Product Monograph - Adrenalin Topical Solution
PRECAUTIONS
ADRENALIN® TOPICAL SOLUTION should be protected from exposure to light. Do not remove from carton until ready to use. Do not use if solution is pinkish or darker than slightly yellow or contains a precipitate.
Epinephrine is readily destroyed by alkalis and oxidizing agents. In the latter category are oxygen, chlorine, bromine, iodine, permanganates, chromates, nitrites and salts of easily reducible metals, especially iron.
The effects of epinephrine may be potentiated by tricyclic antidepressants; certain antihistamines, eg. diphenhydramine, tripelennamine , d-chlorpheniramine; and sodium L-thyroxine.
ADVERSE REACTIONS
Adverse events depend on the systemic absorption of epinephrine following topical use. Systemic pressure can increase as more concentrated solution is used.
Transient and minor side effects of anxiety, headache, fear and palpitations often occur with therapeutic doses, especially in hyperthyroid individuals. “Epinephrine-fastness” can occur with prolonged use.
DOSAGE AND ADMINISTRATION
Vial opening instructions
ADRENALIN® TOPICAL SOLUTION is intended for topical use only. In order to obtain the solution, the cap of the vial should be removed completely by following the steps below:
Topical administration: Apply the 1 mg / mL solution locally with a sterile swab, as required. Do not inject. Sterile until opened.
Step 1: Lift the cap following the arrow that says “LIFT HERE”.
Step 2: Holding the cap, pull the metal ferrule back and all the way around the vial before tearing off.
Note: This is an important step and will help ensure that the rubber stopper can be removed in Step 3.
Step 3: Remove the rubber stopper to pour out the solution.
COMPOSITION
Vial: Each mL of ADRENALIN® TOPICAL SOLUTION contains: epinephrine 1 mg as the hydrochloride dissolved in isotonic sodium chloride solution with sulfites as an antioxidant and 0.5% chlorobutanol as a preservative. Non-medicinal ingredients: chlorobutanol, hydrochloric acid, sodium metabisulfite and sodium chloride.
STABILITY AND STORAGE RECOMMENDATIONS
Protect from light and freezing. Store at room temperature between 15 °C and 30 °C.
AVAILABILITY OF DOSAGE FORMS
ADRENALIN® TOPICAL SOLUTION is for topical application only. Do not inject.
ADRENALIN® TOPICAL SOLUTION is available in vials of 30 mL, each containing 30 mg epinephrine as the hydrochloride. Each vial consists of a removable tear-off metal ferrule and rubber stopper, which allows for the solution to be poured out.
PHARMACEUTICAL INFORMATION
Drug Substance
Proper Name: L-Epinephrine Hydrochloride
Chemical Name: 4-[(1L)-1-hydroxy-2-(methylamino)ethyl]benzene-1,2-diol hydrochloride
Empirical Formula: (Levorotatory isomer) C9H13NO3 • HCl
Molecular Weight: 219.66 g/mol
Structural Formula:
- HCl
In-house revision date: OCT 6, 2022