"SILVER SPRING, MD â€” The US Food and Drug Administration (FDA) is warning of several treatment-related serious adverse events in association with implantable left ventricular assist devices (LVADs) in heart-failure patients.
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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.
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.
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.
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.
Safety and effectiveness in children have not been established.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 9/25/2008
Additional Amyl Nitrite Information
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