Positive Skin Test Control – Histamine

POSITIVE SKIN TEST CONTROL — HISTAMINE- histamine injection
Jubilant HollisterStier LLC

POSITIVE SKIN TEST CONTROL — HISTAMINE

For Percutaneous (Scratch, Prick or Puncture) Administration
Histamine Base: 6mg/mL
(Histamine Dihydrochloride: 10mg/mL)
This product is to be used by a physician or under the supervision of a physician.

DESCRIPTION

Histamine Dihydrochloride contains histamine, a potent vasodilator having the chemical name 2-(4-Imidazolyl) ethylamine. Histamine has an empirical formula of C5 H9 N3 , a molecular weight of 111.15, and the following chemical structure:

Histamine Chemical
(click image for full-size original)

Histamine Dihydrochloride is available in the following strengths:
1. SCRATCH, PRICK or PUNCTURE TEST CONTROL: Positive Skin Test Control — Histamine contains 6.0 mg/mL Histamine Base and is a clear, colorless, sterile solution. It consists of Histamine Dihydrochloride 10mg/mL, Sodium Chloride 0.5%, Sodium Bicarbonate 0.275%, and Glycerin 50.0% (v/v) as a preservative.

CLINICAL PHARMACOLOGY

Pharmacological actions of histamine include the increase of capillary and post capillary venular permeability. This vascular change leads to the wheal-flare response. Large reactions can cause an amplification of a reaction to a nearby skin test. Histamine is degraded either by oxidative deamination or by methylation and oxidative deamination so that the principal excretion products are imidazoleacetic acid-riboside and 1-methyl imidazoleacetic acid respectively.2

10 atopic subjects and 10 non-atopics were tested with Positive Skin Test Control — Histamine Solutions, and two negative control solutions. Thirteen females (35-49 years old; mean age 36.5) and 7 males (23-45 years old; mean age 36.4) were tested. This study included 19 Caucasian subjects and 1 African American subject. Different skin test devices produce different skin test responses. (14,15) Study results are summarized in Table 1 and Table 2. Atopic and non-atopic subject information was combined, as there were no significant differences in their skin responses.

Summation of wheal (∑W) or summation of erythema (∑E) was determined by measuring the longest diameter and the mid-point orthoganol diameter of the wheal or erythema response and summing the two measurements.

Histamine Table1
(click image for full-size original)
Histamine Table2
(click image for full-size original)

Malling tested 25 subjects using a straight needle prick technique with Histamine Dihydrochloride 10mg/mL and found wheal single diameters of 5.4-8.5mm (mean 7 mm). 13

Histamine Dihydrochloride at 10mg/mL has been shown to elicit fewer false negative and false positive reactions than Histamine Dihydrochloride at 1mg/mL. 12 10mg/mL Histamine Dihydrochloride has been shown to be the appropriate strength to perform biological standardization using skin reactivity to histamine as a standard of comparison.11,13

INDICATIONS AND USAGE

Positive Skin Test Control — Histamine is indicated as an adjunct in allergy skin test for diagnosis, as a positive control to test wheal-flare response of skin for evaluation of skin test response to allergenic extracts.

CONTRAINDICATIONS

Positive Skin Test Control — Histamine is contraindicated in patients with a history of hypersensitivity to histamine products, and in patients with hypotension, severe hypertension, vasomotor instability, severe cardiac, pulmonary or renal disease.

WARNINGS

Attacks of severe asthma or other serious allergic conditions may be precipitated by the administration of Histamine Dihydrochloride in patients with bronchial disease. Caution is advised in using histamine in such patients and in those with a history of bronchial asthma. Histamine Dihydrochloride has not been approved for unlabeled use as gastric acid stimulus or for detecting bronchial hyperactivity.

PRECAUTIONS

(1) General: It is necessary that scarifiers, syringes, and needles be properly sterilized before use on each patient to prevent the possibility of accidental transfer of serum hepatitis and other infectious agents from one person to another. Disposable products may also be used.
Always have injectable epinephrine and a tourniquet available when any skin tests are being made. (See ADVERSE REACTIONS Section)
Patients should be observed in the office for 30 minutes after administration of the test and instructed to return to the office promptly if symptoms of an allergic reaction or shock occur.

