Prescription Drugs

CLINICAL PHARMACOLOGY Amyl nitrite (amyl nitrite inhalant) 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 (amyl nitrite inhalant) 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 onethird of the inhaled amyl nitrite (amyl nitrite inhalant) is excreted in the urine.

Amyl Nitrite Inhalant, USP (amyl nitrite (amyl nitrite inhalant) inhalant) DESCRIPTION Amyl nitrite (amyl nitrite inhalant) 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 (amyl nitrite inhalant) 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 ™ 2 %. The structural formula of amyl nitrite is: (CH3)2CHCH2CH2ONO

INDICATIONS Amyl nitrite (amyl nitrite inhalant) is indicated for the rapid relief of angina pectoris. Its effect appears within 30 seconds and lasts for approximately 3 to 5 minutes. DOSAGE AND ADMINISTRATION With the patient in recumbent or seated position a capsule of amyl nitrite (amyl nitrite inhalant) 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 (amyl nitrite inhalant) 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 (26°-46° F). The James Alexander Corporation, Blairstown, New Jersey 07825. Rev. 02 December 2004. FDA revision date: 12/1/2004

PATIENT INFORMATION Amyl nitrite (amyl nitrite inhalant) should be taken by the patient when seated or lying down.

OVERDOSE Symptoms Inhaled doses of 5 to 10 drops of amyl nitrite (amyl nitrite inhalant) 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 post arteriolar 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 shocklike 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. CONTRAINDICATIONS Since it may increase intraocular and intracranial pressures, amyl nitrite (amyl nitrite inhalant) is contraindicated or should be used with great caution in patients with glaucoma, recent head trauma or cerebral hemorrhage. Amyl nitrite (amyl nitrite inhalant) 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.

SIDE EFFECTS Mild transitory headache, dizziness and flushing of the face are common with the use of amyl nitrite (amyl nitrite inhalant) . 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 (amyl nitrite inhalant) 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. DRUG INTERACTIONS Taking amyl nitrite (amyl nitrite inhalant) after drinking alcohol may worsen side effects and may cause severe hypotension and cardiovascular collapse.

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. CAUTION: Amyl Nitrite (amyl nitrite inhalant) is very flammable. Do not use where it might become ignited. PRECAUTIONS General Tolerance to amyl nitrite (amyl nitrite inhalant) 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. 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 (amyl nitrite inhalant) , It is also not known whether amyl nitrite (amyl nitrite inhalant) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Amyl nitrite (amyl nitrite inhalant) 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 (amyl nitrite inhalant) is administered to a nursing woman. Pediatric Use Safety and effectiveness in children have not been established.