Adrenaline 1mg/ml
"Each ml of solution contains:
Active ingredient :
Adrenaline ........... 1 mg .
Inactive ingredients
Sodium Chloride, EDTA disodium , Tartaric acid , Sodium Metabisulphite , Water for Injections.
Company Name
CID
Therapeutic Group
CARDIAC STM EX DOPAM AGTS
Pharmaceutical form
Ampoule
Package
Carton box contains 100 ampoules each of 1 ml.
Indications
"Adrenaline (Adrenaline injection) is indicated in the emergency treatment of severe allergic reactions (Type I) including anaphylaxis to stinging insects (e.g. order Hymenoptera, which includes bees, wasps, hornets, yellow jackets and fire ants), and biting insects (e.g. triatoma, mosquitos), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g. radiocontrast media), and other allergens, as well as anaphylaxis to unknown substances (idiopathic anaphylaxis) or exercise-induced anaphylaxis. Adrenaline is intended for immediate administration in patients with a history of anaphylactic reactions.
Selection of the appropriate dosage strength is determined according to patient body weight
Such 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. Adrenaline is designed as emergency supportive therapy only and is not a replacement or substitute for immediate medical care.
Warning & Precautions
"WARNINGS Adrenaline 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. If there is an accidental injection into these areas, advise the patient to inform the healthcare provider of the accidental injection when he/she goes to the nearest emergency room for further treatment of anaphylaxis. Avoid possible inadvertent intravascular administration. Large doses injection of Adrenaline may result in cerebral hemorrhage due to a sharp rise in blood pressure. DO NOT INJECT INTRAVENOUSLY. Rapidly acting vasodilators can counteract the marked pressor effects of Adrenaline if there is such inadvertent administration. Adrenaline is the preferred treatment for serious allergic reactions or other emergency situations even though this product contains sodium bisulfite, a sulfite that may, in other products, cause allergic-type reactions including anaphylactic symptoms or life-threatening or less severe asthmatic episodes in certain susceptible persons.The alternatives to using Adrenaline in a life-threatening situation may not be atisfactory. 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. Adrenaline 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, Adrenaline 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 adrenaline administration in an acute, life-threatening situation. Adrenaline is light sensitive. Store at temperature not exceeding 30°C. Do not refrigerate; protect from freezing. Patients should periodically check adrenaline for any discoloration and/or precipitates. If the solution is discolored or contains a precipitate, the patient should replace adrenaline . PRECAUTIONS (1) General Adrenaline is not intended as a substitute for immediate medical care. In conjunction with the administration of Adrenaline, the patient should seek appropriate medical care. More than two sequential doses of Adrenaline should only be administered under direct medical supervision. Adrenaline is essential for the treatment of anaphylaxis. Patients with a history of severe allergic reactions should be instructed about the circumstances under which Adrenaline should be used. It should be determined that the patient is at risk of future anaphylaxis, since there are some concerns in specific patients with Adrenaline administration. (a) Adrenaline 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, Adrenaline may precipitate or aggravate angina pectoris as well as produce ventricular arrhythmias. (b) The effects of epinephrine may be potentiated by tricyclic antidepressants and monoamine oxidase inhibitors. (c) Some patients may be at greater risk of developing adverse reactions after Adrenaline administration. These include patients with hyperthyroidism, cardiovascular disease, hypertension, diabetes, and elderly individuals, and pregnant women. It must be noted that, despite these concerns, Adrenaline is essential for the treatment of anaphylaxis. Therefore, patients with these conditions, or any other person who might be in a position to administer Adrenaline to a patient with these conditions experiencing anaphylaxis, should be instructed about the circumstances under which Adrenaline should be used. (2) Information for Patients Adrenaline may produce symptoms and signs that include an increase in pulse rate, the sensation of a more forceful heartbeat, palpitations, a throbbing headache, pallor, feelings of overstimulation, anxiety, weakness, shakiness, dizziness, or nausea. These signs and symptoms usually subside rapidly, especially with rest, quiet, and recumbency. Patients with hypertension or hyperthyroidism may develop more severe or persistent effects, and patients with coronary artery disease could experience angina. Patients with diabetes may develop increased blood glucose levels following Adrenaline administration. Patients with Parkinson's disease may notice a temporary worsening of symptoms. (3) Carcinogenesis, Mutagenesis, Impairment of Fertility There are no data from either animal or human studies regarding the carcinogenicity or mutagenicity of Adrenaline, and no studies have been conducted to determine its potential for the impairment of fertility. (4) Pregnancy: Pregnancy Category C Although there are no adequate and well-controlled studies in pregnant women, Adrenaline crosses the placenta and could lead to fetal anoxia, spontaneous abortion or both. Therefore, Adrenaline should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.
