Drug: Carnitor Injection

CARNITOR® (levocarnitine) is a carrier molecule in the transport of long-chain fatty acids across the inner mitochondrial membrane. The chemical name of levocarnitine is 3-carboxy-2(R)-hydroxy-N,N,N-trimethyl-1-propanaminium, inner salt. Levocarnitine is a 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: C7H15NO3
Molecular Weight: 161.20 CARNITOR® (levocarnitine) Injection is a sterile aqueous solution containing 1 g of levocarnitine per 5 mL vial. The pH is adjusted to 6.0 - 6.5 with hydrochloric acid or sodium hydroxide.

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Transient nausea and vomiting have been observed. Less frequent adverse reactions are body odor, nausea, and gastritis. An incidence for these reactions is difficult to estimate due to the confounding effects of the underlying pathology. Seizures have been reported to occur in patients, with or without pre-existing seizure activity, receiving either oral or intravenous levocarnitine. In patients with pre-existing seizure activity, an increase in seizure frequency and/or severity has been reported. The table below lists the adverse events that have been reported in two double-blind, placebo-controlled trials in patients on chronic hemodialysis. Events occurring at ≥ 5% are reported without regard to causality. Adverse Events with a Frequency ≥ 5% Regardless of Causality by Body System
  Placebo
(n=63) Levocarnitine
10 mg (n=34) Levocarnitine
20 mg (n=62) Levocarnitine
40 mg (n=34) Levocarnitine
10, 20 & 40 mg (n=130) Body as Whole   Abdominal pain 17 21 5 6 9   Accidental injury 10 12 8 12 10   Allergic reaction 5 6     2   Asthenia 8 9 8 12 9   Back pain 10 9 8 6 8   Chest pain 14 6 15 12 12   Fever 5 6 5 12 7   Flu syndrome 40 15 27 29 25   Headache 16 12 37 3 22   Infection 17 15 10 24 15   Injection site reaction 59 38 27 38 33   Pain 49 21 32 35 30 Cardiovascular   Arrhythmia 5 3   3 2   Atrial fibrillation     2 6 2   Cardiovascular disorder 6 3 5 6 5   Electrocardiogram abnormal   3   6 2   Hemorrhage 6 9 2 3 4   Hypertension 14 18 21 21 20   Hypotension 19 15 19 3 14   Palpitations   3 8   5   Tachycardia 5 6 5 9 6   Vascular disorder 2   2 6 2 Digestive   Anorexia 3 3 5 6 5   Constipation 6 3 3 3 3   Diarrhea 19 9 10 35 16   Dyspepsia 10 9 6   5   Gastrointestinal disorder 2 3   6 2   Melena 3 6     2   Nausea 10 9 5 12 8   Stomach atony 5           Vomiting 16 9 16 21 15 Endocrine System   Parathyroid disorder 2 6 2 6 4 Hemic/Lymphatic   Anemia 3 3 5 12 6 Metabolic/Nutritional   Hypercalcemia 3 15 8 6 9   Hyperkalemia 6 6 6 6 6   Hypervolemia 17 3 3 12 5   Peripheral edema 3 6 5 3 5   Weight decrease 3 3 8 3 5   Weight increase 2 3   6 2 Musculo-Skeletal   Leg cramps 13   8   4   Myalgia 6         Nervous   Anxiety 5   2   1   Depression 3 6 5 6 5   Dizziness 11 18 10 15 13   Drug dependence 2 6     2   Hypertonia 5 3     1   Insomnia 6 3 6   4   Paresthesia 3 3 3 12 5   Vertigo   6     2 Respiratory   Bronchitis     5 3 3   Cough increase 16   10 18 9   Dyspnea 19 3 11 3 7   Pharyngitis 33 24 27 15 23   Respiratory disorder 5           Rhinitis 10 6 11 6 9   Sinusitis 5   2 3 2 Skin and Appendages   Pruritis 13   8 3 5   Rash 3   5 3 3 Special Senses   Amblyopia 2   6   3   Eye disorder 3 6 3   3   Taste perversion     2 9 3 Urogenital   Urinary tract infect 6 3 3   2   Kidney failure 5 6 6 6 6 Read the Carnitor Injection (levocarnitine injection) Side Effects Center for a complete guide to possible side effectsLearn More »

