DRUG STUDY

PATIENT PROFILE
DOB: 05/30/85
Age: 29
Sex: Male
Citizenship: Filipino
Civil Status:
Single
Service: Internal Medicine
Doctors 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
admission.
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, supportive 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 -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 administration occurs
partly via carrier-mediated transport and partly by passive diffusion. After oral doses
of 16g, the absolute bioavailability is 518%. 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 administration, the initial
distribution volume of L-carnitine is typically about 0.20.3 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 (13 mL/min) is substantially less than
glomerular filtration rate (GFR), indicating extensive (9899%) tubular reabsorption.
The threshold concentration for tubular reabsorption (above which the fractional
reabsorption begins to decline) is about 4060 mol/L, which is similar to the
endogenous
plasma
L-carnitine
level.
Therefore, the renal clearance of L-carnitine increases
administration, 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 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. 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 administration 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. Supportive management may be given if diarrhea occurs.