LEVOCARNITINE tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Rising Pharmaceuticals, Inc.

INN (Internationale Bezeichnung):

LEVOCARNITINE

Zusammensetzung:

LEVOCARNITINE 330 mg

Verschreibungstyp:

PRESCRIPTION DRUG

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

LEVOCARNITINE- LEVOCARNITINE TABLET
RISING PHARMACEUTICALS, 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
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:
Molecular 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
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 alleviate the metabolic abnormalities of patients wi