CARNITOR- levocarnitine injection, solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Leadiant Biosciences, Inc.

INN (Internationale Bezeichnung):

LEVOCARNITINE

Zusammensetzung:

LEVOCARNITINE 1 g in 5 mL

Verabreichungsweg:

INTRAVENOUS

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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.

Produktbesonderheiten:

CARNITOR ® (levocarnitine) Injection is available in 1 g per 5 mL single dose vials packaged 5 vials per carton (NDC 54482-147-01). CARNITOR ® (levocarnitine) Injection 5 mL vial is distributed by Leadiant Biosciences, Inc. Store vials at controlled room temperature (25°C). See USP. Discard unused portion of an opened vial, as the formulation does not contain a preservative. US Patent Nos. 6,335,369; 6,429,230; 6,696,493 Rx only.

Berechtigungsstatus:

New Drug Application

Fachinformation

CARNITOR- LEVOCARNITINE INJECTION, SOLUTION
LEADIANT BIOSCIENCES, INC.
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CARNITOR
(LEVOCARNITINE) INJECTION 1 G PER 5 ML VIAL
FOR INTRAVENOUS USE ONLY.
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
CARNITOR
(levocarnitine) Injection is a sterile aqueous solution containing 1 g
of
levocarnitine per 5 mL vial. The pH is adjusted to 6.0 - 6.5 with
hydrochloric acid or
sodium hydroxide.
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 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
CARNITOR
. 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. CARNITOR
may alleviate the