pharmacopeia

Histamine

US-FDASourced from openFDA
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Indications

Sourced from openFDA
  • For use as a positive control in evaluation of allergenic (immediate hypersensitivity or "Type I") skin testing.

Contraindications

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  • 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.contraindicated

Dosage & administration

Sourced from openFDA

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.

Warnings & precautions

Sourced from openFDA

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

Sourced from openFDA

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 ).

Use in specific populations

Sourced from openFDA

Pregnancy Category C It is not known whether Histamine can cause fetal harm when administered during pregnancy or whether it can affect reproduction capacity. Histamine should be given during pregnancy only if clearly needed. There are no adequate and well-controlled studies during pregnancy. However, based on histamine's known ability to contract uterine muscle, exposure or repeated doses should be avoided. HISTATROL ® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus or mother.

Overdosage

Sourced from openFDA

A large subcutaneous dose of Histamine Phosphate may cause severe occipital headache, blurred vision, anginal pain, a rapid drop in blood pressure, and cyanosis of the face. Overdosage may cause severe symptoms including vasomotor collapse, shock, and even death. Epinephrine Injection 0.01 mg/kg to a maximum of 1.0 mg given subcutaneously or intramuscularly should be used in case of emergency due to severe reactions (see Precautions ). An antihistamine preparation may be given intramuscularly to ameliorate systemic reaction to overdose.

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
250 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1False Negative Investigation Result5221%
  2. 2Drug Ineffective3916%
  3. 3Pruritus187.2%
  4. 4Cough166.4%
  5. 5Headache166.4%
  6. 6Rash145.6%
  7. 7Back Pain135.2%
  8. 8Diarrhoea135.2%
  9. 9Dyspnoea135.2%
  10. 10Anaphylactic Reaction124.8%
  11. 11Fatigue124.8%
  12. 12Pain124.8%
  13. 13Arthralgia114.4%
  14. 14Dizziness114.4%
  15. 15Erythema114.4%

Literature

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Recent PubMed references pinned to Histamine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 338 ClinicalTrials.gov registrations naming Histamine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

What is Histamine used for?
According to FDA labeling, Histamine carries indications including: For use as a positive control in evaluation of allergenic (immediate hypersensitivity or "Type I") skin testing.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What are the brand names for Histamine?
Histamine is marketed under brand names including ActivOn Arthritis, Alo.
What are the contraindications for Histamine?
Histamine labeling lists contraindications including: 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.. Always consult the full prescribing information and a clinician.
Note. Data for histamine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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