(2) Drug Interactions: Certain medications may lessen the skin test wheal and erythema responses elicited by histamine for varying time periods. Conventional antihistamines should be discontinued at least 5 days before skin testing. Long acting antihistamines should be discontinued for at least 3 weeks prior to skin testing.7 Topical steroids should be discontinued at the skin test site for at least 2-3 weeks before skin testing.7,8

Tricyclic antidepressants such as Doxepin should be withheld for at least 7 days before skin testing.9 The physician must determine whether the risk of severe depression occurring in patients who discontinue their medication outweighs the benefits that could be obtained from skin testing. Topical local anesthetics may suppress the flare responses and should be avoided in skin test sites.10

(3) Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies have not been performed on Positive Skin Test Control-Histamine.

(4) Pregnancy: Positive Skin Test Control-Histamine. Animal reproduction studies have not been conducted on Histamine Dihydrochloride. It is also not known whether Histamine Dihydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Histamine Dihydrochloride should be given to a pregnant woman only if clearly needed.

(5) Nursing Mothers: It is unknown whether Histamine Dihydrochloride affects lactation or is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Positive Skin Test Control-Histamine is administered to a nursing woman.

(6) Pediatric Use: Indications and dosage for the pediatric population are the same as for adults; however, the reactions to histamine are smaller. Studies have shown that the use of histamine solutions for skin test is safe in infants and young children.4,5,6

ADVERSE REACTIONS

Large doses of histamine may precipitate systemic reactions. These reactions may include flushing, dizziness, headache, bronchial constriction, urticaria, asthma, marked hypotension or hypertension, abdominal cramps, vomiting, metallic taste, local or generalized allergic manifestations.

An antihistamine preparation may be given orally, I.M. or I.V. to prevent or ameliorate systemic reactions to the drug.

If a systemic or anaphylactic reaction does occur, apply a tourniquet above the site of injection and inject 1:1000 epinephrine-hydrochloride intramuscularly or subcutaneously into the opposite arm. Loosen the tourniquet at least every 10 minutes. Do not obstruct arterial blood flow with the tourniquet.

Epinephrine Dosage:
ADULT: 0.3 to 0.5 mL should be injected. Repeat in 5 to 10 minutes if necessary.
PEDIATRIC: The usual initial dose is 0.01 mg (mL) per kg body weight or 0.3 mg(mL) per square meter of body surface area. Suggested dosage for infants to 2 years of age is 0.05 mL to 0.1 mL; for children 2 to 6 years, 0.15 mL; and children 6 to 12 years, 0.2 mL. Single pediatric doses should not exceed 0.3 mg (mL). Doses may be repeated as frequently as every 20 minutes, depending on the severity of the condition and the response of the patient.

After administration of epinephrine, profound shock or vasomotor collapse should be treated with intravenous fluids, and possibly vasoactive drugs. Oxygen should be given by mask. Aminophylline or adrenal corticosteroids may be used if necessary after adequate epinephrine and circulatory support has been given.

Emergency resuscitation measures and personnel trained in their use should be available immediately in the event of a serious systemic or anaphylactic reaction not responsive to the above measures (Ref. J. ALLERGY AND CLINICAL IMMUNOLOGY 77s (2): p. 271-273, 1986).16

Rarely are all of the above measures necessary, the tourniquet and epinephrine usually producing prompt responses. However, the physician should be prepared in advance for all contingencies. Promptness in beginning emergency treatment measures is of utmost importance.

Adverse Event Reporting
Report all adverse events to Jubilant HollisterStier LLC Customer Technical Services Department at 1 (800) 992-1120. A voluntary adverse event reporting system for health professionals is available through the FDA MEDWATCH program. Preprinted forms (FDA Form 3500) are available from the FDA by calling 1 (800) FDA-1088. Completed forms should be mailed to MEDWATCH, 5600 Fisher Lane, Rockville, MD 20852-9787 or Fax to: 1 (800) FDA-0178.

Page 1 of 2 1 2

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.