Product Description
LEVOCARNITINE INJECTION
| PRODUCT NAME: |
L-carnitine Liquid for Injection |
| STRENGTH: |
0.5/ 1.0/ 2.0/ 3.0g |
| PACKING DETAILS: |
5 Ampoules/tray/box |
| STORAGE: |
Store in a cool and dry place below 25ºC, protected from light. |
| SHELF LIFE: |
36 months |
| REGISTRATION DOSSIERS ARE AVAILABLE. |
Composition :
The active ingredient is levocarnitine. Each 5ml contains 500 mg levocarnitine.
Pharmaceutical Action :
Levocarnitine is a naturally occurring substance required substance required in
Mammalian energy metabolism. It has been shown to facilitate long-chain fatty acid entry
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 the underlying
organic acidemia, as symptoms of both abnormality may be expected to improve with
carnitine. The literature reports that carnitine can promote the excretion of excess organic
of fatty acids in patients with defects in fatty acid metabolism and/or specific organic
acidopathies that bioaccumulate acyl COA esters.
Indications :
For the acute and chronic treatment of patients with an inborn error of metabolism which
resuIts in secondary carnitine deficiency.
For the prevention and treatment of carnitine deficiency in patients with end stage renal
disease who are undergoing dialysis.
Dosage and Administrations :
levocarnitine Injection is administered intravenously.
Metabolic Disorders
The recommended dose is 50 mg/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 q4h,
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 concentration 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 concentration should be between 35 and 60 umol/L) and overall
clinical condition.
ESRD Patients on Hemodialysis
The recommended starting dose is 10-20 mg/kg dry body weight as a slow 2-3 minute
bolus injection into the venous return line after each dialysis session. Initiation of therapy
may be prompted by trough(pre-dialysis) plasma levocarnitine concentrations that are
below normal (40-50 umol/L). Dose adjustments should be guided by trough(pre-dialysis) levocarnitine concentrations, and downward dose adjustments (e.g. to 5 mg/kg after
dialysis) may be made as early as the third or fourth week of therapy.
Side Effects :
Transient nausea and vomiting have been observed. Less frequent adverse reactions are
body odor, nausea, and gastritis. An incidence for these reactions is difficult to estimate
due to the confounding effects of the underlying pathology.
Seizures have been reported to occur in patients, with or without pre-existing seizurea
activity, receiving either oral or intravenous levocarnitine. In patients with pre-existing
seizure activiy, an increase in seizure frequency and/or severity has been reported.
Warnings :
Diabetic patients taking 1nsulin or oral hypoglycemic drug treatment, levocarnitine can
cause hypoglycemia, so plasma glucose levels in these patients must be constantly
monitored, in order to adjust hypoglycemic treatment. Intravenous administration should
be carried out slowly(2-3 minute).
Because levocarnitine is a physlological property die does not show any danger in the
tolerance and dependence.
Keep out of reach of children.
Levocarnitine has no adverse effect on the ability to drive or operate the machine.
Precautions :
The safety and efficacy of oral levocarnitine has not been evaluated in patients with renal
insufficiency. Chronic administration of high doses of oral levocarnitine in patients with
severely compromised renal function or in ESRD patients on dialysis may result in
accumulation of the potentially toxic metabolites, trimethylamine (TMA) and
trimethylamine-N-oxide(TMAO), since these metabolites are normally excreted in the
urine.
Pregnancy
Reproductive studies have been performed in rats and rabbits at doses up to 3.8 times
the human dose on the basis of surface area and have revealed no evidence of impaired
fertility or harm to the fetus due to levocarnitine injection. There are, however, no
adequate and well controlled studies in pregnant women
Because animal reproduction studies are not always predictive of human response, this
drug should be used during pregnancy only if clearly needed.
Nursing Mothers :
Levocarnitine supplementation in nursing mothers has not been specifically studied.
Contraindications :
Allergic to this medicine should be contraindicated.
Drug Interactions :
No information provided.
Presentation :
Each 5ml ampoule contains 500mg levocarnitine, 5 ampoules in one box.
Storage and Instructions :
Store below 30'C and protect from light.
Keep out of reach of Children.
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