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Levocarnitine

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Last Updated: 22 September 2020

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General | Latest Info

While improving glucose utilisation, administration of levocarnitine to diabetic patients receiving either insulin or hypoglycaemic oral treatment may result in hypoglycaemia. Plasma glucose levels in these subjects must be monitored regularly in order to adjust hypoglycaemic treatment immediately, if require. 30% oral solution contains sucrose. This must be considered when treating diabetics or patients who are following diets to reduce calorie intake. The safety and efficacy of oral levocarnitine has not been evaluated in patients with renal insufficiency. Chronic administration of high doses of oral levocarnitine in patients with severely compromised renal function or in end stage renal disease patients on dialysis may result in accumulation of potentially toxic metabolites, trimethylamine and trimethylamine - Noxide, since these metabolites are usually excreted in urine. This situation has not been observed following intravenous administration of levocarnitine. Patients with rare hereditary problems of fructose intolerance, glucose - galactose malabsorption or sucrase - isomaltase insufficiency should not take this medicine. There have been very rare reports of International Normalised Ratio increase in patients treated concomitantly with levocarnitine and coumarinic drugs. See Section 4. 5 Interactions and Section 4. 8 Undesirable Effects. Reproductive studies were performed in rats and rabbits. There was no evidence of teratogenic effect in either species. In rabbits but not in rats, there was a statistically insignificant greater number of post implantation losses at highest dose test as compared with control animals. The significance of these findings in man is unknown. There is no experience of use in pregnant patients with primary systemic carnitine deficiency. Taking into account serious consequences in pregnant woman who has primary systemic carnitine deficiency stopping treatment, risk to mother of discontinuing treatment seems greater than the theoretical risk to foetus if treatment is continue. Levocarnitine is a normal component of human milk. Use of levocarnitine supplementation in nursing mothers has not been study. Levocarnitine is present as a natural constituent in animal tissues, micro - organisms and plants. In man, physiological metabolic requirements are met both by consumption of food containing carnitine and endogenous synthesis in the liver and kidneys from lysine with methionine serving as methyl donor. Only L - isomer is biologically active, playing an essential role in lipid metabolism as well as in metabolism of ketone bodies as branch chain - amino - acids. The Levocarnitine as factor is necessary in transport of long - chain fatty acids into mitochondria - facilitating oxidation of fatty acids rather than their incorporation into triglycerides. By releasing CoA from its thioesters, through action of CoA; carnitine acetyl transferase, levocarnitine also enhances metabolic flux in Kreb's cycle; with the same mechanism, it stimulates activity of pyruvate dehydrogenase and in skeletal muscle, oxidation of branch - chain amino acids. Levocarnitine is thus involve, directly or indirectly in several pathways, so that its availability should be an important factor controlling not only oxidative utilisation of fatty acids and ketone bodies but also that of glucose and some amino acids. Absorbed levocarnitine is transported to various organ systems via blood.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Uses

This medication is a diet supplement used to prevent and treat low blood levels of carnitine. Carnitine is a substance made in the body from meat and dairy products. It helps the body use certain chemicals for energy and to keep you in good health. Low blood levels of carnitine may occur in people whose bodies cannot properly use carnitine from their diets, people on dialysis due to serious kidney disease, and people being treated with certain drugs. Carnitine levels that are too low can cause liver, heart, and muscle problems. Carnitine comes in 2 forms, this medication and D - carnitine. Over - counter products called vitamin Bt contain a mixture of levocarnitine and D - carnitine. Vitamin Bt should not be used to treat serious carnitine deficiency since it can interfere with the body's use of levocarnitine. Do not use levocarnitine to treat serious carnitine deficiency unless prescribed by your doctor. Form of levocarnitine taken by mouth is not recommended for treating people on dialysis due to serious kidney disease. Injectable form should be used for this treatment. Consult your doctor for details. Some supplement products have been found to contain possibly harmful impurities / additives. Check with your pharmacist for more details about the brand you use. Fda has not reviewed this product for safety or effectiveness. Consult your doctor or pharmacist for more details.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Proper Use TOP

