L-Ornithine- L-Aspartate Injection 5gm/10ml
Each ml contains
L-Ornithine- L-Aspartate 5gm
Water for Injection USP q.s.
Pharmacotherapeutic group Hepatotherapeutics,
ATC code: A05BA
Ornithine and aspartate are important substrates in the metabolic conversion of ammonia to urea and glutamine, respectively. Ornithine brings ammonia into urea cycle, thereby converting ammonia into urea, a non-toxic substance. Aspartate improves the energy balance of the diseased liver Ornithine aspartate thus provides substrates for both of these ammonia-detoxification pathways. Controlled trials suggest that both enteral and parenteral formulations of ornithine aspartate, but not ornithine a-ketoglutarate, significantly reduce ammonia levels and have useful therapeutic effects in patients with cirrhosis and mild hepatic encephalopathy.
LOLA induces an increase of liver and muscle ammonia metabolism, leading to a decrease in blood levels, and is able to cross the blood-brain barrier, increasing the cerebral ammonia disposal. The drug can be administrated both intravenously and orally.
L-ornithine-L-aspartate (OA) is a stable salt of the amino acids ornithine and aspartic acid and provides substrates for ureagenesis and glutamine synthesis, which are important mechanisms in ammonia detoxification19.Ornithine and Aspartate, which are absorbed from the small intestine by active transport across the brush border of the intestinal epithelium, and is dependent upon sodium gradient.
INDICATION AND USAGE
• Hepatic encephalopathy.
It has also been used in Fatty liver diseases.
• Liver Cirrhosis
• Chronic Hepatitis.
L-ornithine-L-aspartate Injection is contraindicated in severe renal insufficiency (serum creatinine value > 3 mg/100
WARNINGS AND PRECAUTIONS
Monitoring of serum and urinary urea levels at regular intervals should be done.
Very rarely side effects like nausea and vomiting occur. These side effects are usually transient and do not necessitate the withdrawal of the drug.
nausea and vomiting.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
As a result of the disease, the ability to drive and operate machinery may be impaired during
treatment with L-ornithine-L-aspartate.
Symptomatic treatment is recommended if overdose occurs.
DOSAGE & MODE OF ADMINISTRATION
The recommended dose is up to 4 ampoules (20 gram) daily. In case of pre-coma or coma up to 8 ampoules (40 gram) within 24 hours, depending on the severity of the condition. Maximum Infusion Rate: 5 gram/hour. Maximum concentration: 6 ampoules per 500 ml of infusion solution. Infusion solutions: Normal saline, Dextrose, Ringer Lactate etc.
PREGNANCY AND LACTATION
Not enough is known about the use of L-ornithine-L-aspartate during pregnancy and breast-feeding. Stay on the safe side and avoid use.
Store in cool and dry place. Protected from light.
KEEP OUT OF REACH OF CHILDREN
L-Ornithine- L-Aspartate Injection 5gm/10ml in 10ml Ampoule in cardboard carton along with pack insert.
L-Ornithine- L-Aspartate Injection