هذه المعلومات للأغراض التعليمية فقط. استشر دائمًا متخصصًا صحيًا. اعرف أكثر

Epinephrine In Sodium Chloride

Prescription

الأسماء التجارية: Adrenalin (epinephrine in sodium chloride)

الشكل الصيدلاني
Injection
طريق الإعطاء
INTRAVENOUS
الشركة المصنِّعة
Par Health USA, LLC

About This Medication

11. DESCRIPTION Adrenalin (epinephrine in sodium chloride injection) is a sympathomimetic catecholamine. The chemical name of epinephrine is: 1,2- Benzenediol, 4-[(1R)-1-hydroxy-2-(methylamino)ethyl]-, or (-)-3,4-Dihydroxy-α-[2- (methylamino)ethyl]benzyl alcohol. The chemical structure of epinephrine is: The molecular weight of epinephrine is 183.2. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Adrenalin (epinephrine in sodium chloride injection) is a clear, colorless, sterile solution administered by intravenous infusion, supplied in a 250 mL infusion bag. It is provided in five (5) ready-to-use concentrations containing: Ingredient Concentration 8 mcg/mL 16 mcg/mL 20 mcg/mL 32 mcg/mL 40 mcg/mL Epinephrine, USP 8 mcg 16 mcg 20 mcg 32 mcg 40 mcg Sodium chloride, USP 9 mg 9 mg 9 mg 9 mg 9 mg Disodium Edetate Dihydrate (EDTA), USP 10 mcg 10 mcg 10 mcg 10 mcg 10 mcg L (+) Tartaric Acid, NF 6.6 mcg 13.1 mcg 16.4 mcg 26.2 mcg 32.8 mcg It may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. It has a pH range of 3.7 - 4.3. The headspace in the containers has been displaced with nitrogen gas. chemical structure

المواد الفعالة

المادة الفعالة التركيز
Epinephrine -

المؤشرات العلاجية والاستخدام

1. INDICATIONS AND USAGE Adrenalin ® is a non-selective alpha and beta adrenergic agonist indicated to: Increase mean arterial blood pressure in adult patients with hypotension associated with septic shock ( 1.1 ) 1.1. Hypotension associated with Septic Shock Adrenalin is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.

آلية العمل

12.1. Mechanism of Action Epinephrine acts on both alpha and beta-adrenergic receptors. The mechanism of the rise in blood pressure is 3-fold: a direct myocardial stimulation that increases the strength of ventricular contraction (positive inotropic action), an increased heart rate (positive chronotropic action), and peripheral vasoconstriction.

الجرعة وطريقة الإعطاء

2. DOSAGE AND ADMINISTRATION No further dilution prior to infusion is required ( 2.1 ) Infuse epinephrine into a large vein ( 2.2 ) Titrate 0.05 mcg/kg/min to 2 mcg/kg/min to achieve desired blood pressure ( 2.2 ) Wean gradually ( 2.2 ) See Full Prescribing Information for instructions on administration of the injection. 2.1. General Considerations Administration Adrenalin is a ready to administer product that requires no further dilution prior to infusion. Inspect visually for particulate matter and discoloration prior to administration; solution should be clear and colorless. Do not use if the solution is colored or cloudy, or if it contains particulate matter. Do not open the aluminum overwrap until time of use. The premixed, ready-to-use infusion bag has a single port for insertion of the infusion set only. This port should not be used to remove content from the bag or add another medication. Once the infusion bag has been connected to the infusion set, it is stable for 24 hours, as long as the bag stays connected to the infusion set. Single dose only. Discontinuation When discontinuing the infusion, reduce the flow rate gradually. Avoid abrupt withdrawal. Discard unused portion. 2.2. Hypotension associated with Septic Shock Whenever possible, give infusions of epinephrine into a large vein. Avoid using a catheter tie-in technique, because the obstruction to blood flow around the tubing may cause stasis and increased local concentration of the drug. Avoid the veins of the leg in elderly patients or in those suffering from occlusive vascular diseases. To provide hemodynamic support in septic shock associated hypotension in adult patients, the suggested dosing infusion rate of intravenously administered epinephrine is 0.05 mcg/kg/min to 2 mcg/kg/min and is titrated to achieve a desired mean arterial pressure (MAP). The dosage may be adjusted periodically, such as every 10 to 15 minutes, in increments of 0.05 mcg/kg/min to 0.2 mcg/kg/min, to achieve the desired blood pressure goal. After hemodynamic stabilization, wean incrementally over time, such as by decreasing doses of epinephrine every 10 minutes to determine if the patient can tolerate gradual withdrawal.

