Combilipen injections 2ml #10

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Instruction for Combilipen injections

You can buy Combilipen injections here

Composition

Active ingredients:
Thiamine Hydrochloride - 100 mg
Pyridoxine hydrochloride - 100 mg
Cyanocobalamin - 1 mg
Lidocaine Hydrochloride - 20 mg
Excipients: benzyl alcohol - 40.0 mg, sodium tripolyphosphate - 20.0 mg, potassium hexacyanoferrate - 0.20 mg, sodium hydroxide - up to pH 4.5 ± 0.2, water for injection - up to 2 ml.

Pharmacodynamics

Combined multivitamin preparation. The action of Combilipen injections is determined by the properties of vitamins that make up its composition. Neurotropic B vitamins have a beneficial effect on inflammatory and degenerative diseases of the nervous system and musculoskeletal system.
Thiamine (vitamin B1) - plays a key role in carbohydrate metabolism, which are crucial in metabolic processes of the nervous tissue (participates in conducting nerve impulses), as well as in the Krebs cycle with subsequent participation in the synthesis of thiamine pyrophosphate (TPP) and adenosine triphosphate (ATP).
Pyridoxine (vitamin B6) - has a vital effect on the metabolism of proteins, carbohydrates and fats, is necessary for normal blood formation, 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 (B1 and B6) is the potentiation of the action of each other, manifested in a positive effect on the nervous, neuromuscular and cardiovascular systems.
Cyanocobalamin (vitamin B12) - is involved in the synthesis of nucleotides, is an important factor in the normal growth, blood formation 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 potential-dependent sodium channels, which prevents the generation of impulses at the end of the sensory nerves and the conduction of pain impulses along the nerve fibers.

Pharmacokinetics

Thiamine

After intramuscular injection, thiamine is rapidly absorbed from the injection site and enters the blood (484 ng / ml after 15 minutes on the first day of a 50 mg dose) and is unevenly distributed in the body when it is 15% in leukocytes. red blood cells 75% and in the blood plasma 10%. Due to the lack of significant reserves of vitamin in the body, it must be ingested daily. Thiamine penetrates the blood-brain and placental barriers, found in breast milk. Thiamine is eliminated 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: thiamincarboxylic acid, pyramine and some unknown metabolites. Of all the vitamins, thiamine is stored in the body in the smallest amounts. An adult 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 rapidly absorbed from the injection site and distributed in the body, acting as a coenzyme after phosphorylation of the CH2OH group in the 5th position. About 80% of the vitamin is bound to plasma proteins. Pyridoxine is distributed throughout the body, crosses the placenta, is found in breast milk. It accumulates in the liver and is oxidized to 4-pyridoxine acid, which is excreted by the kidneys maximum 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%.

Cyanocobalamin

After intramuscular administration, cyanocobalamin binds to transcobalamins I and II and is transferred to various tissues of the body. The maximum concentration after intramuscular injection is achieved after 1 hour. Communication with plasma proteins - 90%. It penetrates the placental barrier, is found in breast milk. Metabolized mainly in the liver with the formation of adenosylcobalamin, which is the active form of cyanocobalamin. Deposited in the liver, with bile enters the intestine and is again absorbed into the blood (the phenomenon of enterohepatic recirculation). The half-life is long, mainly excreted by the kidneys (7-10%) and through the intestines (50%). With a decrease in renal function, excreted by the kidneys - 0-7% and through the intestines - 70-100%.

Lidocaine

With intramuscular administration, the maximum plasma concentration of lidocaine is noted 5-15 minutes after injection. Depending on the dose, about 60-80% of lidocaine binds to plasma proteins. It is quickly distributed (within 6-9 minutes) in organs and tissues with good perfusion, incl. heart, lungs, liver, kidneys, then in muscle and adipose tissue. It penetrates the hematoencephalic and placental barriers, is found in breast milk (up to 40% of the concentration in the blood plasma of the mother).
Metabolized in the liver with the participation of microsomal enzymes with the formation of active metabolites - monoethylglycine and glycine, having a half-life of 2 and 10 hours, respectively. The intensity of metabolism decreases with liver diseases. Excreted mainly in the form of metabolites by the kidneys and up to 10% unchanged.


Indications for use

In complex therapy:
    mono- and polyneuropathy of various genesis;
    dorsalgia;
    plexopathy;
    lumboischialgia;
    radicular syndrome caused by degenerative changes in the spine.

