Arginine: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: May 1, 2026🚩 Report this page

Arginine

Active ingredient

Sold as LysaKare · D-87 · A L O Formula · VITAL II

US FDAGB MHRAEU EMA

Drug class: -
Availability: Over-the-counter
Routes: Oral, Sublingual
Markets covered: 3
Products on record: 7
FDA reports (12 mo): 62

Overview

Arginine is an active pharmaceutical ingredient. The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
US United States	FDA	4	January 8, 2026
GB United Kingdom	MHRA	2	May 1, 2026
EU European Union	EMA	1	April 1, 2026

USUnited States· FDA

4 products

Uses

USOfficial regulatory label· revised July 1, 2024[1]

USES:
Temporarily relieves these symptoms due to aging and/or a run-down condition: • low energy • poor muscle/fat balance • occasional sleeplessness

How to take

GBUnited Kingdom· MHRA

2 products

Uses

GBOfficial regulatory label· revised June 20, 2025[2]

TRIOMEL PERIPHERAL is indicated for parenteral nutrition for adults and children greater than 2 years of age when oral or enteral nutrition is impossible, insufficient or contraindicated.

How to take

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised April 1, 2026[3]

LysaKare is indicated for reduction of renal radiation exposure during peptide-receptor radionuclide therapy (PRRT) with lutetium (177Lu) oxodotreotide in adults.

How to take

Sources & citations

[1]FDA DailyMed · 04cded9a-0431-4e… · revised July 1, 2024 [PDF]
[2]MHRA (UK) · PL001160643 · revised June 20, 2025
[3]European Medicines Agency · EMEA/H/C/004541 · revised April 1, 2026
[4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

2). The maximum daily dose mentioned below should not be exceeded. Due to the static composition of the multi-chamber bag, the ability to simultaneously meet all nutrient needs of the patient may not be possible. Clinical situations may exist where patients require amounts of nutrients varying from the composition of the static bag.
In this situation any volume (dose) adjustments must take into consideration the resultant effect this will have on the dosing of all other nutrient components of TRIOMEL. In adults The dosage depends on the patient’s energy expenditure, clinical status, body weight, and the ability to metabolise the constituents of TRIOMEL, as well as additional energy or proteins provided orally/enterally; therefore, the bag size should be chosen accordingly.
5 mL per expended kcal. 1 mmol/kg potassium. , 2,352 non-protein kcal and 2,793 total kcal). Normally, the flow rate must be increased gradually during the first hour and then be adjusted to take into account the dose being administered, the daily volume intake, and the duration of the infusion.
07 g/kg/hour lipids. In children greater than 2 years of age and adolescents There have been no studies performed in the paediatric population. The dosage depends on the patient’s energy expenditure, clinical status, body weight, and the ability to metabolise constituents of TRIOMEL, as well as additional energy or proteins given orally/enterally; therefore, the bag size should be chosen accordingly.
In addition, daily fluid, nitrogen, and energy requirements continuously decrease with age. Two groups, ages 2 to 11 years and 12 to 18 years, are considered. For TRIOMEL 7 g/l nitrogen 1140 kcal/l with electrolytes in both age groups, the magnesium concentration is the limiting factor for daily dose.
In both age groups, the glucose concentration is the limiting factor for hourly rate. 07 a: Recommended values from 2018 ESPGHAN/ESPEN/ESPR Guidelines Normally, the flow rate must be increased gradually during the first hour and then be adjusted to take into account the dose being administered, the daily volume intake, and the duration of the infusion.
In general, it is recommended to start the infusion for small children with low daily dose and gradually increase it up to the maximal dosage (see above). Method and duration of administration For single use only. It is recommended that, after opening the bag, the contents are used immediately and not stored for subsequent infusion.
After reconstitution, the mixture is homogenous with a milky appearance. 6. Due to its high osmolarity, TRIOMEL can only be administered through a central vein. The recommended duration of infusion for a parenteral nutrition bag is between 12 and 24 hours.
Treatment with parenteral nutrition may be continued for as long as required by the patient’s clinical conditions.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised June 20, 2025[2]

