POSITIVE SKIN TEST CONTROL - HISTAMINE- histamine injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HISTAMINE (UNII: 820484N8I3) (HISTAMINE - UNII:820484N8I3)

Available from:

Jubilant HollisterStier LLC

INN (International Name):

HISTAMINE

Composition:

HISTAMINE 6 mg in 1 mL

Administration route:

PERCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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.

Product summary:

SCRATCH, PRICK or PUNCTURE TEST: Positive Skin Test Control-Histamine (6.0 mg/mL Histamine Base), 5 mL sterile amber vial with dropper assembly.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

POSITIVE SKIN TEST CONTROL - HISTAMINE- HISTAMINE INJECTION
JUBILANT HOLLISTERSTIER LLC
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HISTAMINE 366140-H05 INITIAL UPLOAD TO INTAGRAS SPL PORTAL
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 C H N , a
molecular weight of 111.15, and the following chemical structure:
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
5
9
3
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 signif