CARNITOR- levocarnitine solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Leadiant Biosciences, Inc.

INN (International Name):

LEVOCARNITINE

Composition:

LEVOCARNITINE 1 g in 10 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

CARNITOR ® (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. CARNITOR ® (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

Product summary:

CARNITOR ® (levocarnitine) Tablets are supplied as 330 mg tablets embossed with "CARNITOR ST" in individual blisters, packaged in boxes of 90 (NDC 54482-144-07). Store in original packaging: content hygroscopic. Store at 20°C to 25°C (68°F to 77°F). See USP Controlled Room Temperature. CARNITOR ® (levocarnitine) Tablets are distributed by Leadiant Biosciences, Inc. CARNITOR ® (levocarnitine) Oral Solution is supplied in 118 mL (4 FL. OZ.) plastic containers (NDC 54482-145-08 and NDC 54482-145-09). Store at 20°C to 25°C (68°F to 77°F). See USP Controlled Room Temperature. Avoid excessive heat and protect from freezing. CARNITOR ® (levocarnitine) Oral Solution is distributed by Leadiant Biosciences, Inc. CARNITOR ® SF (levocarnitine) Sugar-Free Oral Solution is supplied in 118 mL (4 FL. OZ.) plastic containers (NDC 54482-148-01 and NDC 54482-148-02). Store at 20°C to 25°C (68°F to 77°F). See USP Controlled Room Temperature. Avoid excessive heat and protect from freezing. CARNITOR ® SF (levocarnitine) Sugar-Free Oral Solution is distributed by Leadiant Biosciences, Inc. Rx only.

Authorization status:

New Drug Application

Summary of Product characteristics

CARNITOR- LEVOCARNITINE SOLUTION
LEADIANT BIOSCIENCES, INC.
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CARNITOR
(LEVOCARNITINE) ORAL SOLUTION (1 G PER 10 ML MULTIDOSE)
FOR ORAL USE ONLY. NOT FOR PARENTERAL USE.
DESCRIPTION
CARNITOR
(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:
Empirical Formula: C
H
NO
Molecular Weight: 161.20
Each CARNITOR
(levocarnitine) Tablet contains 330 mg of levocarnitine and the
inactive
ingredients magnesium stearate, microcrystalline cellulose and
povidone.
Each 118 mL container of CARNITOR
(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.
Each 118 mL container of CARNITOR
SF (levocarnitine) Sugar-Free Oral Solution
contains 1 g of levocarnitine/10 mL. Also contains: Natural 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.
CLINICAL PHARMACOLOGY
CARNITOR
(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 be