Tiamin Reneval (Solution) Instructions for Use

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

ATC Code

A11DA01 (Thiamine)

Active Substance

Thiamine (Rec.INN registered by WHO)

Dosage Form

Thiamine Reneval

Solution for intramuscular administration 50 mg/ml

Dosage Form, Packaging, and Composition

Solution for intramuscular administration

1 ml – ampoules (10 pcs.) – cardboard packs – By prescription
1 ml – ampoules (100 pcs.) – cardboard boxes – By prescription
1 ml – ampoules (20 pcs.) – cardboard packs – By prescription
1 ml – ampoules (3 pcs.) – cardboard packs – By prescription
1 ml – ampoules (5 pcs.) – cardboard packs – By prescription
1 ml – ampoules (50 pcs.) – cardboard boxes – By prescription
2 ml – ampoules (10 pcs.) – cardboard packs – By prescription
2 ml – ampoules (100 pcs.) – cardboard boxes – By prescription
2 ml – ampoules (20 pcs.) – cardboard packs – By prescription
2 ml – ampoules (3 pcs.) – cardboard packs – By prescription
2 ml – ampoules (5 pcs.) – cardboard packs – By prescription
2 ml – ampoules (50 pcs.) – cardboard boxes – By prescription

Clinical-Pharmacological Group

B vitamin

Pharmacotherapeutic Group

Vitamins

Pharmacological Action

Vitamin B₁, belongs to the water-soluble vitamins. In the human body, as a result of phosphorylation processes, it is converted into cocarboxylase, which is a coenzyme of many enzymatic reactions.

Vitamin B₁ plays an important role in carbohydrate, protein, and fat metabolism, as well as in the processes of nerve impulse transmission at synapses.

Pharmacokinetics

After oral administration, it is absorbed from the gastrointestinal tract. Before absorption, Thiamine is released from its bound state by digestive enzymes.

After 15 minutes, Thiamine is detected in the blood, and after 30 minutes – in other tissues. The thiamine content in the blood is relatively low, with free Thiamine predominantly found in plasma, and its phosphoric esters in erythrocytes and leukocytes.

Distribution in the body is quite wide. A relative predominance of thiamine content in the myocardium, skeletal muscles, nervous tissue, and liver has been noted, which is apparently due to the increased consumption of thiamine by these structures.

Half of the total amount of thiamine is contained in striated muscles (including the myocardium) and about 40% in internal organs.

The most active of the phosphoric esters of thiamine is thiamine diphosphate. This compound has coenzyme activity and plays a major role in thiamine’s participation in fat and carbohydrate metabolism.

It is excreted through the intestines and kidneys.

Indications

Hypovitaminosis and avitaminosis B₁ (including in patients on enteral tube feeding, on hemodialysis; with malabsorption syndrome).

Neuritis, radiculitis, neuralgia, peripheral paresis and paralysis; intestinal atony, impaired intestinal absorption, severe liver dysfunction; myocardial dystrophy; thyrotoxicosis; chronic alcoholism; starvation; increased body requirement for vitamin B₁ during pregnancy.

ICD codes

Dosage Regimen

Administer the solution by intramuscular injection only; do not administer intravenously or subcutaneously.

For adults, the typical therapeutic dose is 50 mg (1 ml) once daily.

For severe deficiency states, the dose may be increased to 100 mg (2 ml) per day; the duration of therapy is determined by the clinical response.

Initiate treatment with a small test dose to assess for potential hypersensitivity reactions prior to administering the full therapeutic dose.

Inject deeply into a large muscle mass, such as the gluteal region; rotate injection sites with each administration to minimize local irritation.

The maximum duration of parenteral therapy should not exceed one month; transition to oral thiamine formulations for maintenance therapy when clinically appropriate.

Dosage adjustments may be necessary for patients with specific conditions such as chronic alcoholism or malabsorption syndromes; follow the prescribing physician’s instructions precisely.

Adverse Reactions

Allergic reactions urticaria, skin itching, angioedema; in isolated cases – anaphylactic shock.

Others sweating, tachycardia, pain at the injection site.

Contraindications

Hypersensitivity to thiamine; children’s age – depending on the drug form.

Use in Pregnancy and Lactation

During pregnancy and breastfeeding, it is possible to use according to indications in cases where the intended benefit to the mother outweighs the potential risk to the fetus or infant.

Pediatric Use

It is possible to use in children according to indications, in doses and drug forms recommended according to age. It is necessary to strictly follow the instructions in the thiamine drug leaflets regarding contraindications for the use of specific thiamine drug forms in children of different ages.

Special Precautions

When determining the concentration of theophylline in blood serum by the spectrophotometric method, urobilinogen using Ehrlich’s reagent may distort the results (when using high doses).

Parenteral administration is recommended only if oral administration is impossible (nausea, vomiting, malabsorption syndrome, pre-operative and/or post-operative conditions).

Allergic reactions to thiamine administration occur more often in individuals predisposed to allergies.

Subcutaneous (and sometimes intramuscular) injections of thiamine are painful due to the low pH of the solutions.

Drug Interactions

The physiological function of vitamins B₁ and B₆ is to potentiate each other’s action, manifested in a positive effect on the nervous, muscular, and cardiovascular systems.

Ethanol sharply reduces the absorption of thiamine (blood concentration may decrease by 30%).

Long-term treatment with anticonvulsant drugs may lead to thiamine deficiency.

Thiamine completely decomposes in solutions containing sulfites.

Thiamine is unstable in alkaline and neutral solutions; co-administration with carbonates, citrates, barbiturates, copper preparations is not recommended.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°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.