Product Type
human
Dosage
"The physician who prescribes adrenaline should review this Prescribing Information insert in detail with the patient. This review should include the proper use of adrenaline to ensure that subcutaneous or intramuscular injections are given into the anterolateral aspect of the thigh, through clothing if necessary. The accompanying Patient Information Leaflet should also be reviewed with the patient
Selection of the appropriate Adrenaline dosage strength is determined according to patient body weight.
Adrenaline 0.15 mg For use by patients who weigh 15 - 30 kilograms (approximately 33 - 66 pounds).
Adrenaline 0.3 mg For use by patients who weigh 30 kilograms (approximately 66 pounds) or greater.
The usual dose of adrenaline for allergic emergencies in patients who weigh 30 kilograms or greater is 0.3 mg (0.3 mL of adrenaline).
The prescribing physician should carefully assess each patient to determine the most appropriate dose of Adrenaline, recognizing the life-threatening nature of the reactions for which this drug is being prescribed.
Patients should be instructed to periodically visually inspect the Adrenaline solution for particulate matter and discoloration. If the solution contains particulate matter or develops a pinkish color or becomes darker than slightly yellow, the patient should immediately contact their physician for a replacement, since these changes indicate that the effectiveness of the drug product may be decreased.
Adverse Reactions
"Adverse reactions to of Adrenaline include transient, moderate anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; nausea and vomiting; headache, and/or respiratory difficulties. These symptoms occur in some persons receiving therapeutic doses of of Adrenaline, but are more likely to occur in patients with hypertension or hyperthyroidism. Large doses of of Adrenaline can cause acute hypertension. Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients with underlying cardiac disease or those receiving certain drugs .
Rapid rises in blood pressure have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease. Angina may occur in patients with coronary artery disease. The potential for adrenaline to produce these types of adverse reactions does not contraindicate its use in an acute, life-threatening allergic reaction.
Contra Indications
There are no absolute contraindications to the use of Adrenaline in a life-threatening allergic reaction.
Drug Interactions
" Patients who receive Adrenaline while concomitantly taking cardiac glycosides or diuretics should be observed carefully for the development of cardiac arrhythmias.
The effects of Adrenaline may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors, sodium levothyroxine, and certain antihistamines, notably chlorpheniramine, tripelennamine, and diphenhydramine.
The cardiostimulating and bronchodilating effects of Adrenaline are antagonized by beta-adrenergic blocking drugs, such as propranolol.
The vasoconstricting and hypertensive efffects are antagonized by alpha-adrenergic blocking drugs, such as phentolamine. Ergot alkaloids and phenothiazines may also reverse the pressor effects of Adrenaline.
Such 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. Adrenaline is designed as emergency supportive therapy only and is not a replacement or substitute for immediate medical care.
Warning & Precautions
"WARNINGS Adrenaline 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. If there is an accidental injection into these areas, advise the patient to inform the healthcare provider of the accidental injection when he/she goes to the nearest emergency room for further treatment of anaphylaxis. Avoid possible inadvertent intravascular administration. Large doses injection of Adrenaline may result in cerebral hemorrhage due to a sharp rise in blood pressure. DO NOT INJECT INTRAVENOUSLY. Rapidly acting vasodilators can counteract the marked pressor effects of Adrenaline if there is such inadvertent administration. Adrenaline is the preferred treatment for serious allergic reactions or other emergency situations even though this product contains sodium bisulfite, a sulfite that may, in other products, cause allergic-type reactions including anaphylactic symptoms or life-threatening or less severe asthmatic episodes in certain susceptible persons.The alternatives to using Adrenaline in a life-threatening situation may not be atisfactory. 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. Adrenaline 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, Adrenaline 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 adrenaline administration in an acute, life-threatening situation. Adrenaline is light sensitive. Store at temperature not exceeding 30°C. Do not refrigerate; protect from freezing. Patients should periodically check adrenaline for any discoloration and/or precipitates. If the solution is discolored or contains a precipitate, the patient should replace adrenaline . PRECAUTIONS (1) General Adrenaline is not intended as a substitute for immediate medical care. In conjunction with the administration of Adrenaline, the patient should seek appropriate medical care. More than two sequential doses of Adrenaline should only be administered under direct medical supervision. Adrenaline is essential for the treatment of anaphylaxis. Patients with a history of severe allergic reactions should be instructed about the circumstances under which Adrenaline should be used. It should be determined that the