Positive Skin Test Control - Histamine

Histamine


Jubilant Hollisterstier Llc
Human Prescription Drug
NDC 65044-9998
Positive Skin Test Control - Histamine also known as Histamine is a human prescription drug labeled by 'Jubilant Hollisterstier Llc'. National Drug Code (NDC) number for Positive Skin Test Control - Histamine is 65044-9998. This drug is available in dosage form of Injection. The names of the active, medicinal ingredients in Positive Skin Test Control - Histamine drug includes Histamine - 6 mg/mL . The currest status of Positive Skin Test Control - Histamine drug is Active.

Drug Information:

Drug NDC: 65044-9998
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Positive Skin Test Control - Histamine
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Histamine
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Jubilant Hollisterstier Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Injection
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:HISTAMINE - 6 mg/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:PERCUTANEOUS
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: BLA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 15 Jun, 1995
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 29 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: BLA103891
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Jubilant HollisterStier LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UNII:820484N8I3
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
65044-9998-15 mL in 1 VIAL (65044-9998-1)15 Jun, 1995N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Product Elements:

Positive skin test control - histamine histamine histamine histamine sodium chloride sodium bicarbonate glycerin

Drug Interactions:

(2) drug interactions: certain medications may lessen the skin test wheal and erythema responses elicited by histamine for varying time periods. conventional antihistamines should be discontinued at least 5 days before skin testing. long acting antihistamines should be discontinued for at least 3 weeks prior to skin testing. 7 topical steroids should be discontinued at the skin test site for at least 2-3 weeks before skin testing. 7,8 tricyclic antidepressants such as doxepin should be withheld for at least 7 days before skin testing. 9 the physician must determine whether the risk of severe depression occurring in patients who discontinue their medication outweighs the benefits that could be obtained from skin testing. topical local anesthetics may suppress the flare responses and should be avoided in skin test sites. 10

Boxed Warning:

Positive skin test control - histamine for percutaneous (scratch, prick or puncture) administration histamine base: 6mg/ml (histamine dihydrochloride: 10mg/ml) this product is to be used by a physician or under the supervision of a physician.

Indications and Usage:

Indications and usage positive skin test control - histamine is indicated as an adjunct in allergy skin test for diagnosis, as a positive control to test wheal-flare response of skin for evaluation of skin test response to allergenic extracts.

Warnings:

Warnings attacks of severe asthma or other serious allergic conditions may be precipitated by the administration of histamine dihydrochloride in patients with bronchial disease. caution is advised in using histamine in such patients and in those with a history of bronchial asthma. histamine dihydrochloride has not been approved for unlabeled use as gastric acid stimulus or for detecting bronchial hyperactivity.

General Precautions:

(1) general: it is necessary that scarifiers, syringes, and needles be properly sterilized before use on each patient to prevent the possibility of accidental transfer of serum hepatitis and other infectious agents from one person to another. disposable products may also be used. always have injectable epinephrine and a tourniquet available when any skin tests are being made. (see adverse reactions section) patients should be observed in the office for 30 minutes after administration of the test and instructed to return to the office promptly if symptoms of an allergic reaction or shock occur.

Dosage and Administration:

