NORADRENALINE ELSaad

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NORADRENALINE ELSaad

Chemical Name:

Noradrenaline Bitartrate
Therapeutic Category:

Cardiovascular drugs
Pharmacologic Category:

Alpha-/Beta- Agonist
Pharmaceutical Form:

Ampoule
Composition:

Noradrenaline 1mg/ml ( Eq 2mg/ml Noradrenaline Bitartrate)

Leaflet

NORADRENALINE ELSAAD

Solution for I.V Infusion (After Dilution) - (Ampoule)

Noradrenaline (Bitartrate)

1.COMPOSITION:

NORADRENALINE ELSaad – Solution for I.V Infusion (After Dilution): Each ampoule (4mL) contains 4mg Noradrenaline (Bitartrate).

2.PHARMACOLOGY:

Noradrenaline bitartrate functions as a peripheral vasoconstrictor (alpha-adrenergic action) and as an inotropic stimulator of the heart and dilator of coronary arteries (beta-adrenergic action). Both of these actions result in an increase in systemic blood pressure and coronary artery blood flow. In hypotension, noradrenaline helps raise the blood pressure to an optimal level and establish a more adequate circulation. In myocardial infarction, noradrenalin has been shown to increase greatly the patient survival rate by correcting systemic shock and also by dilating the coronary arteries. On the coronary arteries, noradrenalin cause vasodilatation of coronary arteries and therefore has a great effect in increasing coronary flow.

3.INDICATIONS :

NORADRENALINE ELSaad is indicated for blood pressure restoration & maintence in acute hypotensive or shock states which may result from surgery trauma , pheochromocytomectomy, sympathectomy, poliomyelitis, spinal anesthesia, myocardial infarction, septicemia, blood transfusion, and drug reactions. As an adjunct in the treatment of cardiac arrest and profound hypotension.

4.CONTRAINDICATIONS:

Noradrenaline bitartrate 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. If Noradrenaline bitartrate is continuously administered to maintain blood pressure in the absence of blood volume replacement, the following may occur: severe peripheral and visceral vasoconstriction, decreased renal perfusion and urine output, poor systemic blood flow despite “normal” blood pressure, tissue hypoxia, and lactate acidosis.
Noradrenaline bitartrate should also not be given to patients with mesenteric or peripheral vascular thrombosis (because of the risk of increasing ischemia and extending the area of infarction) unless, in the opinion of the attending physician, the administration of Noradrenaline bitartrate is necessary as a life-saving procedure.

5.WARNINGS:

Noradrenaline should be used with extreme caution in patients receiving MAO inhibitors because severe, prolonged hypertension may result.

Noradrenaline bitartrate injection contains sodium metabisulphite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

6.PRECAUTIONS:

Avoid Hypertension: Because of the potency of Noradrenaline bitartrate and because of varying response to pressor substances, the possibility always exists that dangerously high blood pressure may be produced with overdoses of this pressor agent. It is desirable, therefore, to record the blood pressure every two minutes from the time administration is started until the desired blood pressure is obtained, then every five minutes if administration is to be continued.

The rate of flow must be watched constantly, and the patient should never be left unattended while receiving Noradrenaline bitartrate. Headache may be a symptom of hypertension due to overdosage.

Site of Infusion: Whenever possible, infusions of Noradrenaline bitartrate should be given into a large vein, particularly an antecubital vein because, when administered into this vein, the risk of necrosis of the overlying skin from prolonged vasoconstriction is apparently very slight. Some authors have indicated that the femoral vein is also an acceptable route of administration. A catheter tie-in technique should be avoided; if possible, since the obstruction to blood flow around the tubing may cause stasis and increased local concentration of the drug. Occlusive vascular diseases (for example, atherosclerosis, arteriosclerosis, diabetic endarteritis, and Buerger’s disease) are more likely to occur in the lower than in the upper extremity. Therefore, one should avoid the veins of the leg in elderly patients or in those suffering from such disorders. Gangrene has been reported in a lower extremity when infusions of Noradrenaline bitartrate were given in an ankle vein.

Extravasation: The infusion site should be checked frequently for free flow. Care should be taken to avoid extravasation of Noradrenaline bitartrate into the tissues, as local necrosis might ensue due to the vasocontrictive action of the drug.
Blanching along the course of the infused vein, sometimes without obvious extravasation, has been attributed to vasa vasorum constriction with increased permeability of the vein wall, permitting some leakage.

This also may progress on rare occasions to superficial slough, particularly during infusion into leg veins in elderly patients or in those suffering from obliterative vascular disease. Hence, if blanching occurs, consideration should be given to the advisability of changing the infusion site at intervals to allow the effects of local vasoconstriction to subside.
IMPORTANT-ANTIDOTE FOR EXTRAVASATION ISCHEMIA:

To prevent sloughing and necrosis in areas in which extravasation has taken place, the area should be infiltrated as soon as possible with 10 mL to 15 mL of saline solution containing from 5 mg to 10 mg of phentolamine. A syringe with a fine hypodermic needle should be used, with the solution being infiltrated liberally throughout the area (which is easily identified by its cold, hard, and pallid appearance). Sympathetic blockage with phentolamine causes immediate and conspicuous local hyperemic changes if the area is infiltrated with phentolamine solution within 12 hours. Therefore, phentolamine should be given as soon as possible after the extravasations are noted.

