A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Carnitor Indications, Dosage, Storage, Stability - Levocarnitine
Carnitor Indications, Dosage, Storage, Stability - Levocarnitine
INDICATIONS
For the acute and chronic
treatment of patients
with an inborn error
of metabolism that
results in secondary
carnitine deficiency.
DOSAGE AND ADMINISTRATION
CARNITOR® Injection is administered intravenously. The recommended
dose is 50mg/kg given as a slow
2-3 minute bolus injection
or by infusion. Often a loading
dose is given in patients
with severe metabolic crisis followed by an equivalent
dose over the following
24 hours. It should be administered q3h or q.h.
and never less than q6h either by infusion
or by intravenous
injection. All subsequent daily doses are recommended to be in the
range of 50 mg/kg or as
therapy may require.
The highest dose administered has been 300 mg/kg.
It is recommended that a plasma
carnitine level be
obtained prior to beginning this parenteral
therapy. Weekly and monthly monitoring is recommended as well. This
monitoring should include blood
chemistries, vital signs,
plasma carnitine concentrations
(the plasma free carnitine
level should be between 35 and 60 micromoles/liter) and overall
clinical condition.
Parenteral drug products
should be inspected visually for particulate matter and discoloration
prior to administration, whenever solution
and container permit.
Compatibility and Stability
CARNITOR® Injection is compatible
and stable when mixed
in parenteral solutions of Sodium Chloride 0.9% or Lactated Ringer’s
in concentrations ranging from 250 mg/500 mL (0.5 mg/mL) to 4200
mg/500 mL (8.0 mg/mL) and stored at room
temperature (25°
C) for up to 24 hours in PVC
plastic bags.
HOW SUPPLIED
CARNITOR® (Levocarnitine) Injection, 200 mg
per 1 mL, is available in
5 mL single dose ampules
packaged 5 ampules per carton
(NDC 54482-146-09) and in 2.5 mL single dose
ampules packaged 5 ampules per
carton (NDC 54482-146-10). Made in Italy.
Store ampules at room
temperature (25°
C / 77° F) in carton until their use to protect from light.
Discard unused portion of an opened ampule, as they contain no
preservative.
CARNITOR® (Levocarnitine) is also available in the following
dosage forms for oral administration:
CARNITOR® (Levocarnitine) Tablets are supplied as 330
mg (unit dose), individually foil
wrapped tablets embossed with “CARNITOR-ST” in boxes of 90 (NDC
54482-144-07). Made in Italy.
CARNITOR® (Levocarnitine) Oral Solution, 118 mL (4 fl.
oz.), supplied as a red, cherry flavored solution
in a multiple-dose plastic bottle. (NDC 54482-145-08).
Caution: Federal (U. S. A.) law
prohibits dispensing without prescription.
References
1. Bohmer T, Rynding A, Solberg HE: Carnitine levels
in human serum in health
and disease. Clin Chim Acta 57:55-61, 1974.
2. Brooks H, Goldberg L, Holland R et al: Carnitine-induced
effects on cardiac and
peripheral hemodynam-ics.
J Clin Pharmacol 17:561-578, 1977.
3. Christiansen R, Bremer J: Active transport
of butyrobetaine and carnitine
into isolated liver cells.
Biochem Biophys Acta 448:562-577, 1977.
4. Lindstedt S, Lindstedt G: Distribution and excretion
of carnitine 14002
in the rat. Acta Chim Scand 15:701 -702, 1961.
5. Rebouche CJ, Engel AG: Carnitine metabolism
and deficiency syndromes. Mayo CIin Proc 58:533-540, 1983.
6. Rebouche CJ, Paulson DJ: Carnitine metabolism
and function in humans. Ann Rev Nutr 6:41 -68, 1986.
7. Scriver CR, Beaudet AL, Sly WS, Valle D: The Metabolic
Basis of Inherited Disease. McGraw-Hill, New York, 1989.
8. Schaub J, Van Hoof F, Vis HL: Inborn Errors of
Metabolism. Raven Press, New York, 1991.
9. Marzo A, Arrigoni Martelli E, Mancinelli A, Cardace
G, Corbelletta C, Bassani E, Solbiati M: Protein bind-ing of L-carnitine
family components. Eur J Drug Met Pharmacokin, Special Issue Ill:
364-368, 1992.
10. Rebouche C: Quantitative estimation of absorption
and degradation
of a carnitine supplement
by human adults. Metabolism:1305-1310,
1991.
top
