L-ornithine-L-aspartate infusion concentrate solute 5g/10ml in Prefilled Syringe Taj Pharma

Composition:
L-ornithine-L-aspartate infusion concentrate solute 5g/10ml in Prefilled Syringe
Each ml infusion concentrate solution contains:
L-ornithine-L-aspartate                     500 mg

Pharmacology:
Pharmacodynamics
Pharmacotherapeutic group: liver therapy.
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 phosphatase synthetase) and as a substrate for urea synthesis.

Glutamine synthesis is localized 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 nontoxic 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.

Indications:

  • Treatment of hyperammonemia due to acute or chronic liver disease, e.g., liver cirrhosis, fatty liver and hepatitis.
  • Treatment of precoma of hepatic encephalopathy.

Contraindications:

  • 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.

Dosage and administration:
Unless otherwise indicated, patients may be given up to 4 Prefilled Syringes per day. Patients with incipient clouding of consciousness (precoma) or clouding of consciousness (coma) up to 8 Prefilled Syringes may be given in 24 hours, depending on the severity of the condition. The Prefilled Syringes are added to an infusion solution before use, and infused in this form.

L-ornithine-L-aspartate infusion can be mixed with the usual infusion solutions. So far, no peculiarities have been observed with regards to miscibility. However, the Prefilled Syringes should be admixed to the infusion solution only immediately before application. For venous tolerability, however no more than 6 Prefilled Syringes 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 infusion must not be administered into an artery. Experience in children is limited.

In use stability:

  • 0.9% sodium chloride, 5% dextrose and Ringer’s lactate as a carrier solution are compatible with L-ornithine-L-aspartate 500 mg/ml.
  • The solution mixtures were stable up to 24 hours.

Warnings and precautions:
At high doses of L-ornithine-L-aspartate 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 available on the use of the drug in children.

Pregnancy and lactation
There are no clinical data available on the use of L-ornithine-L-aspartate infusion in pregnancy. L-ornithine-L-aspartate has been investigated for reproduction toxicity only to a limited extent in experimental animal studies. Therefore, the administration of L-ornithine-L-aspartate infusion in pregnancy should be avoided. If treatment with L-ornithine-L-aspartate is nevertheless thought to be necessary, the benefits and risks should be carefully assessed.

It is not known whether L-ornithine-L-aspartate secreted into breast milk. Therefore, administration of L-ornithine-L-aspartate should be avoided during lactation. If treatment with L-ornithine-L-aspartate is nevertheless thought to be necessary, the benefits and risks should be carefully assessed.

Effects on ability to drive and use machinery
Depending on the underlying disease, the ability to drive and operate machines may also be impaired on treatment with L-ornithine-L-aspartate.

Adverse reactions:
Nausea, vomiting, sensation of heat and palpitation. Generally, these symptoms are transient and do not necessitate discontinuation of treatment with L-ornithine-L-aspartate. The symptoms disappear on reduction of the dose or infusion rate.

Drug interaction:
No interaction studies have been performed. Up to now, interactions are not known.

Overdose:
Signs of intoxication have not been observed following an overdose of L-ornithine-L-aspartate. Cases of overdose require symptomatic treatment.

Packaging
Box, 5 Prefilled Syringes @ 10 ml.

ON MEDICAL PRESCRIPTION ONLY

STORE AT TEMPERATURE BELOW 30ºC, PROTECT FROM LIGHT

KEEP OUT OF REACH OF CHILDREN

Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com