Amyl nitrite

Amyl nitrite
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gerald Chi

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Overview

Amyl nitrite is a vasodilator that is FDA approved for the {{{indicationType}}} of rapid relief of angina pectoris. Common adverse reactions include syncope, involuntary passing of urine and feces, hypotension, pallor, cold sweating, tachycardia, restlessness, weakness, vomiting, and nausea.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Angina Pectoris

• Dosing Information

• 0.18 milliliter or 0.3 milliliter by inhalation
• Crush the capsule, wave under the nose and inhale 1 to 6 times; may repeat in 3 to 5 minutes

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Amyl nitrite in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Amyl nitrite in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Amyl nitrite in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Amyl nitrite in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Amyl nitrite in pediatric patients.

Contraindications

• Glaucoma, recent head trauam or cerebral hemorrhage

• 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.

• Pregnancy

• 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.

• Amyl nitrite is very flammable. Do not use where it might become ignited.

• 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.

• 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.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Amyl nitrite in the drug label.

Postmarketing Experience

• 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.

Drug Interactions

• Alcohol

• Taking amyl nitrite after drinking alcohol may worsen side effects and may cause severe hypotension and cardiovascular collapse

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy 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.

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Amyl nitrite in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Amyl nitrite during labor and delivery.

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.

Geriatic Use

There is no FDA guidance on the use of Amyl nitrite with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Amyl nitrite with respect to specific gender populations.

Race

There is no FDA guidance on the use of Amyl nitrite with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Amyl nitrite in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Amyl nitrite in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Amyl nitrite in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Amyl nitrite in patients who are immunocompromised.

Administration and Monitoring

Administration

• Inhalation

Monitoring

There is limited information regarding Monitoring of Amyl nitrite in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Amyl nitrite in the drug label.

Overdosage

• Excessively high doses of amyl nitrite administered chronically may cause methemoglobinemia.

Pharmacology

There is limited information regarding Amyl nitrite Pharmacology in the drug label.

Mechanism of Action

• 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.

Structure

• 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.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Amyl nitrite in the drug label.

Pharmacokinetics

• 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.

Nonclinical Toxicology

• Carcinogenesis, Mutagenesis, Fertility Impairment

• Adequate long term studies to establish adverse carcinogenic potential of this drug have not been reported.

Clinical Studies

There is limited information regarding Clinical Studies of Amyl nitrite in the drug label.

How Supplied

• 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.

Storage

There is limited information regarding Amyl nitrite Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

• Amyl nitrite should be taken by the patient when seated or lying down.

Precautions with Alcohol

• Taking amyl nitrite after drinking alcohol may worsen side effects and may cause severe hypotension and cardiovascular collapse.

Brand Names

• Amyl nitrite®

Look-Alike Drug Names

• N/A

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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