Lornit Syrup

L-Ornithine L-Aspartate syrup

Each 5 mL contains:

L-Ornithine-L-Aspartate………………250 mg

Nicotinamide IP ……………………….20 mg

In a flavoured syrup base

Appropriate overages of Vitamins added

Syrup

4.1 Therapeutic indication

Treatment of associated conditions and sequelae of diseases with impaired hepatic detoxification (e.g. cirrhosis of the liver), when there are symptoms and signs of minimal or overt hepatic encephalopathy.

4.2 Posology and method of administration

Adults: Two teaspoonful twice daily.

Children: One teaspoonful twice daily.

4.3 Contraindications

• Hypersensitivity to LOLA or any other excipients of this product.
• Severe renal insufficiency (serum creatinine value > 3 mg/100 ml).

4.4 Special warnings and precautions for use

• Monitoring of serum and urinary urea levels at regular intervals should be done.
• Should be used during pregnancy only if the potential benefits out-weigh the potential risk to the fetus.

4.5 Drugs interactions

No known drug-drug interaction.

4.6 Use in special populations

Pregnancy & Lactation

The administration in pregnancy and lactation should be avoided. If treatment is nevertheless

thought to be necessary, the benefits and risks should be carefully assessed.

4.7 Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been performed.

4.8 Undesirable effects

Very rarely side effects like nausea and vomiting occur. These side effects are usually transient and do not necessitate the withdrawal of the drug.

Reporting of suspected adverse reactions

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:medico@zuventus.com

Website: https://www.zuventus.com/drug-safety-reporting

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

4.9 Overdose

There is no data available for Lornit syrup overdosage. If any patient consumes excess of drug, it should be managed symptomatically.

5.1 Mechanism of Action/ Pharmacodynamic properties

L-Ornithine-L-Aspartate is a stable salt of the amino acids ornithine and aspartic acid and provides substrates for urea genesis and glutamine synthesis, which are important mechanisms in ammonia detoxification. It is well known that both ornithine and aspartic acid play a key role in the liver metabolism. Ornithine brings ammonia into urea cycle, thereby converting ammonia into urea, a nontoxic substance. The other component of the drug, aspartic acid, not only takes part in an important stage in the reaction sequence involved in the urea cycle, but also features in the tricarboxylic acid cycle as oxaloacetate formed by transamination, thereby improving the energy balance of the diseased liver. Furthermore, aspartic acid promotes natural regeneration of the liver cells by taking part in pryimidine biosynthesis.

Nicotinamide (niacinamide), is the component of two coenzymes nicotinamide adenine dinucleotide (NAD) and nicotinamide adenine dinucleotide phosphate (NADP) necessary for lipid metabolism, tissue respiration, glycogenolysis, inhibition of very low-density lipoprotein (VLDL) synthesis. It may increase chylomicron triglyceride removal from plasma.

5.3 Pharmacokinetic properties

• L-Ornithine-L-Aspartate is rapidly absorbed and cleaved into L-Ornithine and L-Aspartate.
• Elimination half-life of each amino acid is short, approximately 40 min and bioavailability is 82.2 28% after oral administration.
• Some L-Aspartate appears unchanged in the urine.

Following oral administration nicotinamide is rapidly absorbed (60-76%) with peak plasma time varying from 30-60 min. It mainly metabolizes in the liver with half-life of about 20-45 min. Nicotinamide is excreted in urine (60-88% as unchanged drug).

6.1 Animal Toxicology or Pharmacology

No known animal toxicology data

Lornit Syrup is a supportive and maintenance therapy during mild to moderate liver-related concerns. It acts as a hepatic protector. It is used as a liver therapy.

8.1 Incompatibilities

Not applicable

8.2 Shelf-life

Refer on pack

• 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 this medicine if you are allergic to any of its ingredients.

23.09.2024