Carnicetine® capsules

Registration number: ЛСР-000167/08 .

Trade name: Carnicetine®

International non-patented name (INN): acetyl carnitine

 

Drug form: capsules

Composition:

drug substance – acetyl carnitine hydrochloride (carnicetin) 0,295 g (corresponds to 0,25 g  acetyl carnitine);

excipients: cellulose micro-crystalline, colloid silicon dioxide (aerosil А-300), magnesium stearate up to a mass of the capsule  0,34 g;

hard gelatin capsules: composition : gelatine, glycerol, methyl paraxydroxybenzoate,     propyl paraxydroxybenzoate, sodium lauret sulfate, water purified, titanium dioxide.

Description: the content of capsules is a white or yellowish-white powder with a weak smell of acetic acid. Capsules #0 are white.

Pharmacotherapeutic group: metabolic drug.

АТХ Code: [N06BX12]

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Pharmacological properties

Pharmacodynamics. Acetyl-L-carnitine (ALC) is a natural biological compound, it is present in physiological conditions in different tissues and organs of an organism (including CNS), taking a part in the fat acids and carbohydrates metabolism. A pharmacological and biological action of ALC is mainly due to metabolic effects of L-carnitine and acetyl group, present in ALC. Acetyl-L-carnitine (ALC) is an biologically active form of L-carnitine, a key substance in the fat catabolism and the energy production in an organism. ALC is synthesized in a brain tissue, liver and kidneys from L-carnitine by the carnitine transferase enzyme. ALC supplies activated acetate directly into a mytochondrial matrix for acetyl-CoA production (acetyl-CoA plays a role in a tricarbonic acids cycle) without an additional energy consumption, it is a freely accesible substrate for a launch an energy-dependent metabolic processes in mytochondrions. Due to a effective energy supply of organism with a lower oxygen consumption by tissues, ALC protects brain tissues from an ischemia.

Due to a structural similarity with acetylcholine ALC has a cholinergic receptors agonistic action and neuroprotective properties. It also increase an intracellular concentration of aspartic and glutamic acids, taurine; if it is used during prolonged periods it increase a concentration of  N-methyl-D-aspartate receptors in hyppocampus, cortex and striatum and prevents a decrease of their concentration in aging conditions. ALC promotes serotonin effects, it protects brain cells from toxic effects of ammonia and glutamate.

Experimental studies results demonstrated that ALC has an anti-amnesic activity, it improves learning processes and non-associative memory parameters, it has a positive effect on mnestic functions in experimental model of the Alzheimer's disease, without side effects of sedation and myorelaxation.

ALC increase an energy production, it is a freely accessibly substrate for the launch of energy-dependent metabolic processes in mytochondrions. ALC stimulates a proteins and phospholipides synthesis for a membranes building, improves regeneration processes. It has a neuroprotective effect in pathology conditions, especially relatively to neurons and their organelles (mytochondrions), also a neurotrophic effect (due to a modulation of nerve growth factor (NGF). It has an anti-oxidative and membrane-stabilizing action. ALC can accelerate a nerve cells regeneration during traumatic and endocrine affections of peripheral nerves in experimental diabetic polyneuropathy models.

A prominent effect ALC has on decelerating of aging processes due to an increase of fatty acids transport in mytochondrions and support of their work on a level, characteristic to an young organism. ALC can accelerate a nervous cells regeneration in traumatic and endocrine affections of peripheral nerves on an experimental diabetes model.

Pharmacokinetics. In animal studies after the oral use (500 mg/kg) a maximal concentration of the drug is reached after 4 hours, it is equal uM/l during 8 hours. An absorption ALC from GIT is going by active transport or by diffusion through the mucosa (if concentration is high). In most tissues (including a cerebral tissue) ALC is supplied from blood flow in unchanged form (exception – liver and thin intestine). Into a cell ALC is going by direct energy-dependent process against a concentration gradient. ALC is excreted by kidneys.

Indications

• Initial dementia of Alzheimer's type (Alzheimer's disease) and cerebral vascular demention;

• Peripheral neuropathy of a different etiology;

• Primary and secondary involution syndromes on a background of vascular encephalopathys;

• A decrease of the mental workability, for increase an attention and memory.

Contraindications

• Individual hypersensitivity to the drug;

• Age under 18 years (effectiveness and safety are not established)).

Use during pregnancy and lactation

There are no data about the drug use in pregnant or lactating women, so it has to be used only in cases, when predicted benefit for mother higher than the possible risk for fetus. The breast feeding during treatment has to be stopped.

Method of use and dosages

Carnicetine is used orally. One dose for adults is 1-4 capsules, daily dose 6-12 capsules. Treatment duration - 1-4 months.

Side effects

Allergic reactions, nausea, heartburn are possible.

Over-dosage

Over-dosage cases are unknown.

Interaction with other medicines

Cases of the interaction with other medicines are unknown.

Drug form

295 mg capsules.

For FSME «CSCB»  60 capsules in sealed polymer can. Free space in cans is filled by cotton wool.

Can is packed into a carton box with an instruction.

For  «Pik-pharma Pro» Ltd.. 60 capsules in sealed polymer can. Free space in cans is filled by cotton wool.

10 or 15 capsules in blister from PVC film and Al foil with coating and printing.

Can or 6 blisters with 10 capsulers or 4 blisters with 15 capsules are packed into a carton box with an instruction.

Keeping conditions

Keep in protected from direct light place at temperature not higher than 25 °С. Keep out of the reach of children.

Shelf life

2 years. Do not use after the expiry date.

Selling conditions

By prescription.

Manufacturer

PIQ-PHARMA LLC., 129010 Moscow, Spassky blind alley, 2/1.

Manufactured by:

FSME «Central scientific constructor bureau» (FSME «CSCB»), 109240, Moscow,  Goncharnaya st., 20

or

PIQ-PHARMA PRO LLC, 188663 Leningradskaya region, Vsevolozhsky district, Kuzmolovsky, Workshop # 92.

 Claims have to be sent to

PIQ-PHARMA LLC. Phone/fax: +7 495 925 57 00