Carnivita – Levocarnitine 30% Oral Solution

Levocarnitine is present as a natural constituent in animal tissues, micro-organisms and plants. In man the physiological metabolic requirements are met both by the consumption of food containing carnitine and the endogenous synthesis in the liver and kidneys from lysine with methionine serving as the methyl donor.

Only the L-isomer is biologically active, playing an essential role in lipid metabolism as well as in the metabolism of ketone bodies as branched chain-amino-acids. Levocaritine as a factor is necessary in the transport of long-chain fatty acids into the mitochondria- facilitating the oxidation of fatty acids rather than their incorporation into triglycerides.

By releasing COA from its thioesters, through the action of COA; carnitine acetyl transferase, levocamitine also enhances the metabolic flux in the Kreb’s cycle; with the same mechanism it stimulates the activity of pyruvate dehydrogenase and in skeletal muscle, the oxidation of branched-chain amino acids.

Levocarnitine is thus involved, directly or indirectly in several pathways so that its availability should be an important factor controlling not only the oxidative utilisation of fatty acids and ketone bodies but also that of glucose and some amino acids.

Indications

Indicated for the treatment of primary and secondary carnitine deficiency in children under 12 years.

Side Effects

Adverse reactions from any source are listed below by system organ class. Within each system organ class, the adverse drug reactions are ranked by frequency. Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.

In addition the corresponding frequency category for each adverse drug reaction is based on the following conventions: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000). Gastrointestinal disorders: Very rare: vomiting, nausea, diarrhea, abdominal cramp. General disorders and administration site conditions: Very rare: Body odour. Investigations: Very rare: International Normalised Ratio increased.

There have been very rare reports of International Normalised Ratio (INR) increased in patients treated concomitantly with levocarnitine and coumarinic drugs (acenocumarol and warfarin).

Decreasing the dosage often diminishes or eliminates drug related patient body odour or gastro-intestinal symptoms when present. Tolerance should be monitored very closely during the first week of administration and after any dosage increase.

Posology & Method Of Administration

For oral administration only. The paediatric solution can be drunk directly or diluted further in water or fruit juices. Not to be used for neonates & infants under 4 years as it contains propylene glycol.

Infants more than 4 years – up to children under 12 years: It is advisable to monitor therapy by measuring free and acyl carnitine levels in both plasma and urine.

The management of inborn errors of metabolism: The dosage required depends upon the specific inborn error of metabolism concerned and the severity of presentation at the time of treatment. However, the following can be considered as a general guide. An oral dosage of up to 200mg/kg/day in divided doses (2 to 4) is recommended for chronic use in some disorders, with lower doses sufficing in other conditions.

If clinical and biochemical symptoms do not improve, the dose may be increased on a short term basis. Higher doses of up to 400mg/kg/day may be necessary in acute metabolic decompensation or the i.v. route may be required.

Haemodialysis – maintenance therapy: If significant clinical benefit has been gained by a first course of intravenous Levocarnitine then maintenance therapy can be considered using 1g per day of Levocarnitine orally. On the day of the dialysis oral Levocarnitine has to be administered at the end of the session.

OVERDOSE

There have been no reports of toxicity from levocarnitine overdosage. Overdosage should be treated with supportive care.

Contraindications

Hypersensitivity to any of the constituents of the product.

Precaution

While improving glucose utilisation, the administration of levocarnitine to diabetic patients receiving either insulin or hypoglycaemic oral treatment may result in hypoglycaemia. Plasma glucose levels in these subjects must be monitored regularly in order to adjust the hypoglycaemic treatment immediately, if required.

The 30% oral solution contains sucrose. This must be considered when treating diabetics or patients who are following diets to reduce calorie intake.

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 end stage renal disease (ESRD) patients on dialysis may result in an accumulation of the potentially toxic metabolites, trimethylamine (TMA) and trimethylamine-N-oxide (TMAO), since these metabolites are usually excreted in the urine. This situation has not been observed following intravenous administration of levocarnitine.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. There have been very rare reports of International Normalised Ratio (INR) increased in patients treated concomitantly with levocarnitine and coumarinic drugs.

Pregnancy & Lactation

Reproductive studies were performed in rats and rabbits. There was no evidence of a teratogenic effect in either species. In the rabbit but not in the rat there was a statistically insignificant greater number of post implantation losses at the highest dose tested (600mg/kg daily) as compared with control animals.

The significance of these findings in man is unknown. There is no experience of use in pregnant patients with primary systemic carnitine deficiency. Taking into account the serious consequences in a pregnant woman who has primary systemic carnitine deficiency stopping treatment, the risk to the mother of discontinuing treatment seems greater than the theoretical risk to the toetus if treatment is continued.

Levocarnitine is a normal component of human milk. Use of levocarnitine supplementation in nursing mothers has not been studied.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

None known

further information

Composition

Each 100 ml contains Active ingredient: Levocarnitine Inactive ingredients: Sucrose, Methyl paraben, propyl paraben, malic acid, citric acid anhydrous, disodium edetate, glycerin, propylene glycol, cherry flavor, cola flavor, purified water.

Drug-Drug Interactions

There have been very rare reports of International Normalised Ratio (INR) increased in patients treated concomitantly with levocarnitine and coumarinic drugs. INR – or other appropriate test of coagulation should be checked weekly until they become stable, and monthly thereafter, in patients taking such anticoagulants together with levocarnitine.

PHARMACEUTICAL FORM: Solution for oral use.

Storage

Store at a temperature not exceeding 30°C. Keep out of reach of children.

Package

Carton box contain plastic Bottle of 60 ml with insert leaflet.

Carnivita – Arabic Information

كارنيفيتا شراب – ۳۰% ليفوكارنيتين


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