pharmacopeia
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/api/v1/drug/benzylpenicilloyl-polylysine

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Antibody-Receptor Interactions.

Indications

Sourced from openFDA
  • PRE-PEN is indicated for the assessment of sensitization to penicillin (benzylpenicillin or penicillin G) in patients suspected to have clinical penicillin hypersensitivity. A negative skin test to PRE-PEN is associated with an incidence of immediate allergic reactions of less than 5% after the administration of therapeutic penicillin, whereas the incidence may be more than 50% in a history-positive patient with a positive skin test to PRE-PEN.

Contraindications

Sourced from openFDA
  • PRE-PEN is contraindicated in those patients who have exhibited either a systemic or marked local reaction to its previous administration. Patients known to be extremely hypersensitive to penicillin should not be skin tested.contraindicated

Dosage & administration

Sourced from openFDA

SKIN TESTING DOSAGE AND TECHNIQUE Skin testing responses can be attenuated by interfering drugs (e.g. H1-antihistamines and vasopressors). Skin testing should be delayed until the effects of such drugs have dissipated, or a separate skin test with histamine can be used to evaluate persistent antihistaminic effects in vivo. Due to the risk of potential systemic allergic reactions, skin testing should be performed in an appropriate healthcare setting under direct medical supervision. Puncture Testing : Skin testing is usually performed on the inner volar aspect of the forearm. The skin test antigen should always be applied first by the puncture technique. After preparing the skin surface, apply a small drop of PRE-PEN solution using a sterile 22-28 gauge needle. The same needle can then be used to make a single shallow puncture of the epidermis through the drop of PRE-PEN. Very little pressure is required to break the epidermal continuity. Observe for the appearance of a wheal, erythema, and the occurrence of itching at the test site during the succeeding 15 minutes at which time the solution over the puncture site is wiped off. A positive reaction consists of the development within 10 minutes of a pale wheal, sometimes with pseudopods, surrounding the puncture site and varying in diameter from 5 to 15 mm (or more). This wheal may be surrounded by a variable diameter of erythema, and accompanied by a variable degree of itching. The most sensitive individuals develop itching quickly, and the wheal and erythema are prompt in their appearance.

Warnings & precautions

Sourced from openFDA

The risk of sensitization to repeated skin testing with PRE-PEN is not established. Rarely, a systemic allergic reaction including anaphylaxis (see below) may follow a skin test with PRE-PEN. To decrease the risk of a systemic allergic reaction, puncture skin testing should be performed first. Intradermal skin testing should be performed only if the puncture test is entirely negative.

Adverse reactions

Sourced from openFDA

Occasionally, patients may develop an intense local inflammatory response at the skin test site. Rarely, patients will develop a systemic allergic reaction, manifested by generalized erythema, pruritus, angioedema, urticaria, dyspnea, hypotension, and anaphylaxis. The usual methods of treating a skin test antigen-induced reaction — the applications of a venous occlusion tourniquet proximal to the skin test site and administration of epinephrine are recommended. The patient should be kept under observation for several hours.

Use in specific populations

Sourced from openFDA

Pregnancy: Animal reproduction studies have not been conducted with PRE-PEN. It is not known whether PRE-PEN can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. The hazards of skin testing in such patients should be weighed against the hazard of penicillin therapy without skin testing.

Approval history

Sourced from openFDA
  • Jul 25, 1974BLABLA050114Allerquest

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.
34 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. 1Pruritus1132%
  2. 2False Negative Investigation Result824%
  3. 3Urticaria618%
  4. 4Anaphylactic Reaction412%
  5. 5Skin Test Positive412%
  6. 6Erythema38.8%
  7. 7Feeling Hot38.8%
  8. 8Maternal Exposure During Pregnancy38.8%
  9. 9Throat Tightness38.8%
  10. 10Drug Hypersensitivity25.9%
  11. 11Dyspnoea25.9%
  12. 12Exposure During Pregnancy25.9%
  13. 13Peripheral Swelling25.9%
  14. 14Rash25.9%
  15. 15Skin Test Negative25.9%

Literature

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

Clinical trials

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The 2 most recently updated of 2 ClinicalTrials.gov registrations naming Benzylpenicilloyl Polylysine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Benzylpenicilloyl Polylysine work?
Mechanism-of-action class: Antibody-Receptor Interactions.
What is Benzylpenicilloyl Polylysine used for?
According to FDA labeling, Benzylpenicilloyl Polylysine carries indications including: PRE-PEN is indicated for the assessment of sensitization to penicillin (benzylpenicillin or penicillin G) in patients suspected to have clinical penicillin hypersensitivity. A negative skin test to PRE-PEN is associated with an incidence of immediate allergic reactions of less than 5% after the administration of therapeutic penicillin, whereas the incidence may be more than 50% in a history-positive patient with a positive skin test to PRE-PEN.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Benzylpenicilloyl Polylysine?
Benzylpenicilloyl Polylysine is classified as Antibody-Receptor Interactions, Increased Antibody Production, Increased Cellular Migration, Increased Histamine Production.
What are the contraindications for Benzylpenicilloyl Polylysine?
Benzylpenicilloyl Polylysine labeling lists contraindications including: PRE-PEN is contraindicated in those patients who have exhibited either a systemic or marked local reaction to its previous administration. Patients known to be extremely hypersensitive to penicillin should not be skin tested.. Always consult the full prescribing information and a clinician.
Note. Data for benzylpenicilloyl-polylysine 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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