Contraindications

    Hypersensitivity to Combilipen injections.
    Acute heart failure, chronic heart failure in the stage of decompensation.
    Children's age up to 18 years (efficiency and safety are not established).

Period of pregnancy and breastfeeding

The use of Combilipen injections is contraindicated during pregnancy and breastfeeding.

Dosage and administration

Injections Combilipen are performed deeply intramuscularly (see section "Special Instructions").
In cases of severe pain, it is advisable to start treatment with intramuscular injection (deep) in 2 ml daily for 5-10 days with a switch in the future either to oral administration or to rarer Combilipen injections (2-3 times a week for 2-3 weeks) with the possible continuation of therapy with oral dosage form.
Weekly monitoring of therapy by the doctor is required. The duration of treatment is determined by the doctor individually, depending on the severity of the symptoms of the disease.
The transition to therapy with the oral dosage form is recommended as soon as possible.

Side effects of Combilipen injections

The frequency of adverse reactions is given in accordance with the WHO classification:
Very often - 1/10 of appointments, often - 1/100 of appointments, infrequently - 1/1000 of appointments, rarely - 1/10000 of appointments, very rarely - less than 1/10000 of appointments, the frequency is unknown (it is impossible to establish based on the available data).
On the part of the immune system:
rarely: allergic reactions (skin rash, difficulty breathing, anaphylactic shock. Quincke edema).
From the nervous system:
frequency is unknown: dizziness, confusion.
Since the cardiovascular system:
very rarely: tachycardia;
frequency is unknown: bradycardia, arrhythmia.
From the gastrointestinal tract:
frequency unknown: vomiting.
Skin and Subcutaneous Tissues:
very rarely: excessive sweating, acne, pruritus, urticaria.
On the part of the musculoskeletal and connective tissue: the frequency is unknown: convulsions.
General disorders and disorders at the site of administration:
frequency unknown: irritation may occur at the injection site; systemic reactions are possible with rapid administration or overdose.
With rapid administration (for example, due to unintentional intravascular administration or administration to tissues with a rich blood supply) or when the dose is exceeded, systemic reactions may develop, including confusion, vomiting, bradycardia, arrhythmia, dizziness and convulsions.
If any of the side effects indicated in the instruction are aggravated, or you have noticed any other side effects that are not indicated in the instruction, inform your doctor.


Overdose

Symptoms: vomiting, bradycardia, arrhythmia, possible systemic reactions, including dizziness, confusion, convulsions.
Treatment: in case of overdose symptoms, treatment with Combilipen injections should be discontinued, if necessary, prescribe symptomatic therapy.

Interaction with other drugs

Vitamins of group B

Vitamin B1 (thiamine) completely decomposes in solutions containing sulfites. And as a result, the breakdown products of thiamine inactivate the actions of other vitamins. Thiamine is incompatible with oxidizing and reducing compounds, including mercury chloride, iodide, carbonate, acetate, tannin acid, ammonium iron citrate, and also phenobarbital, riboflavin, benzylpenicillin, dextrose, and metabisulphite. Copper accelerates the destruction of thiamine; in addition, thiamine loses its effectiveness with increasing pH values ​​(more than 3).
Therapeutic doses of vitamin B6 (pyridoxine) weaken the effect of levodopa (the anti-Parkinsonian effect of levodopa decreases) with simultaneous use. The interaction with cycloserine, penicillamine, isoniazid is also observed.
Vitamin B12 (cyanocobalamin) is incompatible with ascorbic acid, salts of heavy metals.

Lidocaine

Parenteral administration of lidocaine, in the case of additional use of norepinephrine and epinephrine, may increase unwanted reactions to the heart.
Interaction with sulfonamides is also observed. In case of overdose of local anesthetics, epinephrine and norepinephrine should not be used additionally.

special instructions

Combilipen injections must be administered only intramuscularly, preventing it from falling into the bloodstream. For accidental intravenous administration, the patient should be under the supervision of a physician or hospitalized depending on the severity of the symptoms. Combilipen injections can cause neuropathy with a duration of use over 6 months.

Influence on ability to steer vehicles, mechanisms

Information on the effect of Combilipen injections on the ability to drive vehicles, as well as on the implementation of potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions, is missing. However, caution is advised, given the possibility of adverse drug reactions.

Storage conditions

In the dark place at a temperature of from 2 to 8 ° C. Keep out of the reach of children.
Shelf life - 2 years.
Do not use after the expiration date printed on the package.

Terms of sell

You can buy Combilipen injections without a prescription.