Chemical formula: C₉H₁₃NO₃ Molecular mass: 183.204 g/mol PubChem compound: 5816
Epinephrine interacts in the following cases:
Alpha-blockers antagonise the vasoconstriction and hypertension effects of adrenaline, increasing the risk of hypotension and tachycardia.
Risk of aggravation of pressor action.
Increased pressor action of adrenaline, usually moderate.
Concomitant administration of other sympathomimetic agents with adrenaline may increase toxicity due to possible additive effects.
The risk of toxicity by adrenaline is increased in severe renal impairment.
Adrenaline-induced hyperglycaemia may lead to loss of blood-sugar control in diabetic patients treated with insulin or oral hypoglycaemic agents.
Adrenaline inhibits the secretion of insulin, thus increasing the blood glucose level. It is unlikely if given in an acute emergency situation that adrenaline would have any persistent effect on blood glucose levels, but for diabetic patients receiving adrenaline it may be necessary to increase their dose of insulin or oral hypoglycaemic medicinal products.
Severe hypertension and reflex bradycardia may occur with non-cardioselective beta-blocking agents. Beta-blockers, especially non-cardioselective agents, also antagonise the cardiac and bronchodilator effects of adrenaline.
The beta-stimulating effect of adrenaline may be inhibited by simultaneous treatment with beta-blocking medicinal products, e.g. propanolol.
Severe ventricular arrhythmia (increase in cardiac excitability).
Paroxysmal hypertension with the possibility of arrhythmia (inhibition of the entry of sympathomimetics into sympathetic fibres).
The risk of toxicity by adrenaline is increased if the following conditions are pre-existing:
The risk of toxicity by adrenaline is increased if the following conditions are pre-existing:
Adrenaline may increase intra-ocular pressure in patients with narrow angle glaucoma.
Adrenaline should be used with caution in patients with prostatic hyperplasia with urinary retention.
The risk of toxicity by adrenaline is increased in cerebrovascular disease, organic brain damage or arteriosclerosis.
Teratogenic effect has been demonstrated in animal experiments.
Adrenaline should only be used during pregnancy if the potential benefits outweigh the possible risks to the foetus. If used during pregnancy, adrenaline may cause anoxia to the foetus.
Adrenaline usually inhibits spontaneous or oxytocin induced contractions of the uterus and may delay the second stage of labour. In dosage sufficient to reduce uterine contractions, adrenaline may cause a prolonged period of uterine atony with haemorrhage. For this reason parenteral adrenaline should not be used during the second stage of labour.
There are no data on the effect of nasal adrenaline in pregnant women.
A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicates no malformation or feto/neonatal toxicity of adrenaline. While an endogenous substance and blood levels after administration of nasal adrenaline are within normal physiologic ranges, adrenaline increases blood pressure and heart rate which can impact the foetus.
Animal studies do not indicate reproductive toxicity.
The use of this medicinal product may be considered during pregnancy, if necessary.
Adrenaline is distributed into breast milk. Breast-feeding should be avoided by mothers receiving adrenaline.
There are no data on the effect of adrenaline in breast-feeding mothers. However, nasal adrenaline can be used in breast-feeding mothers.
It is unknown whether adrenaline/metabolites are excreted in human milk.
A risk to the newborns/infants cannot be excluded. However, due to its poor oral bioavailability and short half-life, exposure is expected to be very low in the breastfed infants.
No information available concerning impact of adrenaline on fertility.
There are no data on the effect of nasal adrenaline on human fertility.
Adrenaline is an endogenous substance and blood levels after administration of nasal adrenaline are within normal physiological ranges and as such it is unlikely that there would be any detrimental effects on fertility.
Not applicable in normal conditions of use.
Nasal adrenaline has no or negligible influence on the ability to drive and use machines. It is not recommended that patients who are suffering an anaphylactic reaction drive or use machines because of the anaphylactic reaction.
Frequency not known: hyperglycaemia, hypokalaemia, metabolic acidosis.
Frequency not known: anxiety, nervousness, fear, hallucinations.
Frequency not known: headache, tremors, dizziness, syncope.
Frequency not known: mydriasis.
