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EPIPEN (epinephrine) Warnings And Precautions

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Pfizer reconnaît les préoccupations du grand public concernant la situation liée à la COVID-19, qui continue d'évoluer. Cliquez ici pour savoir comment nous avons réagi.

Warnings And Precautions

Emergency Treatment

EpiPen® and EpiPen Jr® are intended for immediate administration as emergency supportive therapy and are not intended as a substitute for immediate medical care. In conjunction with the administration of epinephrine, the patient should seek immediate medical or hospital care. More than two sequential doses of epinephrine should only be administered under direct medical supervision.

General

All patients who are prescribed EpiPen® and EpiPen Jr® should be thoroughly instructed to understand the indications for use and the correct method of administration. It is strongly advised also to educate the patient's immediate associates (e.g. parents, caregivers, teachers) for the correct usage of EpiPen® and EpiPen Jr® in case support is needed in the emergency situation.

Patients with a history of anaphylaxis are at risk for subsequent episodes and even death. All patients who have had one or more episodes of anaphylaxis should have injectable epinephrine with them or with their parent or caregiver at all times, and should wear some form of medical identification bracelet or necklace.

Following the resolution of an anaphylactic episode and discharge from hospital, the patient should immediately obtain and fill a new EpiPen® or EpiPen® Jr auto-injector prescription.

Epinephrine injection is not intended as a substitute for medical attention or hospital care. In conjunction with the administration of epinephrine, the patient should seek appropriate medical care.

The patient/carer should be informed about the possibility of biphasic anaphylaxis which is characterised by initial resolution followed by recurrence of symptoms some hours later.

In patients with a thick subcutaneous fat layer, there is risk for adrenaline not reaching the muscle tissue resulting in a suboptimal effect.

Antihistamines and asthma medications must not be used as first line treatment for an anaphylactic reaction5.

Injection-Related Complications

Epinephrine should ONLY be injected into the anterolateral aspect of the thigh.

Do not inject intravenously: Large doses or accidental intravenous injection of epinephrine may result in cerebral hemorrhage due to sharp rise in blood pressure. Rapidly acting vasodilators can counteract the marked pressor effects of epinephrine if there is such inadvertent administration.

Do not inject into buttock: Patients should be advised that EpiPen® and EpiPen Jr® is not intended for injection into the buttock. Injection into the buttock may not provide effective treatment of anaphylaxis; advise the patient to go immediately to the nearest emergency room for further treatment of anaphylaxis. Additionally, injection into the buttock has been associated with Clostridial infections (gas gangrene).

Do not inject into digits, hands or feet: Since epinephrine is a strong vasoconstrictor, accidental injection into the hands or feet may result in loss of blood flow to the affected areas and should be avoided. If there is an accidental injection into these areas, the patient must go immediately to the nearest emergency room for treatment.

Hold leg firmly during injection. Lacerations, bent needles, and embedded needles have been reported when EpiPen® and EpiPen Jr® have been injected into the thigh of young children who are uncooperative and kick or move during an injection. To minimize the risk of injection related injury when administering EpiPen® to young children, instruct caregivers to hold the child’s leg firmly in place and limit movement prior to and during injection.

Serious Infections at the Injection Site

Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported at the injection site following epinephrine injection for anaphylaxis. Clostridium spores can be present on the skin and introduced into the deep tissue with subcutaneous or intramuscular injection. While cleansing with alcohol may reduce presence of bacteria on the skin, alcohol cleansing does not kill Clostridium spores. To decrease the risk of Clostridium infection, do not inject EpiPen® into the buttock. Advise patients to seek medical care if they develop signs or symptoms of infection, such as persistent redness, warmth, swelling, or tenderness, at the epinephrine injection site.

The presence of a condition listed below is not a contraindication to epinephrine administration in an acute, life-threatening situation. Therefore, patients with these conditions, or any other person who might be in a position to administer epinephrine to a patient with these conditions experiencing anaphylaxis, should be instructed about the circumstances under which epinephrine should be used:

Cardiovascular

Epinephrine use should be avoided in patients with cardiogenic, traumatic, or hemorrhagic shock; cardiac dilation; and/or cerebral arteriosclerosis.

Epinephrine should be used with caution in patients with cardiac arrhythmias, coronary artery or organic heart disease, hypertension, or in patients who are on medications that may sensitize the heart to arrhythmias, e.g., digitalis, diuretics, or anti-arrhythmics. In such patients, epinephrine may precipitate or aggravate angina pectoris as well as produce ventricular arrhythmias.

Patients with hypertension or hyperthyroidism are prone to more severe or persistent effects.

Endocrine and Metabolism

Patients with diabetes may develop increased blood glucose levels following epinephrine administration.

Neurologic

Epinephrine use should be avoided in patients with organic brain damage.

Patients with Parkinson’s disease may notice a temporary worsening of symptoms after treatment with epinephrine.

Ophthalmologic

Epinephrine use should be avoided in patients with narrow-angle glaucoma.

Respiratory

There is a significantly increased risk of respiratory symptoms in patients with concomitant asthma, especially if poorly controlled. These patients are at increased risk of death from anaphylaxis.

Fatalities may also occur from pulmonary edema resulting from peripheral constriction and cardiac stimulation.

There is also a risk for adverse reactions after the administration of adrenaline to patients with hyperthyroidism, phaeochromocytoma, severe renal impairment, prostate adenoma, hypercalcaemia, hypokalaemia, and in elderly patients and pregnant women.

Sensitivity

This product contains sodium metabisulfite, a substance which may cause allergic-type reactions including anaphylactic symptoms or mild to severe asthmatic episodes in certain susceptible persons.

Nevertheless, epinephrine is the drug of choice for serious allergic reactions and the presence of a sulfite in this product should not deter administration of the drug for treatment of serious allergic or other emergency situations, even if the patient is sulfite-sensitive.

Reproduction

No studies have been conducted to determine epinephrine’s potential effect on fertility.

Special Populations

Geriatrics (>65 years of age):

Elderly patients with hypertension, coronary artery disease or cardiac arrythmias are particularly at risk for epinephrine overdose. More careful monitoring and avoidance of epinephrine overdose is recommended for these patients.

Pediatrics (patients 15-30 kg):

There are no data to suggest a difference in safety or effectiveness of epinephrine between adults and children in this weight group.

See DOSAGE AND ADMINISTRATION section for dosage requirements based on weight.

Pregnancy:

Although there are no adequate and well-controlled studies in pregnant women, epinephrine should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

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