Rx Item-Pre-Pen 0.25 Ml Amp 5X0.25Ml By Alk Abello

PRE-PEN- benzylpenicilloyl polylysine injection
AllerQuest LLC

DESCRIPTION

PRE-PEN� (benzylpenicilloyl polylysine injection USP) is a sterile solution of benzylpenicilloyl polylysine in a concentration of 6.0X10-5M (benzylpenicilloyl) in 0.01 M phosphate buffer and 0.15 M sodium chloride. The benzylpenicilloyl polylysine in PRE-PEN is a derivative of poly-l-lysine, where the epsilon amino groups are substituted with benzylpenicilloyl groups (50-70%) forming benzylpenicilloyl alpha amide. Each single dose ampule contains 0.25 mL of PRE-PEN.
CLINICAL PHARMACOLOGY

PRE-PEN is a skin test antigen reagent that reacts specifically with benzylpenicilloyl IgE antibodies initiating the release of chemical mediators which produce an immediate wheal and flare reaction at a skin test site. All individuals exhibiting a positive skin test to PRE-PEN possess IgE against the benzylpenicilloyl structural group which is a hapten. A hapten is a low molecular weight chemical that conjugates with a carrier (e.g. poly-l-lysine) resulting in the formation of an antigen with the hapten's specificity. The benzylpenicilloyl hapten is the major antigenic determinant in penicillin-allergic individuals. However, many individuals reacting positively to PRE-PEN will not develop a systemic allergic reaction on subsequent exposure to therapeutic penicillin, especially among those who have not reacted to penicillins in the past. Thus, the PRE-PEN skin test determines the presence of penicilloyl IgE antibodies which are necessary but not sufficient for acute allergic reactions due to the major penicilloyl determinant.

Non-benzylpenicilloyl haptens are designated as minor determinants, since they less frequently elicit an immune response in penicillin treated individuals. The minor determinants may nevertheless be associated with significant clinical hypersensitivity. PRE-PEN does not react with IgE antibodies directed against non-benzylpenicilloyl haptens.

INDICATIONS AND USAGE

PREPEN 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 PREPEN 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 PREPEN. These allergic reactions are predominantly dermatologic. Whether a negative skin test to PREPEN predicts a lower risk of anaphylaxis is not established. Similarly, when deciding the risk of proposed penicillin treatment, there are not enough data at present to permit relative weighing in individual cases of a history of clinical penicillin hypersensitivity as compared to positive skin tests to PREPEN and/or minor penicillin determinants.
DOSAGE AND ADMINISTRATION

SKIN TESTING DOSAGE AND TECHNIQUE

Skin testing responses can be attenuated by interfering drugs (e.g. H1antihistamines 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.

RX ITEM-Pre-Pen 0.25 Ml Amp 5X0.25Ml By
NDC 49471-0001-05 UPC/GTIN No.3-49471-00105-6 Mfg.Part No.105

Pre-Pen 0.25 Ml Amp 5X0.25Ml By Alk Abel
BRAND: PRE-PEN NDC: 49471-0001-05,49471000105 UPC: 3-49471-00105-6,349471001056 Alk/Abello Inc.

BENZYLPENICILLOYL POLYLYS
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