Combilipen Neo solution 2ml ampoules, 5pcs

Composition

Active ingredients: Thiamine Hydrochloride-100.0 Mgpyridoxine hydrochloride-100.0 mgCyanocobalamin-1.0 MGM Auxiliary substances:  diethanolamine-5.0 mg, water for injection-up to 2.0 ml

Pharmacological action

Pharmacotherapy group: Vitamins of the VKOD group ATX: A11DBPHARMACOLOGICAL properties

Pharmacodynamics

Pharmacological action is determined by the properties of vitamins that make up the drug. The drug contains vitamins B1 (thiamine), B6 (pyridoxine) and B12 (cyanocobalamin), the deficiency of which can lead to neurological disorders, mainly from the peripheral nervous system. Neurotropic B vitamins have a beneficial effect on inflammatory and degenerative diseases of the nerves and musculoskeletal system.

A special role in the metabolic processes of the nervous system is played by the combined action of vitamins B1, B6, B12. It has been proven that the effectiveness of the combination exceeds the effectiveness of a single component. The combined use of B vitamins accelerates the regeneration of damaged nerve fibers, and the analgesic effect of the complex is also proven.

Thiamine plays a key role in the processes of carbohydrate metabolism, which are crucial in the metabolic processes of nervous tissue (it participates in the conduction of a nerve impulse), as well as in the Krebs cycle with subsequent participation in the synthesis of thiamine pyrophosphate (TPP) and adenosine triphosphate (ATP).

Pyridoxine has a vital effect on the metabolism of proteins, carbohydrates and fats, is necessary for normal hematopoiesis, the functioning of the central and peripheral nervous system. It provides synaptic transmission, inhibition processes in the central nervous system (CNS), participates in the transport of sphingosine, which is part of the nerve sheath, and participates in the synthesis of catecholamines.

The physiological function of both vitamins is to potentiate the action of each other, which manifests itself in a positive effect on the nervous, neuromuscular and cardiovascular systems. It is a cofactor in single-carbon group transfer reactions, participates in the synthesis of the myelin sheath, stimulates hematopoiesis, reduces pain associated with damage to the peripheral nervous system, and stimulates nucleic exchange through the activation of folic acid.

Pharmacokinetics

After intramuscular use, thiamine is rapidly absorbed from the injection site and enters the blood (484 ng / ml after 15 minutes on the first day of use of a 50 mg dose) and is distributed unevenly in the body with its content in white blood cells of 15%, red blood cells of 75% and plasma of 10%.

Thiamine penetrates the blood-brain and placental barriers and is found in human milk. Thiamine is excreted in the urine in the alpha phase after 0.15 hours, in the beta phase – after 1 hour and in the terminal phase-within 2 days. The main metabolites are: thiaminecarboxylic acid, pyramine, and some unknown metabolites. Of all the vitamins, thiamine is stored in the body in the smallest amounts. The adult body contains about 30 mg of thiamine in the form of 80% thiamine pyrophosphate,10% thiamine triphosphate and the rest in the form of thiamine monophosphate.

After intramuscular use, pyridoxine is rapidly absorbed into the bloodstream and distributed in the body, acting as a coenzyme after phosphorylation of the CH2 group, IT forms metabolically active pyridoxal phosphate in the 5th position. About 80% of the vitamin binds to plasma proteins.

Pyridoxine is distributed throughout the body and crosses the placenta and is found in breast milk, deposited in the liver and oxidized to 4-pyridoxic acid, which is excreted in the urine, a maximum of 2-5 hours after absorption. The human body contains 40-150 mg of vitamin B6 and its daily elimination rate is about 1.7-3.6 mg with a replenishment rate of 2.2-2.4%.

After parenteral use, cyanocobalamin forms complexes with the transport protein transcobalamin, which are rapidly absorbed by the liver, bone marrow, and other organs. Cyanocobalamin is excreted in the bile and participates in the intestinal-hepatic circulation. Penetrates through the placenta.

Indications

In complex therapy: mono-and polyneuropathies of various origins; dorsalgia; plexopathies; lumboishialgia of the radicular syndrome caused by degenerative changes of the spine.

