LEVOCARNITINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LEVOCARNITINE (UNII: 0G389FZZ9M) (LEVOCARNITINE - UNII:0G389FZZ9M)

Available from:

Avera McKennan Hospital

INN (International Name):

LEVOCARNITINE

Composition:

LEVOCARNITINE 330 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

LEVOCARNITINE- LEVOCARNITINE TABLET
AVERA MCKENNAN HOSPITAL
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LEVOCARNITINE TABLETS USP (330 MG)
DESCRIPTION
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:C H NO
Molecular Weight: 161.20
Each Levocarnitine Tablet USP contains 330 mg of levocarnitine and the
inactive ingredients
magnesium stearate, microcrystalline cellulose and povidone.
CLINICAL PHARMACOLOGY
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 an energy substrate in all
tissues except the brain. In skeletal and cardiac muscle, fatty acids
are the main substrate 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 an underlying organic acidemia, as
symptoms of both abnormalities may
be expected to improve with levocarnitine. The literature reports that
carnitine can promote the
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
may alleviate the metabolic abnormalities of patients with inborn
errors that result in accumulation of
toxic organic acids. Conditions for which this effect has bee