9). At the beginning of the infusion, any of the following abnormal signs (sweating, fever, shivering, headache, skin rashes, dyspnoea) should be cause for immediate discontinuation of the infusion: The adverse drug reactions (ADRs) reported with TRIOMEL 9 g/l nitrogen 1070 kcal/l in a randomized, double-blind, active-controlled, efficacy and safety study are listed in the table below.
, postsurgical fasting, severe malnutrition, enteral intake insufficient or forbidden) were included and treated; patients in the TRIOMEL group received drug product up to 40 mL/kg/d over 5 days. The pooled data from clinical trials and the postmarketing experience indicate the following adverse drug reactions (ADRs) related to TRIOMEL.
System Organ Class MedDRA Preferred Term Frequencya Immune System Disorders Hypersensitivity reactions including hyperhidrosis, pyrexia, chills, headache, skin rash (erythematous, papular, pustular, macular, generalised rash), pruritus, hot flush, dyspnoea Not knownb Cardiac Disorders Tachycardia Commona Decreased appetite Commona Metabolism and Nutrition Disorders Hypertriglyceridemia Commona Abdominal pain Commona Diarrhoea Commona Nausea Commona Gastrointestinal Disorders Vomiting Not knownb Vascular Disorders Hypertension Commona General disorders and administration site conditions Extravasation which may result at infusion site level in: pain, irritation, swelling/oedema, erythema/warmth, skin necrosis, blisters/vesicles, inflammation, induration, skin tightness Not knownb a: Frequency is defined as very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); or not known (cannot be estimated from the available data).
b: ADRs reported during post-marketing experience with TRIOMEL The following class-like-adverse drug reactions (ADRs) have been described in other sources in relation to similar parenteral nutrition products; the frequency of these events is not known.
4) Fat overload syndrome (very rare) Fat overload syndrome has been reported with similar products. g. 9); however, the signs and symptoms of this syndrome may also occur at the start of an infusion when the product is administered according to instructions.
The reduced or limited ability to metabolize the lipids contained in TRIOMEL accompanied by prolonged plasma clearance may result in a “fat overload syndrome”. g. coma). The syndrome is usually reversible when infusion of the lipid emulsion is stopped.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme.
uk/yellowcard.

GBOfficial regulatory label· Warnings and precautions· revised June 20, 2025[2]

An excessively fast administration of total parenteral nutrition (TPN) solutions may result in severe or fatal consequences. The infusion must be stopped immediately if any signs or symptoms of an allergic reaction (such as sweating, fever, chills, headache, skin rashes, or dyspnea) develop.
This medicinal product contains soya-bean oil, and egg phospholipids. Soya-bean and egg proteins may cause hypersensitivity reactions. Cross-allergic reactions between soya-bean and peanut proteins have been observed. 3). Ceftriaxone must not be mixed or administered simultaneously with any calcium- containing IV solutions even via different infusion lines or different infusion sites.
Ceftriaxone and calcium-containing solutions may be administered sequentially one after another if infusion lines at different sites are used or if the infusion lines are replaced or thoroughly flushed between infusions with physiological salt-solution to avoid precipitation.
In patients requiring continuous infusion with calcium-containing TPN solutions, healthcare professionals may wish to consider the use of alternative antibacterial treatments which do not carry a similar risk of precipitation. If use of ceftriaxone is considered necessary in patients requiring continuous nutrition, TPN solutions and ceftriaxone can be administered simultaneously, albeit via different infusion lines at different sites.
2). Pulmonary vascular precipitates causing pulmonary vascular embolism and respiratory distress have been reported in patients receiving parenteral nutrition. In some cases, fatal outcomes have occurred. 2). Suspected precipitate formation in the blood stream has also been reported.
In addition to inspection of the solution, the infusion set and catheter should also periodically be checked for precipitates. If signs of respiratory distress occur, the infusion should be stopped and medical evaluation initiated. Do not add other medicinal products or substances to any components of the bag or to the reconstituted emulsion without first confirming their compatibility and the stability of the resulting preparation (in particular, the stability of the lipid emulsion).
6). Severe water and electrolyte equilibration disorders, severe fluid overload states, and severe metabolic disorders must be corrected before starting the infusion. Specific clinical monitoring is required when an intravenous infusion is started.

This is not medical advice. Consult a qualified healthcare professional.

