World Medicine İlaç Sanayi ve Ticaret A.Ş. #Digestive_system #Other #HEALTH_CARE
Product description
Carnitine is a natural component of cells in which it plays a fundamental role in the synthesis and transport of energy. It is actually the only irreplaceable factor for the process of penetration of long-chain fatty acids into mitochondria and their participation in β-oxidation. In addition, carnitine controls the transport of energy produced by mitochondria to the cytoplasm by modulating the enzyme adenine nucleotide translocase.
Compound
active substance: levocarnitine;
1 bottle (10 ml) of the preparation contains levocarnitine 2 g
excipients: malic acid, sodium benzoate (E 211), sodium saccharin, orange flavor, purified water.
Indications
Primary and secondary carnitine deficiency.
Contraindications
Hypersensitivity to the active substance or to the excipients of the preparation.
Mode of application
The medicinal product is intended for oral administration. Before use, the solution should be diluted in a glass of water and taken 30 minutes before meals. For dosing, use a dosing syringe or measuring cup.
When using the preparation, it is advisable to control the level of free carnitine and acyl-carnitine in both blood plasma and urine.
Dosage
Doses and duration of treatment with levocarnitine are determined by the doctor individually, depending on the age, body weight and nosological form of the patient's disease.
Adults
Primary and secondary carnitine deficiency
The dosage depends on the specific congenital metabolic disorder and the severity of the patient's condition during treatment.
In general, the recommended oral dose is 100 to 200 mg / kg per day in 2-4 divided doses; in less severe conditions, the dose may be lower (50-100 mc / kg per day).
If the clinical and biochemical signs do not improve, the dose can be increased for a short period.
In acute metabolic disorders, higher doses (up to 400 mg / kg / day) or the introduction of levocarnitine at a daily dose of 100 mg / kg may be required.
Secondary carnitine deficiency in patients undergoing hemodialysis.
If significant clinical results have been achieved after the first course of administration, maintenance therapy can be used at a dose of 1 g per day by oral administration. On the day of dialysis, oral administration of the preparation is carried out after the procedure.
The maximum daily dose for adults is 6 g (30 ml).
The average course of treatment for adults and children is 1-3 months. If necessary, the course of treatment can be repeated. In the case of primary and secondary carnitine deficiency, the preparation should be used continuously or until the cause of the latter is eliminated.
Children
The preparation should be used in children from the first day of life, including premature babies. The solution is taken starting at a dose of 50 mg / kg per day. The usual dose for children is 50-100 mg / kg per day (see table).
The maximum daily dose for children is 3 g (15 ml).
Overdose
Overdose or prolonged use of levocarnitine can lead to diarrhea. Levocarnitine is easily removed from blood plasma by dialysis.
Adverse Reactions
Adverse reactions (according to clinical studies, literature and post-registration experience) are given by classes of organ systems in accordance with the medical dictionary of regulatory activity MedDRA and are classified according to the following frequency: very often (≥1 / 10), often (≥1 / 100, <10 ), infrequently (≥1 / 1000, <100), rarely (≥1 / 10000, <100), very rare (<1/10000), the frequency is unknown (the frequency cannot be estimated from the available data). Within each frequency group, adverse reactions are listed in descending order of severity.
From the nervous system:
- infrequently - headache frequency unknown - convulsions1, dizziness.
From the side of the heart:
- frequency unknown - heartbeat.
From the side of the vessels:
- infrequently - arterial hypotension, arterial hypertension.
From the respiratory system, chest and mediastinal organs:
- frequency unknown - shortness of breath.
From the digestive tract:
- often - nausea, vomiting, diarrhea, abdominal pain; infrequently - dysgeusia, dyspepsia, dry mouth.
On the part of the skin and subcutaneous tissues:
- infrequently - abnormal body odor2; frequency unknown - pruritus, rash.
On the part of the musculoskeletal system and connective tissue:
- infrequently - muscle spasms; frequency unknown - myasthenia gravis3, muscle tension.
General disorders and disorders at the injection site:
- often - chest pain, abnormal sensations, pyrexia.
Study:
- infrequently - increased blood pressure; very rarely - an increase in INR4.
Application features
Use during pregnancy or lactation
Pregnancy
Levocarnitine was not found to have a teratogenic effect in preclinical studies. When using the studied dose of 600 mg / kg of body weight in animals, a statistically insignificant increase in the frequency of post-implantation fetal death in early pregnancy was noted. The relevance of these results to humans is unknown.
Adequate clinical studies with the participation of pregnant women have not been carried out. During pregnancy, the preparation should be used if the benefits of its use for a woman outweighs the potential risk to the fetus.
Breastfeeding period
Levocarnitine is a common component of human milk. The use of levocarnitine in breastfeeding women has not been studied. During breastfeeding, the preparation should be used if the benefits of its use for a woman outweighs the potential risk to a child caused by excessive exposure to carnitine.
Fertility
In clinical studies, there was no negative effect on fertility.
Children
The preparation can be used in children from the first day of life.
The ability to influence the reaction rate when driving vehicles or other mechanisms.
Levocarnitine does not affect the ability to drive vehicles or other mechanisms.
Interaction with other medicinal products and other forms of interaction
Interactions between levocarnitine and coumarin preparations cannot be ruled out. In very rare cases, an increase in the international normalized ratio (INR) was reported with the simultaneous use of levocarnitine with coumarin preparations (see Sections "Peculiarities of use", "Adverse reactions"). In the case of the simultaneous use of these funds, the INR should be monitored or other tests for coagulation should be carried out weekly to stabilize and monthly thereafter (see Section "Peculiarities of use").
The simultaneous use of levocarnitine with preparations that induce hypocarnitinemia, increased excretion of carnitine by the kidneys (for example, valproic acid, prodrugs containing pivalonic acid, cephalosporins, cisplatin, carboplatin, ifosfamide), can reduce its level.
Storage conditions
Store at a temperature not exceeding 25 ° C, out of the reach of children.
Shelf life is 4 years.
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