R-GENE 10

Clinical safety rating: caution

Comprehensive clinical and safety monograph for R-GENE 10 (R-GENE 10).

How it works

Arginine is a semi-essential amino acid that serves as a substrate for nitric oxide (NO) synthesis via nitric oxide synthase (NOS), leading to vasodilation. It also stimulates growth hormone release and is involved in the urea cycle for ammonia detoxification.

What the body does with it

Metabolism	Metabolized via the urea cycle (arginase to ornithine) and nitric oxide synthase pathway; partly converted to creatine and other amino acids.
Excretion	Primarily renal (approximately 80-90% unchanged). Biliary/fecal elimination accounts for <5%.
Half-life	Terminal elimination half-life is 2-4 hours (mean 3 hours) in adults with normal renal function; prolonged to 8-18 hours in renal impairment.
Protein binding	Approximately 30-40%, primarily to albumin.
Volume of Distribution	0.5-1.0 L/kg; distributes widely into total body water including cerebrospinal fluid.
Bioavailability	Oral: 10-20% (extensive first-pass metabolism). Intramuscular: approximately 80-90%.
Onset of Action	Intravenous: within 1-2 minutes. Intramuscular: 10-20 minutes. Oral: 30-60 minutes.
Duration of Action	Intravenous: 15-30 minutes. Intramuscular: 30-60 minutes. Oral: 2-3 hours.

Classification & Brands

Dosing & administration

10 mg intravenously over 1-2 minutes, once daily for 5 days, repeat course after 2-3 weeks if needed.

Dosage form	INJECTABLE
Renal impairment	GFR >50 mL/min: no adjustment. GFR 10-50 mL/min: 5 mg intravenously once daily. GFR <10 mL/min: not recommended.
Liver impairment	Child-Pugh A: no adjustment. Child-Pugh B: reduce dose by 50%. Child-Pugh C: contraindicated.
Pediatric use	0.2 mg/kg intravenously once daily, max 10 mg per dose, for 5 days.
Geriatric use	Consider starting at 5 mg intravenously once daily due to age-related renal impairment; titrate based on response and tolerance.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for R-GENE 10 (R-GENE 10).

Breastfeeding	Excreted in breast milk; M/P ratio not established. Potential for serious adverse reactions in nursing infants, including immunosuppression and growth retardation. Contraindicated during breastfeeding.
Teratogenic Risk	FDA Pregnancy Category X. First trimester: High risk of major congenital malformations, including craniofacial defects, cardiovascular anomalies, and neural tube defects. Second and third trimesters: Risk of intrauterine growth restriction, preterm birth, and fetal death. Contraindicated in pregnancy.

Warnings & precautions

■ FDA Black Box Warning

None.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to arginine","Severe renal failure","Severe hepatic failure with hyperammonemia","Patients with schizophrenia (theoretical exacerbation)"]

Clinical Precautions

Precautions

["Hypersensitivity reactions","Hyperkalemia risk in renal impairment","Fluid/electrolyte imbalance","Potential for vascular irritation at infusion site","Use with caution in hepatic or renal impairment"]

Clinical Tips & Counseling

Drug interactions

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R-GENE 10

Clinical safety rating: caution

Comprehensive clinical and safety monograph for R-GENE 10 (R-GENE 10).

How it works

What the body does with it

Metabolism	Metabolized via the urea cycle (arginase to ornithine) and nitric oxide synthase pathway; partly converted to creatine and other amino acids.
Excretion	Primarily renal (approximately 80-90% unchanged). Biliary/fecal elimination accounts for <5%.
Half-life	Terminal elimination half-life is 2-4 hours (mean 3 hours) in adults with normal renal function; prolonged to 8-18 hours in renal impairment.
Protein binding	Approximately 30-40%, primarily to albumin.
Volume of Distribution	0.5-1.0 L/kg; distributes widely into total body water including cerebrospinal fluid.
Bioavailability	Oral: 10-20% (extensive first-pass metabolism). Intramuscular: approximately 80-90%.
Onset of Action	Intravenous: within 1-2 minutes. Intramuscular: 10-20 minutes. Oral: 30-60 minutes.
Duration of Action	Intravenous: 15-30 minutes. Intramuscular: 30-60 minutes. Oral: 2-3 hours.

Classification & Brands

Dosing & administration

10 mg intravenously over 1-2 minutes, once daily for 5 days, repeat course after 2-3 weeks if needed.

Dosage form	INJECTABLE
Renal impairment	GFR >50 mL/min: no adjustment. GFR 10-50 mL/min: 5 mg intravenously once daily. GFR <10 mL/min: not recommended.
Liver impairment	Child-Pugh A: no adjustment. Child-Pugh B: reduce dose by 50%. Child-Pugh C: contraindicated.
Pediatric use	0.2 mg/kg intravenously once daily, max 10 mg per dose, for 5 days.
Geriatric use	Consider starting at 5 mg intravenously once daily due to age-related renal impairment; titrate based on response and tolerance.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for R-GENE 10 (R-GENE 10).

Breastfeeding	Excreted in breast milk; M/P ratio not established. Potential for serious adverse reactions in nursing infants, including immunosuppression and growth retardation. Contraindicated during breastfeeding.
Teratogenic Risk	FDA Pregnancy Category X. First trimester: High risk of major congenital malformations, including craniofacial defects, cardiovascular anomalies, and neural tube defects. Second and third trimesters: Risk of intrauterine growth restriction, preterm birth, and fetal death. Contraindicated in pregnancy.

Warnings & precautions

■ FDA Black Box Warning

None.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to arginine","Severe renal failure","Severe hepatic failure with hyperammonemia","Patients with schizophrenia (theoretical exacerbation)"]