LysaKare is indicated for administration with PRRT with lutetium (177Lu) oxodotreotide. It should therefore only be administered by a healthcare professional experienced in the use of PRRT. Posology Adults The recommended treatment regimen in adults consists of infusion of a full bag of LysaKare concomitantly with lutetium (177Lu) oxodotreotide infusion, even when patients require PRRT dose reduction.
Antiemetics Pre-treatment with an antiemetic 30 minutes prior to the start of LysaKare infusion is recommended to reduce the incidence of nausea and vomiting. In case of severe nausea or vomiting during the infusion of LysaKare despite administration of a preventive antiemetic, an antiemetic of a different pharmacological class can be administered.
Please refer to the full prescribing information of the antiemetic for administration instructions. Special populations Elderly There are limited data on the use of LysaKare in patients aged 65 years or above. 4). 4). 3 Renal impairment Due to the potential for clinical complications related to volume overload and an increase in serum potassium associated with the use of LysaKare, this medicinal product should not be administered in patients with creatinine clearance <30 mL/min.
Care should be taken with LysaKare use in patients with creatinine clearance between 30 and 50 mL/min, due to a potential increased risk of transient hyperkalaemia in these patients. The pharmacokinetic profile and safety of lutetium (177Lu) oxodotreotide in patients with baseline severe renal impairment (creatinine clearance <30 mL/min by Cockcroft-Gault formula) or end-stage renal disease have not been studied.
Treatment with lutetium (177Lu) oxodotreotide in patients with kidney failure with creatinine clearance <30 mL/min is contraindicated. Treatment with lutetium (177Lu) oxodotreotide in patients with baseline creatinine clearance <40 mL/min (using Cockcroft-Gault formula) is not recommended.
No dose adjustment is recommended for renally impaired patients with baseline creatinine clearance ≥40 mL/min and the benefit/risk balance for these patients will therefore always need to be weighed carefully. 4). Paediatric population The safety and efficacy of LysaKare in children aged less than 18 years have not been established.
No data are available. Method of administration For intravenous use. To achieve optimal renal protection LysaKare should be administered as a 4-hour infusion (250 mL/hour) starting 30 minutes prior to administration of lutetium (177Lu) oxodotreotide.
Infusion of LysaKare and lutetium (177Lu) oxodotreotide through a separate venous access in each of the patient’s arms is the preferred method. However, if two intravenous lines are not possible due to poor venous access or institutional/clinical preference, LysaKare and lutetium (177Lu) oxodotreotide may be infused through the same line via a three-way valve, taking into consideration flow rate and maintenance of venous access.
The dose of the amino acid solution should not be decreased even if a reduced dose of lutetium (177Lu) oxodotreotide is administered.

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised April 1, 2026[3]

1), which also includes the use of anti-emetics as pre-medication and often the concomitant use of short-acting somatostatin analogues. The main adverse reactions which are related mainly to the amino acid solution are nausea (approximately 25%), vomiting (approximately 10%) and hyperkalaemia.
These adverse reactions are mostly mild to moderate. Tabulated list of adverse reactions The adverse reactions listed below have been identified in publications of studies involving amino acid solutions that had the same composition as LysaKare with regard to amino acid content.
These studies included over 900 patients receiving more than 2 500 doses of arginine and lysine during PRRT with various radiolabelled somatostatin analogues. The adverse reactions are listed according to MedDRA system organ class and by frequency.
The frequencies are categorised as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1 000 to <1/100), rare (≥1/10 000 to <1/1 000), very rare (<1/10 000) and not known (cannot be estimated from the available data).
Table 1 Adverse reactions Adverse reaction Frequency category Metabolism and nutrition disorders Hyperkalaemia Not known Nervous system disorders Dizziness Not known Headache Not known Vascular disorders Flushing Not known Gastrointestinal disorders Nausea Very common Vomiting Very common Abdominal pain Not known Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V. 7

EUOfficial regulatory label· Warnings and precautions· revised April 1, 2026[3]

Hyperkalaemia A transient increase in serum potassium levels occurs in most patients receiving LysaKare, with maximum serum potassium levels reached approximately 4 to 5 hours after the start of infusion and usually returning to normal levels by 24 hours after the start of the amino acid solution infusion.
Such increases are generally mild and transient. 4). Serum potassium levels must be tested before each administration of LysaKare. If hyperkalaemia is determined, the patient’s history of hyperkalaemia and any concomitant medicinal product should be checked.
1). 1). g. dyspnoea, weakness, numbness, chest pain and cardiac manifestations (conduction abnormalities and cardiac arrhythmias). An electrocardiogram (ECG) should be performed prior to discharging the patient. Vital signs should be monitored during the infusion regardless of baseline serum potassium levels.
g. 1 glass of water every hour) to facilitate elimination of excess serum potassium. If hyperkalaemia symptoms develop during LysaKare infusion, appropriate corrective measures must be taken. In case of severe symptomatic hyperkalaemia, discontinuation of LysaKare infusion should be considered, taking into consideration the risk-benefit of renal protection versus acute hyperkalaemia.
Renal impairment The use of arginine and lysine has not been specifically studied in patients with renal impairment. Arginine and lysine are substantially excreted and reabsorbed by the kidney, and their efficacy in the reduction of renal radiation exposure is dependent on this.
Due to the potential for clinical complications related to volume overload and an increase in serum potassium associated with the use of LysaKare, this medicinal product should not be administered in patients with creatinine clearance <30 mL/min.
Kidney function (creatinine and creatinine clearance) should be tested before each administration. Care should be taken with LysaKare use in patients with creatinine clearance between 30 and 50 mL/min, due to a potential increased risk of transient hyperkalaemia in these patients.
The pharmacokinetic profile and safety of lutetium (177Lu) oxodotreotide in patients with baseline severe renal impairment (creatinine clearance <30 mL/min by Cockcroft-Gault formula) or end-stage renal disease have not been studied.

This is not medical advice. Consult a qualified healthcare professional.