Frequency not known: palpitations, tachycardia. Takotsubo cardiomyopathy (stress cardiomyopathy) may occur. In high dosage or for patients sensitive to adrenaline: cardiac dysrhythmia (sinus tachycardia, ventricular fibrillation/cardiac arrest), acute angina attacks, and risk of acute myocardial infarction.
Frequency not known: pallor, coldness of the extremities. In high dosage or for patients sensitive to adrenaline: hypertension (with risk of cerebral haemorrhage), vasoconstriction (for example cutaneous, in the extremities or kidneys).
Frequency not known: dyspnoea.
Frequency not known: nausea, vomiting.
Frequency not known: sweating, weakness
Repeated local injections may produce necrosis at sites of injection as a result of vascular constriction.
The most frequently occurring adverse reactions (very common events ≥10%) observed in clinical studies of nasal adrenaline were reported only after second 2 mg dose (4 mg total) and include throat irritation (18.8%), headache (17.6%), nasal discomfort (12.9%) and feeling jittery (10.6%). None of the adverse drug reactions observed in the clinical studies were serious.
Adverse reactions are summarized based on analysis of pooled safety data from primary PK/PD studies using nasal adrenaline 2 mg in adult healthy volunteers, in patients with Type 1 allergies and in patients with allergic rhinitis. The adverse reactions are ranked according to system organ class and frequency according to the following convention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1 000 to <1/100), Rare (≥1/10 000 to <1/1 000), Very rare (<1/10 000), Not known (frequency cannot be estimated from the available data).
Adverse drug reactions identified with nasal adrenaline:
| System organ class | Frequency | Adverse reaction |
|---|---|---|
| Psychiatric disorders | Common | Anxiety |
| Uncommon | Euphoric mood Nervousness | |
| Not known | Disorientation1 Memory impairment1 Panic reaction1 | |
| Nervous system disorders | Very Common | Headache |
| Common | Tremor | |
| Uncommon | Dizziness Paraesthesia Head discomfort Presyncope | |
| Not known | Psychomotor hyperactivity1 Somnolence1 | |
| Eye disorders | Uncommon | Lacrimation increased |
| Cardiac disorders | Common | Palpitations |
| Not known | Angina1 Cardiac arrhythmias1,2 Stress cardiomyopathy1 Tachyarrhythmia1 Tachycardia1 Ventricular ectopy1 | |
| Vascular disorders | Not known | Hypertension1 Vasoconstriction1 |
| Respiratory, thoracic and mediastinal disorders | Very Common | Nasal discomfort Throat irritation |
| Common | Rhinorrhoea Nasal oedema Rhinalgia Nasal congestion | |
| Uncommon | Oropharyngeal pain Nasal pruritus Sneezing Intranasal paraesthesia Paranasal sinus discomfort Epistaxis Nasal dryness Nasal mucosal disorder | |
| Gastrointestinal disorders | Uncommon | Nausea Paresthesia oral Salivary hypersecretion Toothache Gingival discomfort |
| Skin and subcutaneous tissue disorders | Uncommon | Pruritus |
| Not known | Paraesthesia1 | |
| General disorders and administration site conditions | Very Common | Feeling jittery |
| Uncommon | Chest discomfort Energy increased Fatigue Feeling hot | |
| Investigations | Common | Blood pressure increased Heart rate increased |
| Uncommon | Body temperature increased |
1 Adverse reactions that have not been observed in clinical studies with nasal adrenaline, but are known to occur with other adrenaline formulations including intravenous, intramuscular, and subcutaneous administrations.
2 Cardiac arrhythmias may follow administration of adrenaline.
In a clinical trial of paediatric subjects, 16 subjects between 8 and 17 years of age weighing more than 30 kg were treated with nasal adrenaline 2 mg. The most common adverse reactions included: nasal discomfort and intranasal paraesthesia (25.0%); sneezing (18.8%); fatigue, feeling jittery, paraesthesia, rhinalgia, and rhinorrhoea (12.5%); and epistaxis, lacrimation increased, oropharyngeal pain, and pharyngeal paraesthesia (6.3%).
There were no clinically relevant differences in the safety between the paediatric and adult populations treated with nasal adrenaline 2 mg.
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