Source: http://www.rxlist.com

CARNITOR® (levocarnitine injection) Injection is administered intravenously. Metabolic Disorders The recommended dose is 50 mg/kg given as a slow 2-3 minute bolus injection or by infusion. Often a loading dose is given in patients with severe metabolic crisis, followed by an equivalent dose over the following 24 hours. It should be administered q3h or q4h, and never less than q6h either by infusion or by intravenous injection. All subsequent daily doses are recommended to be in the range of 50 mg/kg or as therapy may require. The highest dose administered has been 300 mg/kg. It is recommended that a plasma carnitine concentration be obtained prior to beginning this parenteral therapy. Weekly and monthly monitoring is recommended as well. This monitoring should include blood chemistries, vital signs, plasma carnitine concentrations (the plasma free carnitine concentration should be between 35 and 60 ┬Ámol/L) and overall clinical condition. ESRD Patients on Hemodialysis The recommended starting dose is 10-20 mg/kg dry body weight as a slow 2-3 minute bolus injection into the venous return line after each dialysis session. Initiation of therapy may be prompted by trough (pre-dialysis) plasma levocarnitine concentrations that are below normal (40-50 ┬Ámol/L). Dose adjustments should be guided by trough (pre-dialysis) levocarnitine concentrations, and downward dose adjustments (e.g. to 5 mg/kg after dialysis) may be made as early as the third or fourth week of therapy. Parenteral drug products should be inspected visua ly for particulate matter and discoloration prior to administration, whenever solution and container permit. Compatibility And Stability CARNITOR® (levocarnitine injection) Injection is compatible and stable when mixed in parenteral solutions of Sodium Chloride 0.9% or Lactated Ringer's in concentrations ranging from 250 mg/500 mL (0.5 mg/mL) to 4200 mg/500 mL (8.0 mg/mL) and stored at room temperature (25°C) for up to 24 hours in PVC plastic bags.

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No information provided. Last reviewed on RxList: 5/28/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

For the acute and chronic treatment of patients with an inborn error of metabolism which results in secondary carnitine deficiency. For the prevention and treatment of carnitine deficiency in patients with end stage renal disease who are undergoing dialysis. (US Patent Nos. 6,335,369; 6,429,230; 6,696,493)

Source: http://www.rxlist.com

None known. Last reviewed on RxList: 5/28/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

There have been no reports of toxicity from levocarnitine overdosage. Levocarnitine is easily removed from plasma by dialysis. The intravenous LD50 of levocarnitine in rats is 5.4 g/kg and the oral LD50 of levocarnitine in mice is 19.2 g/kg. Large doses of levocarnitine may cause diarrhea.

Source: http://www.rxlist.com

CARNITOR® (levocarnitine) Injection is available in 1 g per 5 mL single dose vials packaged 5 vials per carton (NDC 54482-147-01). CARNITOR® (levocarnitine) Injection 5 mL vial is manufactured for Sigma-Tau Pharmaceuticals, Inc. by Sigma-Tau S.p.A., 00040 Pomezia (Rome), Italy or Chesapeake Biological Laboratories, Inc. Baltimore, MD 21230-2591. Store vials at controlled room temperature (25°C). See USP. Discard unused portion of an opened vial, as the formulation does not contain a preservative. CARNITOR® (levocarnitine) is also available in the following dosage forms: CARNITOR® (levocarnitine) Tablets are supplied as 330 mg tablets embossed with “CARNITOR ST” in blister packages, in boxes of 90 tablets (NDC 54482-144-07). Made in Italy. CARNITOR® (levocarnitine) Oral Solution is supplied in 118 mL (4 FL. OZ.) multiple-unit plastic cotainers. The multiple-unit containers are packaged 24 per case (NDC 54482-145-08). CARNITOR® (levocarnitine) Oral Solution is manufactured for Sigma-Tau Pharmaceuticals, Inc. by Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701. Sigma-tau Pharmaceuticals, Inc. Gaithersburg, MD 20877. Date of Issue: 03/04 Last reviewed on RxList: 5/28/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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 ESRD patients on dialysis may result in accumulation of the potentially toxic metabolites, trimethylamine (TMA) and trimethylamine-N-oxide (TMAO), since these metabolites are normally excreted in the urine. Carcinogenesis, mutagenesis, impairment of fertility Mutagenicity tests performed in Salmonella typhimurium, Saccharomyces cerevisiae, and Schizosaccharomyces pombeindicate that levocarnitine is not mutagenic. No long-term animal studies have been performed to evaluate the carcinogenic potential of levocarnitine. Pregnancy Pregnancy Category B. Reproductive studies have been performed in rats and rabbits at doses up to 3.8 times the human dose on the basis of surface area and have revealed no evidence of impaired fertility or harm to the fetus due to CARNITOR® (levocarnitine injection) . There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers Levocarnitine supplementation in nursing mothers has not been specifically studied. Studies in dairy cows indicate that the concentration of levocarnitine in milk is increased following exogenous administration of levocarnitine. In nursing mothers receiving levocarnitine, any risks to the child of excess carnitine intake need to be weighed against the benefits of levocarnitine supplementation to the mother. Consideration may be given to discontinuation of nursing or of levocarnitine treatment. Pediatric Use See DOSAGE AND ADMINISTRATION. Last reviewed on RxList: 5/28/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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