Carnitex^® (Capsules) Instructions for Use

Marketing Authorization Holder

FP Obolenskoe, JSC (Russia)

ATC Code

N06BX12 (Acetylcarnitine)

Active Substance

Acetylcarnitine (Grouping name)

Dosage Form

Carnitex®

Capsules 295 mg: 10, 15, 20, 30, 40, 45, 50, 60, 75, 80, 90, 100, 120, 150 or 180 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size 0, with a white body and cap; the capsule contents are a white or almost white powder.

Excipients: microcrystalline cellulose – 17.8 mg, colloidal silicon dioxide – 6.8 mg, crospovidone type A – 17 mg, magnesium stearate – 3.4 mg.

Capsule shell composition: titanium dioxide – 1.25%, gelatin – up to 100%.

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
15 pcs. – contour cell packaging (1) – cardboard packs.
15 pcs. – contour cell packaging (2) – cardboard packs.
15 pcs. – contour cell packaging (3) – cardboard packs.
15 pcs. – contour cell packaging (4) – cardboard packs.
15 pcs. – contour cell packaging (5) – cardboard packs.
15 pcs. – contour cell packaging (6) – cardboard packs.
20 pcs. – contour cell packaging (1) – cardboard packs.
20 pcs. – contour cell packaging (2) – cardboard packs.
20 pcs. – contour cell packaging (3) – cardboard packs.
20 pcs. – contour cell packaging (4) – cardboard packs.
20 pcs. – contour cell packaging (5) – cardboard packs.
20 pcs. – contour cell packaging (6) – cardboard packs.
30 pcs. – contour cell packaging (1) – cardboard packs.
30 pcs. – contour cell packaging (2) – cardboard packs.
30 pcs. – contour cell packaging (3) – cardboard packs.
30 pcs. – contour cell packaging (4) – cardboard packs.
30 pcs. – contour cell packaging (5) – cardboard packs.
30 pcs. – contour cell packaging (6) – cardboard packs.

Clinical-Pharmacological Group

A drug that improves tissue metabolism and energy supply

Pharmacotherapeutic Group

Metabolic agent

Pharmacological Action

Acetyl-L-carnitine (ALC) is a natural biologically active substance present in various organs and tissues of the body, including the central nervous system (CNS), and is involved in the metabolism of fatty acids and carbohydrates.

The pharmacological action of ALC is largely due to the metabolic effects of L-carnitine and the acetyl group that are part of it. Acetyl-L-carnitine is the biologically active form of L-carnitine, a key substance in the process of fat catabolism and energy production in the body.

ALC is synthesized in brain tissue, liver, and kidneys from L-carnitine with the participation of the enzyme carnitine acetyltransferase. Since ALC supplies activated acetate directly into the mitochondrial structure for the formation of acetyl-CoA, which is involved in the tricarboxylic acid cycle, without additional energy expenditure, it represents a readily available substrate for initiating energy-dependent metabolic processes in the mitochondria.

By ensuring adequate energy supply to the body with lower oxygen consumption by tissues, ALC protects brain tissue from ischemia.

Due to its structural similarity to acetylcholine, ALC has a cholinomimetic effect and also exhibits neuroprotective properties. It increases the cellular concentration of aspartic and glutamic acids, as well as taurine; with long-term use, it increases the density of N-methyl-D-aspartate receptors in the hippocampus, cortex, and striatum and prevents a decrease in their density under aging conditions.

ALC enhances the effects of serotonin and also protects brain cells from the neurotoxic effects of ammonia and glutamate.

Results of experimental studies have shown that ALC has anti-amnesic activity, the ability to improve learning processes, indicators of non-associative memory, and has a positive effect on mnestic functions in an experimental model of Alzheimer’s disease, without causing sedative or muscle relaxant side effects.

ALC increases energy production, being a readily available substrate for initiating energy-dependent metabolic processes in the mitochondria. It stimulates the synthesis of proteins and phospholipids for membrane construction and improves regeneration processes.

In pathology, it has a neuroprotective effect, especially towards neurons and their organelles (mitochondria), as well as a neurotrophic effect by modulating the activity of the nerve growth factor (NGF). ALC can accelerate the regeneration of nerve cells in traumatic and endocrine damage to peripheral nerves in experimental models of polyneuropathy in diabetes.

A noticeable effect of ALC is on slowing the processes of aging by enhancing the transport of fatty acids into the mitochondria and maintaining their function at the level of a young organism.

Pharmacokinetics

Acetyl-L-carnitine is absorbed by active transport or simple diffusion through the gastrointestinal mucosa (provided its concentration is high). It enters most tissues, including cerebral tissue, from the bloodstream (with the exception of the liver and small intestine) unchanged. It is excreted from the body by the kidneys.

In animal studies with oral administration (500 mg/kg), the maximum concentration of the drug in the blood occurs after 4 hours and is 40 μM/L for 8 hours.

Indications

As part of complex therapy

• Initial manifestations of Alzheimer’s type dementia (Alzheimer’s disease) and cerebrovascular dementia;
• Peripheral neuropathy, including in diabetes mellitus;
• Primary and secondary involutional syndromes against the background of chronic ischemia;
• Decreased mental performance, to improve concentration and memory.

ICD codes

Dosage Regimen

Orally, with a sufficient amount of water.

The single dose for adults is usually 1-4 capsules, the daily dose is 6-12 capsules. The course of treatment is from 1 to 4 months.

For Alzheimer’s disease, the recommended dose is 1500-4000 mg per day in 2-3 doses. For involutional syndromes – 1500-2000 mg per day. For neuropathy, the daily dose is 1500-3000 mg.

Adverse Reactions

Allergic reactions, gastrointestinal disorders, nausea, heartburn, anxiety, the possible appearance of a specific odor in urine, sweat, and breath.

If any of the adverse reactions listed in the instructions worsen, or you notice any other adverse reactions not listed in the instructions, inform your doctor.

Contraindications

• Hypersensitivity to acetylcarnitine or other components of the drug;
• Children under 18 years of age (efficacy and safety have not been established).

Use in Pregnancy and Lactation

No specific studies on the possibility of use during pregnancy and breastfeeding have been conducted.

The drug should be used only if the intended benefit to the mother outweighs the risk to the fetus. Breastfeeding should be discontinued during treatment.

Pediatric Use

Contraindicated in children under 18 years of age.

Special Precautions

Effect on the ability to drive vehicles and perform work requiring increased attention

Does not affect the ability to drive vehicles and perform work requiring increased concentration and speed of psychomotor reactions.

Overdose

No cases of overdose have been reported to date.

Drug Interactions

Not recommended for concurrent use with acenocoumarol.

Caution should be exercised when used concomitantly with warfarin.

Storage Conditions

In a dry place, protected from light, at a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life – 2 years. Do not use after the expiration date printed on the package.

Dispensing Status

By prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.