Contraindications

Hypersensitivity to the components of the drug. Children’s age. Pregnancy and lactation period

Side effects

The following concepts and frequencies apply: very common (≥1/10), (often (≥1/100, <1/10); infrequent (≥1/1000, <1/100); rare (≥1/10000, <1/1000); very rare (Immune system disorders: Rare: shortness of breath, anaphylactic shock Frequency unknown: allergic reactions in the form of skin pruritus and rash, urticaria, quincken’s edema Cardiovascular disorders: Frequency unknown: tachycardia Skin and subcutaneous tissue disorders: Frequency unknown: increased sweating, acne, eczema. Gastrointestinal disorders: Frequency unknown: nausea, vomiting, diarrhea, abdominal pain General disorders and disorders at the injection site: Frequency unknown: reactions at the injection site

Interaction

When used concomitantly with levodopa, vitamin B6 may reduce the antiparkinsonian effect of levodopa. Concomitant use of pyridoxine antagonists (e. g., isoniazid, hydralazine, penicillamine, or cycloserine) may increase the need for pyridoxine. “Loop” diuretics, such as furosemide, can block tubular reabsorption, thus increasing the excretion of thiamine with prolonged use, which leads to a decrease in the content of thiamine in the blood. Vitamin B1 is destroyed when interacting with solutions containing sulfites. It is not recommended to mix the drug with other drugs in the same syringe. Cyanocobalamin is incompatible with ascorbic acid and heavy metal salts.

How to take, course of use and dosage

The drug is administered intramuscularly (deep injections into the gluteal muscle). Treatment is recommended to start with intramuscular use of 1 ampoule (2 ml) per day until acute symptoms are relieved. After improvement of symptoms or in cases of moderate severity of the disease: one ampoule 2-3 times a week for 2-3 weeks. For maintenance therapy, to prevent relapse, or to continue the current course of treatment, it is recommended to switch to oral use of the drug Kombilipen ® tabs in the dosage form of film-coated tablets. The duration of treatment is determined by the doctor individually, depending on the severity of the symptoms of the disease.

Overdose

Vitamins B1, B6 and B12 have a wide therapeutic range. Symptoms of overdose are not observed when using the drug in the recommended doses and regimen. Vitamin B-1:  The following symptoms are reported after use of a dose exceeding the recommended dose by more than 100 times (>10 g): curare-like ganglioblocking effects that cause disruption of nerve impulses. Vitamin B6:  prolonged use (>6-12 months) of vitamin B6 in a daily dose of >50 mg may cause peripheral sensory neuropathy. Prolonged use of vitamin B6 in a daily dose of more than 1 g for more than 2 months can cause neurotoxic effects. After use of more than 2 g per day, cases of hypochromic anemia and seborrheic dermatitis, neuropathy with ataxia, sensitivity disorders, epileptiform seizures with changes in the EEG were described. Vitamin B12:  after parenteral use of a high dose, allergic reactions, eczematous skin disorders and a benign form of acne were observed. Treatment:  If symptoms of overdose occur, treatment with the drug should be discontinued. If necessary, symptomatic therapy is prescribed, including desensitizing.

Description

Transparent pinkish-red liquid with a characteristic smell.

Special instructions

The drug should be administered only intramuscularly, not allowing it to enter the vascular bed. In case of accidental intravenous use, the patient should be monitored by a doctor or be hospitalized, depending on the severity of the symptoms. Other vitamins, especially cyanocobalamin, can be inactivated in the presence of vitamin B1 degradation products.

The clinical picture, as well as laboratory tests for funicular myelosis or pernicious anemia, may lose their specificity when vitamin B12 is administered.

The drug can cause neuropathies with prolonged use for more than 6 months.

Influence on the ability to drive vehicles and mechanisms

Warning information regarding the use of Combilipen® There is no NEO for drivers of vehicles and persons working with potentially dangerous mechanisms. However, caution is recommended, given the possibility of developing adverse drug reactions.

Form of production

Solution for intramuscular use. 2 ml in ampoules made of light-proof glass of hydrolytic class I with a yellow ring and a yellow break point. A self-adhesive label is applied to each ampoule. 5 ampoules each in a contour cell package made of polyvinyl chloride film. 1 or 2 contour cell packages together with the instructions for use are placed in a pack of cardboard.

Storage conditions

In a dark place at a temperature of 2 to 8 °C. For patients: it is allowed to store the drug at a temperature not exceeding 25 °C for 14 days. Keep out of reach of children.

Shelf

life is 2 years. Do not use after the expiration date indicated on the package.

Active ingredient

Pyridoxine, Thiamine, Cyanocobalamin

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection