Version May 2024
Diagnostic aid for detection of penicillin allergy:
Note: Benzylpenicilloyl polylysine should always be applied first via the puncture technique. Do not administer intradermally to patients who have a positive reaction to the puncture test.
Puncture test: Apply a small drop of the skin test solution using a 22- to 28-gauge needle and make a single shallow puncture of the epidermis through the drop of solution. A positive reaction consists of a pale wheal surrounding the puncture site which develops within 10 minutes and ranges from 5-15 mm or more in diameter (wheal may be surrounded by erythema and variable degrees of itching). If a positive response is evident, the solution should be wiped off immediately. If the puncture test is negative or equivocal (<5 mm wheal, with little or no erythema and no itching) 15 minutes following the puncture test, an intradermal test may be performed.
Intradermal test: Using a 0.5-1 mL tuberculin syringe with a 3/8 to 5/8 inch, 26- to 30-gauge short bevel needle, inject a volume of skin test solution sufficient to raise a small intradermal bleb ~3 mm in diameter intradermally, in duplicate at least 2 cm apart. A control of 0.9% sodium chloride or allergen-diluting solution should be injected at least 5 cm from the antigen test site. Most skin responses to the intradermal test will develop within 5-15 minutes. A response to the skin test is read at 20 minutes.
Interpretation of intradermal test:
(-) Negative: No increase in size of original bleb or no greater reaction compared to the control site
(±) Ambiguous: Wheal only slightly larger than original bleb with or without erythematous flare and slightly larger than control site; OR discordance between duplicate test sites
(+) Positive: Itching and marked increase in size of original bleb to ≥5 mm. Wheal may exhibit pseudopods and be >20 mm in diameter.
Control site should be reactionless. If wheal >2-3 mm develops at control site, repeat the test. If same reaction occurs, consultation is necessary.
No dosage adjustment provided in manufacturer's labeling.
No dosage adjustment provided in manufacturer's labeling.
Refer to adult dosing.
(For additional information see "Benzylpenicilloyl polylysine (Penicilloyl-polylysine): Pediatric drug information")
Diagnostic aid for detection of penicillin allergy (penicillin G and benzylpenicillin): Limited data available for assessment of other beta-lactams and cephalosporins allergy: Children and Adolescents:
Note: Benzylpenicilloyl polylysine should always be applied first via the puncture technique. Do not administer intradermally to patients who have positive reactions to a puncture test.
Puncture scratch test: Apply a small drop of the skin test solution using a 22- to 28-gauge needle and make a single shallow puncture of the epidermis through the drop of solution. A positive reaction consists of a pale wheal surrounding the puncture site which develops within 10 minutes and ranges from 5 to 15 mm or more in diameter (wheal may be surrounded by erythema and variable degrees of itching). If a positive response is evident, the solution should be wiped off immediately. If the puncture test is negative or equivocal (<5 mm wheal, with little or no erythema and no itching) 15 minutes following the puncture test, an intradermal test may be performed.
Intradermal test: Using a 0.5 to 1 mL tuberculin syringe with a 3/8- to 5/8-inch, 26- to 30-gauge short bevel needle; inject a volume of skin test solution sufficient to raise a small intradermal bleb ~3 mm in diameter intradermally and duplicate at least 2 cm apart. A control of 0.9% sodium chloride or allergen-diluting solution should be injected at least 5 cm from the antigen test site. Most skin responses to the intradermal test will develop within 5 to 15 minutes. A response to the skin test is read at 20 minutes.
Interpretation of intradermal test:
(-) Negative: No increase in size of original bleb or no greater reaction compared to the control site.
(±) Ambiguous: Wheal only slightly larger than original bleb with or without erythematous flare and slightly larger than control site; or discordance between duplicate test sites.
(+) Positive: Itching and marked increase in size of original bleb to ≥5 mm. Wheal may exhibit pseudopods and be >20 mm in diameter.
Control site should be reactionless. If wheal >2 to 3 mm develops at control site, repeat the test. If same reaction occurs, consultation is necessary.
There are no dosage adjustments provided in manufacturer’s labeling.
There are no dosage adjustments provided in manufacturer’s labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined.
Cardiovascular: Hypotension
Dermatologic: Erythema, pruritus, urticaria (including local reaction at skin test site)
Hypersensitivity: Angioedema, hypersensitivity reaction (including anaphylaxis; rare)
Local: Local inflammation (intense; at skin test site)
Respiratory: Dyspnea
Systemic or marked local reaction to a previous administration of benzylpenicilloyl polylysine skin test; patients with a known severe hypersensitivity to penicillin should not be tested
Concerns related to adverse effects:
• Allergic reactions: Rare systemic allergic reactions, including anaphylaxis, have been associated with penicillin skin testing. Penicillin skin testing should only be performed by skilled medical personnel under direct supervision of a physician, and testing should be performed only in an appropriate healthcare setting prepared for the immediate treatment with epinephrine. To decrease the risk of a systemic allergic reaction, the manufacturer recommends puncture skin testing prior to intradermal testing.
