Vitamin B12 in ampoules: instructions for use

Composition of injections and release form

The vitamin-containing product is produced by a Russian pharmaceutical company. The Latin name of the drug is Combilipen

.

Active components:

• 100 mg vitamin B1 (thiamine hydrochloride);
• 100 mg vitamin B6 (pyridoxine hydrochloride);
• 1 mg vitamin B12 (cyanocobalamin hydrochloride);
• 0.2 g lidocaine.

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One ampoule also contains the following additional components: potassium hydroxide, deionized water, potassium hexacyanoferrate, benzyl alcohol, sodium tripolyphosphate. The drug is sold in glass ampoules of 2 ml. The solution itself has a rich pink tint and a specific smell.

Sold in packs of 20, 10 and 5 pcs.

Ampoules may have notches for opening or be made of homogeneous glass. In the latter case, a scarifier is attached to them.

Combilipen 2ml 10 pcs. injection

pharmachologic effect

Replenishes the deficiency of B vitamins.

Composition and release form Combilipen 2ml 10 pcs. injection

Solution for intramuscular administration - 2 ml:

• active ingredients: thiamine hydrochloride - 100 mg; pyridoxine hydrochloride - 100 mg; cyanocobalamin - 1 mg; lidocaine hydrochloride - 20 mg;
• excipients: benzyl alcohol - 40 mg; sodium tripolyphosphate - 20 mg; potassium hexacyanoferrate - 0.2 mg; sodium hydroxide - up to pH 4.5±0.2; water for injection - up to 2 ml.

Solution for intramuscular administration. 2 ml in light-protective glass ampoules. 5 amp. placed in a blister pack made of PVC film. 1 or 2 blister packs are placed in a cardboard pack.

Description of the dosage form

Transparent pinkish-red liquid with a specific odor.

Directions for use and doses

Injections are performed deep intramuscularly.

In cases of severe pain, it is advisable to begin treatment with intramuscular injection (deep) of 2 ml daily for 5-10 days, with subsequent transition either to oral administration or to more rare injections (2-3 times a week for 2-3 weeks) with possible continuation of therapy with the oral dosage form.

Weekly monitoring of therapy by a physician is required. The duration of treatment is determined by the doctor individually depending on the severity of the symptoms of the disease.

It is recommended to switch to therapy with an oral dosage form as soon as possible.

Pharmacodynamics

Combined multivitamin preparation. The effect of the drug is determined by the properties of the vitamins included in its composition. Neurotropic B vitamins have a beneficial effect on inflammatory and degenerative diseases of the nervous system and musculoskeletal system.

Thiamine hydrochloride (vitamin B1) - plays a key role in the processes of carbohydrate metabolism, which are crucial in the metabolic processes of nervous tissue (participates in the conduction of nerve impulses), as well as in the Krebs cycle with subsequent participation in the synthesis of thiamine pyrophosphate (TPP) and ATP.

Pyridoxine hydrochloride (vitamin B6) - has a vital effect on the metabolism of proteins, carbohydrates and fats, is necessary for normal hematopoiesis, the functioning of the central nervous system and the peripheral nervous system. Provides synaptic transmission, inhibition processes in the central nervous system, 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 (B1 and B6) is to potentiate each other’s action, manifested in a positive effect on the nervous, neuromuscular and cardiovascular systems.

Cyanocobalamin (vitamin B12) - is involved in the synthesis of nucleotides and is an important factor in normal growth, hematopoiesis and development of epithelial cells; necessary for folic acid metabolism and myelin synthesis.

Lidocaine has an anesthetic effect at the injection site, dilates blood vessels, promoting the absorption of vitamins. The local anesthetic effect of lidocaine is due to the blockade of voltage-gated Na+ channels, which prevents the generation of impulses in the endings of sensory nerves and the conduction of pain impulses along nerve fibers.

Pharmacokinetics

Thiamine

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

Due to the lack of significant reserves of the vitamin in the body, it must be ingested daily. Thiamine penetrates the blood-brain and placental barriers and is found in breast milk. Thiamine is excreted by the kidneys in the alpha phase - after 0.15 hours, in the beta phase - after 1 hour, in the final (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 quantities. The adult human body contains about 30 mg of thiamine: 80% in the form of thiamine pyrophosphate, 10% in the form of thiamine triphosphate and the rest in the form of thiamine monophosphate.

