ftangel
01-12-2010, 12:20 AM
Sciele Pharma, Inc., a Shionogi company, today announced the U.S. availability of Adrenaclick™, a single-dose, epinephrine auto-injector for the emergency treatment for severe allergic reactions (Type I) such as anaphylaxis. Adrenaclick™ will be available as a single unit or a convenient Two-Pack. It is also available in two dosing options (0.15 mg and 0.3 mg).
Adrenaclick™ delivers epinephrine, the drug of choice for anaphylactic reactions, with the use of an auto-injector. The Adrenaclick™ auto-injector is designed to ensure accurate delivery of epinephrine in the thigh through a "press-and-hold" administration technique. It is also designed for ease-of-use with clearly labeled caps, a red injector tip, and color-coded instructions on the side of the unit. Sciele is also offering free training information to help educate patients on the proper administration; full details are available online at h**p://www.adrenaclick.com.
Indication
Adrenaclick™ is indicated for the emergency treatment of severe allergic reactions (Type I) including anaphylaxis to stinging and biting insects, allergen immunotherapy, foods, drugs, diagnostic testing substances, and other allergens, as well as anaphylaxis to unknown substances or exercise-induced anaphylaxis.
Important Safety Information About Adrenaclick™
Adrenaclick™ should only be injected into the anterolateral aspect of the thigh. Accidental injection into the hands or feet may result in loss of blood flow to the affected area and should be avoided. Do Not Inject Into Buttock. Do Not Inject Intravenously.
Epinephrine should be administered with caution to patients with cardiac arrhythmias, coronary artery or organic heart disease, or hypertension. In patients with coronary insufficiency or ischemic heart disease, epinephrine may precipitate or aggravate angina pectoris as well as produce ventricular arrhythmias. It should be recognized that the presence of these conditions is not a contraindication to epinephrine administration in an acute, life-threatening situation.
Adverse reactions to epinephrine include transient, moderate anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; nausea and vomiting; headache, and/or respiratory difficulties.
The effects of epinephrine may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors, sodium levothyroxine, and certain antihistamines, notably chlorpheniramine, tripelennamine, and diphenhydramine.
Adrenaclick™ is designed as an emergency supportive therapy only and is not a replacement or substitute for immediate medical care. Since the dose of epinephrine delivered from Adrenaclick™ is fixed, the physician should consider other forms of injectable epinephrine if doses lower than those available from Adrenaclick™ are felt to be necessary (e.g., patients who weigh less than 15 kilograms, approximately 33 pounds). Full prescribing information for Adrenaclick is at h**p://www.adrenaclick.com.
Source
Sciele Pharma, Inc.
Shionogi & Co., Ltd.
Adrenaclick™ delivers epinephrine, the drug of choice for anaphylactic reactions, with the use of an auto-injector. The Adrenaclick™ auto-injector is designed to ensure accurate delivery of epinephrine in the thigh through a "press-and-hold" administration technique. It is also designed for ease-of-use with clearly labeled caps, a red injector tip, and color-coded instructions on the side of the unit. Sciele is also offering free training information to help educate patients on the proper administration; full details are available online at h**p://www.adrenaclick.com.
Indication
Adrenaclick™ is indicated for the emergency treatment of severe allergic reactions (Type I) including anaphylaxis to stinging and biting insects, allergen immunotherapy, foods, drugs, diagnostic testing substances, and other allergens, as well as anaphylaxis to unknown substances or exercise-induced anaphylaxis.
Important Safety Information About Adrenaclick™
Adrenaclick™ should only be injected into the anterolateral aspect of the thigh. Accidental injection into the hands or feet may result in loss of blood flow to the affected area and should be avoided. Do Not Inject Into Buttock. Do Not Inject Intravenously.
Epinephrine should be administered with caution to patients with cardiac arrhythmias, coronary artery or organic heart disease, or hypertension. In patients with coronary insufficiency or ischemic heart disease, epinephrine may precipitate or aggravate angina pectoris as well as produce ventricular arrhythmias. It should be recognized that the presence of these conditions is not a contraindication to epinephrine administration in an acute, life-threatening situation.
Adverse reactions to epinephrine include transient, moderate anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; nausea and vomiting; headache, and/or respiratory difficulties.
The effects of epinephrine may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors, sodium levothyroxine, and certain antihistamines, notably chlorpheniramine, tripelennamine, and diphenhydramine.
Adrenaclick™ is designed as an emergency supportive therapy only and is not a replacement or substitute for immediate medical care. Since the dose of epinephrine delivered from Adrenaclick™ is fixed, the physician should consider other forms of injectable epinephrine if doses lower than those available from Adrenaclick™ are felt to be necessary (e.g., patients who weigh less than 15 kilograms, approximately 33 pounds). Full prescribing information for Adrenaclick is at h**p://www.adrenaclick.com.
Source
Sciele Pharma, Inc.
Shionogi & Co., Ltd.