Take levocarnitine with or just after meals. Also, if you are taking it in liquid form, drink it slowly. It will be less likely to upset your stomach if you take it this way. Liquid form may be taken alone or dissolved in drink or other liquid food. This medicine is also less likely to cause unwanted effects when there is a constant amount in blood. If you are taking more than one per day, take doses at evenly spaced times throughout the day. Doses should be spaced at least 3 to 4 hours apart. If you need help in planning the best times to take your medicine, check with your health care professional.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Drug Interactions TOP

The carnitor is a carrier molecule in transport of long - chain fatty acids across the inner mitochondrial membrane. The chemical name of levocarnitine is 3 - carboxy - 2 - hydroxy - N, NN - trimethyl - 1propanaminium, inner salt. Levocarnitine is white crystalline, hygroscopic powder. It is readily soluble in water, hot alcohol, and insoluble in acetone. The specific rotation of levocarnitine is between - 29 and - 32. Its chemical structure is: empirical Formula: C 7 H 15 NO 3 Molecular Weight: 161. 20 CARNITOR Injection is a sterile aqueous solution containing 1 G of levocarnitine per 5 mL vial. Ph is adjusted to 6. 0 - 6. 5 with hydrochloric acid or Sodium hydroxide.


CONTRAINDICATIONS / PRECAUTIONS

Serious hypersensitivity reactions have been reported with both oral and intravenous levocarnitine. Discontinue levocarnitine and initiate appropriate medical treatment if signs and symptoms of hypersensitivity occur. Consider risks and benefits of re - administering levocarnitine after serious reaction. If re - administration is necessary, monitor patients closely. Levocarnitine may cause gastrointestinal symptoms and should be used conservatively in patients with diarrhea. Levocarnitine should be used during pregnancy only if clearly needed. No adequate, well controlled studies exist in pregnant women. Reproductive studies were performed in rats and rabbits at doses of up to 3. 8 times human dose have reported no evidence of impaired fertility or harm to the fetus. Levocarnitine therapy has been associated with increased seizure activity. It should be administered with caution to patients with a history of seizure disorder. Although levocarnitine is used in treatment of some types of cardiomyopathy, it should be administered with caution to patients with a history of cardiac disease or cardiac dysfunction. Various cardiovascular adverse effects have been reported with administration of intravenous levocarnitine in dialysis patients, including hypertension, peripheral edema, and ventricular arrhythmias. The safety and efficacy of oral levocarnitine has not been evaluated in the setting of renal impairment. Do not use oral formulations of levocarnitine to treat patients with severe renal impairment or renal failure, including patients on dialysis. Major metabolites formed following chronic oral administration, trimethylamine and trimethylamine - Noxide will accumulate in patients with renal failure since they can not be efficiently removed by kidneys. Accumulation of these potentially toxic metabolites is not desirable since it increases the amount of nitrogenous waste to be removed in dialysis procedure. In addition, increased levels of TMA in dialysis patients have been reported to be associated with possible neurophysiologic effects. Inefficient removal of these metabolites may result in the development of fishy body odor. Only the intravenous form of levocarnitine is indicated for use in ESRD patients on hemodialysis; accumulation of metabolites does not occur to the same extent following intravenous administration of levocarnitine. Use levocarnitine with caution in hepatic disease since no specific information is available. Supplementation with levocarnitine in women who are breast - feeding has not been specifically study; however, levocarnitine is a normal component of human milk which is required for fat metabolism. Consumption of levocarnitine within the normal range of dietary intake leads to excretion into breast - milk, which is relatively constant. Women with carnitine deficiency and preterm infants may require prescription levocarnitine supplementation under supervision of healthcare professional. It is unlikely that maternal levocarnitine supplements during nursing would be harmful to infant, but it is probably best to avoid over - counter supplementation until more data is available. Levocarnitine has been studied in dairy cows; data indicate that concentration of levocarnitine in milk increases following exogenous administration of levocarnitine. In nursing mothers receiving levocarnitine, any risks to child of excess carnitine intake need to be weighed against the benefits of levocarnitine supplementation to mother. Consideration may be given to discontinuation of nursing or of levocarnitine treatment.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Rett Syndrome (Orphan)

