Levocarnitine oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of levocarnitine.
Drugs List
Therapeutic Indications
Uses
Primary carnitine deficiency
Secondary carnitine deficiency
Unlicensed Uses
Organic acidaemias
Dosage
Adults
Primary deficiency
Up to 200 mg/kg a day, given in 2 to 4 divided doses. If symptoms do not improve, the dose may be increased up to 400mg/kg a day, on a short term basis or administered intravenously. Some sources suggest up to a maximum of 3g a day.
Dosage depends on the specific error of metabolism and its severity at time of treatment.
Secondary deficiency in dialysis patients
If significant clinical benefit has been gained by an initial course of levocarnitine intravenously then maintenance therapy can be considered using an oral dose of 1g daily.
Levocarnitine should be administered after dialysis therapy.
Children
The chewable tablets and the 10% oral solution are not licensed for children under 12 years.
Paediatric 30% solution is suitable for treating children under 12 years only.
Primary deficiency
Children aged 1 month to 18 years
Up to 200mg/kg a day, given in 2 to 4 divided doses. If symptoms do not improve, the dose may be increased up to 400mg/kg a day, on a short term basis or administered intravenously. Some sources suggest up to a maximum of 3g a day.
Dosage depends on the specific error of metabolism and its severity at time of treatment.
Organic acidaemias (unlicensed)
Children aged 1 month to 18 years
Up to 200mg/kg a day, give in 2 to 4 divided doses. Maximum daily dose of 3g.
Secondary deficiency in dialysis patients
Children aged 1 month to 18 years
If significant clinical benefit has been gained by an initial course of levocarnitine intravenously then maintenance therapy can be considered using an oral dose of 1g daily.
Levocarnitine should be administered after dialysis therapy.
Neonates
Primary deficiency
Up to 200mg/kg a day, give in 2 to 4 divided doses.
Organic acidaemias (unlicensed)
Up to 200mg/kg a day, give in 2 to 4 divided doses.
Patients with Renal Impairment
The safety and efficacy of oral levocarnitine have not been evaluated in patients with renal impairment. Chronic administration of high doses of oral levocarnitine in patients with severe renal impairment or in end stage renal disease patients on dialysis may result in an accumulation of potentially toxic metabolites. This situation has not been observed following intravenous administration of levocarnitine.
Contraindications
None known
Precautions and Warnings
Diabetes mellitus
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
Renal impairment
Not all formulations are suitable for use in children under 12 years
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain hydroxybenzoate
Some formulations contain sucrose
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
Pregnancy and Lactation
Pregnancy
Levocarnitine is considered appropriate for use during pregnancy.
The manufacturer states that, due to the serious consequences to a pregnant woman who has primary systemic carnitine deficiency, the risk to the mother on discontinuing treatment seems greater than the theoretical risk to the fetus if treatment is continued. Studies on rats and rabbits show no evidence of a teratogenic effect in either species. There is no experience of use in pregnant patients with primary systemic carnitine deficiency.
Lactation
Levocarnitine is considered safe for use during breastfeeding.
The manufacturer states that use in nursing mothers has not been studied, however, levocarnitine is a normal component of breast milk.
Side Effects
Abdominal cramps
Abnormal INR
Body odour
Diarrhoea
Hypoglycaemia in diabetes mellitus
Nausea
Vomiting
Overdosage
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 ).
Further Information
Last Full Review Date: November 2013
Reference Sources
Summary of Product Characteristics: Carnitor 1g Oral Solution. Sigma-tau Pharma Limited UK. Revised June 2013.
Summary of Product Characteristics: Carnitor 30% Paediatric Oral Solution. Sigma-tau Pharma Limited UK. Revised January 2013.
Summary of Product Characteristics: Carnitor 1g Chewable Tablets. Sigma-tau Pharma Limited UK. Revised June 2013.
Summary of Product Characteristics: Levocarnitine 30% Paediatric Oral Solution. Logixx Pharma Solutions Ltd. Revised July 2013.
Summary of Product Characteristics: Levocarnitine Paediatric Sugar fee 30% Oral Solution. Cenote Pharma Ltd. Revised February 2022.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 08 July 2022
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