Pyridoxine

After intramuscular injection, pyridoxine is quickly absorbed from the injection site and distributed in the body, acting as a coenzyme after phosphorylation of the CH2OH group at the 5th position. About 80% of the vitamin binds to blood plasma proteins. Pyridoxine is distributed throughout the body, penetrates the placenta, and is found in breast milk. It accumulates in the liver and is oxidized to 4-pyridoxic acid, which is excreted by the kidneys within 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 replacement rate of 2.2–2.4%.

Cyanocobalamin

After intramuscular administration, cyanocobalamin binds to transcobalamins I and II and is transported to various tissues of the body. Cmax after intramuscular administration is achieved after 1 hour. Communication with blood plasma proteins is 90%. Penetrates the placental barrier and is found in breast milk. Metabolized primarily in the liver to form adenosylcobalamin, which is the active form of cyanocobalamin.

It is deposited in the liver, enters the intestines with bile and is reabsorbed into the blood (the phenomenon of enterohepatic recirculation). T1/2 is long, excreted mainly by the kidneys (7–10%) and through the intestines (50%). With a decrease in renal function, 0–7% is excreted by the kidneys and 70–100% through the intestines.

Lidocaine

With intramuscular administration, plasma Cmax of lidocaine is observed 5–15 minutes after injection. Depending on the dose, about 60–80% of lidocaine is bound to plasma proteins. Rapidly distributed (within 6–9 minutes) in organs and tissues with good perfusion, incl. heart, lungs, liver, kidneys, then in muscle and adipose tissue. Penetrates the blood-brain and placental barriers and is found in breast milk (up to 40% of the concentration in the mother's blood plasma). Metabolized in the liver with the participation of microsomal enzymes with the formation of active metabolites - monoethylglycine xylyl and glycine xylyl, having a half-life of 2 and 10 hours, respectively. Metabolic intensity decreases in liver diseases. It is excreted mainly in the form of metabolites by the kidneys and up to 10% unchanged.

Indications for use Combilipen 2ml 10 pcs. injection

In the complex therapy of mono- and polyneuropathies of various origins:

• dorsalgia;
• plexopathies;
• lumboischialgia;
• radicular syndrome caused by degenerative changes in the spine.

Contraindications

• hypersensitivity to the components of the drug;
• acute heart failure, chronic heart failure in the stage of decompensation;
• pregnancy;
• lactation period;
• children under 18 years of age (efficacy and safety have not been established).

Application of Combilipen 2ml 10 pcs. solution for injection during pregnancy and lactation

The use of the drug is contraindicated during pregnancy and breastfeeding.

special instructions

The drug must be administered only intramuscularly, avoiding its entry into the vascular bed. In case of accidental IV administration, the patient should be under medical supervision or hospitalized, depending on the severity of symptoms. The drug can cause neuropathies when used for more than 6 months.

Influence on the ability to drive vehicles and machinery. There is no information on the effect of the drug on the ability to drive vehicles, as well as on the performance of potentially hazardous activities that require increased concentration and speed of psychomotor reactions. However, caution is recommended, given the possibility of developing adverse drug reactions.

Overdose

Symptoms: vomiting, bradycardia, arrhythmia, possible systemic reactions including dizziness, confusion, convulsions.

Treatment: treatment with the drug should be discontinued and, if necessary, symptomatic therapy should be prescribed.

Side effects Combilipen 2ml 10 pcs. injection

The frequency of adverse side reactions is given in accordance with the WHO classification: very often - 1/10 prescriptions; often - 1/100 prescriptions; infrequently - 1/1000 prescriptions; rarely - 1/10,000 prescriptions; very rare - less than 1/10,000 prescriptions, frequency unknown (cannot be determined based on available data).

From the immune system: rarely - allergic reactions (skin rash, difficulty breathing, anaphylactic shock, Quincke's edema).

From the nervous system: frequency unknown - dizziness, confusion.

From the cardiovascular system: very rarely - tachycardia; frequency unknown - bradycardia, arrhythmia.

From the gastrointestinal tract: frequency unknown - vomiting.

From the skin and subcutaneous tissues: very rarely - increased sweating, acne, itching, urticaria.

From the musculoskeletal system and connective tissue: frequency unknown - convulsions.

General disorders and disorders at the injection site: frequency unknown - irritation may occur at the injection site; systemic reactions are possible with rapid administration or overdose. If administered rapidly (eg, due to inadvertent intravascular injection or administration into tissues with a rich blood supply) or if the dose is exceeded, systemic reactions may occur, including confusion, vomiting, bradycardia, arrhythmia, dizziness and convulsions.

