LEVOCARNITINE- levocarnitine oral solution solution LEVOCARNITINE (levocarnitine oral solution- suguar free 1 g/10 ml solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Novitium Pharma LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Levocarnitine Oral Solution is clear, flavored solution. Levocarnitine Oral Solution, USP is supplied in 118 mL (4 fl.oz.) White colored HDPE bottle (NDC 70954-139-10). Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Levocarnitine Oral Solution (Sugar Free) is clear, flavored solution. Levocarnitine  Oral Solution (Sugar-Free) is supplied in 118 mL (4 fl.oz.) Amber colored HDPE bottle  (NDC 70954-140-10). Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Rx only

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEVOCARNITINE - LEVOCARNITINE ORAL SOLUTION SOLUTION
NOVITIUM PHARMA LLC
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LEVOCARNITINE ORAL SOLUTION, USP (1 G PER 10 ML MULTI-DOSE)
FOR ORAL USE ONLY. NOT FOR PARENTERAL USE.
LEVOCARNITINE ORAL SOLUTION, USP (1 G PER 10 ML MULTI-DOSE) (SUGAR
FREE)
FOR ORAL USE ONLY. NOT FOR PARENTERAL USE.
DESCRIPTION
Levocarnitine, USP 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
Empirical Formula: C H
NO
Molecular Formula: 161.20
Each 118 mL container of Levocarnitine Oral Solution, USP contains 1 g
of levocarnitine /
10mL. 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.
Each 118 mL container of Levocarnitine Oral Solution, USP (Sugar Free)
contains 1 g of
levocarnitine/10 mL. Also contains: Artificial Cherry Flavor,
D,L,-Malic Acid, Purified
Water, Sodium Saccharin USP.
Methylparaben NF and Propylparaben NF are added as preservatives. The
pH is
approximately 5.
7
15
3
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 carniti