L-Carnitine Syrup – Ampoule…PATIENT INFORMATION LEALFET

Composition

Each 1 ml syrup contains

L-Carnitine…300 mg .

Each 5 ml ampoule contains

L-Carnitine  …1mg.

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Pharmacological action

L-Carnitine is an essential co-factor that exerts a beneficial effect in different pathology involving both vascular and muscle tissues.

L-Carnitine is an amino acid derivative of lysine and methionine.

L-Carnitine is an essential co-factor of fatty acid metabolism in skeletal muscles, heart and liver.L-Carnitine is concentrated in tissues, with about 97% in skeletal muscles.

In the muscle cell L- Carnitine is the molecule that transports long chain fatty acids across the membrane of the mitochondria which stimulate its energy production, so L-Carnitine is considered a natural metabolic modulator as it is the essential factor for fatty acids oxidation into cellular mitochondria.

L-carnitine is readily absorbed, the maximal concentration is reached after 4 hours, L-Carnitine is eliminated in urine, its half-life is nearly 15 hours.

Pharmacokinetics

The plasma concentrations profiles of L-carnitine after a slow 3 minutes  intervenous  bolus dose of 20 mg/kg. Approximately 76% of L-carnitine dose was excreted in the urine during the 0-24 h interval. The mean distribution half life was 0.585. The absolute bioavailability of L-carnitine was 15.9 ± 4.9%  for oral solution.

The total body clearance of L-carnitine was a mean of 4.00 L/h.

Indications

  1. Primary carnitine deficiency skeletal and cardiac muscle myopathy, hepatic encephalopathy.
  2. Secondary carnitine deficiency due to genetically determined disorders, acidurias and disorders of beta-oxidation.
  3. Secondary carnitine deficiency due to acquired conditions
  4. Haemodialysis and renal Fanconi Syndrome, Anticonvulsants  Sodium valproate, Pivampicilline therapy.
  5. L-Carnitine has a cardioprotective effect during Antineoplastic therapy.
  6. Myocardial infarction: L-Carnitine decreases the infarct size.
  7. Low birth weight infants.
  8. Full term infants receiving Soya based formula.
  9. Improve athletic performance in healthy subjects.
  10. Long standing leg ulcers.
  11. Idiopathic asthenozoospermia.
  12. Hemolytic anemia (Thalassaemia & Sickle cell anemia).

 Dosage and administration

Children  50 – 100 mg/kg body weight, maximal dose is up to 3 g/day.

Injection is administered intravenously. The recommended dose is 50 mg/kg given as slow 2-3 minutes 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 q 3h or q.3h. and never less than q 6h 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.

L-Carnitine-Indications
L-Carnitine-Indications

Contra-indications

None known.

 Side effects

L -Carnitine MEPACO has no significant side effects.

Rarely oral L-Carnitine in high doses causes nausea and diarrhea, especially at the beginning of usage. In this condition it is advisable to continue the treatment and symptoms will disappear gradually.

Transient nausea and vomiting have been observed. Less frequent adverse reactions are body odor, nausea and gastritis.

Pregnancy and lactation

No adequate and well controlled studies in pregnant or lactating women.

 Precautions and warnings

Patient should consult the doctor before taking L-carnitine.

 Drug Interaction

No information provided.

 Package and storage

Bottle containing   30 ml.

Box containing 5 ampoules.

PATIENT INFORMATION LEAFLET

L-Carnitine-Patient Information leaflet


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