No medications are available to treat people with RS. Bromocriptine and carbidopa - levodopa, which are dopamine agonists, have been tried as treatments for motor dysfunction in persons with RS; however, benefits are neither substantial nor long lasting. Case reports have suggested that levocarnitine may be effective. Double - blind placebo - control trials of folate and betaine have not demonstrated objective evidence of improvement, despite the theory that methyl - group pools might promote transcriptional repression. Individuals with gastroesophageal reflux may respond to conservative medical treatment with antireflux agents, thickened feeding solutions, and semiupright positioning at bedtime. Aeds may be prescribed to control seizurelike activity. Sarizotan, 5HT1A agonist and D2 agonist / antagonist, has been associated with 70 - 85% reduction of apneas and hyperventilation episodes in preclinical testing with both acute and chronic dosing. Sarizotan has been designated Orphan Drug status by the US Food and Drug Administration and the Committee for Orphan Medicinal Products from European Medicines Agency.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Cardiomyopathy (Orphan)

Sigma - Tau Pharmaceuticals, Inc. Claims that the Food and Drug Administration Act contrary to law in approving generic versions of its Levocarnitine Drug because generics infringe on seven - year period of Orphan exclusivity that its Drug currently enjoys under Orphan Drug Act, 21 USC 360aa - ee. District Court disagree, concluding that FDA did not act unlawfully in approving generics for indication that it was no longer protected by market exclusivity under the Act. Because the district Court correctly interpreted the governing statute's clear language, we affirm. Sigma - Tau Pharmaceuticals develops drugs to treat a rare condition known as carnitine deficiency in people with inborn metabolic disorders. 1 FDA designated Sigma - Tau's Levocarnitine Drug Orphan Drug - one designed to treat rare diseases or conditions - and approved Sigma - Tau's application to market it. Under the Orphan Drug Act, 21 USC 360aa - ee, Sigma - Tau was entitled to seven years of market exclusivity to sell its drug, known as Carnitor, For that Orphan indication. Its exclusivity for inborn metabolic disorders expired in 1999. Sigma - Tau later received FDA approval for use of its Levocarnitine Drug for prevention and treatment of the second rare condition - carnitine deficiency in patients with end - stage Renal disease who are undergoing dialysis. Sigma - Tau's exclusivity for treating carnitine deficiency in ESRD patients expired in 2006. Fda recently approved applications of two drug manufacturers, private intervenor Gensia Sicor Pharmaceuticals, Inc. And Bedford Laboratories, to market and sell generic forms of Sigma - Tau's Levocarnitine Drug. Agency approves generics for treatment of patients with inborn metabolic disorders, unprotected indication. Generics compete with Carnitor. As result of these generic drug approvals, Sigma - Tau brought suit against FDA on May 10 2001. Sigma - Tau seeks to have approvals rescind, or, in alternative, to have the FDA change generics labeling to protect Sigma - Tau's Orphan exclusivity. Sigma - Tau claims that FDA had violated ODA Amendments to Federal Food, Drug, and Cosmetic Act, 21 USC 360aa - ee, ODA's implementing regulations, and Administrative Procedure Act, 5 USC 706. In particular, Sigma Tau alleges that FDA ignored substantial evidence that generics were intended for use in Orphan - protected market, and that agency's approvals were arbitrary and capricious because generics infringe on seven - year period of Orphan exclusivity that Carnitor currently enjoys under ODA. After two hearings, district Court ruled against Sigma Tau. In this ruling, district Court applies well - settle principles of Chevron USA Inc. V. Natural Resources Defense Council, Inc., 467 US 837 104 SCt. 2778 81 lead. 2d 694. Under first step of Chevron analysis, id. At 842 - 43 104 SCt. 2778, Court concluded that Congress had spoken directly to the issue, and that FDA's approvals of generic manufacturers products were consistent with the clear language of the governing statute, 360cc of ODA.


