Carnicor

Carnicor

Manufacturer:

PPC

Distributor:

Zuellig
Full Prescribing Info
Contents
L-carnitine.
Description
Each tablet contains 330 mg L-Carnitine (Carnicor) inner salt.
Each bottle of 10 mL contains 1 g L-Carnitine (Carnicor) inner salt.
L-Carnitine (Carnicor) is a natural substance present in all cells of the body. It is a transport protein. Chemically, L-Carnitine is β - OH -(Y- N- trimethylammonio) butyrate. L-Carnitine (Carnicor) is synthesized by both animals and humans in the liver, kidney and brain from 2 amino acids-lysine and methionine, methionine being the methyl donor for transmethylation of lysine, to butyrobutaine and finally L-Carnitine (Carnicor). However, not enough is synthesized to meet body requirements which is fulfilled by red meat and dairy products in the diet.
L-Carnitine (Carnicor) is concentrated in the heart and skeletal muscle where 95% of total body carnitine is found. This high content reflects the considerable ability of these muscles to obtain energy from oxidation of free fatty acids, which requires L-Carnitine (Carnicor).
Action
Pharmacology: Pharmacodynamics/Pharmacokinetics: L-Carnitine (Carnicor) acts as a co-factor in fatty acid metabolism specifically it transports into the mitochondrion for β-oxidation and ultimately, for energy production.
L-Carnitine (Carnicor) indirectly regulates glucose (G) utilization thru control of acetyl CoA/CoA ratio, an important regulator of pyruvate dehydrogenase (PDH) activity and consequent acetyl CoA formation which enters the TCA cycle and releases energy.
The above continuing reactions prevent lactic acid (LA) formation and accumulation.
L-Carnitine (Carnicor) by preventing acyl CoA accumulation preserves mitochondrial adenine nucleotide translocase (ANT) activity thus allowing ATP/ADP exchange (ATP for extramitochondrial utilization, ADP for mitochondrial ATP synthesis).
Of three (3) major substrates available to it, cardiac muscle utilizes free fatty acid (FFA) as preferential substrate over glucose and lactate. In fact, it is the most important energy yielding substrate for oxidative metabolism in cardiomyocytes. 60-80% of ATP generated derives from FA oxidation, the remainder from Glucose and Lactate metabolism. Important to note is that there is no anaerobic reserve for residual energy production from FA metabolism. Lipids require more oxygen than glucose or lactate forgiven amount of energy to be released.
L-Carnitine (Carnicor) has a vital role in the mitochondrial membrane transfer of FFA and energy generation of oxidative metabolism.
L-Carnitine (Carnicor) is a key metabolite of the intermediate metabolism involved in membrane transport and without which metabolic products formed in the mitochondrion under ischemic conditions cannot be eliminated.
As L-Carnitine (Carnicor) levels increase: Acyl carnitine formed from acyl CoA is transferred out of the mitochondrion and cell.
CoA is free to react with other acyl groups to reduce cell toxicity.
FFA extraction increases.
Enzyme systems regenerate e.g., pyruvate dehydrogenase (PDH) is activated, lactate production decreases, glycolysis and TCA cycle proceed and energy supply is restored. Adenine nucleotide translocase (ANT) is activated, mitochondrial transport of ATP and ADP restores energy supply.
Mitochondrial transmembrane potential is stabilized.
Restoration of energy supply improves cardiac function.
Oxygen supply improves, ischemia is relieved.
β-oxidation and other oxidative metabolic processes improve.
Cardiac performance improves.
Clinical Signs of the Ischemic Heart Improved by L-Carnitine: Rhythm restored; Extent of ST segment depression lessened; Frequency and intensity of anginal attacks decreased and nitroglycerine consumption reduced; Improved exercise tolerance; Positive inotropic effect: decreased ventricular diastolic pressure and the pre-ejection pd/LV ejection time ratio; Reduced LVEDP.
Indications/Uses
Acute and chronic myocardial ischemia, angina pectoris, arrhythmia, chronic cardiac failure.
Dosage/Direction for Use
Tablet: Chronic myocardial ischemia, chronic cardiac failure: 2-3 tablets 3 times a day (total 2-3 g).