Phentolamine (5 to 10 mg) could be also added directly to the infusion flask as an effective antidote, whereas the systemic vasopressor activity of the Noradrenaline is not impaired.

In the treatment of patients with severe hypotension following myocardial infarction, thrombosis in the infused vein and perivenous reactions and necrosis may usually be prevented if 10mg of heparin are added to each 500ml of infusion fluid (5% Dextrose) containing Noradrenaline.

Sympathetic nerve block has also been suggested.

Use in children: Safety and effectiveness of Noradrenaline bitartrate in children has not been established.

Pregnancy and lactation: Noradrenaline bitartrate should be given to a pregnant woman only if clearly needed. Caution should be exercised when Noradrenaline bitartrate is administered to a nursing woman.

7.DRUG INTERACTIONS:

The use of Noradrenaline bitartrate during cyclopropane and halothane anesthesia 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 bitartrate in patients with profound hypoxia or hypercarbia.

8.ADVERSE REACTIONS:

Ischemic injury due to potent vasoconstrictor action tissue hypoxia, bradycarclia, probably as a reflex result of a rise in blood pressure, arrhythmias, anxiety, transient headache, respiratory difficulty, extravasations 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. If plasma volumes are not corrected, hypotension may recur when Noradrenaline bitartrate is discontinued, or blood pressure may be maintained at the risk of severe peripheral and visceral vasoconstriction (e.g., decreased renal perfusion) with diminution in blood flow and tissue perfusion with subsequent tissue hypoxia and lactic acidosis and possible ischemic injury. Gangrene of extremities has been rarely reported.
Overdoses or conventional doses in hypersensitive persons (e.g., hyperthyroid patients) cause severe hypertension with violent headache, photophobia, stabbing retrosternal pain, pallor, intense sweating, and vomiting.

9.DOSAGE AND ADMINISTRATION:

NORADRENALINE ELSaad injection is a concentrated, potent drug which must be diluted in dextrose containing solutions prior to infusion. An infusion of NORADRENALINE ELSaad should be given into a large vein.

Restoration of Blood Pressure in Acute Hypotensive States:

Blood volume depletion should always be corrected as fully as possible before any vasopressor is administered. When, as an emergency measure, intra aortic pressures must be maintained to prevent cerebral or coronary artery ischemia, NORADRENALINE ELSaad can be administered before and concurrently with blood volume replacement.

Dilution:

NORADRENALINE ELSaad should be administered in 5 % dextrose solution in distilled water or 5 % dextrose in saline solution. These fluids containing Dextrose are 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.

Average dosage: Add a 4 ml (4 mg) of NORADRENALINE ELSaad to 1000 ml of a 5% dextrose solution. Each 1 ml of this dilution contains 4 µg of the Noradrenaline base. Give this dilution I.V. Insert a plastic I.V catheter through a suitable bore needle well advanced centrally into the vein and securely fixed with adhesive tape, avoiding if possible, a catheter tie-in technique as this promotes stasis. A drip bulb is necessary to permit an accurate estimation of the rate of flow in drops per minute After observing the response to an initial dose of 2 to 3 ml (from 8 to 12 µg of base) / minute, adjust the rate of flow to establish and maintain a low normal blood pressure (usually 80 to 100 mm Hg systolic) sufficient to maintain the circulation of vital organs.
In previously hypertensive patients, it is recommended that the blood pressure should be raised no higher than 40 mm Hg below the preexisting systolic pressure. The average maintenance dose ranges from 0.5 ml to 1 ml per minute (from 2 µg to 4 µg of Noradrenaline base).

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 µg per ml should be used. On the other hand, when large volumes of fluid are clinically undesirable, a concentration greater than 4 µg per ml may be necessary.

High Dosage: Great individual variation occurs in the dose required to attain and maintain an adequate blood pressure. In all cases, dosage of NORADRENALINE ELSaad should be titrated according to the response of the patient. Occasionally much larger or even enormous daily doses (as high as 68 mg of Noradrenaline base or 17 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.
Duration of Therapy: The infusion should be continued until adequate blood pressure and tissue perfusion are maintained without therapy. Infusions of NORADRENALINE ELSaad 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 six days.

Adjunctive Treatment in Cardiac Arrest:

Infusions of NORADRENALINE ELSaad 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.
Average Dosage: To maintain systemic blood pressure during the management of cardiac arrest, NORADRENALINE ELSaad is used in the same manner as described under Restoration of Blood Pressure in Acute Hypotensive States.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use.

10.OVERDOSAGE:

Overdosage with Noradrenaline bitartrate may result in headache, severe hypertension, reflex bradycardia, marked increase in peripheral resistance, and decreased cardiac output. In case of accidental overdosage, as evidenced by excessive blood pressure elevation, discontinue Noradrenaline bitartrate until the condition of the patient stabilizes.

11.PACKAGING :

NORADRENALINE ELSaad – Solution for I.V Infusion (After Dilution): A Pack of 5 ampoules of 4mL.

12.STORAGE CONDITIONS:

Store NORADRENALINE ELSaad – Solution for I.V Infusion (After Dilution) at temperature between (15-30)°C. Protect from light.