- Approval Id
- cff3e4b5c545079a
- Drug Name
- EPIPEN (EPINEPHRINE) AUTO-INJECTOR 0.3MG/DOSE (1MG/ML)
- Product Name
- EPIPEN (EPINEPHRINE) AUTO-INJECTOR 0.3MG/DOSE (1MG/ML)
- Approval Number
- SIN13288P
- Approval Date
- 2007-06-07
- Registrant
- GOOD PHARMACEUTICAL PTE. LTD.
- Licence Holder
- GOOD PHARMACEUTICAL PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION
- Dosage
- <p><strong>2 DOSAGE AND ADMINISTRATION</strong></p>
<p><strong>2.1 Recommended Dosage According to Patient Body Weight</strong></p>
<ul>
<li>Patients greater than or equal to 30 kg (approximately 66 pounds or more): EpiPen 0.3 mg</li>
<li>Patients 15 kg to 30 kg (33 pounds to 66 pounds): EpiPen Jr 0.15 mg</li>
</ul>
<p><strong>2.2 Administration Instructions</strong></p>
<ul>
<li>It is recommended that patients are prescribed and have immediate access to two EpiPen or EpiPen Jr devices at all times.</li>
<li>Inject the single-dose EpiPen or EpiPen Jr intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary. Do not inject intravenously, and do not inject into buttocks, into digits, hands or feet <em>[see Warnings and Precautions (5.2)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</li>
<li>Instruct caregivers of young children who are prescribed an EpiPen or EpiPen Jr and who may be uncooperative and kick or move during an injection to hold the leg firmly in place and limit movement prior to and during an injection <em>[see Warnings and Precautions (5.2)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</li>
<li>Each EpiPen or EpiPen Jr is a single-dose epinephrine injection for single use. Since the doses of epinephrine delivered from EpiPen or EpiPen Jr are fixed, consider using other forms of injectable epinephrine if doses lower than 0.15 mg are deemed necessary.</li>
<li>With severe persistent anaphylaxis, repeat injections with an additional EpiPen or EpiPen Jr may be necessary. More than two sequential doses of epinephrine should only be administered under direct medical supervision <em>[see Warnings and Precautions (5.1)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</li>
<li>The epinephrine solution in the clear window of the EpiPen or EpiPen Jr Auto-Injector should be inspected visually for particulate matter and discoloration.</li>
</ul>
<p><u>Discarding After Use:</u><br>
The EpiPen and EpiPen Jr each contain 2 mL epinephrine solution. Approximately 1.7 mL remains in the auto-injector after activation, but is not available for future use, and should be discarded.</p>
- Route Of Administration
- INTRAMUSCULAR
- Indication Info
- <p><strong>1 INDICATIONS AND USAGE</strong></p>
<p>EpiPen and EpiPen Jr are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.</p>
<p>EpiPen and EpiPen Jr are intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions.</p>
<p>Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema.</p>
<p>EpiPen and EpiPen Jr are intended for immediate administration as emergency supportive therapy only and are not a substitute for immediate medical care.</p>
- Contraindications
- <p><strong>4 CONTRAINDICATIONS</strong></p>
<p>None</p>
- Atc Code
- C01CA24
- Atc Item Name
- epinephrine
- Pharma Manufacturer Name
- GOOD PHARMACEUTICAL PTE. LTD.
