Milgamma^® (Solution) Instructions for Use

Marketing Authorization Holder

Woerwag Pharma GmbH & Co. KG (Germany)

Manufactured By

Soluparm Pharmazeutische Erzeugnisse, GmbH (Germany)

ATC Codes

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

N07X (Other nervous system drugs)

Dosage Form

Milgamma®

Solution for intramuscular injection 100 mg+100 mg+1 mg+20 mg/2 ml: amp. 5, 10 or 25 pcs.

Dosage Form, Packaging, and Composition

Solution for intramuscular injection transparent, red in color, with a characteristic odor.

Excipients : benzyl alcohol, sodium polyphosphate, potassium hexacyanoferrate, sodium hydroxide, water for injections.

2 ml – ampoules^× made of brown light-protective hydrolytic glass type I (5) – PVC trays with dividers (1) – cardboard boxes.
2 ml – ampoules^× made of brown light-protective hydrolytic glass type I (5) – PVC trays with dividers (2) – cardboard boxes.
2 ml – ampoules^× made of brown light-protective hydrolytic glass type I (5) – PVC trays with dividers (5) – cardboard boxes.

^×A white dot is applied to the ampoule with paint.

Clinical-Pharmacological Group

B complex vitamins

Pharmacotherapeutic Group

B vitamins + other

Pharmacological Action

Combined multivitamin agent. The action of the combination 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 the musculoskeletal system.

Thiamine (vitamin B₁) is involved in nerve impulse conduction.

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

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

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

After intramuscular injection, thiamine is rapidly absorbed and enters the bloodstream. The thiamine concentration is 484 ng/ml 15 minutes after administration of the drug at a dose of 50 mg (on the 1st day of administration). Thiamine is unevenly distributed in the body. The thiamine content in leukocytes is 15%, in erythrocytes – 75%, and in plasma – 10%. Due to the absence of significant vitamin reserves in the body, it must be supplied to the body daily. Thiamine crosses the blood-brain barrier and the placental barrier and is found in breast milk. The main metabolites of thiamine are thiamine carboxylic acid, pyramidine, and some unknown metabolites. Of all vitamins, thiamine is retained in the body in the smallest amounts. The body of an adult contains about 30 mg of thiamine in the form of 80% thiamine pyrophosphate, 10% thiamine triphosphate, and the remaining amount as thiamine monophosphate. Thiamine is excreted in the urine, T_1/2 α-phase – 0.15 h, β-phase – 1 h, and terminal phase – within 2 days.

After intramuscular injection, pyridoxine is rapidly absorbed into the systemic circulation and distributed throughout the body, acting as a coenzyme after phosphorylation of the CH₂OH group at the 5th position. Pyridoxine is distributed throughout the body, crosses the placental barrier, and is found in breast milk. The body contains 40-150 mg of vitamin B₆, its daily elimination rate is about 1.7-3.6 mg with a replenishment rate of 2.2-2.4%. About 80% of pyridoxine is bound to plasma proteins. Pyridoxine is deposited in the liver and oxidized to 4-pyridoxic acid, which is excreted in the urine, maximum within 2-5 hours after absorption.

After parenteral administration, Cyanocobalamin forms complexes with the transport protein transcobalamin, which are rapidly absorbed by the liver, bone marrow, and other organs. Cyanocobalamin is excreted in bile and participates in enterohepatic circulation. It crosses the placental barrier.

After intramuscular injection, the absorption of lidocaine is almost complete. Distribution is rapid, V_d is about 1 L/kg (lower in patients with heart failure). Protein binding depends on the concentration of the active substance in plasma and is 60-80%. It is metabolized mainly in the liver with the formation of active metabolites, which may contribute to the manifestation of therapeutic and toxic effects, especially after infusion for 24 hours or more. T_1/2 tends to be biphasic with a distribution phase of 7-9 min. Overall, T_1/2 is dose-dependent, is 1-2 hours, and may increase to 3 hours or more during prolonged intravenous infusions (more than 24 hours). It is excreted by the kidneys in the form of metabolites, 10% unchanged.

Indications

As part of complex therapy for the following neurological diseases: trigeminal neuralgia; facial nerve neuritis; pain syndrome caused by spinal diseases (intercostal neuralgia, lumbosciatica, lumbar syndrome, cervical syndrome, cervicobrachial syndrome, radicular syndrome caused by degenerative changes of the spine); polyneuropathy of various etiologies (diabetic, alcoholic).

ICD codes

Dosage Regimen

Administer the solution by deep intramuscular injection only. Do not administer intravenously.

For severe pain, initiate therapy with 2 ml daily for 5 to 10 days.

Following the initial intensive phase, transition to a maintenance regimen.

Inject 2 mltwo to three times per week for an additional 2 to 3 weeks.

Alternatively, switch to an oral formulation of the vitamin combination for continued therapy.

Adjust the treatment duration based on the clinical response and the severity of the neurological condition.

Use the solution immediately after opening the ampoule. Discard any unused portion.

Adverse Reactions

Possible allergic reactions in the form of itching, urticaria; difficulty breathing, angioedema, anaphylactic shock.

In individual cases sweating, tachycardia, acne.

Contraindications

Severe and acute forms of decompensated heart failure; pregnancy; lactation period (breastfeeding); children’s age (due to lack of data); hypersensitivity to the components of the combined agent.

With caution

Cardiac arrhythmias, severe arterial hypotension.

Use in Pregnancy and Lactation

Use during pregnancy and lactation (breastfeeding) is contraindicated.

Pediatric Use

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

Special Precautions

In case of accidental intravenous administration, the patient should be under medical supervision or hospitalized depending on the severity of symptoms.

In case of overdose, dizziness, nausea, vomiting, itching, urticaria, increased sweating, and tachycardia may occur.

Drug Interactions

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

Levodopa reduces the effect of therapeutic doses of vitamin B₆.

Vitamin B₁₂ is incompatible with salts of heavy metals, ascorbic acid.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.