Drugplain

histamine positive skin test control .275 mg/mL

histamine phosphate · INJECTION, SOLUTION · ALK-Abello, Inc.

No Recall History
Plain English

Histamine Phosphate is an injection used as a control substance during allergy skin testing to verify that the skin is responding properly to the test. It is injected just under the skin to produce a reaction that helps doctors interpret the results of allergy tests.

Key Facts

Brand Name
histamine positive skin test control
Generic Name
histamine phosphate
NDC Code (Product)
0268-0248
Manufacturer
ALK-Abello, Inc.
Strength
.275 mg/mL
Dosage Form
INJECTION, SOLUTION
Route
INTRADERMAL
Marketing Status
Application #
BLA103754
Marketing Start
10/23/1989

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

false negative investigation result52 reports
drug ineffective17 reports
anaphylactic reaction7 reports
skin test positive4 reports
skin wound4 reports
erythema3 reports
hypersensitivity2 reports
injection site pain2 reports
injection site ulcer2 reports
intentional product use issue2 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

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 tes

Warnings

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.

Contraindications

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.

Drug Interactions

Drug Interactions Drugs can interfere with the performance of skin tests in general, and specifically with histamine 1 . Antihistamines: Response to histamine is suppressed by antihistamines. The length of suppression varies, and is dependent on individual patient, type of antihistamine and length of time the patient has been on antihistamines. The duration of this suppression may be as little as 24 hours (chlorpheniramine), and can be as long as 40 days (astemizole). Tricyclic Antidepressants: These exert a potent and sustained decrease of skin reactivity to histamine, which may last for a few weeks. Beta 2 Agonists: Oral terbutaline and parenteral ephedrine, in general, have been shown to decrease allergen induced wheal. Theoretically, this may also reduce whealing capacity to histamine. Dopamine: Intravenous infusion of dopamine has been shown to inhibit skin test responses to histamine. Beta Blocking Agents: Propranolol can significantly increase skin test reactivity, including histamine. Other Drugs: Short acting steroids, inhaled beta agonists, theophylline and cromolyn do not seem to affect skin test response.

Adverse Reactions

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 ).

Frequently Asked Questions

What is histamine positive skin test control used for?

Histamine Phosphate is an injection used as a control substance during allergy skin testing to verify that the skin is responding properly to the test. It is injected just under the skin to produce a reaction that helps doctors interpret the results of allergy tests.

Is histamine positive skin test control a controlled substance?

histamine positive skin test control is not classified as a controlled substance by the DEA.

What is the generic name for histamine positive skin test control?

The generic name for histamine positive skin test control is histamine phosphate. There are 1 other brand versions of histamine phosphate.

What is the NDC code for histamine positive skin test control .275 mg/mL?

The NDC (National Drug Code) for histamine positive skin test control .275 mg/mL is 0268-0248, listed by ALK-Abello, Inc..

Product NDC

0268-0248

Package NDC

0268-0248-05

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)