patient is at risk of future anaphylaxis, since there are some concerns in specific patients with Adrenaline administration. (a) Adrenaline 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, Adrenaline may precipitate or aggravate angina pectoris as well as produce ventricular arrhythmias. (b) The effects of epinephrine may be potentiated by tricyclic antidepressants and monoamine oxidase inhibitors. (c) Some patients may be at greater risk of developing adverse reactions after Adrenaline administration. These include patients with hyperthyroidism, cardiovascular disease, hypertension, diabetes, and elderly individuals, and pregnant women. It must be noted that, despite these concerns, Adrenaline is essential for the treatment of anaphylaxis. Therefore, patients with these conditions, or any other person who might be in a position to administer Adrenaline to a patient with these conditions experiencing anaphylaxis, should be instructed about the circumstances under which Adrenaline should be used. (2) Information for Patients Adrenaline may produce symptoms and signs that include an increase in pulse rate, the sensation of a more forceful heartbeat, palpitations, a throbbing headache, pallor, feelings of overstimulation, anxiety, weakness, shakiness, dizziness, or nausea. These signs and symptoms usually subside rapidly, especially with rest, quiet, and recumbency. Patients with hypertension or hyperthyroidism may develop more severe or persistent effects, and patients with coronary artery disease could experience angina. Patients with diabetes may develop increased blood glucose levels following Adrenaline administration. Patients with Parkinson's disease may notice a temporary worsening of symptoms. (3) Carcinogenesis, Mutagenesis, Impairment of Fertility There are no data from either animal or human studies regarding the carcinogenicity or mutagenicity of Adrenaline, and no studies have been conducted to determine its potential for the impairment of fertility. (4) Pregnancy: Pregnancy Category C Although there are no adequate and well-controlled studies in pregnant women, Adrenaline crosses the placenta and could lead to fetal anoxia, spontaneous abortion or both. Therefore, Adrenaline should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.
Product Type
human
Dosage
"The physician who prescribes adrenaline should review this Prescribing Information insert in detail with the patient. This review should include the proper use of adrenaline to ensure that subcutaneous or intramuscular injections are given into the anterolateral aspect of the thigh, through clothing if necessary. The accompanying Patient Information Leaflet should also be reviewed with the patient
Selection of the appropriate Adrenaline dosage strength is determined according to patient body weight.
Adrenaline 0.15 mg For use by patients who weigh 15 - 30 kilograms (approximately 33 - 66 pounds).
Adrenaline 0.3 mg For use by patients who weigh 30 kilograms (approximately 66 pounds) or greater.
The usual dose of adrenaline for allergic emergencies in patients who weigh 30 kilograms or greater is 0.3 mg (0.3 mL of adrenaline).
The prescribing physician should carefully assess each patient to determine the most appropriate dose of Adrenaline, recognizing the life-threatening nature of the reactions for which this drug is being prescribed.
Patients should be instructed to periodically visually inspect the Adrenaline solution for particulate matter and discoloration. If the solution contains particulate matter or develops a pinkish color or becomes darker than slightly yellow, the patient should immediately contact their physician for a replacement, since these changes indicate that the effectiveness of the drug product may be decreased.
Adverse Reactions
"Adverse reactions to of Adrenaline include transient, moderate anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; nausea and vomiting; headache, and/or respiratory difficulties. These symptoms occur in some persons receiving therapeutic doses of of Adrenaline, but are more likely to occur in patients with hypertension or hyperthyroidism. Large doses of of Adrenaline can cause acute hypertension. Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients with underlying cardiac disease or those receiving certain drugs .
Rapid rises in blood pressure have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease. Angina may occur in patients with coronary artery disease. The potential for adrenaline to produce these types of adverse reactions does not contraindicate its use in an acute, life-threatening allergic reaction.
Contra Indications
There are no absolute contraindications to the use of Adrenaline in a life-threatening allergic reaction.
Drug Interactions
" Patients who receive Adrenaline while concomitantly taking cardiac glycosides or diuretics should be observed carefully for the development of cardiac arrhythmias.
The effects of Adrenaline may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors, sodium levothyroxine, and certain antihistamines, notably chlorpheniramine, tripelennamine, and diphenhydramine.
The cardiostimulating and bronchodilating effects of Adrenaline are antagonized by beta-adrenergic blocking drugs, such as propranolol.
The vasoconstricting and hypertensive efffects are antagonized by alpha-adrenergic blocking drugs, such as phentolamine. Ergot alkaloids and phenothiazines may also reverse the pressor effects of Adrenaline.
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