NDC 46414-2222 Amyl Nitrite

Amyl Nitrite

NDC Product Code 46414-2222

NDC 46414-2222-8

Package Description: 144 AMPULE in 1 CARTON > .3 mL in 1 AMPULE (46414-2222-1)

NDC Product Information

Amyl Nitrite with NDC 46414-2222 is a a human prescription drug product labeled by James Alexander Corporation. The generic name of Amyl Nitrite is amyl nitrite. The product's dosage form is inhalant and is administered via respiratory (inhalation) form.

Labeler Name: James Alexander Corporation

Dosage Form: Inhalant - A special class of inhalations consisting of a drug or combination of drugs, that by virtue of their high vapor pressure can be carried by an air current into the nasal passage where they exert their effect; the container from which the inhalant generally is administered is known as an inhaler.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Amyl Nitrite Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • AMYL NITRITE .3 g/.3mL

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: James Alexander Corporation
Labeler Code: 46414
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 02-07-1979 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Amyl Nitrite Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

Description: Amyl nitrite is a rapidly  acting vasodilator administered by inhalation.  0.3 ml 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 Flexol(tm) 2 percent. The structural formula of amyl nitrite is:

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 symptons. 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.

Indications & 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.

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.

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.

Precautions

Amyl nitrite is very flammable.  Do not use where it might become ignited.  General - Tolerance to amyl nitrite may develop with repeated use of the drug for prolonged periods of time.  Tolerance may be minimized by beginning with the smallest effective dose and alternating the drug with another coronary vasodilator.  High doses of nitrites may produce methemoglobinemia, especially in individuals with methemoglobin reductase deficiency or other metabolic abnormality that interferes with the normal conversion of methemoglobin back to hemoglobin. Patient Information - Amyl nitrite should be taken by the patient when seated or lying down. Drug Interactions - Taking amyl nitrite after drinking alcohol may worsen side effects and may cause severe hypotension and cardiovascular collapse.  Carcinogenesis, Mutagenesis, Fertility Impairment - Adequate long term studies to establish adverse carcinogenic potential of this drug have not been reported. Pregnancy - Teratogenic effects. Category C. Animal studies have not been conducted with amyl nitrite.  It is also not known whether amyl nitrite can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Amyl nitrite should be given to a pregnant woman only if clearly needed. Nursing Mothers - It is not known whether this drug is excreted in human milk.  Because many drugs are excreted in human milk, caution should be exercised when amyl nitrite is administered to a nursing woman. Pediatric Use - Safety and effectiveness in children have not been established.

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.

Drug Abuse And Dependence

Abuse. Volatile nitrites are abused for sexual stimulation, with headache as a common side effect. Dependence. Tolerance to nitrites can develop conditions and duration have not been established.

Overdosage

Symptons. 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. Symptons comparable to shock may be produced such as weakness, restlessness sweating pallor nausea vomiting snycope 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.

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.

How Supplied

James Alexander brand amyl nitrite is furnished in covered glass capsules. Each capsule contains 0.3 ml in boxes of 12. The capsule contents are flammable and should be protected from light. Storage should be in a cold place. 2 - 8 C 36 to 46 F. The James Alexander Corporation Blairstown, NJ 07825.

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