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Solution for injection containing levocarnitine.
Primary carnitine deficiency
Secondary carnitine deficiency
Treatment of primary and secondary carnitine deficiency in adults, children, infants and neonates.
Treatment of secondary carnitine deficiency in haemodialysis patients.
Organic acidaemias in children and neonates
Up to 100mg/kg a day, given in 2 to 4 divided doses over a period of 2 to 3 minutes.
Dosage depends on the specific inborn error of metabolism and severity of presentation at the time of treatment.
Higher doses can lead to an increase of adverse events and primarily diarrhoea.
Secondary carnitine deficiency in haemodialysis patients
Secondary carnitine deficiency is present when a plasma ratio of acyl to free carnitine is greater than 0.4 and/or when free carnitine concentrations are lower than 20 micromole/litre.
20mg/kg administered as a single intravenous injection at the end of each dialysis session, on the assumption of 3 sessions a week. Minimum duration of treatment should be at least 3 months.
The maintenance dose is 1g oral levocarnitine daily, at the end of a dialysis session, if there is a significant clinical benefit after the first course of intravenous levocarnitine.
(See Dosage; Adult)
The following alternate dosing schedule may also be suitable:
Intravenous infusion (unlicensed)
Initial dose of 100mg/kg over a period of 30 minutes. Maintenance dose of 4mg/kg per hour by continuous infusion.
Organic acidaemias (unlicensed)
Initial dose of 100mg/kg by intravenous infusion, over a period of 30 minutes. Followed by a maintenance dose of 4mg/kg per hour.
Alternatively, up to 100mg/kg a day by intravenous injection, given in 2 to 4 divided doses over a period of 2 to 3 minutes.
Intravenous injection over 2 to 3 minutes
Intravenous infusion (unlicensed)
Precautions and Warnings
Adjustment of hypoglycaemic therapy may be necessary in diabetes mellitus
Measurement of plasma carnitine is recommended before initiating therapy
Monitor blood glucose closely in patients with diabetes mellitus
Monitor free and acyl carnitine levels in blood and urine during treatment
Monitor tolerance in first week of therapy and after any dose increase
Accumulation of metabolites has been observed with chronic oral administration in severe renal impairment.
Pregnancy and Lactation
Use levocarnitine with caution in pregnancy.
At the time of writing there is limited published information regarding the use of levocarnitine during pregnancy. Studies on rats and rabbits show no evidence of a teratogenic effect in either species. The risk to the mother on discontinuing treatment seems greater than the potential risk to the foetus.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Use levocarnitine with caution in breastfeeding.
At the time of writing there is limited published information regarding the use of levocarnitine during breastfeeding. Levocarnitine is a normal component of breast milk and it is considered not likely to be hazardous in Hale (2014).
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Hypoglycaemia in diabetes mellitus
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: February 2017
Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.
Summary of Product Characteristics: Carnitor 1 g solution for injection. Sigma-tau Pharmaceuticals Ltd. Revised April 2014.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 05 September 2017
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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