Histamine Positive Skin Test Control

Histamine Positive Skin Test Control is an FDA-registered drug product whose active ingredient is HISTAMINE PHOSPHATE. It is labelled by ALK-Abello, Inc. taken by percutaneous and marketed as a human prescription drug product. Identifiers on file: NDC 0268-0247, application BLA103754, label effective 20200828. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing HISTAMINE PHOSPHATE are most often described in connection with: positive control, evaluation allergenic, immediate hypersensitivity, type skin. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

INDICATIONS AND USAGE For use as a positive control in evaluation of allergenic (immediate hypersensitivity or "Type I") skin testing.

DOSAGE AND ADMINISTRATION Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. For Prick, Puncture and Scratch Testing Histamine base 1 mg/mL (Histamine Phosphate 2.75 mg/mL) should be used to give a reaction. (Refer to Interpretation Section.) Prick, Puncture or Scratch Test Techniques The skin in the test area should be cleansed with alcohol and air dried. The histamine control skin test solution should be placed at the same site with the other skin test antigens, either on the patient's back or on the volar surface of the forearm. The patient should be placed in a comfortable position before the testing is begun. For the prick test, a sharp needle is used to puncture the skin, but not to draw blood. If the scratch test is used, carefully break or scratch the skin with a sterile scarifier. Do not draw blood. Each scratch should be about 2 mm - 4 mm in length. A small drop of the histamine base 1 mg/mL (Histamine Phosphate 2.75 mg/mL) is placed on the abraded skin site no closer than 4 or 5 cm from an adjacent test site. Some physicians prefer to place the solution on the test area and then prick through the drop with a sharp needle. Use a separate sterile scarifier or needle for each patient. The test should be read at 15 minutes; if a large wheal reaction occurs before that time the test site should be wiped free of histamine. Interpretation The patient's response is based on the size of: erythema (degree of redness) and/or size of wheal (smooth, slightly elevated area) which appear after 10 minutes. For percutaneous testing, different devices and/or techniques influence the size of the reaction. Therefore, it is important to refer to the device manufacturer's or distributor's instructions when grading reactions. For prick, puncture and scratch testing, histamine base 1 mg/mL (Histamine Phosphate 2.75 mg/mL) should be used to give a positive reaction. In a large population, the NHANES II survey reports a mean diameter (average of length and width) wheal of 4.4 mm ± 1.65 mm (± standard deviation) and a mean erythema of 18.4 mm ± 8.55 mm (± standard deviation) when using 25 gauge B-D needle by prick puncture (Pepys) technique. 7 All positive reactions should be interpreted against an appropriate negative control. For Intradermal Skin Testing Histamine base 0.1 mg/mL (Histamine Phosphate 0.275 mg/mL) or 0.01 mg/mL should be used to give a reaction. (Refer to Interpretation Section.) Intracutaneously (Intradermal) Test Techniques The skin should be cleansed with alcohol and air dried. A sterile one milliliter tuberculin syringe with 26 or 27 gauge needle should be used. A single sterile syringe should be used for each solution to assure sterility. Only the histamine base 0.1 mg/mL (Histamine Phosphate, 0.275 mg/mL) or greater dilution solution should be used. The histamine base skin test solution should be injected at the same site with the other skin test allergens, either on the patient's back or on the arm. The patient should be placed in a comfortable position before the testing is begun. The skin is held tense and the needle is inserted almost parallel to the skin, bevel side up, far enough to cover the beveled portion. Slowly inject 0.01 mL or 0.02 mL, making a small bleb approximately 3 mm - 5 mm in diameter. The test should be read in 15 minutes. Interpretation The patient's response is based on the size of: erythema (degree of redness) and/or size of wheal (smooth, slightly elevated area) which appear after 10 minutes. For intradermal skin testing, histamine base 0.1 mg/mL (Histamine Phosphate 0.275 mg/mL) or 0.01 mg/mL should be used to give a positive reaction. The available 0.1 mg/mL concentration must be diluted ten-fold to achieve this dose. All positive reactions should be interpreted against an appropriate negative control. In two successive years of testing, the Committee on Standardization of the American College of Allergy reported positive reactions at histamine base doses of 0.01 mg/mL and higher. Mean sum of wheal diameters was approximately 14 mm ± 4.8 mm and sum of erythema diameter was approximately 52 mm ± 21.6 mm following 0.01 mL intradermal doses of 0.01 mg/mL histamine base. When 0.01 mL of 0.1 mg/mL histamine base was injected, the sum of cross-diameters of wheal ranged from 15-20 mm and the sum of cross-diameters of erythema ranged from 60-80 mm. 8

CONTRAINDICATIONS Histamine should not be injected into individuals with hypotension, severe hypertension, severe cardiac, pulmonary, or renal disease. Not to be used for diagnosis of pheochromocytoma or to test the ability of the gastric mucosa to secrete hydrochloric acid.

WARNINGS Care must be taken in intracutaneous testing to avoid injection into a venule or capillary. Pull back gently on the syringe plunger and note if blood is drawn. If blood is drawn, withdraw needle and inject into another skin site. Small doses by any route of administration may precipitate asthma in patients with bronchial hyperactivity. This product is not intended for inhalation, or subcutaneous injection. The utmost caution is advised in using histamine in such patients and in those with a history of bronchial asthma.

ADVERSE REACTIONS Local: Reactions such as wheal, erythema and localized pruritus are to be expected, but if very large (i.e. greater than 4+ as described dosage and administration) may be the first manifestation of a systemic reaction. Systemic: Following the injection of large doses of histamine, systemic reactions may include flushing, dizziness, headache, bronchial constriction, urticaria, asthma, marked hypertension or hypotension, abdominal cramps, vomiting, metallic taste, and local or generalized allergic manifestations (see also OVERDOSAGE ).

What is Histamine Positive Skin Test Control used for?
INDICATIONS AND USAGE For use as a positive control in evaluation of allergenic (immediate hypersensitivity or "Type I") skin testing.

Who makes Histamine Positive Skin Test Control?
ALK-Abello, Inc. is the labeler of record for Histamine Positive Skin Test Control.

What form does Histamine Positive Skin Test Control come in?
administered by percutaneous. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Histamine Positive Skin Test Control prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Histamine Positive Skin Test Control been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.