenocorticosteroids may be administered parenterally or intravenously. 8


Individual treatment sets as prescribed by the physician. The allergenic extract contains a variable number of individual doses depending on the patient’s sensitivity and maximum tolerated maintenance treatment dose.


1. Baer, Harold E.: The Regulation of Allergenic Extracts by the• U.S. Food and Drug Administration, Regulatory Control and Standardization of Allergenic Extracts, First International Paul-Ehrlich Seminar, May 20-22, 1979, Frankfurt, Germany, pp. 10-11.

2. Baer, Harold E.: Evaluation of RAST Inhibition, International Joint Steering Committee for Allergen Standardization, Course on Allergen Standardization, The Protein Laboratory, University of Copenhagen, August 4-9, 1980.

3. Baer, Harold E., L. Bolin, D. Levy, H. Lowenstein, & A. DeWeck: Standard reference extracts, (round table discussion), International Joint Steering Committee for Allergen Standardization, Course on Allergen Standardization. The Protein Laboratory, University of Copenhagen, August 4-9, 1980.

4. Baer, Harold E.: Second International Paul-Ehrlich Seminar on Regulatory Control and Standardization of Allergenic Extract, Frankfurt, Germany, September 13-15, 1981.

5. Evans, Richard, III and Summers, Richard: In vivo and in vitro tests to confirm clinical findings — Diagnostic tests for allergic patients. Journal of Respiratory Diseases, Vol. 65, No. 7, July 1981.

6. Fadal, Richard G. & Nalebuff, Donald J.: Tools of the Allergists: Old and New. Continuing Education for the Family Physician, Vol. 10, No. 5, May 1979, pp. 37-61.

7. Allergenic Products: Antigen E. Potency Test: Additional Standards for Miscellaneous Products, 21 CFR Part 680, Federal Register, Vol. 46, No. 147, Friday, July 31, 1981, Rules and Regulations, pp. 39128-39136.

8. Goodman, Louis S., Gillman, Alfred: Editors, The Pharmacological Basis of Therapeutics. MacMillan Publishing Co., Inc., Chapter 19, p. 375.

9. Kniker, William T.: Clinical Science and Common Sense in the Diagnosis and Immunotherapy of Respiratory Allergy. Continuing Education for the Family Physician, Vol. 10, No. 5, May 1979, pp. 16-33.

10. Matthews, Kenneth, et al: Rhinitis, Asthma and the Other Allergic Diseases, NIAID Task Force Report, U.S. Dept. HEW, NIH Publication No. 79-387, Chapter 4, pp. 213-217, May 1979.

11. Nalebuff, Donald J. and Fadal, Richard G.: The Modified RAST Assay: An Aid in the Diagnosis and Management of Allergic Disorders. Continuing Education for the Family Physician, Vol. 10, No. 5, May 1979, pp. 64-76.

12. Nelson, Harold S.: The Effect of Preservatives and Dilution on the Deterioration of Russian Thistle (Salsola pestifer), a pollen extract. The Journal of Allergy and Clinical Immunology. Vol. 63, No. 6, pp. 417-425, June 1979.

13. Norman, Philip S., Lichtenstein, L.M., Ishizaka, K.: Diagnostic tools in ragweed hay fever. A comparison of direct skin tests IgE antibody measurements and basophil histamine release. The Journal of Allergy and Clinical Immunology. Vol. 52, 1973, pp. 210.

14. Rocklin, Ross E., Sheffer, Albert L., Grainader, Dirk K., and Melmon, Kenneth: Generation of antigen-specific suppressor cells during allergy desensitization. New England Journal of Medicine, 302: May 29, 1980, pp. 1213-1219.

15. Seebohm, Paul M., et al: Panel on Review of Allergenic Extracts, Final Report, Food and Drug Administration, March 13, 1981, pp. 9-48.

16. Stevens, E.: Cutaneous Tests, Regulatory Control and Standardization of Allergenic Extracts, First International Paul-Ehrlich Seminar, May 20-22, 1979, Frankfurt, Germany, pp. 133-138.

17. Van Metre, Thomas E., Jr., Adkinson, N. Franklin, Jr., Amodio, Frank J., Lichtenstein, Lawrence L., Mardinay, Michael R., Jr., Norman, Philip S., Rosenberg, Gary L., Sobotka, Anne K., & Valentine, Martin D.: A comparative study of the effectiveness of the Rinkel method and the current standard method of immunology for ragweed pollen hay fever. The Journal of Clinical Allergy and Immunology, Vol. 66, No. 6, p. 511, December 1980.

18. Wasserman, S.: The mast cell and the inflammatory response, The Mast Cell — its role in health and disease. Edited by J. Pepys & A.M. Edwards, Proceedings of an International Symposium, Davos, Switzerland, Pitman Medical Publishing Co., 1979, pp. 9-20.

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