Description

L-Arginine HCl Injection is a sterile, nonpyrogenic, hypertonic injectable solution containing 100 mg/mL of L-Arginine Hydrochloride in Sterile Water for Injection. The formulation contains benzyl alcohol 2% as a preservative, with pH adjusted to 5.0–6.5 using Hydrochloric Acid and/or Sodium Hydroxide.

Each mL contains:

L-Arginine HCl 100 mg
Benzyl Alcohol 2%
Sterile Water for Injection q.s.

The solution is supplied as a multiple-dose vial for intravenous administration by a licensed healthcare professional. The calculated osmolarity is approximately 1148 mOsm/L.

L-Arginine is an amino acid involved in multiple metabolic and physiologic pathways, including nitric oxide synthesis and nitrogen metabolism. The product is compounded by Xseer Pharmaceuticals as a sterile injectable preparation for office or clinical use only.

Active Ingredient:

L-Arginine Hydrochloride 100 mg/mL

Inactive Ingredients:

Benzyl Alcohol 2% (preservative)
Sterile Water for Injection

pH Adjusters:

Hydrochloric Acid and/or Sodium Hydroxide may be used to adjust pH to 5.0–6.5.

Osmolarity:

Hypertonic solution; calculated osmolarity approximately 1148 mOsm/L.

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.

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.

Store at USP Controlled Room Temperature, 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F to 86°F).

Protect from light and from deep freezing. Do not freeze.

Inspect visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not use if the solution is cloudy, discolored, or contains visible particles.

This product is supplied as a sterile multiple-dose vial for intravenous administration. Use aseptic technique when entering the vial. Discard unused portion in accordance with institutional procedures and applicable regulations.

Keep out of reach of children.

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.

Front labelNDC 85551-123-30

L-Arginine HCl Injection
100 mg/mL

For Intravenous Administration

30 mL Multi-Dose Vial

Rx Only

Sterile, Preservative-Containing Solution

Each mL contains:
L-Arginine HCl 100 mg, Benzyl Alcohol 2%, Sterile Water for Injection q.s. pH adjusted with Hydrochloric Acid and/or Sodium Hydroxide.

Store at USP Controlled Room Temperature 20°C to 25°C (68°F to 77°F). Protect from light and freezing.

Compounded by:
Xseer Pharmaceuticals
1990 Westwood Blvd., Suite 300
Los Angeles, CA 90025
Phone: (888) 658-8005

Lot #: __________

Exp. Date: __________

To report suspected adverse reactions, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.