LEVOCARNITINE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

TRUPHARMA, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Levocarnitine oral solution 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 oral solution is also indicated for the acute and chronic treatment of patients with an inborn error of metabolism which results in a secondary carnitine deficiency. None known.

Product summary:

Levocarnitine oral solution, USP is a clear colorless solution with cherry flavor, supplied in 118 mL (4 fl. oz.) plastic containers (NDC 52817-830-04). Store at controlled room temperature 15º to 30 ºC (59º to 86º F) [see USP].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEVOCARNITINE- LEVOCARNITINE SOLUTION
TRUPHARMA, LLC
----------
LEVOCARNITINE ORAL SOLUTION
FOR ORAL USE ONLY. NOT FOR PARENTERAL USE.
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, USP is a white crystalline,
hygroscopic powder.
It is freely soluble in water, soluble in warm alcohol, and
practically 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 118 mL container of levocarnitine oral solution, USP contains 1 g
of levocarnitine,
USP/10 mL. Also contains: artificial cherry flavor, ethyl alcohol
(0.0094%), malic acid,
purified water, sucrose. Methylparaben and propylparaben are added as
preservatives.
The pH is between 4.0 to 6.0.
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 a 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
7
15
3
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 acyl-CoA esters.
Secondary carnitine deficiency can be a consequen