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Product Details
Product Name : STERILE NORADRENALINE
Brand Name : Nodresol
Model Name :
Product Features : STERILE NORADRENALINE CONCENTRATE I.P. 2mg / 2ml PRESENTATION : NODRESOL is supplied as 4 mg Noradrenaline Bitartrate in 2 ml aqueous solution. Such 2 ampoules of 2 ml are packed in a Box.
Technical Details : Nodresol STERILE NORADRENALINE CONCENTRATE I.P. 2mg / 2ml A Synthetic Catecholamine An Inotropic Stimulator of the Heart Specification : CHEMISTRY : Noradrenaline - C8H11NO3•C4H6O6•H2O DESCRIPTION OF INJECTION : NODRESOL is a clear sterile solution filled in 2 ml amber glass ampoule. PHARMACOLOGY : Noradrenaline functions as a peripheral vasoconstrictor (alpha-adrenergic action) and as an inotropic stimulator of the heart and dilator of coronary arteries (beta-adrenergic action). These actions result in an increase in systemic blood pressure and coronary artery blood flow. In myocardial infarction accompanied by hypertension, Sterile Noradrenaline Concentrate I.P. usually increases aortic blood pressure, coronary artery blood flow and myocardial oxygenation, thereby helping to limit the area of myocardial ischaemia and infarction. Venous return is increased and the heart tends to resume a more normal rate and rhythm than in the hypotensive state. In hypotension that persists after correction of blood volume deficits, Sterile Noradrenaline Concentrate I.P. helps raise the blood pressure to an optimal level and establish a more adequate circulation. PHARMACOKINETICS : Oral absorption poor Duration of action short The drug crosses the placenta but not the blood-brain barrier. Noradrenaline metabolites are excreted in urine primarily as the sulfate conjuges and to a lesser extent, as the glucuronide conjugates. Only small quantities of noradrenaline are excreted unchanged. INDICATIONS : 1. Acute hypotensive states (e.g. phaeochromocytomectomy, sympathectomy, poliomyelitis, spinal anaesthesia, myocardial infarction, septicaemia, blood transfusion and drug reactions). 2. As an adjunct in the treatment of cardiac arrest. DOSAGE AND ADMINISTRATION : Administration : Nodresol contains Noradrenaline as the acid tartrate. It is a concentrated, potent drug which must be diluted in dextrose containing solutions prior to infusion. An infusion of noradrenaline should be given into a large vein. Dosage : Restoration of Blood Pressure in Acute Hypotensive States : Blood volume depletion should always be corrected as fully as possible before any vasopressor is administered. Diluent : Nodresol should be diluted in 5 % Dextrose Injection I.P. or 5 % Dextrose and Sodium Chloride Injections I.P. These Dextrose containing fluids provide protection against significant loss of potency due to oxidation. Administration in saline solution alone is not recommended. Whole blood or plasma, if indicated to increase blood volume, should be administered separately (for example, by use of a Y-tube and individual containers if given simultaneously). Average Dosage : Add a two, 2 mL ampoules (4 mL of Nodresol equivalent to 4 mg of noradrenaline) to 1,000 mL of a 5 % Dextrose containing solution. Each mL of this dilution contains 4 mcg of noradrenaline (or 8 mcg of the noradrenaline acid tartrate). Give this solution by intravenous infusion. After observing the response to an initial dose of 2 mL to 3 mL (from 8 mcg to 12 mcg of base) per minute, adjust the rate of flow to establish and maintain a low normal blood pressure (usually 80 mmHg to 100 mmHg systolic) sufficient to maintain the circulation to vital organs. In previously hypertensive patients, it is recommended that the blood pressure should be raised no higher than 40 mmHg below the pre-existing systolic pressure. The average maintenance dose ranges from 0.5 mL to 1mL per minute (from 2 mcg to 4 mcg of base). High Dosage : Great individual variation occurs in the dose required to attain and maintain an adequate blood pressure. In all cases, dosage of noradrenaline should be titrated according to the response of the patient. Occasionally much larger or even enormous daily doses (as high as 68 mg base or 34 ampoules) may be necessary if the patient remains hypotensive, but occult blood volume depletion should always be suspected and corrected when present. Central venous pressure monitoring is usually helpful in detecting and treating this situation. Fluid Intake : The degree of dilution depends on clinical fluid volume requirements. If large volumes of fluid (dextrose) are needed at a flow rate that would involve an excessive dose of the pressor agent per unit of time, a solution more dilute than 4 mcg per mL should be used. On the other hand, when large volumes of fluid are clinically undesirable, a concentration greater