Methods

Patients in the control group were administered the following oral drugs after initial diagnosis: hydrochlorothiazide 1 - 2 mg / kg / day, enalapril 0. 08 - 0. 10 mg / kg / day, spironolactone l - 2 mg / kg / day. Those with NYHA grade IV heart failure were additionally administered oral digoxin twice a day at 1 / 5 loading dose for 3 - 6 months, and those who were refractory were administered intravenous dopamine and dobutamine 2 - 5 g / kg / min for 3 - 5 days. When cardiac function was restored to NYHA grade II - III, patients were administered oral metoprolol 1. 0 - 1. 5 mg / kg / day. Renal function and serum potassium were monitored after 2 - 4 weeks. In the experimental group, patients were administered oral levocarnitine solution 50 - 100 mg / kg / day in addition to above - mention conventional therapy. During the treatment period, patients were hospitalized in case of exacerbation of clinical symptoms.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Pharmacology

Levocarnitine is a carrier molecule in transport of long - chain fatty acids across the inner mitochondrial membrane. The chemical name of Levocarnitine is 3 - carboxy - 2 - hydroxy - N, NN - trimethyl - 1propanaminium, inner salt. Levocarnitine is white crystalline, hygroscopic powder. It is readily soluble in water, hot alcohol, and insoluble in acetone. The specific rotation of Levocarnitine is between - 29 and - 32. Its chemical structure is: Molecular Formula: C 7 H 15 NO 3 Molecular Weight: 161. 20 Levocarnitine Oral Solution USP is intended solely for Oral Administration. Each 10 mL contains 1 gram of Levocarnitine. Levocarnitine Oral Solution USP is available as 1 G / 10 mL in bottles of 118 mL with the following inactive ingredients: Artificial Cherry Flavor, D, L - Malic Acid, Purified Water, Sucrose Syrup. Methylparaben NF and Propylparaben NF are added as preservatives. Ph is approximately 5. Levocarnitine is a naturally occurring substance required in mammalian energy metabolism. It has been shown to facilitate long - chain fatty Acid entry into cellular mitochondria, thereby delivering substrate for oxidation and subsequent energy production. Fatty acids are utilized as energy substrates in all tissues except the brain. In skeletal and cardiac muscle, fatty acids are main substrates for energy production. Primary systemic carnitine deficiency is characterized by low concentrations of Levocarnitine in plasma, RBC, and / or tissues. It has not been possible to determine which symptoms are due to carnitine deficiency and which are due to underlying organic acidemia, as symptoms of both abnormalities may be expected to improve with Levocarnitine Oral Solution USP. Literature reports that carnitine can promote excretion of excess organic or fatty acids in patients with defects in fatty Acid Metabolism and / or specific organic acidopathies that bioaccumulate acylCoA esters. 1 - 6 secondary carnitine deficiency can be a consequence of inborn Errors of Metabolism. Levocarnitine Oral Solution USP may alleviate metabolic abnormalities of patients with inborn errors that result in accumulation of toxic organic acids. Conditions For which this effect has been demonstrated are: glutaric aciduria II, methyl malonic aciduria, propionic acidemia, and medium chain fatty acylCoA dehydrogenase deficiency. 7 8 Autointoxication occurs in these patients due to accumulation of acylCoA compounds that disrupt intermediary metabolism. Subsequent hydrolysis of acylCoA compound to its free acid results in acidosis which can be life - threatening. Levocarnitine clears acylCoA compound by formation of acylcarnitine, which is quickly excrete. Carnitine deficiency is defined biochemically as abnormally low plasma concentrations of free carnitine, less than 20 mol / L at one week post term and may be associated with low tissue and / or urine concentrations. Further, this condition may be associated with plasma concentration ratio of acylcarnitine / Levocarnitine greater than 0. 4 or abnormally elevated concentrations of acylcarnitine in urine. In premature infants and newborns, secondary deficiency is defined as plasma Levocarnitine concentrations below age - related normal concentrations. In relative Bioavailability study in 15 healthy adult male volunteers, Levocarnitine Tablets were found to be bio - equivalent to Levocarnitine Oral Solution.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Sources

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

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