L- Arginine

Dosage Forms and Strengts L-Arginine HCl Injection is supplied as a sterile, nonpyrogenic injectable solution containing 100 mg/mL of L-Arginine Hydrochloride in a multiple-dose vial for intravenous administration. Strength: 100 mg/mL Container Closure: 30 mL multiple-dose amber vial.

L-Arginine HCl Injection is contraindicated in: Patients with known hypersensitivity to L-Arginine, benzyl alcohol, or any component of the formulation. Neonates, premature infants, or low birth weight infants due to the risk of benzyl alcohol toxicity (“gasping syndrome”). Patients with severe metabolic acidosis or conditions where administration of hypertonic solutions may worsen fluid or electrolyte imbalance. Patients with severe renal impairment or anuria unless clinically justified and closely monitored by a healthcare professional. Patients with hyperchloremic acidosis or known disorders of amino acid metabolism where L-Arginine administration may be inappropriate.

For intravenous administration only under the supervision of a licensed healthcare professional. This product is a hypertonic solution and should be administered cautiously to minimize the risk of vein irritation, phlebitis, or infusion-related reactions. Use with caution in patients with renal impairment, hepatic impairment, electrolyte imbalance, or acid-base disorders, as L-Arginine may affect metabolic and electrolyte status. Monitor patients for signs of hypersensitivity reactions, including rash, dyspnea, hypotension, or anaphylactoid reactions. Discontinue administration if a serious reaction occurs. Contains benzyl alcohol 2% as a preservative. Benzyl alcohol has been associated with serious adverse reactions, including fatal “gasping syndrome,” in neonates and premature infants. Use caution in patients with cardiovascular disease or compromised fluid balance, as intravenous administration may contribute to circulatory overload in susceptible individuals. Rapid or excessive administration may increase the risk of nausea, vomiting, flushing, headache, or hypotension. Protect from light and from deep freezing. Do not use if the solution is discolored, cloudy, or contains particulate matter. Use aseptic technique when entering the multiple-dose vial. Discard unused portion according to institutional policy and applicable regulations.