Dosage and administration (1) general parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. prior to testing, clean the skin area with ether or alcohol and allow to dry. the back or the volar surface of the arms are the most satisfactory sites for testing. skin of the posterior thighs or abdomen may be used if necessary. avoid very hairy areas where possible, since the reactions will be smaller and more difficult to interpret there. the most satisfactory areas of the back are from the posterior axillary fold to 2.5 cm from the spinal column, and from the top of the scapula to the lower rib margins. the best areas of the arms are the volar surfaces from the axilla to 2.5 or 5 cm above the wrist, skipping the anti-cubital space. the histamine test should be applied in the same test area as other allergenic extracts tests, but spaced no closer than 4 to 5 cm from adjacent test sites.
use the same technique or procedure that you use for allergen testing. the negative control is the diluent used in the extract to be tested (e.g. 50% glycerin, sterile albumin saline with phenol, sterile buffered saline with phenol). with each skin testing method, in order for the reaction to positive skin test control-histamine (6 mg/ml histamine base) to be considered valid, erythema must be present which exceeds the respective negative control by 4 mm (∑e). a wheal reaction does not have to be elicited unless there is a wheal reaction to the respective negative control. in this case, the wheal of the positive control must exceed the negative control by 4 mm (∑w) in order to be considered appropriate. record measurement of erythema and wheal diameters. tables 1 and 2 summarize skin testing results with histamine base and controls in atopic and non-atopic subjects using four different devices and methods. (2) scratch, prick or puncture test: positive skin test control-histamine, 6.0 mg/ml histamine base. the scratch, prick or puncture test should be read in 15 minutes. if a large wheal reaction occurs before that time, wipe excess histamine solution from test site. a) use a sterile scarifier for each patient. hold the scarifier between the thumb and index finger, press the sharp edge of the instrument against the skin and twirl instrument rapidly. the scratch should disrupt the outer layers of epidermis down to the germinal layer, but should not produce immediate oozing of blood. the amount of pressure needed to produce a satisfactory scratch will vary between patients according to the thickness or fragility of their skin. apply one drop of positive skin test control-histamine to the scratch test site. b) prick or puncture test: prick tests are performed by placing a drop of extract on the skin and piercing through the drop into the skin with a slight lifting motion. puncture tests are performed by placing a drop of extract on the skin and piercing through the drop perpendicular to the skin with a device such as a prick lancetter. after about 1 minute the extract may be wiped away with a dry sponge.

Contraindications:

Contraindications positive skin test control - histamine is contraindicated in patients with a history of hypersensitivity to histamine products, and in patients with hypotension, severe hypertension, vasomotor instability, severe cardiac, pulmonary or renal disease.

Adverse Reactions:

Adverse reactions large doses of histamine may precipitate systemic reactions. these reactions may include flushing, dizziness, headache, bronchial constriction, urticaria, asthma, marked hypotension or hypertension, abdominal cramps, vomiting, metallic taste, local or generalized allergic manifestations. an antihistamine preparation may be given orally, i.m. or i.v. to prevent or ameliorate systemic reactions to the drug. if a systemic or anaphylactic reaction does occur, apply a tourniquet above the site of injection and inject 1:1000 epinephrine-hydrochloride intramuscularly or subcutaneously into the opposite arm. loosen the tourniquet at least every 10 minutes. do not obstruct arterial blood flow with the tourniquet. epinephrine dosage: adult: 0.3 to 0.5 ml should be injected. repeat in 5 to 10 minutes if necessary. pediatric: the usual initial dose is 0.01 mg (ml) per kg body weight or 0.3 mg(ml) per square meter of body surface area. suggested dosage for infants to 2 years of ag
e is 0.05 ml to 0.1 ml; for children 2 to 6 years, 0.15 ml; and children 6 to 12 years, 0.2 ml. single pediatric doses should not exceed 0.3 mg (ml). doses may be repeated as frequently as every 20 minutes, depending on the severity of the condition and the response of the patient. after administration of epinephrine, profound shock or vasomotor collapse should be treated with intravenous fluids, and possibly vasoactive drugs. oxygen should be given by mask. aminophylline or adrenal corticosteroids may be used if necessary after adequate epinephrine and circulatory support has been given. emergency resuscitation measures and personnel trained in their use should be available immediately in the event of a serious systemic or anaphylactic reaction not responsive to the above measures (ref. j. allergy and clinical immunology 77s (2): p. 271-273, 1986). 16 rarely are all of the above measures necessary, the tourniquet and epinephrine usually producing prompt responses. however, the physician should be prepared in advance for all contingencies. promptness in beginning emergency treatment measures is of utmost importance. adverse event reporting report all adverse events to jubilant hollisterstier llc customer technical services department at 1 (800) 992-1120. a voluntary adverse event reporting system for health professionals is available through the fda medwatch program. preprinted forms (fda form 3500) are available from the fda by calling 1 (800) fda-1088. completed forms should be mailed to medwatch, 5600 fisher lane, rockville, md 20852-9787 or fax to: 1 (800) fda-0178.

