PT Novell


Prosweal Healthcare
Full Prescribing Info
Each mL contains: L-Ornithine L-Aspartate 500 mg.
Pharmacology: Pharmacodynamics: Mechanism of Action: In vivo, L-Ornithine L-Aspartate acts two key ammoniac detoxification pathways through urea synthesis and glutamine synthesis via the amino acids ornithine and aspartate.
Ornithine serves both as an activator of the two enzymes ornithine carbamoyl transferase and carbamoyl phosphate synthetase and as a substrate for urea synthesis.
Aspartate and other dicarboxylates including metabolic product of ornithine are taken up into the cells where they are used in the form of glutamine to bind ammonia. Glutamine serves an ammonia - binding amino acid, which not only provides a non-toxic form for the excretion of ammonia but also activates the important urea cycles.
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.
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 for the treatment of incipient disturbances of consciousness (pre-coma) or neurological complications (hepatic encephalopathy).
Dosage/Direction for Use
Patients may be given up to 4 ampoules per day. With incipient clouding of consciousness (pre-coma) or clouding of consciousness (coma), up to 8 ampoules may be given in 24 hours, depending on the severity of the condition. The ampoules are added to an infusion solution before use and infused in this form. L-Ornithine L-Aspartate (Ornispar) can be mixed with the usual infusion solutions without any problem. 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 content of 1 ampoule) per hour. L-Ornithine L-Aspartate (Ornispar) must not be administered into an artery.
Cases of overdose require symptomatic treatment.
Severe renal impairment (renal failure). A serum creatinine level in excess 3 mg/100 mL can be taken as a guide. L-Ornithine L- Aspartate (Ornispar) should not be used in cases of hypersensitivity to L-Ornithine L-Aspartate.
Special Precautions
Administration of high doses of L-Ornithine L-Aspartate (Ornispar) requires monitoring of serum and urinary urea levels. If liver function is substantially impaired, the infusion rate must be adjusted to the individual patient in order to prevent nausea and vomiting.
Depending on the underlying disease, the ability to drive and operate machines may also be impaired on treatment with L-Ornithine L-Aspartate.
Use In Pregnancy & Lactation
Use in Pregnancy: The administration of L-Ornithine L-Aspartate in pregnancy should be avoided. If treatment thought to be necessary, the benefits and risk should be carefully assessed.
Use in Lactation: 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 thought to be necessary, the benefits and risks should be carefully assessed.
Adverse Reactions
Mild to moderate sensation of heat palpitation, nausea and vomiting. In isolated cases, transient gastrointestinal complaints such as nausea and vomiting were observed which did not require discontinuation of the treatment, and disappeared after reduction of the dose.
Store at temperatures not exceeding 30°C.
ATC Classification
A05BA - Liver therapy ; Used in liver therapy.
Soln for IV infusion 500 mg/mL x 10 mL x 5's.
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