Standardized Mite Dermatophagoides pteronyssinus 5000 [AU]/mL
Dermatophagoides pteronyssinus · CONCENTRATE · Greer Laboratories, Inc.
Standardized Mite Dermatophagoides pteronyssinus is a concentrate containing dermatophagoides pteronyssinus at 5000 [AU]/mL, taken intradermal. Manufactured by Greer Laboratories, Inc..
Key Facts
- Brand Name
- Standardized Mite Dermatophagoides pteronyssinus
- Generic Name
- Dermatophagoides pteronyssinus
- NDC Code (Product)
22840-0035- Manufacturer
- Greer Laboratories, Inc.
- Strength
- 5000 [AU]/mL
- Dosage Form
- CONCENTRATE
- Route
- INTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
- Marketing Status
- Application #
- BLA101835
- Drug Class
- Standardized Insect Allergenic Extract [EPC]
- Marketing Start
- 06/27/1989
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
1 INDICATIONS AND USAGE Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus ) Extracts are allergenic extracts indicated for: skin test diagnosis of mite allergy treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis. For immunotherapy, patients must show hypersensitivity to Dermatophagoides farinae ( D. farinae ) or Dermatophagoides pteronyssinus ( D. pteronyssinus ) based on their clinical history, allergen exposure history, and skin test reactivity. Greer Standardized Mite Extracts are allergenic extracts indicated for: Diagnosis of skin test reactivity to dust mite allergen (1) Treatment of mite-induced allergic asthma, rhinitis and conjunctivitis in patients that show hypersensitivity to dust mites based on clinical history, allergen exposure history, and skin test reactivity (1)
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Do not inject intravenously. Greer Standardized Mite extracts are diluted with sterile diluent for allergenic extracts when used for intradermal testing or subcutaneous immunotherapy. Dosages vary by mode of administration, and by individual response and tolerance. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Greer Standardized Mite Extracts should be a light brown solution that is free of particulate matter. If particulate matter is observed then the solution should be discarded. 2.1 Diagnostic Testing For diagnosis of a patient with a suspected allergy to either species of dust mite ( D. farinae or D. pteronyssinus ), diagnostic skin testing should include the standardized mite mixture or the single-species mite extracts. If a skin test with the standardized mite mixture elicits a positive reaction, then the single-species mite extracts can be used to determine the degree of sensitivity to each, and to guide in the selection of extracts and their concentration for immunotherapy, if indicated. A positive skin test reaction to any allergen m…
Contraindications
4 CONTRAINDICATIONS None. None (4)
Drug Interactions
7 DRUG INTERACTIONS 7.1 Beta Adrenergic Drugs Patients receiving beta blocker drugs may not be responsive to beta adrenergic drugs used to treat anaphylaxis 10 , and may wish to temporarily postpone treatment day of skin testing. All such decisions should be made in consultation with the physician [see Warnings and Precautions (5.2)]. 7.2 Antihistamines 1 Skin testing with allergenic extracts should not be performed within 2-3 days of first-generation H 1 -histamine receptor blockers (e.g., clemastine, diphenhydramine) and within 3 to 10 days of second-generation antihistamines (e.g., loratadine, terfenadine), except for astemizole, which requires an interval of 30-60 days between allergenic extract exposure and use. These products suppress histamine skin test reactions and could mask a positive response. 7.3 Topical Corticosteroids and Topical Anesthetics 1 Topical corticosteroids may suppress skin reactivity and should be discontinued at the skin test site for at least 2-3 weeks before skin testing. Topical local anesthetics may suppress flare responses and should be avoided at skin test sites. 7.4 Tricyclic Antidepressants 1 Tricyclic antidepressants can have potent antihistamin…
Adverse Reactions
6 ADVERSE REACTIONS Systemic reactions consist primarily of allergic symptoms, such as generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema, and hypotension. Additional symptoms that are not usually associated with allergy also may occur, such as nausea, emesis, abdominal cramps, and diarrhea. Serious reactions may cause shock, loss of consciousness, and even death. Based on published studies, 7,8 systemic reactions occur in less than 1% of patients receiving conventional immunotherapy to greater than 36% in some studies of patients receiving rush immunotherapy. Local reactions at the injections site are the most commonly occurring reactions (e.g., erythema, itching, swelling, tenderness, pain). Although most adverse systemic reactions occur within 30 minutes of injection (some within minutes of extract exposure), such reactions also can occur up to six hours after skin tests or immunotherapy [see Dosage and Administration (2.2)]. 9 Systemic reactions may be fatal or near fatal (6) Systemic reactions (e.g. generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema, and hypotension) occur in 4-7% of pati…
Frequently Asked Questions
What is Standardized Mite Dermatophagoides pteronyssinus used for?
Standardized Mite Dermatophagoides pteronyssinus contains Dermatophagoides pteronyssinus. It is a concentrate taken intradermal. Consult your doctor for specific uses.
Is Standardized Mite Dermatophagoides pteronyssinus a controlled substance?
Standardized Mite Dermatophagoides pteronyssinus is not classified as a controlled substance by the DEA.
What is the generic name for Standardized Mite Dermatophagoides pteronyssinus?
The generic name for Standardized Mite Dermatophagoides pteronyssinus is Dermatophagoides pteronyssinus. There are 1 other brand versions of Dermatophagoides pteronyssinus.
What is the NDC code for Standardized Mite Dermatophagoides pteronyssinus 5000 [AU]/mL?
The NDC (National Drug Code) for Standardized Mite Dermatophagoides pteronyssinus 5000 [AU]/mL is 22840-0035, listed by Greer Laboratories, Inc..