LEVOCARNITINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Akorn

INN (International Name):

LEVOCARNITINE

Composition:

LEVOCARNITINE 330 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Levocarnitine is indicated in the treatment of primary systemic carnitine deficiency. In the reported cases, the clinical presentation consisted of recurrent episodes of Reye-like encephalopathy, hypoketotic hypoglycemia, 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 be low and that the patient does not have a primary defect in fatty acid or organic acid oxidation (see CLINICAL PHARMACOLOGY). 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. Levocarnitine is also indicated for acute and chronic treatment of patients with an inborn error of metabolism which results in a secondary carnitine deficiency. None known.

Product summary:

Levocarnitine Tablets USP are supplied as 330 mg tablets embossed with "LC 77" in individual blisters, packaged in boxes of 90 (NDC 50383-172-90). Store at controlled room temperature (25°C). See USP. Levocarnitine Tablets USP are distributed by Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701. Rx only.

Authorization status:

New Drug Application

Summary of Product characteristics

LEVOCARNITINE- LEVOCARNITINE TABLET
AKORN
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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
been demonstrated