Disease-related concerns:
• Severe penicillin allergy: Patients with a reliable history of a severe life-threatening penicillin allergy, including Stevens-Johnson syndrome or TEN, should NOT receive penicillin skin testing.
Concurrent drug therapy issues:
• Histamine H1 antagonists: Responses to skin testing may be attenuated by concurrent administration of antihistamines. Consider delaying testing until these medications can be withheld to allow time for their effects dissipate.
Other warnings/precautions:
• Accuracy: According to the manufacturer, a negative skin test is associated with an incidence of immediate allergic reactions of <5% after penicillin administration and a positive skin test may indicate >50% incidence of allergic reaction occurring after penicillin administration.
• Appropriate use: Adequate penicillin skin testing should ideally involve reagents of both the major antigenic determinant (penicilloyl-polylysine) and minor determinants (penicilloate or penilloate). Benzylpenicilloyl polylysine alone does not identify those patients who react to a minor antigenic determinant. The minor determinant mixture (MDM) is not commercially available in the United States; however, diluted penicillin G (concentration: 10,000 units/mL) has been used as a minor determinant for skin testing purposes (Bernstein, 2008). Penicillin skin testing does not predict the occurrence of late reactions (eg, type II, III, IV or idiopathic reactions).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, solution:
Pre-Pen®: 6 x 10-5 M (0.25 mL)
No
Solution (Pre-Pen Intradermal)
0.25 mL (per 0.25 mL): $194.88
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Puncture test: Administer initially by puncture technique on the inner volar aspect of the forearm, followed by an intradermal injection only in patients with a negative reaction.
Intradermal: Do not administer intradermally to patients with a positive reaction (wheal of 5 to 15 mm or more in diameter) after puncture test. Administer the intradermal test on the upper, outer arm, below the deltoid muscle in the event a severe hypersensitivity reaction occurs and a tourniquet needs to be applied. During the skin test, immediate treatment with epinephrine should also be available.
Puncture test: Administer initially by puncture technique on the inner volar aspect of the forearm; observe 15 minutes for reaction. If negative reaction, follow with an intradermal injection.
Intradermal test: Do not administer intradermally to patients with a positive reaction to a puncture test (wheal of 5 to 15 mm or more in diameter). Administer the intradermal test on the upper, outer arm, below the deltoid muscle in the event a severe hypersensitivity reaction occurs and a tourniquet needs to be applied. During the skin test, immediate treatment with epinephrine should also be available. Observe 20 minutes for reaction.
Diagnostic aid for detection of penicillin allergy: Adjunct in assessing the risk of administering penicillin (penicillin G or benzylpenicillin) in patients suspected of clinical penicillin hypersensitivity.
Adjunct in assessment of hypersensitivity to other beta-lactam antibiotics (penicillins and cephalosporins) to determine the safety of penicillin administration in patients with a history of reaction to cephalosporins
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Alpha-/Beta-Agonists: May diminish the diagnostic effect of Benzylpenicilloyl Polylysine. Management: Consider use of a histamine skin test as a positive control to assess a patient's ability to mount a wheal and flare response. Risk D: Consider therapy modification
Alpha1-Agonists: May diminish the diagnostic effect of Benzylpenicilloyl Polylysine. Management: Consider delaying skin testing until alpha1-agonists are no longer required, or use of a histamine skin test as a positive control to assess a patient's ability to mount a wheal and flare response. Risk D: Consider therapy modification
Antihistamines: May diminish the diagnostic effect of Benzylpenicilloyl Polylysine. Management: Suspend systemic H1 antagonists for benzylpenicilloyl-polylysine skin testing and delay testing until systemic antihistaminic effects have dissipated. A histamine skin test may be used to assess persistent antihistaminic effects. Risk D: Consider therapy modification
The CDC states that penicillin skin testing may be useful in identifying pregnant patients at risk for acute allergic reactions who are diagnosed with syphilis (of any stage) due to a lack of proven alternatives to the use of penicillin in this population (CDC [Workowski 2021]).
Benzylpenicilloyl polylysine, a conjugate of the benzylpenicilloyl structural group (hapten) and the poly-l-lysine carrier (protein), is an antigen which reacts with benzylpenicilloyl IgE antibodies to elicit the release of chemical mediators, thereby producing type I (immediate or accelerated) urticarial reactions in patients hypersensitive to penicillins.
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