Side Effects Overview

6. ADVERSE REACTIONS The following adverse reactions are discussed elsewhere in labeling: Hypertension [see Warnings and Precautions ( 5.1 )] Pulmonary Edema [see Warnings and Precautions ( 5.2 )] Cardiac Arrhythmias and Ischemia [see Warnings and Precautions ( 5.3 )] Extravasation and Tissue Necrosis with Intravenous Infusion [see Warnings and Precautions ( 5.4 )] Renal Impairment [see Warnings and Precautions ( 5.5 )] The following adverse reactions associated with the infusion of epinephrine were identified in the literature. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Cardiovascular disorders : tachycardia, supraventricular tachycardia, ventricular arrhythmias, myocardial ischemia, myocardial infarction, limb ischemia, pulmonary edema Gastrointestinal disorders : Nausea, vomiting General disorders and administrative site conditions : Chest pain, extravasation Metabolic : hypoglycemia, hyperglycemia, insulin resistance, hypokalemia, lactic acidosis Nervous system disorders : Headache, nervousness, paresthesia, tremor, stroke, central nervous system bleeding Psychiatric disorders : Excitability Renal disorders : Renal insufficiency Respiratory : Pulmonary edema, rales Skin and subcutaneous tissue disorders : Diaphoresis, pallor, piloerection, skin blanching, skin necrosis with extravasation Most common adverse reactions to systemically administered epinephrine are headache; anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; peripheral coldness; nausea/vomiting; and/or respiratory difficulties. Arrhythmias, including fatal ventricular fibrillation, rapid rises in blood pressure producing cerebral hemorrhage, and angina have occurred. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Endo at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

التحذيرات والاحتياطات

موانع الاستعمال

الحرائك الدوائية

12.3. Pharmacokinetics Following intravenous injection, epinephrine is rapidly cleared from the plasma with an effective half-life of < 5 minutes. A pharmacokinetic steady state following continuous intravenous infusion is achieved within 10-15 minutes. In patients with septic shock, epinephrine displays dose-proportional pharmacokinetics in the infusion dose range of 0.03 to 1.7 mcg/kg/min. Epinephrine is extensively metabolized with only a small amount excreted unchanged. Epinephrine is rapidly degraded to vanillylmandelic acid, an inactive metabolite, by monoamine oxidase and catechol-O-methyltransferase that are abundantly expressed in the liver, kidneys and other extraneuronal tissues. The tissues with the highest contribution to removal of circulating exogenous epinephrine are the liver (32%), kidneys (25%), skeletal muscle (20%), and mesenteric organs (12%). Specific Populations Elderly In a pharmacokinetic study of 45-minute epinephrine infusions given to healthy men aged 20 to 25 years and healthy men aged 60 to 65 years, the mean plasma metabolic clearance rate of epinephrine at steady state was greater among the older men (144.8 versus 78 mL/kg/min for a 0.0143 mcg/kg/min infusion). Body Weight Body weight has been found to influence epinephrine pharmacokinetics. Higher body weight was associated with a higher plasma epinephrine clearance and a lower concentration plateau.

Frequently Asked Questions

1. INDICATIONS AND USAGE Adrenalin ® is a non-selective alpha and beta adrenergic agonist indicated to: Increase mean arterial blood pressure in adult patients with hypotension associated with septic shock ( 1.1 ) 1.1. Hypotension associated with Septic Shock Adrenalin is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.

2. DOSAGE AND ADMINISTRATION No further dilution prior to infusion is required ( 2.1 ) Infuse epinephrine into a large vein ( 2.2 ) Titrate 0.05 mcg/kg/min to 2 mcg/kg/min to achieve desired blood pressure ( 2.2 ) Wean gradually ( 2.2 ) See Full Prescribing Information for instructions on administration of the injection. 2.1. General Considerations Administration Adrenalin is a ready to administer product that requires no further dilution prior to infusion. Inspect visually for particulate matter and discoloration …

5. WARNINGS AND PRECAUTIONS Monitor blood pressure frequently ( 5.1 ) Increases cardiac output and causes peripheral vasoconstriction ( 5.2 ) May induce cardiac arrhythmias and myocardial ischemia. ( 5.3 ) Avoid extravasation into tissues, which can cause local necrosis ( 5.4 ) May aggravate angina pectoris or produce ventricular arrhythmias ( 5.5 ) Constricts Renal blood vessels which may result in oliguria or renal impairment ( 5.5 ) 5.1. Hypertension Because individual response to epinephrine may vary significantly, monitor …

4. CONTRAINDICATIONS None. None ( 4 )

Epinephrine In Sodium Chloride is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

Similar Injection Products

Browse all Injection products →

References & Data Sources

إخلاء المسؤولية الطبية

المعلومات الواردة في هذه الصفحة مخصصة للأغراض التعليمية فقط ولا ينبغي استخدامها بديلًا عن المشورة الطبية المتخصصة أو التشخيص أو العلاج.

استشر دائمًا طبيبك أو أي مقدم رعاية صحية مؤهل بشأن أي أسئلة تتعلق بحالة طبية أو دواء.

مصادر البيانات: DailyMed (NLM), openFDA, MFDS

Medical Disclaimer

This content is for educational and informational purposes only. It is not a substitute for professional medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider before making medication decisions.

Data sources: ChEMBL, PubChem, DailyMed.