- Approval Id
- c0de2d9e8500a34b
- Drug Name
- NORADRENALINE SINTETICA CONCENTRATE FOR SOLUTION FOR INFUSION 1MG/ML
- Product Name
- NORADRENALINE SINTETICA CONCENTRATE FOR SOLUTION FOR INFUSION 1MG/ML
- Approval Number
- SIN16622P
- Approval Date
- 2022-10-05
- Registrant
- INTEVIS PTE LTD
- Licence Holder
- INTEVIS PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INFUSION, SOLUTION CONCENTRATE
- Dosage
- _**DOSAGE AND ADMINISTRATION**_
**Noradrenaline Sintetica is a concentrated, potent drug which must be diluted in glucose containing solutions prior to infusion. An infusion of Noradrenaline Sintetica should be given into a large vein (see PRECAUTIONS** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ **).**
**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, intraaortic pressures must be maintained to prevent cerebral or coronary artery ischemia, Noradrenaline Sintetica can be administered before and concurrently with blood volume replacement.
**Diluent:** Noradrenaline Sintetica should be diluted in 5 percent glucose solution or 0.9 percent sodium chloride with 5 percent glucose. These glucose containing fluids are protection against significant loss of potency due to oxidation. 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). Noradrenaline Sintetica contains no antimicrobial preservative. It is for single use in one patient only. Discard any residue.
Chemical and physical in-use stability (following dilution) has been demonstrated for 24 hours at 25°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
_Average Dosage_: Add 2 mL of the Noradrenaline Sintetica to 500 mL, or 4 mL of Noradrenaline Sintetica to 1000 mL of a 5 percent glucose solution or 0.9 percent sodium chloride with 5 percent glucose. Each mL of this dilution contains 4 mcg of the base of Noradrenaline Sintetica. Give this solution by intravenous infusion. Insert a plastic intravenous 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. An IV drip chamber or other suitable metering device is essential to permit an accurate estimation of the rate of flow in drops per minute. 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 mm Hg to 100 mm Hg 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 mm Hg below the preexisting systolic pressure. The average maintenance dose ranges from 0.5 mL to 1 mL 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 Sintetica should be titrated according to the response of the patient. Occasionally much larger or even enormous daily doses (as high as 68 mg base) 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. Dilution can be varied depending on the clinical fluid volume requirement.
_Fluid Intake_: The degree of dilution depends on clinical fluid volume requirements. If large volumes of fluid (glucose) 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. The infusion rate of Noradrenaline Sintetica 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 Sintetica 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 Sintetica 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, whenever solution and container permit.
Do not use the solution if its color is pinkish or darker than slightly yellow or if it contains a precipitate.
Avoid contact with iron salts, alkalis, or oxidizing agents.
- Route Of Administration
- INTRAVENOUS
- Indication Info
- _**INDICATIONS AND USAGE**_
For the restoration of blood pressure in certain acute hypotensive states (e.g., pheochromocytomectomy, sympathectomy, poliomyelitis, spinal anesthesia, myocardial infarction, septicemia, blood transfusion, and drug reactions).
As an adjunct in the treatment of cardiac arrest.
To restore and maintain an adequate blood pressure after an effective heartbeat and ventilation have been established by other means.
- Contraindications
- _**CONTRAINDICATIONS**_
Noradrenaline Sintetica 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 Sintetica 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 Sintetica 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 Sintetica is necessary as a life-saving procedure.
Cyclopropane and halothane anesthetics increase cardiac autonomic irritability and therefore seem to sensitize the myocardium to the action of intravenously administered adrenaline or noradrenaline. Hence, the use of Noradrenaline Sintetica 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 Sintetica in patients with profound hypoxia or hypercarbia.
- Atc Code
- C01CA03
- Atc Item Name
- norepinephrine
- Pharma Manufacturer Name
- INTEVIS PTE. LTD.
- Company Detail Path
- /organization/intevis-pte-ltd