If any of the side effects indicated in the description worsen or the patient notices any other side effects not listed in the instructions, the doctor should be informed.

Drug interactions

B vitamins

Vitamin B1 (thiamine) is completely degraded in solutions containing sulfites. And, as a result, thiamine breakdown products inactivate the actions of other vitamins. Incompatible with oxidizing and reducing compounds, incl. mercuric chloride, iodide, carbonate, acetate, tannic acid, ferric ammonium citrate, as well as phenobarbital, riboflavin, benzylpenicillin, dextrose and metabisulfite. Copper accelerates the destruction of thiamine, in addition, thiamine loses its effectiveness with increasing pH values ​​(more than 3).

Vitamin B6 (pyridoxine). Therapeutic doses of vitamin B6 (pyridoxine) weaken the effect of levodopa (the antiparkinsonian effect of levodopa decreases) when used simultaneously. Interactions with cycloserine, penicillamine, and isoniazid are also observed.

Vitamin B12 (cyanocobalamin) is incompatible with ascorbic acid and heavy metal salts.

Lidocaine. With parenteral use of lidocaine, in the case of additional use of norepinephrine and epinephrine, adverse reactions on the heart may increase. Interaction with sulfonamides is also observed. In case of overdose of local anesthetics, additional epinephrine and norepinephrine should not be used.

Therapeutic effect

The B vitamins included in the injections are neurotropic. They have a beneficial effect on the condition of the nerve endings of the spinal cord and brain. In particular, vitamin B1 accelerates the conduction of nerve impulses along fibers in tissues of different structures. Paralysis and paresis are also indications for the use of Combilipen.

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Pyridoxine

necessary for complete metabolism, hematopoiesis, and the action of the central and peripheral nervous system. It is actively involved in the stimulation of synapses (fiber connection points) and the synthesis of sphingosine. And vitamin B12 is indispensable for the formation of new cells in various tissues and organs. Cyanocobalamin is a catalyst in the process of synthesis of nucleotides that make up DNA.

Papaverine hydrochloride is an effective antispasmodic agent, the history of its use dates back to the 19th century. To improve your well-being with the help of a medicine, you need to know what it helps and how to use it. Read more in the article: “What does papaverine hydrochloride help with?”

Thanks to this “bouquet” of useful substances, the drug has a number of therapeutic effects:

• accelerates the restoration of the sheath of nerve fibers and specific elements of nervous tissue;
• increases the production of neurotransmitters - substances necessary to control inhibition and excitation in the central nervous system;
• normalizes metabolism;
• helps the body resist the negative external environment;
• accelerates the regeneration of nerve cells.

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Unlike Combilipen Tabs tablets, injections are widely prescribed to eliminate moderate pain.

This action is due to the presence of lidocaine in the composition.

The peculiarity of this product is that all trace elements are contained in very high dosages.

Combilipen solution d/in 2 ml box x10

Registration certificate holder: PHARMSTANDARD-UfaVITA, JSC (Russia)

Contacts for inquiries: PHARMSTANDARD JSC (Russia)

ATX codes

A11DB (Combination of vitamin B1 with vitamins B6 and/or B12) N07X (Other drugs for the treatment of diseases of the nervous system)

Dosage form

COMBILIPEN®

Solution for intramuscular administration 100 mg+100 mg+1 mg+20 mg/2 ml: amp. 5 or 10 pcs.reg. No.: LS-001680 from 08/02/10 - Indefinitely Re-registration date: 07/06/17

Release form, packaging and composition of Combilipen®

The solution for intramuscular administration is transparent, pinkish-red in color, with a specific odor.

1 amp.

thiamine hydrochloride 100 mg

pyridoxine hydrochloride 100 mg

cyanocobalamin 1 mg

lidocaine hydrochloride 20 mg

Excipients: benzyl alcohol - 40 mg, sodium tripolyphosphate - 20 mg, potassium hexacyanoferrate - 0.2 mg, sodium hydroxide - up to pH 4.5±0.2, water for injection - up to 2 ml.

2 ml - dark glass ampoules (5) - contour cell packaging (1) - cardboard packs. 2 ml - dark glass ampoules (5) - contour cell packaging (2) - cardboard packs.

Clinical-pharmacological group: B complex of vitamins Pharmaco-therapeutic group: B vitamins + other drugs

pharmachologic effect

Combined multivitamin preparation. The effect of the drug is determined by the properties of the vitamins included in its composition. Neurotropic B vitamins have a beneficial effect on inflammatory and degenerative diseases of the nervous system and musculoskeletal system.

