LEVOCARNITINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

ANI Pharmaceuticals, Inc.

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 Tablets, USP are supplied as 330 mg white to off white, round, standard biconvex, uncoated tablets debossed with N492 on one side and plain on the other side in individual blisters, packaged in boxes of 90 (NDC 70954-492-10). Store at 20°C to 25°C (68°F to 77°F); excursions permitted 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Levocarnitine Oral Solution, USP is a clear cherry flavored solution supplied in 118 mL (4 fl. oz.) amber colored HDPE bottles (NDC 70954-139-10). Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Levocarnitine Oral Solution, USP (Sugar Free) is a clear cherry flavored solution supplied in 118 mL (4 fl. oz.) white colored HDPE bottles (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 TABLET
ANI PHARMACEUTICALS, INC.
----------
LEVOCARNITINE TABLETS (330 MG)
LEVOCARNITINE ORAL SOLUTION (1 G/10 ML MULTIPLE-UNIT CONTAINER)
LEVOCARNITINE ORAL SOLUTION (SUGAR FREE) (1 G/10 ML MULTIPLE-UNIT
CONTAINER)
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:
Empirical Formula: C H
NO
Molecular Weight: 161.20
Each Levocarnitine Tablet, USP for oral use contains 330 mg of
levocarnitine and the
inactive ingredients Magnesium Stearate, Microcrystalline Cellulose
and Povidone.
Each 118 mL container of Levocarnitine Oral Solution, USP 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 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
7
15
3
preservatives. The pH is approximately 5.
FDA approved dissolution test specifications differ from USP.
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
alltissues except the brain.
In skeletal and cardiac muscle, fatty acids are the main substrate for
ener