LEVOCARNITINE tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Rising Pharma Holdings, Inc.

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Levocarnitine tablets, USP are 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 tablets, USP are also indicated for acute and chronic treatment of patients with an inborn error of metabolism which results in a secondary carnitine deficiency. None known.

Produktbesonderheiten:

Levocarnitine tablets, USP are supplied as white, round compressed tablets debossed “Cor ” over “160 ” on one side and other side is plain. They are supplied as follows: Blister pack of 10 tablets, packaged in boxes of 90 tablets (NDC 16571-762-09) Store at 20o to 25o C (68o to 77o F) [see USP Controlled Room Temperature]. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

LEVOCARNITINE - LEVOCARNITINE TABLET
RISING PHARMA HOLDINGS, INC.
----------
LEVOCARNITINE TABLETS, USP
330 MG
RX ONLY
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
(R)-3-carboxy-2-hydroxy-N,N,N-trimethy-1-
propanaminium hydroxide, inner salt. Levocarnitine is a white,
crystalline powder or
colourless crystals. It is freely soluble in water, soluble in warm
alcohol, practically
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 intended for oral administration
contains 330 mg of
levocarnitine. In addition, it also contains the following inactive
ingredients: magnesium
stearate, microcrystalline cellulose, povidone and sodium starch
glycolate.
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
7
15
3
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.
Secondary carnitine deficiency can be a consequence of inborn errors
of metabolism.
Levocarnitine may allev