Neurogamma (Solution) Instructions for Use

Marketing Authorization Holder

Woerwag Pharma GmbH & Co. KG (Germany)

Manufactured By

Soluparm Pharmazeutische Erzeugnisse, GmbH (Germany)

ATC Code

A11DB (Vitamin B1 in combination with vitamins B6 and/or B12)

Active Substances

Pyridoxine (Rec.INN registered by WHO)

Thiamine (Rec.INN registered by WHO)

Dosage Form

Neurogamma

Solution for intravenous and intramuscular administration 100 mg+50 mg/1 ml: amp. 5 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular administration transparent, with a slight yellowish-green tint.

Excipients : tartaric acid – 1.6 mg, water for injections – up to 1 ml.

1 ml – dark glass ampoules (5) – blister packs (1) – cardboard packs.

Clinical-Pharmacological Group

B complex vitamins

Pharmacotherapeutic Group

Multivitamin

Pharmacological Action

Neurotropic B vitamins have a beneficial effect on inflammatory and degenerative diseases of the nerves and locomotor system.

They promote increased blood flow and improve the function of the nervous system.

Thiamine plays a key role in carbohydrate metabolism, as well as in the Krebs cycle with subsequent participation in the synthesis of TPP (Thiamine pyrophosphate) and ATP (adenosine triphosphate).

Pyridoxine is involved in protein metabolism, and partially, in the metabolism of carbohydrates and fats.

The physiological function of both vitamins is to potentiate each other’s action, manifested in a positive effect on the nervous, neuromuscular, and cardiovascular systems.

In cases of vitamin B₆ deficiency, widespread deficiency conditions are quickly relieved after the administration of these vitamins.

Pharmacokinetics

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

Due to the absence of significant vitamin reserves in the body, it must be supplied daily.

Thiamine crosses the blood-brain and placental barriers and is found in breast 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 retained in the body in the smallest amounts.

The adult human body contains about 30 mg of thiamine in the form of 80% thiamine pyrophosphate, 10% thiamine triphosphate, and the remaining amount as thiamine monophosphate.

After intramuscular injection, Pyridoxine is rapidly absorbed into the bloodstream and distributed throughout the body, acting as a coenzyme after phosphorylation of the CH₂OH group at 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, is deposited in the liver, and is oxidized to 4-pyridoxic acid, which is excreted in the urine, with a maximum after 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%.

Indications

As an auxiliary agent in the complex therapy of diseases of the nervous system of various origins

• Neuropathy;
• Neuralgia; including retrobulbar neuritis;
• Ganglionitis;
• Herpes zoster;
• Facial nerve paresis;
• Plexopathy, including solaritis;
• Polyneuropathy: diabetic, alcoholic, etc.

Neurological manifestations of spinal osteochondrosis

• Myalgia;
• Radiculopathy;
• Sciatica;
• Lumbago;
• Nocturnal muscle cramps, especially in the elderly.

ICD codes

Dosage Regimen

Administer Neurogamma solution by intravenous or intramuscular injection only.

For severe manifestations of neurological disease, administer 1-2 ml daily for a duration of 5-7 days.

Following the initial intensive phase, reduce the frequency to 1-2 ml, administered 2-3 times per week for an additional 2 weeks.

For mild to moderate clinical cases, initiate therapy with 1-2 ml, administered 2-3 times per week.

Continue this regimen for a total of 7-10 days.

Do not exceed the recommended dosage or duration of therapy.

Adjust the treatment schedule based on the patient’s clinical response and tolerance.

Administer intravenous injections at a slow rate to prevent adverse reactions such as dizziness or arrhythmia.

Adverse Reactions

Allergic reactions.

In some cases, sweating, tachycardia, and acne may occur.

Skin reactions such as itching, urticaria; difficulty breathing, angioedema, anaphylactic shock have been described.

Contraindications

• Decompensated heart failure;
• Childhood;
• Increased individual sensitivity to the components of the drug.

Use in Pregnancy and Lactation

Not recommended for use during pregnancy and lactation.

Pediatric Use

Contraindicated in childhood.

Overdose

In cases of very rapid administration of the drug, dizziness, arrhythmia, and convulsions may occur; they may also be the result of an overdose. Overdose treatment is symptomatic.

Drug Interactions

Thiamine is completely destroyed in solutions containing sulfites.

Other vitamins are inactivated in the presence of vitamin B degradation products.

Levodopa reduces the effect of therapeutic doses of vitamin B₆.

Interaction with cycloserine, D-penicillamine, epinephrine, norepinephrine, sulfonamides may also occur, which reduces the effect of pyridoxine.

Thiamine is incompatible with oxidizing and reducing substances, mercuric chloride, iodide, carbonate, acetate, tannic acid, iron-ammonium citrate, as well as phenobarbital, riboflavin, benzylpenicillin, dextrose, and metabisulfite.

Copper accelerates the destruction of thiamine; furthermore, Thiamine loses its effect when pH values increase (above pH 3).

Storage Conditions

At a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life – 2 years.

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.