Lornit sachet

L - Ornithine L - Aspartate Granules 3 g

Granules for oral solution

Composition:

Each sachet contains:

L - Ornithine L - Aspartate 3 g

Flavoured base

Colour: Sunset Yellow FCF

Dosage form - Granules for oral solution.

Dosage Strength – 3g

4.1 Therapeutic Indications

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.

4.2 Posology and method of administration

The dissolved contents of 1-2 sachets of Lornit granules are taken up to 3 times daily. Lornit granules are dissolved in plenty of fluid (e.g. a glass of water, tea or juice) and taken after meals. The experiences on the use of the drug in children are limited.

4.3 Contraindications

Hypersensitivity to L-Ornithine-L-Aspartate, or any of the excipients.

Severely impaired renal function (renal insufficiency). A serum creatinine value over 3 mg / 100 ml can be used as a guideline value.

4.4 Special warnings and special precautions for use

Lornit granules may be harmful to the teeth (caries) in long-term use. No data are so far available on the use of the drug in children.

4.5 Drug Interactions

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

4.6 Use in Special population

Pregnancy and lactation

No clinical data are available relating to intake of Lornit granules during pregnancy. No exhaustive animal studies have been performed for L-Ornithine-L-Aspartate, to investigate its toxicity in relation to reproduction. Administration of Lornit granules during pregnancy should therefore be avoided. If, however, treatment with Lornit granules is considered necessary, careful consideration should be given to the benefit versus risk ratio.

It is not known whether L-Ornithine-L-Aspartate is excreted into the breast milk. Administration of Lornit granules should therefore be avoided during lactation. If, however, treatment with Lornit granules is considered necessary, careful consideration should be given to the benefit versus risk ratio.

4.7 Effects on ability to drive and use machines

As a result of the disease, the ability to drive and use machines may be impaired during treatment with L-Ornithine-L-Aspartate.

4.8 Undesirable effects

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)

Gastrointestinal disorders

Uncommon: Nausea, vomiting, stomach ache, flatulence, diarrhoea.

Musculoskeletal and connective tissue disorders

Very rare: pain in the limbs

These undesirable effects are usually transient and do not require withdrawal of the medicine.

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via email to: www.medico@zuventus.com

Website: http://www.zuventus.co.in/safety.aspx

By reporting side effects, you can help provide more information on the safety of this medicine.

4.9 Overdose

So far signs of intoxication have not been observed following an overdose of L-ornithine L-aspartate. Symptomatic treatment is recommended if overdose occurs.

5.1 Pharmacodynamic properties/Mechanism of action

Pharmacotherapeutic group: Liver therapy, ATC code: A05BA

In vivo, 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 takes 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 localised 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.

Glutamate is an amino acid that binds ammonia under both physiological and pathophysiological conditions. The resulting amino acid glutamine not only represents 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.

Animal studies suggest that the ammonia-reducing effect of L-Ornithine-L-Aspartate is caused by enhanced glutamine synthesis. Individual clinical studies have shown an improved branched-chain amino acid/aromatic amino acid quotient.

5.2 Pharmacokinetic properties

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.

6.1 Preclinical safety data

Based on pharmacological safety studies, preclinical data show that with correct use there is no particular risk of toxicity following repeated administration or mutagenicity in humans. No studies on carcinogenic potential have been carried out. In a dose discovery study, L-ornithine L-aspartate was investigated for reproduction toxicity only to a limited extent.

L-Ornithine-L-Aspartate is a stable salt of the amino acids ornithine and aspartic acid. Reduces blood ammonia concentrations and improves mental function when administered IV in patients with hepatic encephalopathy.

Molecular Formula: C₉H₁₉N₃O₆

Molecular Weight: 265.26 g/mol

8.1 Incompatibilities

Not applicable.

8.2 Shelf life

Refer on pack

8.3 Packaging information

10 Sachets of 3.25 g each The granules are Sunset Yellow FCF in colour.

8.4 Special precautions for storage

Store protected from light & moisture at a temperature not exceeding 25°C.

• You will be regularly monitored for blood creatinine and blood/urine urea levels.
• Inform your doctor if you are pregnant, planning a pregnancy, or breastfeeding.
• Do not take Lornit Granules if you are allergic to any of its ingredients.
• It is not known whether it is safe to consume alcohol with Lornit Granules.