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DRUG STUDY PATIENT PROFILE DOB: 05/30/85 Age: 29 Sex: Male Citizenship: Filipino Civil Status: Single Service: Internal Medicine Doctor’s Complete Drug Order: L-Carnitine (Godex DS capsule) 1cap orally thrice daily

Pertinent History and PE: One month PTA, patient noted onset of numbness of both hands that occurred during performance of activities like driving and typing. Condition tolerated. No other signs and symptoms noted. Two days PTA, patient had onset of jaw fitness with no triggering factors and with spontaneous resolution. Persistence of signs and symptoms prompted consult and subsequent ission. Laboratory/ Diagnostic Procedure related to Drug Therapy:

HBA1c: (Old and New Method) 4.6% and

Generic Name: L- Carnitine Godex

Brand Name:

Category: HAMS

Regular Drug

LASA Therapeutic Category: Uses: Indicated in the treatment of primary systemic carnitine deficiency. In the reported cases, the clinical presentation consisted of recurrent episodes of Reye-like encephalopathy, hypoketotichypoglycemia, and/or cardiomyopathy. Associated symptoms included hypotonia, muscle weakness and failure to thrive. A diagnosis of primary carnitine deficiency requires that serum, red cell and/or tissue carnitine levels below and that the patient does not have a primary defect in fatty acid or organic acid oxidation. In some patients, particularly those presenting with cardiomyopathy, carnitine supplementation rapidly alleviated signs and symptoms. Treatment should include, in addition to carnitine, ive and other therapy as indicated by the condition of the patient. Is also indicated for acute and chronic treatment of patients with an inborn error of metabolism which results in a secondary carnitine deficiency.

Pharmacokinetics: L-Carnitine is a naturally occurring compound that facilitates the transport of fatty acids into mitochondria for β-oxidation. Exogenous L-carnitine is used clinically for the treatment of carnitine deficiency disorders and a range of other conditions. In humans, the endogenous carnitine pool, which comprises free L-carnitine and a range of short-, medium- and long-chain esters, is maintained by absorption of Lcarnitine from dietary sources, biosynthesis within the body and extensive renal tubular reabsorption from glomerular filtrate. In addition, carrier-mediated transport ensures high tissue-to-plasma concentration ratios in tissues that depend critically on fatty acid oxidation. The absorption of L-carnitine after oral istration occurs partly via carrier-mediated transport and partly by ive diffusion. After oral doses of 1–6g, the absolute bioavailability is 5–18%. In contrast, the bioavailability of dietary L-carnitine may be as high as 75%. Therefore, pharmacological or supplemental doses of L-carnitine are absorbed less efficiently than the relatively smaller amounts present within a normal diet. L-Carnitine and its short-chain esters do not bind to plasma proteins and, although

DRUG STUDY 2.7% decreased Eosinophils: Absolute: 0.92 103/uL increased Relative: 10.8% increased

blood cells contain L-carnitine, the rate of distribution between erythrocytes and plasma is extremely slow in whole blood. After intravenous istration, the initial distribution volume of L-carnitine is typically about 0.2–0.3 L/kg, which corresponds to extracellular fluid volume. There are at least three distinct pharmacokinetic compartments for L-carnitine, with the slowest equilibrating pool comprising skeletal and cardiac muscle. L-Carnitine is eliminated from the body mainly via urinary excretion. Under baseline conditions, the renal clearance of L-carnitine (1–3 mL/min) is substantially less than glomerular filtration rate (GFR), indicating extensive (98–99%) tubular reabsorption. The threshold concentration for tubular reabsorption (above which the fractional reabsorption begins to decline) is about 40–60 µmol/L, which is similar to the endogenous plasma L-carnitine level. Therefore, the renal clearance of L-carnitine increases istration, approaching GFR after high intravenous doses.

after

exogenous

Contraindications: Allergy to Carnitine Analogues Special Concerns/ Warnings/ Precautions: The safety and efficacy of oral levocarnitine has not been evaluated in patients with renal insufficiency. Chronic istration 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. 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 tablets, oral solution, sugar-free) . 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. Side Effects: Various mild gastrointestinal complaints have been reported during the longterm istration of oral L- or D,L-carnitine; these include transient nausea and vomiting, abdominal cramps, and diarrhea. Mild myasthenia has been described only in uremic patients receiving D,L-carnitine Food and Drug Interactions: Acenocoumarol (Sintrom) is used to slow blood clotting. Lcarnitine might increase the effectiveness of acenocoumarol (Sintrom). Increasing the

DRUG STUDY effectiveness of acenocoumarol (Sintrom) might slow blood clotting too much. The dose of your acenocoumarol (Sintrom) might need to be changed. L-carnitine seems to decrease how well thyroid hormone works in the body. Taking Lcarnitine with thyroid hormone might decrease the effectiveness of the thyroid hormone. Warfarin (Coumadin) is used to slow blood clotting. L-carnitine might increase the effects of warfarin (Coumadin) and increase the chances of bruising and bleeding. Be sure to have your blood checked regularly. The dose of your warfarin (Coumadin) might need to be changed. Overdose Management: 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. ive management may be given if diarrhea occurs.