LEVOCARNITINE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rising Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Levocarnitine Oral Solution USP 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 USP is also indicated for acute and chronic treatment of patients with an inborn error of metabolism which results in a secondary carnitine defic

Product summary:

Levocarnitine Oral Solution USP is supplied in 118 mL (4 FL. OZ.) multiple-dose plastic containers. The multiple-dose containers are packaged 24 per case (NDC 64980-503-12). Store at 20° to 25°C (68° to 77°F); excursion permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Rx only.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEVOCARNITINE - LEVOCARNITINE SOLUTION
RISING PHARMACEUTICALS, INC.
----------
LEVOCARNITINE ORAL SOLUTION USP
1G/10ML
(118ML 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:
Molecular Formula: C H
NO
Molecular Weight: 161.20
Levocarnitine Oral Solution USP is intended solely for oral
administration. Each 10 mL
contains 1 gram of levocarnitine. Levocarnitine Oral Solution USP is
available as 1 g/10
mL in bottles of 118 mL with the following inactive ingredients:
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
7
15
3
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 Oral Solution USP. The literature reports that carnitine
can promote the
excretion of excess organic or fatty acids in patients with defects in
fatt