Drug Interactions:

(2) drug interactions: certain medications may lessen the skin test wheal and erythema responses elicited by histamine for varying time periods. conventional antihistamines should be discontinued at least 5 days before skin testing. long acting antihistamines should be discontinued for at least 3 weeks prior to skin testing. 7 topical steroids should be discontinued at the skin test site for at least 2-3 weeks before skin testing. 7,8 tricyclic antidepressants such as doxepin should be withheld for at least 7 days before skin testing. 9 the physician must determine whether the risk of severe depression occurring in patients who discontinue their medication outweighs the benefits that could be obtained from skin testing. topical local anesthetics may suppress the flare responses and should be avoided in skin test sites. 10

Use in Pregnancy:

(4) pregnancy: positive skin test control-histamine. animal reproduction studies have not been conducted on histamine dihydrochloride. it is also not known whether histamine dihydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. histamine dihydrochloride should be given to a pregnant woman only if clearly needed.

Pediatric Use:

(6) pediatric use: indications and dosage for the pediatric population are the same as for adults; however, the reactions to histamine are smaller. studies have shown that the use of histamine solutions for skin test is safe in infants and young children. 4,5,6

Overdosage:

Overdosage overdosage may cause severe symptoms, including circulatory collapse, shock, and even death. intravenous administration of histamine in normal volunteers at doses of up to 1.0 µg/kg/min produced flushing, headaches, tachycardia and decreased diastolic blood pressure. 1,2,3 see adverse reactions section for emergency treatment steps.

Description:

Description histamine dihydrochloride contains histamine, a potent vasodilator having the chemical name 2-(4-imidazolyl) ethylamine. histamine has an empirical formula of c 5 h 9 n 3 , a molecular weight of 111.15, and the following chemical structure: histamine dihydrochloride is available in the following strengths: 1. scratch, prick or puncture test control: positive skin test control - histamine contains 6.0 mg/ml histamine base and is a clear, colorless, sterile solution. it consists of histamine dihydrochloride 10mg/ml, sodium chloride 0.5%, sodium bicarbonate 0.275%, and glycerin 50.0% (v/v) as a preservative. histamine chemical

Clinical Pharmacology:

Clinical pharmacology pharmacological actions of histamine include the increase of capillary and post capillary venular permeability. this vascular change leads to the wheal-flare response. large reactions can cause an amplification of a reaction to a nearby skin test. histamine is degraded either by oxidative deamination or by methylation and oxidative deamination so that the principal excretion products are imidazoleacetic acid-riboside and 1-methyl imidazoleacetic acid respectively. 2 10 atopic subjects and 10 non-atopics were tested with positive skin test control - histamine solutions, and two negative control solutions. thirteen females (35-49 years old; mean age 36.5) and 7 males (23-45 years old; mean age 36.4) were tested. this study included 19 caucasian subjects and 1 african american subject. different skin test devices produce different skin test responses. (14,15) study results are summarized in table 1 and table 2. atopic and non-atopic subject information was combined,
as there were no significant differences in their skin responses. summation of wheal (∑w) or summation of erythema (∑e) was determined by measuring the longest diameter and the mid-point orthoganol diameter of the wheal or erythema response and summing the two measurements. malling tested 25 subjects using a straight needle prick technique with histamine dihydrochloride 10mg/ml and found wheal single diameters of 5.4-8.5mm (mean 7 mm). 13 histamine dihydrochloride at 10mg/ml has been shown to elicit fewer false negative and false positive reactions than histamine dihydrochloride at 1mg/ml. 12 10mg/ml histamine dihydrochloride has been shown to be the appropriate strength to perform biological standardization using skin reactivity to histamine as a standard of comparison. 11,13 histamine table1 histamine table2

Carcinogenesis and Mutagenesis and Impairment of Fertility:

(3) carcinogenesis, mutagenesis, impairment of fertility: studies have not been performed on positive skin test control-histamine.

How Supplied:

How supplied scratch, prick or puncture test: positive skin test control-histamine (6.0 mg/ml histamine base), 5 ml sterile amber vial with dropper assembly.

Package Label Principal Display Panel:

Positive skin test control - histamine 5 ml carton label positive skin test control - histamine 5 ml carton label

Positive skin test control - histamine 5 ml vial label positive skin test control - histamine 5 ml vial label


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