Angina pectoris; Arrhythmia: 2 tablets 3 times a day.
Oral Solution: Adult: 1-3 g per day for a 50 kg subject.
Infants and Children: 50-100 mg L-Carnitine per kg/day.
Overdosage
There have been no reports of toxicity from levocarnitine overdosage. Levocarnitine is easily removed from plasma by dialysis. Large doses of levocarnitine may cause diarrhea.
Special Precautions
Administration of high doses of the oral formulations of levocarnitine for long periods of time is not recommended in patients with severely compromised renal function or in ESRD patients on dialysis due to the fact that major metabolites formed following oral administration trimethylamine (TMA) and trimethylamine-N-oxide (TMAO) will accumulate since they can not be efficiently removed by the kidneys. Moreover, increased levels of TMA in dialysis patients have been reported to be associated with possible neurophysiologic effects. Also, the inefficient removal of TMA may result in the development of 'fishy odor' syndrome.
Only the intravenous form of levocarnitine is indicated for use in ESRD patients on hemodialysis.
Oral Solution: L-Carnitine (Carnicor) 10% oral solution is for oral use only. Not for parental use.
Use In Pregnancy & Lactation
Use in pregnancy is not recommended unless clearly needed. Pregnancy category: B Discontinuation of treatment in a pregnant woman with primary systemic carnitine deficiency may carry serious consequences; the risk of stopping treatment may outweigh the theoretical risks to the fetus. Animal studies showed no evidence of impaired fertility or fetal harm, however at 600 mg/kg daily there was a statistically insignificant increase in post implantation losses. There are no controlled data in human pregnancy.
In use during breastfeeding, the risks to the infant from excess carnitine intake should be weighed against the benefits of supplementation to the mother. L-Carnitine (Carnicor) concentration in milk is increased in dairy cows after exogenous administration. There is no available data on L-carnitine excretion in human milk.
Adverse Reactions
Various mild gastrointestinal complaints such as transient nausea and vomiting, abdominal cramps, and diarrhea have been reported during the long-term administration of oral L- or D,L-carnitine. Mild myasthenia has been described only in uremic patients receiving D,L-carnitine. Significant increases in platelet aggregation and significant hypertriglyceridemia associated with high doses of levocarnitine (3 g/day) given to hemodialysis patients have been reported.
Drug Interactions
L-Carnitine (Carnicor) may increase the effects of certain anticoagulants such as acenocoumarol, warfarin and heparin. Taking L-carnitine with thyroid hormone might decrease the effectiveness of the thyroid hormone. Cephalosporin antibiotics may reduce plasma carnitine levels. Anticonvulsants (phenobarbital, phenytoin, carbamazepine) may decrease serum carnitine in children. Cisplastin may increase urinary excretion of carnitine. Ifosfamide may increase urinary loss of carnitine. Patients suffering from neuropathy induced by nucleosides may have reduced levels of acetyl carnitine. L-Carnitine (Carnicor) may decrease the need for certain drugs, such as glycosides, digoxin, diuretics, beta-blockers, channel blockers, hypolipidemic drugs, and nitro derivatives. L-Carnitine (Carnicor) supplementation may reduce side effects associated with interleukin-2 (IL-2) or nortriptyline. It may also improve liver and muscular side effects associated with isotretinoin in acne patients. Carnitine may reduce nerve damage symptoms associated with paclitaxel use.
Storage
Store at temperatures not exceeding 30°C. Protect from light and moisture.
Shelf-Life: 48 months (tablet) & 36 months (oral solution).
MIMS Class
ATC Classification
A16AA01 - levocarnitine ; Belongs to the class of amino acids and derivatives products. Used in treatment of alimentary tract and metabolism problems.
Presentation/Packing
Tab 330 mg x 100's. Oral soln 1 g/10 mL x 10's.
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