Thiamine hydrochloride (vitamin B1) is involved in the conduction of nerve impulses.

Pyridoxine hydrochloride (vitamin B6) has a vital effect on the metabolism of proteins, carbohydrates and fats, and is necessary for normal hematopoiesis and the functioning of the central and peripheral nervous systems. Provides synaptic transmission, inhibition processes in the central nervous system, participates in the transport of sphingosine, which is part of the nerve sheath, and participates in the synthesis of catecholamines.

Cyanocobalamin (vitamin B12) is involved in the synthesis of nucleotides, is an important factor in normal growth, hematopoiesis and development of epithelial cells, and is necessary for the metabolism of folic acid and myelin synthesis.

Lidocaine has an anesthetic effect at the injection site, dilates blood vessels, promoting the absorption of vitamins. The local anesthetic effect of lidocaine is due to the blockade of voltage-dependent Na+ channels, which prevents the generation of impulses in the endings of sensory nerves and the conduction of pain impulses along nerve fibers.

Pharmacokinetics No pharmacokinetic data provided.

Indications for the drug Combilipen®

In complex therapy of the following neurological diseases:

trigeminal neuralgia, neuritis of the facial nerve, pain syndrome caused by diseases of the spine (intercostal neuralgia, lumboischialgia, lumbar syndrome, cervical syndrome, cervical-brachial syndrome, radicular syndrome caused by degenerative changes in the spine), polyneuropathy of various etiologies (diabetic, alcoholic). ICD-10 codes

Dosage regimen

In case of severe pain syndrome, it is advisable to begin treatment with intramuscular injection (deep) of 2 ml daily for 5-10 days, with subsequent transition to either oral administration of the drug or to more rare injections (2-3 times/week for 2-3 weeks) with possible continuation of therapy with the oral dosage form.

Side effect

Possible: allergic reactions in the form of itching, urticaria, difficulty breathing, Quincke's edema, anaphylactic shock.

In some cases: sweating, tachycardia, acne.

Contraindications for use

severe and acute forms of decompensated heart failure, pregnancy, lactation (breastfeeding), childhood (due to lack of data), hypersensitivity to the components of the drug.

Use during pregnancy and breastfeeding

The use of the drug during pregnancy and lactation is not recommended.

Use in children

The use of the drug is contraindicated in childhood due to lack of data.

Special instructions Due to the lack of data, the use of the drug is not recommended in childhood.

Overdose

Symptoms: dizziness, nausea, vomiting, itching, urticaria, increased sweating, tachycardia.

Treatment: symptomatic therapy.

Drug interactions

Vitamin B1 completely disintegrates in solutions containing sulfites, is incompatible with oxidizing and reducing substances (mercuric chloride, iodide, carbonate, acetate, tannic acid, iron(III)-ammonium citrate), as well as sodium phenobarbital, riboflavin, benzylpenicillin, dextrose and metabisulfite sodium

Levodopa reduces the effect of therapeutic doses of vitamin B6.

Vitamin B12 is incompatible with heavy metal salts and ascorbic acid.

Storage conditions for Combilipen®

The drug should be stored in a place protected from light, out of reach of children, at a temperature of 2° to 8°C.

Shelf life of Combilipen® Shelf life - 2 years.

Terms of sale

The drug is available with a prescription.

Contacts for inquiries

PHARMSTANDARD JSC (Russia)

141700 Moscow region Dolgoprudny Likhachevsky pr-d 5B Tel./fax

Instructions for use

Combilipen should only be taken intramuscularly

. It's best to hit the outer upper part of the buttock. The muscle layer in this area is well developed: the medicine will be absorbed gradually, providing a long-lasting therapeutic effect. If the patient is forced to inject himself, then the optimal place for injection is the anterior outer upper third of the thigh.

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1. Before administering the medicine, you need to disinfect the desired area of ​​skin with cotton wool moistened with any antiseptic. This can be a solution of ethyl alcohol, Belasept or Chlorhexidine.

2. The penetration of the needle must be strictly vertical, and the solution must be released slowly.

Administer the opened ampoule immediately; if it does not work, use it after no more than 30 minutes of storage at a temperature of no more than 6 degrees. For severe pain, a 10-day course is prescribed: one injection per day. If therapy needs to be continued, you should limit yourself to 2-3 injections per week or switch to tablet form. Regardless of what Combilipen helps with, injections and tablets should not be taken for longer than 3 weeks.

