Adrenalin
Generic: EPINEPHRINE
Basic Information
Manufacturer
Medical Purchasing Solutions, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAMUSCULAR
FDA Set ID
b622a9b9-2f09-46e4-e053-2995a90aae01
Indications & Usage
1 INDICATIONS AND USAGE Adrenalin ® is a non-selective alpha and beta adrenergic agonist indicated for: Emergency treatment of allergic reactions (Type 1), including anaphylaxis ( 1.1 ) To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock ( 1.2 ) 1.1 Anaphylaxis Emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.
1.2 Hypotension associated with Septic Shock Adrenalinis indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
1.2 Hypotension associated with Septic Shock Adrenalinis indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
Adverse Reactions
6 ADVERSE REACTIONS Common adverse reactions to systemically administered epinephrine include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and respiratory difficulties.
These symptoms occur in some persons receiving therapeutic doses of epinephrine, but are more likely to occur in patients with heart disease, hypertension, or hyperthyroidism [ see Warnings and Precautions (5.7) ] .
The true incidence of adverse reactions associated with the systemic use of epinephrine is difficult to determine.
Adverse reactions reported in observational trials, case reports, and studies are listed below by body system: Cardiovascular : angina, arrhythmias, hypertension, pallor, palpitations, tachyarrhythmia, tachycardia, vasoconstriction, ventricular ectopy and stress cardiomyopathy.
Rapid rises in blood pressure associated with epinephrine use have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease [ see Warnings and Precautions (5.7) ] .
Neurological : disorientation, impaired memory, panic, psychomotor agitation, sleepiness, tingling.
Psychiatric : anxiety, apprehensiveness, restlessness.
Other : Patients with Parkinson’s disease may experience psychomotor agitation or a temporary worsening of symptoms [ see Warnings and Precautions (5.7) ] .
Diabetic patients may experience transient increases in blood sugar.
Injection into the buttock has resulted in cases of gas gangrene [ see Warnings and Precautions (5.1) ] .
Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported following epinephrine injection in the thigh [ see Warnings and Precautions (5.2) ].
Common adverse reactions to systemically administered epinephrine include anxiety, tremor, weakness, dizziness, sweating, palpitations and pallor ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Par Pharmaceutical at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
These symptoms occur in some persons receiving therapeutic doses of epinephrine, but are more likely to occur in patients with heart disease, hypertension, or hyperthyroidism [ see Warnings and Precautions (5.7) ] .
The true incidence of adverse reactions associated with the systemic use of epinephrine is difficult to determine.
Adverse reactions reported in observational trials, case reports, and studies are listed below by body system: Cardiovascular : angina, arrhythmias, hypertension, pallor, palpitations, tachyarrhythmia, tachycardia, vasoconstriction, ventricular ectopy and stress cardiomyopathy.
Rapid rises in blood pressure associated with epinephrine use have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease [ see Warnings and Precautions (5.7) ] .
Neurological : disorientation, impaired memory, panic, psychomotor agitation, sleepiness, tingling.
Psychiatric : anxiety, apprehensiveness, restlessness.
Other : Patients with Parkinson’s disease may experience psychomotor agitation or a temporary worsening of symptoms [ see Warnings and Precautions (5.7) ] .
Diabetic patients may experience transient increases in blood sugar.
Injection into the buttock has resulted in cases of gas gangrene [ see Warnings and Precautions (5.1) ] .
Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported following epinephrine injection in the thigh [ see Warnings and Precautions (5.2) ].
Common adverse reactions to systemically administered epinephrine include anxiety, tremor, weakness, dizziness, sweating, palpitations and pallor ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Par Pharmaceutical at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.