Indications:
Adjunctive therapy for functional asthenia.
Administration – dosage:
Administration: ARPYXIN should be taken orally with some water.
Dosage:
Adults: 2 tablets per dose, 2 to 3 times a day.
The duration of treatment should be limited to 4 weeks.
Some special attention on the handling of the medicine before and after use:
There are no special requirements for handling this medicine after use.
Contraindications:
Hypersensitivity to one of the ingredients of the medicine.
Hypercalcemia, hypercalciuria, calcium lithiasis, tissue calcifications.
Combination with levodopa.
Warnings and precautions for use:
Conditions where caution should be taken:
This drug should be used with caution in patients with renal disease or anuria because arginine causes hyperkalemia due to decreased potassium excretion.
Pregnancy and lactation:
Pregnancy:
There are no teratogenic studies available in animals.
In clinical practice, no malformation or fetotoxic effect has appeared to date. However, monitoring of pregnancies exposed to this medicine is insufficient to exclude any risk. Therefore, as a precaution, it is best not to use this medication during pregnancy.
Lactation:
Due to lack of data, it is not known whether arginine is secreted in appreciable amounts in breast milk or not, avoid using the drug during breastfeeding.
Effects on ability to drive and use machines:
There is no evidence of an effect on the ability to drive or use machines.
Interactions, incompatibilities of medicine:
Interaction with other medicinal products and other forms of interaction:
Related to the presence of pyridoxine:
Levodopa: Inhibition of the activity of levodopa when used without an inhibitor of peripheral dopadecarboxylase. Avoid any pyridoxine intake in the absence of a dopadecarboxylase inhibitor.
Related to the presence of calcium:
Cyclins: Decreased digestive absorption of cyclins. If in need of taking this medicine, take it more than 2 hours apart.
Digitalis: Risk of rhythm disturbances. Clinical monitoring, and if necessary, ECG and calcemia control.
Diphosphonates: Risk of decreased digestive absorption of diphosphonates. If possible, take this medication more than 2 hours apart from the diphosphonates.
Thiazide diuretics: Risk of hypercalcemia due to decreased urinary calcium excretion.
Incompatibilities:
Because there are no studies about the incompatibility of the medicine, it should not be mixed with other medicines.
Undesirable effects:
Side effects are classified according to frequency: Very common (≥ 1/100, <1/10); uncommon (≥ 1/1,000, <1/100), rare (≥ 1/10,000, <1/1,000), very rare (<1/10,000); cannot be estimated from the available data “Not known”.
Rare: Nausea and vomiting can occur when vitamin B6 is discontinued after severe doses and extended cures of vitamin B6.
Inform your physician about undesirable effects encountered when using the drug.
Overdose and management:
There are no data on drug overdose, do not exceed the indicated dose of the drug.
Pharmacodynamics:
Pharmacological group: Drugs affecting the alimentary tract and metabolism.
ATC code: B05XB01, A1DA01, A11HA02.
This drug is a combination of amino acids and B vitamins, which are essential for the body’s metabolism. The drug has effect against asthenia on the body.
Arginine is a key amino acid in the urea cycle in patients with enzyme deficiencies such as: N-acetylglutamate synthetase (NAGS), carbamoyl phosphate synthetase (CPS), ornithine transcarbamylase (OTC), argininosuccinate synthetase (ASS) or argininosuccinate lyase (ASL).
Administration of arginine hydrochloride in patients with these disorders restores blood arginine levels, preventing protein catabolism.
Arginine stimulates the pituitary gland to release growth hormone and prolactin, and the pancreas to release glucagon and insulin.
Vitamin B1 combines with adenosine triphosphate (ATP) in liver, kidneys and leukocytes to form thiamine diphosphate (thiamine pyrophosphate), a physiologically active form of thiamine. Thiamine diphosphate is a carbohydrate-metabolizing coenzyme responsible for the decarboxylation of alpha-cetoacids such as pyruvate and alpha-ketoglutarate and pentose utilization in the hexose monophosphate cycle.
When entering the body, vitamin B6 is converted into the active forms pyridoxal phosphate and pyridoxamine phosphate. These two substances act as coenzymes in protein, glucose and lipid metabolism. Pyridoxine participates in the synthesis of gamma-aminobutyric acid (GABA) in the central nervous system and participates in the synthesis of hemoglobulin.
Pharmacokinetics:
The drug is well absorbed from the gastrointestinal tract.
The drug is extensively metabolised in the liver and eliminated by the kidneys.
A1202059301