The gap between injection sites is at least 1.5 cm.

To prevent exacerbations of chronic diseases, it is enough to undergo a 2-week course of therapy. In this case, injections are needed every other day.

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Side effects

Most side effects are associated with an allergic reaction to the components of the drug. Patients prone to allergies may experience:

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• hives;
• swelling of the mucous membranes, resulting in difficulty breathing;
• itching of extremities;
• Quincke's edema;
• anaphylactic shock.

In extremely rare cases, the following symptoms have been recorded:

• tachycardia;
• increased sweating;
• swelling of the lower extremities;
• acne or acne;

As a rule, side effects appear if the drug is taken for more than 4 weeks, as well as in cases of overdose.

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The role of vitamin B12 in the body

Cyanocobalamin (vitamin B12)

was first opened in 1948. Scientists isolated a new substance from raw liver and prescribed it to treat pernicious anemia.

Over the past 70 years, cyanocobalamin has been well studied by scientists and doctors, as a result of which it was possible to establish its effect on the body:

• blocking stress hormones;
• improvement of blood clotting;
• amino acid synthesis;
• reducing the amount of cholesterol in the blood;
• detoxification of the body during alcoholism;
• improving liver function.

Cyanocobalamin helps athletes withstand heavy loads, accelerates weight loss and prevents the development of cardiovascular diseases.

It plays a special role in the functioning of the central nervous system. The vitamin complements the main therapy for cerebral palsy in children, Down's disease, intercostal neuralgia, etc.

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Contraindications

Due to the fact that the useful elements in Kombilipen are contained in the “shock”, it is not advisable to take it:

• patients who have a tendency to develop thrombosis;
• children under 18 years of age;
• during pregnancy and lactation;
• people with heart failure;
• suffering from Parkinson's disease.

The drug is strictly contraindicated if there is an individual intolerance to any of the components. Caution should be exercised when prescribing the drug to patients with cancer, hepatitis, diabetes mellitus and serious nervous disorders.

Interaction with other drugs

Despite the fact that Combilipen is a vitamin-containing product, it is incompatible with a wide range of medications. The drug is not prescribed together with Levodopa, as it reduces the absorption of the solution. And lidocaine, which is contained in injections, neutralizes the effect of Levodopa.

Drinking alcohol while using Kombipilen sharply reduces its effectiveness.

You cannot prescribe the medicine with the following drugs:

• Mercury acetate, chloride, carbonate and iodide;
• Phenobarbital sodium;

• Tannic acid;
• Vitamin B2 (riboflavin);
• Benzylpenicillin;
• Dextrose;
• Metabisulfite.

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The injections are incompatible with salts of heavy metals and vitamin C. It is strictly forbidden to take the drug together with any vitamin complexes, adrenaline and norepinephrine. This combination will cause interruptions in the heart rhythm, even to the point of cardiac arrest.

The active ingredients are completely decomposed by sulfites. Therefore, it is not advisable to prescribe the drug with injectable forms of Tetracycline, Doxycycline, Oxytetracycline and Minocycline.

Analogues of the drug

It is a mistake to assume that such a therapeutic effect can be achieved by taking regular vitamin complexes. Kombipilen is a unique drug, but you can also find analogs for it in the pharmacy.

True, there is a difference in additional elements, the vitamin content is lower, and the price is higher. Here is a list of injections similar in the amount of active substances:

And in tablet form you can find drugs that have a common element with Combilipen - pyridoxine. These are Vitaxon, Neuromax, Milgamma and Unigamma tablets.

Indications for use of cyanocobalamin

Vitamin B12 in ampoules

used as adjunctive therapy. It enhances the effect of drugs and helps the body overcome many diseases. In rare cases, it is prescribed as the only means to prevent anemia.

Indications for use of vitamin B12:

• chronic migraine;
• Down syndrome;
• cerebral palsy;
• neuralgia;
• radiation sickness;
• alcohol poisoning;
• dystrophy;
• anemia;
• radiculitis;
• diseases of the pancreas and liver;
• gastritis;
• photodermatosis;
• sclerosis.

Taking cyanocobalamin is indicated for vitamin deficiency and frequent respiratory diseases. A lack of substance in the body leads to deterioration of the condition of hair, nails and teeth. For this reason, the drug is taken in ampoules not only for therapeutic purposes, but also for cosmetic purposes.

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