PRE-PEN 60 umol/.25mL
benzylpenicilloyl polylysine · INJECTION · ALK-ABELLO, INC.
PRE-PEN is a prescription injection containing benzylpenicilloyl polylysine at 60 umol/.25mL, taken intradermal. Manufactured by ALK-ABELLO, INC..
Key Facts
- Brand Name
- PRE-PEN
- Generic Name
- benzylpenicilloyl polylysine
- NDC Code (Product)
49471-001- Manufacturer
- ALK-ABELLO, INC.
- Strength
- 60 umol/.25mL
- Dosage Form
- INJECTION
- Route
- INTRADERMAL, SUBCUTANEOUS
- Marketing Status
- HUMAN PRESCRIPTION DRUG
- Application #
- BLA050114
- Marketing Start
- 07/25/1974
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE: 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. These allergic reactions are predominantly dermatologic. Whether a negative skin test to PRE-PEN 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 PRE-PEN and/or minor penicillin determinants.
Dosage & Administration
DOSAGE AND ADMINISTRATION: 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…
Warnings
WARNINGS: 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.
Contraindications
CONTRAINDICATIONS: 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.
Adverse Reactions
ADVERSE REACTIONS: 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.
Frequently Asked Questions
What is PRE-PEN used for?
PRE-PEN contains benzylpenicilloyl polylysine. It is a injection taken intradermal. Consult your doctor for specific uses.
Is PRE-PEN a controlled substance?
PRE-PEN is not classified as a controlled substance by the DEA.
What is the generic name for PRE-PEN?
The generic name for PRE-PEN is benzylpenicilloyl polylysine. There are no other listed brand versions of benzylpenicilloyl polylysine.
What is the NDC code for PRE-PEN 60 umol/.25mL?
The NDC (National Drug Code) for PRE-PEN 60 umol/.25mL is 49471-001, listed by ALK-ABELLO, INC..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)