Description

Metaraminol Bitartrate Injection USP is a specialized pharmaceutical product developed by Slayback Pharma LLC. It is primarily used in the short-term management of acute hypotension, providing critical support in medical situations where rapid blood pressure stabilization is necessary. This injection acts as a vasopressor agent, leveraging its sympathomimetic properties to stimulate alpha-1 adrenergic receptors, leading to peripheral vasoconstriction and increased blood pressure.

Clinical Applications

Metaraminol is particularly beneficial in scenarios such as:

• Acute hypotensive states during spinal anesthesia, hemorrhage, or shock.
• Complications arising from surgical procedures or brain trauma.
• As an adjunct treatment in cardiogenic shock or septicemia when other interventions are insufficient.

Mechanism of Action

The effectiveness of Metaraminol lies in its dual action:

• Direct Action: Stimulates alpha-1 adrenergic receptors for vasoconstriction.
• Indirect Action: Releases endogenous noradrenaline and exhibits weak beta-1 adrenergic receptor agonism at low doses, enhancing cardiac inotropic effects.

Dosage and Administration

Metaraminol is administered intravenously, with flexible dosing options to suit clinical needs:

• IV Bolus: 0.5–1 mg every 2–5 minutes as required.
• Continuous IV Infusion: 0.5–10 mg per hour, adjustable based on patient response.

Preparation involves diluting the solution in compatible fluids such as glucose 5% or sodium chloride 0.9%, with specific concentrations tailored for bolus or infusion use.

Onset and Duration

• Onset: Rapid, within 1–2 minutes for IV administration.
• Duration: Typically 20–60 minutes per dose, with potential cumulative effects over prolonged use.

Formulation and Packaging

The product is available in multi-dose vials and glass ampoules, with concentrations designed for precise dosing. Excipients include sodium chloride, sodium metabisulfite, and preservatives, maintaining a pH of 3.2–4.5.

Storage Instructions

• Store below 25°C.
• Protect from light and freezing.
• Prepared infusion solutions remain stable for up to 24 hours.

Safety and Monitoring

Continuous monitoring of blood pressure and cardiac function is recommended during administration. Precautions include avoiding use in patients with hypersensitivity to metaraminol or sulfites, uncorrected hypovolemia, and certain cardiac conditions. Potential adverse effects range from hypertension and arrhythmias to allergic reactions, particularly in asthmatic individuals.

Regulatory Information

This formulation holds approval under ANDA 211304, with a regulatory status as a generic equivalent to Aramine Injection. It benefits from Competitive Generic Therapy exclusivity, marking its significance in the pharmaceutical landscape since its first approval in October 2020.