L-Arginine Injection
100 mg/mL
Size: 30 mLL-arginine is a conditionally essential amino acid involved in protein synthesis, nitrogen metabolism, the urea cycle, and nitric oxide production. It also serves as a precursor for compounds including ornithine, creatine, and polyamines [1–4].
Sterile L-Arginine HCl Injection is supplied as a 100 mg/mL, preservative-containing hypertonic solution in a 30 mL multiple-dose amber vial for intravenous administration by licensed healthcare professionals. The presentation is designed for office or clinical use under appropriate medical supervision [1].
Parenteral L-arginine may be incorporated into clinician-directed diagnostic or metabolic protocols when intravenous administration is appropriate. Dose, dilution, administration rate, and treatment protocol should be individualized according to the clinical objective, patient condition, renal function, fluid and electrolyte status, and institutional procedures [1–4].
More About This Product
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• Concentration: 100 mg/mL
• Volume: 30 mL Multi-Dose Vial
• Route of Administration: Intravenous (IV) Use.
• Dosage form: Sterile, nonpyrogenic, preservative-containing hypertonic injectable solution
• Administration setting: Office or clinical use; for administration by licensed healthcare professionals
Each mL contains L-arginine hydrochloride 100 mg, benzyl alcohol 2%, and Sterile Water for Injection. The pH is adjusted to 5.0–6.5 with hydrochloric acid and/or sodium hydroxide. The calculated osmolarity is approximately 1148 mOsm/L [1].
Administer only by the intravenous route. Because the solution is hypertonic, verify catheter patency and use a controlled administration rate to reduce the risk of venous irritation, phlebitis, extravasation, and infusion-related reactions [1].
Inspect the solution and container before each administration. Do not use if the solution is cloudy, unexpectedly discolored, contains visible particulate matter, or if the vial or closure is damaged. Use strict aseptic technique during every vial entry, withdrawal, and administration [1].
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L-arginine serves as the substrate for nitric oxide synthase, which converts arginine to nitric oxide and citrulline. Nitric oxide activates soluble guanylate cyclase in vascular smooth muscle, increasing cyclic guanosine monophosphate and contributing to vascular smooth-muscle relaxation [2–4].
L-arginine also participates in the urea cycle, where nitrogen derived from amino acid metabolism is converted to urea for excretion. It additionally contributes to protein synthesis and serves as a precursor for ornithine, creatine, and polyamines [2,3].
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Contraindications: Do not administer to patients with known hypersensitivity to L-arginine, benzyl alcohol, or any component of the formulation. The Xseer label also identifies severe metabolic acidosis, severe renal impairment or anuria without close monitoring, and selected amino-acid metabolism disorders as contraindications [1].
Hypersensitivity: Monitor for rash, dyspnea, hypotension, or anaphylactoid reactions. Discontinue administration immediately and initiate appropriate medical treatment if a serious reaction occurs [1].
Formulation-specific precautions: This product is hypertonic and contains 2% benzyl alcohol. It should not be used in neonates, premature infants, or low-birth-weight infants. Confirm catheter placement and stop administration if pain, swelling, blanching, erythema, or suspected extravasation occurs [1].
Clinical monitoring: Use caution in patients with renal or hepatic impairment, electrolyte imbalance, acid-base disorders, cardiovascular disease, or compromised fluid balance. Monitor clinical tolerance and relevant laboratory parameters according to the administration protocol [1].
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Formal interaction studies have not been conducted for this compounded parenteral formulation. Concurrent medications should be reviewed for effects on blood pressure, renal function, potassium balance, fluid status, nitrogen metabolism, and acid-base balance.
Do not combine L-Arginine Injection with another medication in the same syringe, vial, infusion container, or intravenous line unless physical and chemical compatibility has been established for the specific concentrations and administration conditions.
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Reported or clinically relevant reactions may include:
Hypersensitivity: Rash, facial swelling, dyspnea, hypotension, or anaphylactoid reactions
Injection site: Venous irritation, pain, erythema, phlebitis, extravasation, or tissue injury
Gastrointestinal: Nausea or vomiting
Neurologic: Headache, dizziness, numbness, or paresthesia
General: Flushing, warmth, or malaise
Cardiovascular or metabolic: Hypotension, fluid imbalance, electrolyte disturbance, or hyperchloremic metabolic acidosis
Suspected extravasation, serious hypersensitivity, marked hypotension, respiratory compromise, or significant metabolic disturbance requires immediate discontinuation and medical evaluation [1].
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Pregnancy: Adequate controlled studies of this formulation during pregnancy are not available. Administer only when the prescribing healthcare professional determines that the potential benefit justifies the potential risk.
Lactation: Clinical data concerning parenteral L-arginine during lactation are limited. Use should be based on maternal clinical need and professional assessment.
Pediatric use: Pediatric administration requires precise calculation and independent dose verification. This benzyl-alcohol-containing formulation should not be used in neonates, premature infants, or low-birth-weight infants [1].
Older adults and organ impairment: Evaluate renal and hepatic function, electrolyte balance, acid-base status, cardiovascular status, fluid balance, and concurrent therapies before administration [1].
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Store at USP Controlled Room Temperature, 20°C to 25°C (68°F to 77°F). Excursions are permitted between 15°C and 30°C (59°F to 86°F) [1].
Protect from light and from deep freezing. Do not freeze.
Inspect the solution and container before each use. Do not use if the solution is cloudy, unexpectedly discolored, or contains visible particulate matter.
Use strict aseptic technique during vial entry and product withdrawal. Follow the product-specific label and applicable facility procedures for handling after initial puncture, beyond-use dating, and disposal.
Keep out of the reach of children.
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[1] DailyMed. L-Arginine HCl Injection, 100 mg/mL [Xseer Pharmaceuticals product label]. NDC 85551-123-30. Revised May 2026.
[2] Morris SM Jr. Arginine metabolism: boundaries of our knowledge. J Nutr. 2007;137(6 Suppl 2):1602S–1609S.
[3] Wu G, Bazer FW, Davis TA, et al. Arginine metabolism and nutrition in growth, health and disease. Amino Acids. 2009;37(1):153–168. PMID:19030957.
[4] Böger RH. The pharmacodynamics of L-arginine. J Nutr. 2007;137(6 Suppl 2):1650S–1655S. doi:10.1093/jn/137.6.1650S.
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This information is intended for licensed healthcare professionals and is provided for product-information purposes only. Refer to the product-specific label, lot-specific Certificate of Analysis, applicable institutional protocols, and independent clinical judgment before ordering, preparing, or administering this compounded drug product.
