Norepinephrine (Biemefrin) 1mg/ml (4mg/4ml) Concentrate Solution for IV Infusion Adrenergic Agent 10 Ampoule x 4ml

Here's the detailed information for Norepinephrine (Biemefrin) 1mg/ml (4mg/4ml) Concentrate Solution for IV Infusion Adrenergic Agent 10 Ampoules x 4ml:

Product Description:

Norepinephrine (Biemefrin) is a concentrated solution for intravenous (IV) infusion that contains 1 mg/ml of norepinephrine (also known as noradrenaline). It is a potent adrenergic agent primarily used to manage hypotension (low blood pressure) in critical care settings, especially in patients with shock. Norepinephrine works by stimulating alpha-1 and beta-1 adrenergic receptors, causing vasoconstriction and increasing blood pressure. It also has a positive inotropic effect on the heart, increasing heart contractility and improving blood flow to vital organs.

This formulation is provided in 4ml ampoules, with each ampoule containing 4mg of norepinephrine in 4ml of solution, intended for dilution before IV infusion.

Indications:

Norepinephrine (Biemefrin) is indicated for:

1. Acute Hypotension:

   • Used in critical care settings for patients with severe hypotension (low blood pressure), especially when due to shock (e.g., septic shock, cardiogenic shock, neurogenic shock, or hypovolemic shock).

   • It is primarily used when blood pressure needs to be raised to ensure adequate perfusion of vital organs like the brain, heart, and kidneys.

2. Shock Management:

   • Norepinephrine is used for managing shock, particularly in patients who are unresponsive to other therapies like fluid resuscitation. It helps increase systemic vascular resistance (SVR) and improve blood pressure.

Dosage:

The dosage of Norepinephrine (Biemefrin) depends on the individual patient's condition, response to treatment, and the clinical scenario. Here is the general dosage guideline:

1. Adults:

   • Initial infusion rate: The typical starting dose is 0.01 to 0.05 mcg/kg/min by IV infusion.

   • Adjust dose: The infusion rate can be adjusted depending on the patient's response, typically ranging from 0.05 to 0.5 mcg/kg/min.

   • If needed, the dosage can be increased gradually until the desired blood pressure response is achieved.

2. Infusion Preparation:

   • The concentrated solution should be diluted before use. Typically, the contents of the 4mg/4ml ampoule are diluted in an appropriate IV fluid (e.g., D5W or normal saline) to a final concentration of 8 mcg/ml to 16 mcg/ml for infusion.

   Note: The exact dilution and infusion rate should be based on the clinical condition, body weight, and response to therapy, and the healthcare provider will adjust the infusion rate accordingly.

3. Continuous Monitoring:

   • Blood pressure and heart rate should be closely monitored during treatment. Adjust the infusion rate to maintain the target blood pressure and minimize side effects.

Side Effects:

Like all medications, Norepinephrine (Biemefrin) can cause side effects. Common and serious side effects include:

Common Side Effects:

1. Hypertension (high blood pressure) due to the vasoconstrictor action.

2. Bradycardia (slow heart rate) or tachycardia (fast heart rate) as a result of adrenergic stimulation.

3. Headache.

4. Nausea or vomiting.

5. Anxiety or restlessness.

Serious Side Effects:

1. Arrhythmias (irregular heart rhythms), which may be life-threatening.

2. Severe hypertension: Excessive vasoconstriction may cause a dangerous rise in blood pressure.

3. Ischemia (reduced blood flow to organs): Prolonged use or high doses can result in decreased blood flow to extremities or other organs, leading to tissue injury or necrosis.

4. Extravasation (leakage of the drug from the IV site) can lead to local tissue damage, including necrosis at the site of infusion.

5. Pulmonary edema (fluid accumulation in the lungs) due to increased blood pressure and fluid overload.

Contraindications:

Norepinephrine (Biemefrin) should not be used in the following situations:

1. Hypersensitivity to norepinephrine or any other ingredients in the formulation.

2. Uncorrected Hypovolemia:

   • Norepinephrine should not be used if there is severe blood loss or shock without proper volume resuscitation, as it could worsen tissue perfusion.

3. Mesenteric Ischemia:

   • Patients with mesenteric ischemia (lack of blood supply to the intestines) should not receive norepinephrine, as it can exacerbate ischemic injury.

4. Severe Cardiovascular Disorders:

   • Norepinephrine should be avoided in patients with severe coronary artery disease or ventricular arrhythmias, unless the benefits outweigh the risks.

5. Wide Complex Arrhythmias:

   • The use of norepinephrine in patients with ventricular arrhythmias or other serious arrhythmias should be avoided, as it may exacerbate these conditions.

Precautions:

1. Monitoring:

   • Continuous monitoring of blood pressure, heart rate, and other cardiovascular parameters is necessary during treatment. Adjust the infusion rate to avoid excessive blood pressure increase or arrhythmias.

2. Extravasation Risk:

   • Norepinephrine can cause severe local tissue damage if it leaks out of the vein (extravasation). Always ensure proper IV catheter placement and consider using a central line for administration when possible.

3. Vasoconstriction:

   • Since norepinephrine causes vasoconstriction, it should be used with caution in patients with peripheral vascular disease or other conditions that could worsen with reduced blood flow to extremities.

4. Renal and Hepatic Impairment:

   • Caution is needed in patients with severe renal or liver impairment, as the drug's metabolism may be altered.

5. Pregnancy and Breastfeeding:

   • Norepinephrine (Biemefrin) should be used during pregnancy or breastfeeding only if the potential benefit justifies the potential risk to the fetus or infant. Consult with a healthcare provider for proper risk assessment.

Summary:

Norepinephrine (Biemefrin) is a potent adrenergic agent used in critical care to treat severe hypotension and shock. It works by increasing blood pressure through vasoconstriction and enhancing heart function. It is administered by IV infusion after dilution and should be adjusted based on the patient's condition. Monitoring of blood pressure, heart rate, and infusion site is essential during treatment.

Common side effects include hypertension and arrhythmias, while serious risks involve extravasation, ischemia, and pulmonary edema. Norepinephrine is contraindicated in patients with hypovolemia, certain types of cardiovascular disease, and those with hypersensitivity to the drug.

Always consult with a healthcare provider for specific dosing instructions, precautions, and monitoring during treatment.

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