Levophed Norepinephrine Bitartrate Injection 1 mg/mL Single-dose Vial 4 mL, 10/Box - Pfizer

Levophed, also known by its generic name Norepinephrine Bitartrate, is a sterile, non-pyrogenic solution intended for intravenous infusion. This medication comes in a single-dose vial containing 1 mg/mL of Norepinephrine Bitartrate, distributed in a 4 mL solution, professionally packaged by Pfizer Injectables. 

Active Ingredient: Norepinephrine Bitartrate: 1 mg/mL
Dosage Form: Injection, for intravenous use
Concentration: 1 mg/mL
Volume:4 mL per vial

Indications:

Levophed is utilized primarily in the treatment of acute hypotension and shock to restore and maintain adequate blood pressure. It acts as a sympathomimetic amine with potent vasoconstrictive properties, increasing both the systolic and diastolic blood pressures.

Mechanism of Action:

Norepinephrine works by stimulating alpha-adrenergic receptors, leading to peripheral vasoconstriction and increasing systemic vascular resistance, which raises blood pressure. It also exhibits beta-adrenergic activity that increases myocardial contractility and heart rate.

Administration:

Levophed is administered via intravenous infusion. Proper dilution and administration under the supervision of a healthcare professional are required to ensure safety and efficacy.

Storage:

Store at controlled room temperature, 20° to 25°C (68° to 77°F). Protect from light and retain in the original carton until use to maintain product integrity.

Warnings and Precautions:

• Hypersensitivity: Use caution in patients with known hypersensitivity to norepinephrine.
• Vascular Extravasation: Proper intravenous administration technique must be employed as extravasation may cause tissue necrosis.
• Use in Patients with Ventricular Tachycardia: It should be used cautiously in patients with preexisting conditions such as ventricular tachycardia.
• Hypovolemia: Ensure adequate fluid replacement in patients with hypovolemia before initiating therapy.

Adverse Effects:

According to clinical use, common adverse effects include hypertension, bradycardia, arrhythmias, and ischemic injury due to potent vasoconstriction. Monitoring of blood pressure and heart rate is recommended during treatment.

Contraindications:

Levophed is contraindicated in patients with the following conditions:

• Hyperthyroidism: Patients with hyperthyroidism may experience increased sensitivity to the effects of norepinephrine.
• Hypersensitivity: Known hypersensitivity or allergic reaction to norepinephrine or any component of the formulation.
  
• Mesenteric or Peripheral Vascular Thrombosis: Use with extreme caution as it may increase the risk of ischemic complications.

Drug Interactions:

• Monoamine Oxidase Inhibitors (MAOIs): Concomitant use may potentiate the hypertensive effect of norepinephrine.
• Tricyclic Antidepressants: May also potentiate the pressor response.
• Cyclopropane or Halothane Anesthetics: Increase the risk of serious cardiac arrhythmias if used concurrently.
• Beta-Blockers: May exacerbate the hypertensive effects and reduce the therapeutic action of norepinephrine.

Use in Specific Populations:

• Pregnancy: Category C. It should only be used if clearly needed and the potential benefits justify the potential risk to the fetus.
• Nursing Mothers: Caution should be exercised as it is unknown whether norepinephrine is excreted in human milk.
• Pediatric Use: Safety and effectiveness in pediatric patients