LEVOCARNITINE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

American Regent, Inc.

INN (International Name):

LEVOCARNITINE

Composition:

LEVOCARNITINE 200 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

For the acute and chronic treatment of patients with an inborn error of metabolism which results in secondary carnitine deficiency. For the prevention and treatment of carnitine deficiency in patients with end stage renal disease who are undergoing dialysis. None known.

Product summary:

How supplied : Levocarnitine Injection, USP is available in 5 mL and 20 mL single-dose vials.  Each 5 mL vial contains 1 g/5 mL and each 20 mL vial contains 4 g/20 mL (200 mg/mL). NDC 0517-1045-05       1 gram/5 mL (200 mg/mL) Single-Dose Vial         Packages of 5 NDC 0517-1075-01       4 grams/20 mL (200 mg/mL) Single-Dose Vial      Individually boxed Store at or below 25°C (77°F) (See USP).  Do not freeze.  Store vials in carton until their use to protect from light.  Discard unused portion of an opened vial, as the formulation does not contain a preservative.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEVOCARNITINE- LEVOCARNITINE INJECTION, SOLUTION
AMERICAN REGENT, INC.
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LEVOCARNITINE INJECTION, USP
1 G PER 5 ML VIAL AND 4 G PER 20 ML VIAL
FOR INTRAVENOUS USE ONLY
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 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:
Levocarnitine injection, USP is a sterile aqueous solution containing
1 g of levocarnitine
per 5 mL vial, and 4 g of levocarnitine per 20 mL vial, and water for
injection q.s. The pH
is adjusted to 6 to 6.5 with hydrochloric acid or sodium hydroxide.
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 carnitine deficiency and which are due to an
underlying organic
acidemia, as symptoms of both abnormalities may be expected to improve
with
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 acylCoA esters.
Secondary carnitine deficiency can be a consequence of inborn errors
of metabolism or
iatrogenic factors such as hemodialysis. Levoc