Falola

Falola

l-ornithine-l-aspartate

Manufacturer:

Fahrenheit
Full Prescribing Info
Contents
L-ornithine L-aspartate.
Description
Each sachet contains: L-Ornithine L-Aspartate 3 g.
Action
Pharmacology: Pharmacodynamics: L- Ornithine-L-Aspartate exerts its effects through the amino acids, ornithine and aspartate, via two key methods of ammonia detoxification: urea synthesis and glutamine synthesis.
Urea synthesis take place in the periportal hepatocytes. In these cells, ornithine serves both as an activator of the enzymes ornithine-carbamoyltransferase and carbamoyl phosphate synthetase and also as the substrate of urea synthesis.
Glutamine synthesis is localized in the perivenous hepatocytes. Particularly under pathological conditions, aspartate and other dicarboxylates, including the metabolic products of ornithine, are absorbed into the cells and used there to bind ammonia in the form of glutamine.
Glutamine is an amino acid that binds ammonia under both physiological and pathophysiological conditions. The resulting amino acid glutamine not only represents a 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.
Pharmacokinetics: L- Ornithine-L-Aspartate is rapidly absorbed and cleaved to form Ornithine and Aspartate. Both amino acids have a short elimination half-life of 0.3-0.4 hours. A fraction of the aspartate is recovered in unmetabolised form in the urine.
Indications/Uses
Treatment of concomitant disease and sequelae due to impaired hepatic detoxification activity (e.g. in cirrhosis of the liver) with the symptoms of latent and manifest hepatic encephalopathy.
Dosage/Direction for Use
Granules for oral solution.
The dissolved contents of 1-2 sachets of L- Ornithine-L-Aspartate granules are taken up to 3 times daily.
L- Ornithine-L-Aspartate granules are dissolved in plenty of fluid (e.g. a glass of water, tea or juice) and taken with or after meals. The experiences on the use of the drug in children are limited.
Overdosage
Symptomatic treatment is recommended if overdose occurs.
Contraindications
Severely impaired renal function (renal insufficiency). A serum creatinine value over 3 mg/100 mL can be used as a guideline value.
L-Ornithine-L-Aspartate granules must be taken by the patients with known hypersensitivity to L-Ornithine-L-Aspartate, or any of the excipients.
Special Precautions
L- Ornithine-L-Aspartate granules contain sucralose. Patients with rare hereditary problems of sucralose intolerance should not take this medicine.
L- Ornithine-L-Aspartate granules contain 62 mg sucralose per sachet. This should be taken into account in patients with diabetes mellitus.
L- Ornithine-L-Aspartate granules may be harmful to the teeth (caries) in long-term use.
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.
Use In Pregnancy & Lactation
Pregnancy: Administration of L- Ornithine-L-Aspartate granules during pregnancy should therefore be avoided. If, however, treatment with L- Ornithine-L-Aspartate granules is considered necessary, careful consideration should be given to the benefit versus risk ratio.
Lactation: It is not known whether L- Ornithine-L-Aspartate is excreted into breast milk. Administration of L- Ornithine-L-Aspartate granules should therefore be avoided during lactation. If, however, treatment with L- Ornithine-L-Aspartate granules is considered necessary, careful consideration should be given to the benefit versus risk ratio.
Side Effects
Gastrointestinal disorders: Nausea, vomiting, stomach ache, flatulence and diarrhea are uncommon occurrences.
Musculoskeletal and connective tissue disorders: In very rare cases, pain in the limbs has been observed.
These side effects are usually transient and do not require withdrawal of the medicine.
Storage
Store below 30°C.
ATC Classification
A05BA06 - ornithine oxoglurate ; Belongs to the class of drugs used in liver therapy.
Presentation/Packing
Granules for oral soln (sachet) 3 g x 10's.
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