than 4 mcg per mL may be necessary. Duration of Therapy : The infusion should be continued until adequate blood pressure and tissue perfusion are maintained without therapy. Infusions of Nodresol should be reduced gradually, avoiding abrupt withdrawal. In some of the reported cases of vascular collapse due to acute myocardial infarction, treatment was required for up to 6 days. Adjunctive Treatment in Cardiac Arrest : Infusions of Nodresol are usually administered intravenously during cardiac resuscitation to restore and maintain an adequate blood pressure after an effective heartbeat and ventilation have been established by other means. [Noradrenaline's powerful beta-adrenergic stimulating action is also thought to increase the strength and effectiveness of systolic contractions once they occur.] Average Dosage : To maintain systemic blood pressure during the management of cardiac arrest, Nodresol is used in the same manner as described under Restoration of Blood Pressure in Acute Hypotensive States. CONTRAINDICATIONS : 1. It should not be given to patients who are hypotensive from blood volume deficits except as an emergency measure to maintain coronary and cerebral artery perfusion until blood volume replacement therapy can be completed. 2. Mesenteric or peripheral vascular thrombosis (because of the risk of increasing ischaemia and extending the area of infarction) 3. Use of Nodresol during cyclopropane and halothane anaesthesia is contraindicated because of risk of producing ventricular tachycardia or fibrillation. WARNINGS : Allergic reactions : Nodresol Injection contains sodium metabisulphite, a sulphite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulphite sensitivity in the general population is unknown. Sulphite sensitivity is seen more frequently in asthmatic than in non-asthmatic people. PREGNANCY AND LACTATION : Pregnancy : Category A : Animal reproduction studies have not been conducted with noradrenaline. It is also not known whether noradrenaline can cause foetal harm when administered to a pregnant woman or can affect reproduction capacity. Noradrenaline should be given to a pregnant woman only if clearly needed. Nursing mothers : It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when noradrenaline is administered to a nursing woman. Paediatric Use : Safety and effectiveness in paediatric patients has not been established. Geriatric Use : Clinical studies of noradrenaline dose not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Although clinical experience has not identified differences in responses between the elderly and younger patients, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other therapy. ADVERSE REACTIONS: The following reactions can occur : Body As A Whole : Ischemic injury due to potent vasoconstrictor action and tissue hypoxia. Cardiovascular System : Bradycardia, probably as a reflex result of a rise in blood pressure, arrhythmias. Nervous System : Anxiety, transient headache. Respiratory System : Respiratory difficulty. Skin and Appendages : Extravasation necrosis at injection site. Prolonged administration of any potent vasopressor may result in plasma volume depletion which should be continuously corrected by appropriate fluid and electrolyte replacement therapy. DRUG INTERACTIONS : Cyclopropane and halothane : Cyclopropane and halothane anaesthetics increase cardiac autonomic irritability and therefore seem to sensitise the myocardium to the action of intravenously administered adrenaline or Noradrenaline. Hence, the use of noradrenaline during cyclopropane and halothane anaesthesia is generally considered contraindicated because of the risk of producing ventricular tachycardia or fibrillation. The same type of cardiac arrhythmias may result from the use of noradrenaline in patients with profound hypoxia or hypercarbia. Monoamine oxidase inhibitors (MAOI) : Noradrenaline should be used with extreme caution in patients receiving monoamine oxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types, because severe, prolonged hypertension may result. Other drugs : Nodresol infusion solutions should not be mixed with other drugs. Infusion solutions containing noradrenaline acid tartrate have been reported to be incompatible with alkalis and oxidising agents, barbiturates, chlorpheniramine, chlorothiazide, nitrofurantoin, phenytoin, sodium bicarbonate, sodium iodide, streptomycin, sulfadiazine and sulfafurazole. STORAGE CONDITION : Store below 30°C (86°F), protected from light. Do not refrigerate.
Fact Sheet
Year of Incorporation : 1947
Countries of Export : more than 25 countries in South America, Central America, Caribbean, South East Asia, West Africa &
Quality Certification : WHO-GMP cert.
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