Histamine (topical)

FDA label, Jubilant HollisterStier LLC, percutaneous, effective 2026-04-03. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Boxed warning

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.

Dosing in kidney impairment

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.

Preparation and administration

DOSAGE AND ADMINISTRATION General Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Prior to testing, clean the skin area with ether or alcohol and allow to dry. The back or the volar surface of the arms are the most satisfactory sites for testing.

Scratch, Prick or Puncture Test: Positive Skin Test Control-Histamine, 6.0 mg/mL Histamine Base. The Scratch, Prick or Puncture test should be read in 15 minutes. If a large wheal reaction occurs before that time, wipe excess histamine solution from test site. a) Use a sterile scarifier for each patient. Hold the scarifier between the thumb and index finger, press the sharp edge of the instrument against the skin and twirl instrument rapidly.

Drug interactions

Check histamine (topical) against a medication list
Label text (2 paragraphs)

(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

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.

Pregnancy and lactation

Pregnancy

(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.

Lactation

(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.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

Supply and cost

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Therapeutic equivalence (Orange Book)

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