LEVOCARNITINE solution

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Akorn

INN (International namn):

LEVOCARNITINE

Sammansättning:

LEVOCARNITINE 1 g in 10 mL

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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.

Produktsammanfattning:

Levocarnitine Oral Solution is supplied in 118 mL (4 FL. OZ.) multiple-unit plastic containers. The multiple-unit containers are packaged 24 per case (NDC 50383-171-04). Store at controlled room temperature (25°C). See USP. Levocarnitine Oral Solution, USP is distributed by Akorn Operating Company LLC, Gurnee, IL 60031. Rx only.

Bemyndigande status:

New Drug Application

Produktens egenskaper

LEVOCARNITINE- LEVOCARNITINE SOLUTION
AKORN
----------
LEVOCARNITINE ORAL SOLUTION, USP (1 G PER 10 ML MULTIDOSE)
FOR ORAL USE ONLY. NOT FOR PARENTERAL USE.
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:
Each 118 mL container of Levocarnitine Oral Solution contains 1 g of
levocarnitine/10
mL. Also contains: Artificial Cherry Flavor, D,L,-Malic Acid, Purified
Water, Sucrose Syrup.
Methylparaben NF and Propylparaben NF are added as preservatives. The
pH is
approximately 5.
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
Empirical Formula: C H
NO
7
15
3
Molecular Weight: 161.20
1-6
organic acidopathies that bioaccumulate acylCoA esters.
Secondary carnitine deficiency can be a consequence of inborn errors
of metabolis