Adrenalin (EPINEPHrine (Nasal))

Name: Adrenalin (EPINEPHrine (Nasal))

What are some things I need to know or do while I take Adrenalin?

  • Tell all of your health care providers that you take Adrenalin. This includes your doctors, nurses, pharmacists, and dentists.
  • If you are 65 or older, use this medicine with care. You could have more side effects.
  • Talk with the doctor before you give Adrenalin to a child younger than 6 years old.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

For the Consumer

Applies to epinephrine topical: nasal solution

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to epinephrine topical: topical solution

Cardiovascular

Cardiovascular side effects have included elevations in heart rate or blood pressure in up to 55% and arrhythmias in 3% to 17% (including fatal ventricular arrhythmias) when used to treat cardiac arrest. In smaller doses, epinephrine has caused peripheral coronary arterial vasodilation, but in larger doses, epinephrine has caused diffuse vasoconstriction. This has caused increased peripheral vascular resistance, which was important in patients with coronary artery disease (worsened myocardial ischemia/angina) or hypertension (risk of emergent hypertension/stroke). Dilated cardiomyopathy and acute left ventricular dysfunction have been associated with the use of epinephrine.[Ref]

Epinephrine can induce hypokalemia with resultant T wave changes on the electrocardiogram.

Rare cases of myocardial infarction have been associated with relatively small doses of epinephrine in patients at risk for coronary artery disease.

Rare cases of cardiomyopathy have been associated with brief and chronic exposure to epinephrine (including inhaled epinephrine). Animal studies have shown that catecholamines can cause an influx of calcium into myocardial cells, which may cause myocardial injury, particularly during periods of epinephrine-induced coronary vasoconstriction. Limited animal data suggest that calcium antagonists may protect against the cardiotoxic effects of catecholamines by preventing the generation of plasma borne cytotoxic compounds, which are probably free radicals.

Epinephrine may be more arrhythmogenic in some patients, such as patients with congenital long QT syndrome.[Ref]

Nervous system

Nervous system side effects have included fear, agitation, anxiety, tenseness, restlessness, headache, tremor, dizziness, lightheadedness, nervousness, sleeplessness, excitability, weakness, and increased parkinsonian tremors. Complications associated with epidural anesthesia with epinephrine have included nerve root ischemia and clinical paralysis/plegia..[Ref]

Respiratory

Respiratory side effects have rarely included pulmonary edema. In some cases, acute left ventricular dysfunction has been documented in the presence of epinephrine-induced pulmonary edema. In some patients, epinephrine has precipitated severe, prolonged asthmatic attacks.[Ref]

Hypersensitivity

Hypersensitivity side effects have been extremely unusual. Contact dermatitis has been associated with ocularly applied epinephrine. These reactions have typically presented with lid edema and a thick yellow discharge.[Ref]

Local

Local side effects have included local tissue ischemia after repeated injections. Chronic IM epinephrine injections have induced local vasoconstriction, predisposing patients to Clostridial infections.[Ref]

Metabolic

Metabolic side effects have included severe metabolic acidosis because of elevated blood concentrations of lactic acid after prolonged use of intravenous epinephrine. Catecholamines have induced glycogenolysis, elevated blood glucose and insulin concentrations, and hypokalemia. Rare cases of hyperglycemia and acidosis have been associated with high catecholamine states, such as anaphylaxis.[Ref]

Psychiatric

Psychiatric side effects have included agitation, disorientation, impaired memory, aggressive or assaultive behavior, hallucinations, and psychosis.[Ref]

Renal

Mattana and Singhal reviewed 420 consecutive cases of cardiac arrest and found a 28.6% incidence of acute renal failure (ARF) among patients who survived for at least 24 hours after cardiac arrest. Patients in whom ARF developed received markedly higher doses of epinephrine during resuscitative efforts than patients without ARF. High doses of epinephrine were associated with a longer duration of cardiopulmonary resuscitation. The patients with ARF had a significantly decreased survival rate. It is possible that patients with severe cardiac disease were less resuscitatable, required more epinephrine, and were prone to develop ARF anyway. Other data have failed to associated ARF with the use of high dose epinephrine.[Ref]

Renal side effects have included new or worsened renal insufficiency in adult survivors of cardiac arrest, adults who underwent epinephrine-assisted venography, and in rare pediatric cases.[Ref]

Some side effects of epinephrine topical may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Epinephrine topical Pregnancy Warnings

Because epinephrine is an endogenous catecholamine its relationship to adverse pregnancy outcomes is difficult to determine. Moreover, it is usually only used in dire situations that may otherwise portend fetal risk, such as shock, allergic reactions, and severe bronchial asthma. Epinephrine crosses the human placenta and may, in high concentrations, cause both maternal and fetal glycogenolysis and elevated blood glucose concentrations. Animal data indicate that epinephrine may cause decreased placental blood flow, increasing the risk of fetal hypoxemia. There has been an interesting debate in the medical literature as to whether endogenous epinephrine and other vasoactive substances play an etiologic role in placental insufficiency, preeclampsia or toxemia of pregnancy. Data from the Collaborative Perinatal Project (CPP), in which 50,282 mother-child pairs were retrospectively examined, reveal a survival- and race-standardized relative risk for any malformation associated with epinephrine and any sympathomimetic agent of 1.99 and 1.30, respectively. These data are based on an incidence of 22 malformed children from 189 cases (of the 50,282 pairs) where there was first trimester exposures to epinephrine. These data reveal evidence of an association between the use of epinephrine and congenital malformations, although underlying diseases were not accounted for in the analysis. Data from the Michigan Medicaid Birth Defects Study (MMBDS) reveal no evidence of an association between the use of epinephrine and congenital malformations (written communication, Franz Rosa, MD, Food and Drug Administration, 1994). The MMBDS is a retrospective study of 229,101 deliveries between 1985 and 1992. Of the 229,101 deliveries, 35 were exposed to epinephrine during the first trimester. No defects were observed. Epinephrine has been extensively and safely used to prolong the analgesic effect of epidurally administered local anesthetics during human pregnancy. In vitro data have shown that epinephrine increases placental lactate production and increases placental glycogenolysis. While some in vitro data have shown that epinephrine stimulates the spontaneous contractile activity of the nonpregnant uterus, in vivo data have shown that the drug may inhibit uterine contractions and prolong the first stage of labor.

Epinephrine has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of teratogenicity when epinephrine was given in doses approximately 25 times the usual recommended human dose (on a per kg basis). There are no reports of teratogenicity in humans. There are no controlled data from human pregnancy. Epinephrine is only recommended for use during pregnancy when benefit outweighs risk.

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