Each mL contains: L-Ornithine L-Aspartate 500 mg.
Pharmacotherapeutic group: Liver therapy. ATC code: A05BA.
Pharmacology: Pharmacodynamics: In vivo, L-Ornithine L-Aspartate acts on two key ammonia detoxification pathways-urea synthesis and glutamine synthesis-via the amino acids Ornithine and Aspartate. Urea synthesis takes place in the periportal hepatocytes, in which Ornithine serves both as an activator of the two enzymes ornithine carbamoyl transferase and carbamoyl phosphate synthetase and as a substrate for urea synthesis.
Glutamine synthesis is localised in the perivenous hepatocytes. Under pathological conditions in particular, aspartate and other dicarboxylates-including metabolic products of ornithine-are taken up into the cells where they are used in the form of glutamine to bind ammonia. Both physiologically and pathophysiologically glutamate serves as an ammonia-binding amino acid. The resulting amino acid glutamine not only provides a non-toxic form for the excretion of ammonia but also activates the important urea cycle (intercellular glutamine exchange).
Under physiological conditions Ornithine and Aspartate are not limiting for urea synthesis. Experimental studies in animals point to increased glutamine synthesis as a mechanism of the ammonia-lowering effect. Some clinical studies have shown an improvement in the ratio of branched-chain to aromatic amino acids.
Pharmacokinetics: Ornithine and Aspartate have a short elimination half-life of 0.3-0.4 hours. Some of the aspartate is excreted unchanged in the urine.
L-Ornithine L-Aspartate indicated for reducing plasma ammonia level in condition of hyperammonemia as a result of acute and chronic liver disease such as liver cirrhosis, fatty liver, hepatitis, especially in the treatment of incipient disturbances of consciousness (precoma) or neurological complications (hepatic encephalopathy).
Unless otherwise indicated, patients may be given up to 4 ampoules per day.
With incipient clouding of consciousness (precoma) or clouding of consciousness (coma), up to 8 ampoules may be given in 24 hours, depending on the severity of the condition. The vials are added to an infusion solution before use, and infused in this form.
L-Ornithine L-Aspartate injection infusion can be mixed with NaCl 0.9% and Dextrose 5% infusion solutions. So far no peculiarities have been observed with regard to miscibility. However, the vials should be admixed to the infusion solution only immediately before application. For venous tolerability, however, no more than 6 ampoules should be dissolved per 500 mL infusion.
The maximum infusion rate is 5 g L-Ornithine L-Aspartate (corresponding to the content of 1 ampoule) per hour. L-Ornithine L-Aspartate injection infusion must not be administered into an artery. Experience in children is limited (see Precautions).
So far signs of intoxication have not been observed following on overdose of L-Ornithine L-Aspartate. Cases of overdose require symptomatic treatment.
Hypersensitivity to L-Ornithine L-Aspartate.
Severely impaired renal function (renal insufficiency). A serum creatinine value over 3 mg/100 mL can be used as a guidance value.
At high dose of L-Ornithine L-Aspartate injection infusion, serum and urine urea levels should be monitored. If liver function is substantially impaired, the infusion rate must be adjusted to the individual patient in order to prevent nausea and vomiting. No data are so far available on the use of the drug in children.
Effects on ability to drive and use machines: Depending on the underlying disease, the ability to drive and operate machines may also be impaired on treatment with L-Ornithine L-Aspartate.
There are no clinical data available on the use of L-Ornithine L-Aspartate injection infusion in pregnancy. L-Ornithine L-Aspartate has been investigated for reproduction toxicity only to a limited extent in experimental animal studies. The administration of L-Ornithine L-Aspartate injection infusion in pregnancy should therefore be avoided. If treatment with L-Ornithine L-Aspartate is nevertheless thought to be necessary, the benefits and risk should be carefully assessed.
It is not known whether L-Ornithine L-Aspartate passes into breast milk. Administration of L-Ornithine L-Aspartate should therefore be avoided during lactation. If treatment with Ornithine Aspartate is nevertheless thought to be necessary, the benefits and risks should be carefully assessed.
Very common: (≥1/10); Common: (≥1/100, <1/10); Uncommon (≥1/1000, <1/100); Rare (≥1/10000, <1/1000); Very rare (≥1/10000, not known (cannot be estimated from the available data)).
Rare: Vomiting, sensation of heat and palpitation.
Generally, however, these symptoms are transient, and do not necessitate discontinuation of treatment with L-Ornithine L-Aspartate. They disappear on reduction of the dose or infusion rate.
No interaction studies have been performed. Up to now interactions are not known.
A05BA06 - ornithine oxoglurate ; Belongs to the class of drugs used in liver therapy.
Inj 500 mg/mL x 10 mL x 1's.