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EpiPen 0.3 mg Auto Injector

EpiPen 0.3 mg Auto Injector

EpiPen

Pharmaceutical Product
  • Licensed in the UK as a prescription Only medicine (POM) under Marketing Authorisation number PL 46302/0171 for EpiPen 0.3 mg Auto Injector.
  • Regulated by the UK Medicines and Healthcare products Regulatory Agency (MHRA), with summary of product characteristics (SmPC) and patient information leaflet (PIL) available.
  • Manufactured and controlled in accordance with Good Manufacturing Practice (GMP) for medicinal products.
  • Complies with relevant pharmacopoeial and regulatory quality requirements for sterile injectable solutions.
Prescription-only adrenaline (epinephrine) auto-injector for anaphylaxis

Description

EpiPen 0.3 mg Auto-Injector is a pre-filled, single-use adrenaline (epinephrine) auto-injector indicated for the emergency treatment of severe allergic reactions (anaphylaxis). Each device delivers a fixed 0.3 mg dose of adrenaline intramuscularly into the outer thigh to rapidly treat life-threatening symptoms caused by allergens such as foods, insect stings or bites, medicines and other triggers, as well as idiopathic or exercise-induced anaphylaxis. It is a prescription-only medicine and patients at risk are advised to carry two devices at all times and use EpiPen immediately at the first signs of anaphylaxis while seeking urgent medical assistance.

Bnefits

  • Provides a rapid, fixed 0.3 mg dose of adrenaline for the emergency treatment of anaphylaxis.
  • Pre-filled, single-use auto-injector designed for fast, simple intramuscular administration into the outer thigh, including through clothing if necessary.
  • Intended for use by patients and caregivers following training, enabling early treatment outside hospital.
  • Indicated for severe allergic reactions caused by foods, insect stings or bites, medicines and other allergens, as well as idiopathic and exercise-induced anaphylaxis.
  • Helps reverse key life-threatening symptoms such as airway swelling, low blood pressure and shock by stimulating alpha and beta adrenergic receptors.
  • Compact and portable design so patients at risk can carry the device at all times.
  • Well-established product with extensive post-marketing experience and regulatory oversight.
  • Available in different strengths (0.3 mg and 0.15 mg as EpiPen Jr); 0.3 mg is typically used in adults and children over a certain weight threshold in line with prescribing information.

Indications

  • Emergency treatment of acute allergic reactions (anaphylaxis) to insect stings or bites, foods, medicines and other allergens.
  • Emergency treatment of anaphylaxis of idiopathic origin.
  • Emergency treatment of exercise-induced anaphylaxis.
  • EpiPen is intended for immediate self-administration or administration by a caregiver in patients with a known history or clear risk of anaphylaxis, as prescribed by a healthcare professional.

Composition

  • Active ingredient: Adrenaline (epinephrine) 0.3 mg per 0.3 ml dose (1 mg/ml) in a pre-filled pen.
  • Each dose also contains sodium metabisulfite (E223) as an antioxidant, sodium chloride and water for injections.
  • May contain trace amounts of sodium; excipients are present in small quantities to stabilise the solution.
  • Solution is clear and colourless; contained in a glass cartridge within the auto-injector.

Formulation

  • Solution for injection in a pre-filled auto-injector (pre-filled pen) delivering 0.3 mg adrenaline (epinephrine) in 0.3 ml via intramuscular injection into the outer thigh.

Packaging

  • Single pre-filled auto-injector containing 0.3 mg adrenaline per dose (EpiPen 0.3 mg).
  • Supplied in an individual carton with patient information leaflet.
  • In many markets also supplied as a twin pack; the Crystal Pharmacy listing is for a single 0.3 mg auto-injector.

Usage

  • EpiPen should be prescribed and patients trained by a healthcare professional in when and how to use the device.
  • Carry EpiPen at all times; many patients are advised to carry two auto-injectors in case a second dose is required.
  • Use immediately at the first signs of anaphylaxis such as widespread hives, swelling of the face or throat, difficulty breathing, wheezing, feeling faint or collapse following exposure to a known or suspected allergen.
  • Remove the safety cap as described in the instructions for use, hold the device firmly in the fist, and place the orange/needle end against the outer thigh at a right angle.
  • Press firmly until a click is heard and hold the device in place against the outer thigh for several seconds (typically about 3 seconds; follow the current instructions in the patient leaflet) to deliver the full dose.
  • EpiPen can be injected through clothing if necessary; avoid injecting into the buttock, hands, feet, or other areas.
  • After injection, remove the device and massage the injection site gently for a short period as advised in the patient leaflet.
  • Call emergency services immediately or have someone call for you, stating that anaphylaxis is suspected and adrenaline has been administered.
  • A second EpiPen dose may be administered with a new pen after approximately 5–15 minutes if symptoms do not improve or recur, in accordance with medical advice.
  • After use, place the used pen safely in its tube or a sharps container and give it to medical personnel for disposal.
  • Regularly check the solution through the viewing window; do not use if it is discoloured or contains particles, or if the expiry date has passed.

Contraindications

  • In a life-threatening anaphylactic reaction there are no absolute contraindications to the use of adrenaline.
  • Use with caution in patients with underlying cardiac disease, hyperthyroidism, hypertension, diabetes, or those receiving certain medicines such as tricyclic antidepressants or monoamine oxidase inhibitors, as recommended in the summary of product characteristics.
  • Known hypersensitivity to adrenaline or any of the excipients (including sodium metabisulfite) should be considered, but the potential benefit in anaphylaxis usually outweighs the risk.
  • Do not inject into the buttock, fingers, toes, hands or feet because of the risk of tissue ischaemia.

Adverse Effects

  • Common adrenergic effects such as palpitations, tachycardia, tremor, anxiety, headache and sweating.
  • Possible increase in blood pressure; in susceptible individuals, risk of serious cardiac events such as arrhythmias, angina or myocardial infarction, particularly in those with pre-existing heart disease.
  • Pallor, dizziness, weakness, nausea and vomiting may occur.
  • Injection site reactions including pain, bruising, bleeding, swelling or, rarely, tissue damage if injected into small extremities or injected incorrectly.
  • In rare cases, severe adverse reactions such as intracranial haemorrhage or arrhythmias have been reported, primarily in patients with significant risk factors or dosing errors.
  • All suspected adverse reactions should be reported to a healthcare professional and via national pharmacovigilance schemes.

Storage Conditions

  • Store below 25°C; do not refrigerate or freeze.
  • Keep the auto-injector in its outer carton to protect it from light.
  • Do not use EpiPen after the expiry date printed on the label and carton.
  • Periodically check the solution through the viewing window; discard and replace if the solution is discoloured (brown) or contains precipitate.
  • Keep out of the sight and reach of children.
  • Do not expose the device to extreme temperatures or direct sunlight (for example, leaving it in a parked car).

Duration

EpiPen is for single-dose, emergency use during an acute anaphylactic episode. People at continuing risk of anaphylaxis should have replacement pens prescribed before expiry and use them as needed in future reactions according to medical advice.

Onset

Adrenaline administered via intramuscular injection into the thigh generally starts to act within minutes, producing rapid increases in blood pressure, bronchodilation and reduction of oedema; clinical improvement may be seen very quickly after correct use.

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