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Inlex

Inlex

Manufacturer:

Mergers Drugfil

Distributor:

Han Seo Pharma
Full Prescribing Info
Contents
Hepatoprotector.
Description
See table.

Click on icon to see table/diagram/image
Action
Pharmacology: Pharmacodynamics: Carnitine orotate is the pharmacologically active salt of carnitine and orotic acid. These two compounds act synergistically for histological restoration and lipotropic effect in the liver. Carnitine, an indispensable biostimulant for the metabolism of fat, promotes ß-oxidation of free fatty acids in the hepatocytes. Orotic acid is a precursor in nucleic acid (i.e., DNA and RNA) biosynthesis which is essential in the synthesis of proteins. Orotic acid prohibits the necrosis of injured liver cells by normalizing cell proliferation and the enzymatic system in the liver.
Hepatic extract antitoxic fraction (i.e., purified liver extract hydrolysate) detoxifies intrinsic and extrinsic hepatotoxic substances. Pyridoxine, cyanocobalamin and adenine act through amino acid metabolism, thereby augmenting the treatment of hepatic disease.
The combined substances result in marked improvement on various histological profiles (i.e., SGOT, SGPT, bilirubin, biopsy) and vital signs (i.e., weight loss, nausea).
Pharmacokinetics: Peak plasma concentrations are observed about 30 minutes after dosing.
Absorption and Distribution: Carnitine orotate is non-hygroscopic and less deliquescent than L-carnitine. The ionic complex salt is also more soluble and more easily absorbed by the injured cells compared to the administration of carnitine individually.
Adenine combines with the sugar ribose to form adenosine, which in turn can be bonded with from one to three phosphoric acid units, yielding AMP, ADP and ATP. These adenine derivatives perform important functions in cellular metabolism. Adenine is one of four nitrogenous bases utilized in the synthesis of nucleic acids.
Pyridoxine hydrochloride (vitamin B6) is readily absorbed from the gastrointestinal tract, mainly in the jejunum and is converted to pyridoxal phosphate which is totally bound to plasma proteins.
Riboflavin (vitamin B2) is an easily absorbed, water-soluble micronutrient with a key role in maintaining human health. Like the other B vitamins, it supports energy production by aiding in the metabolizing of fats, carbohydrates, and proteins. Vitamin B2 is also required for red blood cell formation and respiration, antibody production, and for regulating human growth and reproduction. It is essential for healthy skin, nails, hair growth and general good health, including regulating thyroid activity.
Cyanocobalamin (vitamin B12) has a cobalt content of 4.34%. Vitamin B12 is bound to intrinsic factor during transit through the stomach. Separation occurs in the terminal ileum in the presence of calcium and vitamin B12 enters the mucosal cell for absorption. It is then transported by the transcobalamin binding proteins.
Hepatic extract antitoxic fraction is a specifically hydrolysed 17 amino acid complex, which is prepared by enzymatic hydrolysis from the liver. It is readily absorbed from the gastrointestinal tract.
Elimination: Carnitine Orotate + Hepatic Extract Antitoxic Fraction + Adenine HCl + Pyridoxine HCl + Riboflavin + Cyanocobalamin (Inlex) is predominantly metabolized in the liver and excreted via urine.
Carnitine orotate is metabolized in the liver. When metabolized, it leaves its free carnitine content. A different behavior was observed in the elimination of exogenous carnitine via urine. In a test in healthy humans, the moderate ingestion of carnitine orotate does not produce increased carnitine elimination in the urine. This retention of carnitine in the body tissues means a better utilization of the substance in the body.
Pyridoxine is stored mainly in the liver, with lesser amounts stored in muscle and brain. Biotransformation is hepatic and almost entirely as metabolites excreted in the urine. Excess beyond daily needs is excreted, largely unchanged, in the urine. In dialysis, it is removed.
After a single oral dose, the biologic half-life of riboflavin is about 66 to 84 minutes in healthy people. Riboflavin is metabolized to FMN in erythrocytes, GI mucosal cells, and the liver. FMN is converted to FAD in the liver. About 9% of the drug is excreted unchanged in urine after normal ingestion. Excretion involves tubular secretion and glomerular filtration. Amount renally excreted unchanged is directly proportional to the dose. Drug removal by hemodialysis is slower than by natural renal excretion.
Within 48 hours after injection of 100 or 1,000 mcg of cyanocobalamin, 50-98% of the injected dose may appear in the urine. The major portion is excreted within the first eight hours. Intravenous administration results in even more rapid excretion with little opportunity for liver storage.
Indications/Uses
Used for treating and preventing clinical disorders secondary to mitochondrial dysfunction. Mitochondria are cellular organelles present in most eukaryotic cells. One of their primary functions is oxidative phosphorylation, a process through which energy derived from metabolism of fuels like glucose or fatty acids is converted to adenosine triphosphate (ATP), which is then used to drive various energy-requiring biosynthetic reactions.
Mitochondrial dysfunction refers to disorders in which deficits in the mitochondrial respiratory chain activity contribute in the development of the pathophysiology of particular diseases affecting the liver, heart, skeletal muscle and pancreas, such as: Fatty liver disease; Drug-induced liver injury; Cardiomyopathy; Drug-induced muscle fatigue; Hyperthyroidism; Treatment of acute and chronic hepatitis.
Dosage/Direction for Use
For adults, take 1 capsule 3 times a day or as prescribed by a physician.
Overdosage
Supportive therapy should be instituted according to symptoms in case of suspected overdosage. There is presently a lack of experience with overdosage with the product.
Contraindications
Patients with history of hypersensitivity to any components of the drug.
Special Precautions
Administration of doses greater than 10 mcg of cyanocobalamin daily may produce a hematologic response in patients with folate deficiency. Indiscriminate use may mask precise diagnosis. Long-term use of large doses of pyridoxine is associated with the development of severe peripheral neuropathies.
Use In Pregnancy & Lactation
It is not known whether it can cause fetal harm when taken by a pregnant woman. Seek medical advice before use.
Adverse Reactions
Gastrointestinal disturbances such as nausea, vomiting, diarrhea and abdominal cramps have been reported after the daily use of large doses of carnitine. Body odor has also been observed in some patients, possibly due to the formation of the metabolite trimethylamine.
Drug Interactions
Pyridoxine reduces the effects of levodopa and activity of altretamine. It has also been reported to decrease serum concentrations of phenobarbital and phenytoin. Absorption of vitamin B12 from the gastrointestinal tract may be reduced by neomycin, aminosalicylic acid, H2 antagonists, and colchicine.
Storage
Store at temperatures not exceeding 30°C. Avoid exposure to sunlight. Keep cool and dry.
MIMS Class
Cholagogues, Cholelitholytics & Hepatic Protectors
ATC Classification
A05BA - Liver therapy ; Used in liver therapy.
Presentation/Packing
Form
Inlex cap
Packing/Price
100's
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