Amyl Nitrite
James Alexander Corporation
Human Prescription Drug
NDC 46414-2222Amyl Nitrite is a human prescription drug labeled by 'James Alexander Corporation'. National Drug Code (NDC) number for Amyl Nitrite is 46414-2222. This drug is available in dosage form of Inhalant. The names of the active, medicinal ingredients in Amyl Nitrite drug includes Amyl Nitrite - .3 g/.3mL . The currest status of Amyl Nitrite drug is Active.
Drug Information:
| Drug NDC: | 46414-2222 |
| 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: | Amyl Nitrite |
| 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: | Amyl Nitrite |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | James Alexander Corporation |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Inhalant |
| 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: | AMYL NITRITE - .3 g/.3mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | RESPIRATORY (INHALATION)
|
| 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: | UNAPPROVED DRUG OTHER |
| 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: | 07 Feb, 1979 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 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. |
| 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: | James Alexander Corporation
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 577307
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 22T8Z09XAK
|
| 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 NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 46414-2222-8 | 144 AMPULE in 1 CARTON (46414-2222-8) / .3 mL in 1 AMPULE (46414-2222-1) | 07 Feb, 1979 | N/A | No |
| 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:
Amyl nitrite amyl nitrite amyl nitrite amyl nitrite linseed oil
Indications and Usage:
Indications and usage: amyl nitrite is indicated for the rapid relief of angina pectoris. its effect appears within 30 seconds and lasts for approximately 3 to 5 minutes.
Warnings:
Warnings: transient episodes of dizziness, weakness, or syncope or other signs of cerebral ischemia due to postural hypotension may develop following inhalation of amyl nitrite, particularly if the patient is standing immobile. to hasten recovery, measures which facilitate venous return such as head low posture, deep breathing and movement of extremities may be used.
Dosage and Administration:
Dosage & administration: with the patient in recumbent or seated position a capsule of amyl nitrite is held away from the face, crushed between the fingers, and held under the patient's nose. two to six inhalations of the vapors from the capsule are usually sufficient to promptly produce therapeutic effects. caution is recommended to avoid inhalation of excessive amounts of the drug when it is administered by someone other than the patient. if necessary, the dose may be repeated in 3 to 5 minutes.
Contraindications:
Contraindications: since it may increase intraocular and intracranial pressures, amyl nitrite is contraindicated or should be used with great caution in patients with glaucoma, recent head trauma or cerebral hemorrhage. amyl nitrite can cause harm to the fetus when it is administered to a pregnant woman because it significantly reduces systemic blood pressure and blood flow on the maternal side of the placenta.
Adverse Reactions:
Adverse reactions: mild transitory headache, dizziness and flushing of the face are common with the use of amyl nitrite. the following adverse reactions may occur in susceptible patients: syncope, involuntary passing of urine and feces, hypotension, pallor, cold sweat, tachycardia, restlessness, weakness, vomiting and nausea. excessively high doses of amyl nitrite administered chronically may cause methemoglobinemia.
Overdosage:
Overdosage: symptoms - inhaled doses of 5 to 10 drops of amyl nitrite may cause violent flushing of the face, accompanied by a feeling of imminent bursting of the head and very excessive heart action. the inhalation of larger amounts may produce a feeling of suffocation and muscular weakness. symptoms comparable to shock may be produced (such as weakness, restlessness, sweating, pallor, nausea, vomiting, syncope and incontinence) attributable to pooling of blood in the postarteriolar vessels and failure of the venous blood to return to the heart. treatment - measures which facilitate venous return such as head-low posture, deep breathing and movement of extremities may be used. the use of epinephrine aggravates the shock- like reaction. methylene blue should be injected for treatment of severe methemoglobinemia with dyspnea. for treating cyanide poisoning, methylene blue is contraindicated where nitrites cause iatrogenic methemoglobinemia.
Description:
Description: amyl nitrite is a rapidly acting vasodilator administered by inhalation. 0.3ml is supplied in a covered thin glass capsule which is easily crushed between the fingers. amyl nitrite is a clear, yellowish liquid having a peculiar ethereal, fruity odor. it is volatile, even at low temperatures, and is flammable. this product is stabilized with linseed oil epoxy. the structural formula of amyl nitrite is: (ch 3 ) 2 chch 2 ch 2 ono
Clinical Pharmacology:
Clinical pharmacology: amyl nitrite causes a non specific relaxation of smooth muscle with the most prominent actions occurring in vascular smooth muscle. this effect on vascular smooth muscle results in coronary vasodilation and decreased systemic vascular resistance and left ventricular preload and afterload. myocardial ischemia is relieved in patients with angina pectoris, with an abatement of chest pain and possibly other related symptoms. amyl nitrite vapors are absorbed rapidly through the pulmonary alveoli, manifesting therapeutic effects within one minute after inhalation. the drug is metabolized rapidly, probably by hydrolytic denitration; approximately one-third of the inhaled amyl nitrite is excreted in the urine.
How Supplied:
How supplied: james alexander brand amyl nitrite is furnished in covered glass capsules. each capsule contains 0.3 ml in boxes of 12. capsule contents are flammable and should be protected from light. storage should be in a cold place. 2 o - 8 o c (36 o - 46 o f) the james alexander corporation blairstown, new jersey 07825. rev. 03 july 2012 rx only.
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