Unigamma (Tablets) Instructions for Use

Marketing Authorization Holder

Unipharm, Inc. (USA)

Contact Information

Unipharm, Inc. (USA)

ATC Code

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

Active Substances

Benfotiamine (Rec.INN registered by WHO)

Cyanocobalamin (Rec.INN registered by WHO)

Pyridoxine (Rec.INN registered by WHO)

Dosage Form

Unigamma

Film-coated tablets 100 mg+100 mg+2 mcg: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets from white to almost white, round, biconvex.

Excipients: calcium hydrogen phosphate, microcrystalline cellulose, stearic acid, croscarmellose sodium, magnesium stearate, colloidal silicon dioxide.

Shell composition: Opadry II white (hypromellose, titanium dioxide, polydextrose, talc, maltodextrin, medium-chain triglycerides).

30 pcs. – blisters (1) – cardboard packs.
30 pcs. – blisters (2) – cardboard packs.
30 pcs. – high-density polyethylene bottles (1) – cardboard packs.
60 pcs. – high-density polyethylene bottles (1) – cardboard packs.

* due to the peculiarities of the technological process, it is added as a 1% mixture of cyanocobalamin in microcrystalline cellulose in an amount of 24 mg.

Clinical-Pharmacological Group

B complex vitamins

Pharmacotherapeutic Group

Multivitamin

Pharmacological Action

A complex of B vitamins (B₁, B₆, B₁₂) that affects the condition and function of nervous tissue.

Benfotiamine is a fat-soluble form of vitamin B₁ (thiamine). In the human body, thiamine is converted into active thiamine pyrophosphate and, as a coenzyme, is included in the pyruvate decarboxylase and α-ketoglutarate decarboxylase complexes, which are involved in the oxidative decarboxylation of pyruvic and α-ketoglutaric acids: transketolase is an enzyme of the pentose phosphate pathway. An important result of benfotiamine’s action is a significant increase in transketolase activity: one of the serious biochemical disorders in diabetes mellitus is the inhibition of the transketolase enzyme. Thiamine actively participates in the synthesis of ATP, which is involved in impulse transmission in autonomic fibers and ganglia. It regulates nerve impulse conduction, improving synaptic transmission. The effect of benfotiamine is several times greater than that of thiamine, due to its high tropism for the phospholipids of nervous tissue cell membranes.

Pyridoxine (vitamin B₆) is necessary for the normal functioning of the central and peripheral nervous systems. Upon entering the body, it is phosphorylated, converted into pyridoxal-5-phosphate, and becomes part of enzymes that carry out the decarboxylation, transamination, and racemization of amino acids, as well as the enzymatic transformation of sulfur-containing and hydroxylated amino acids. It is involved in tryptophan metabolism (participation in the biosynthesis reaction of serotonin). It accelerates regenerative processes in nervous tissue.

Cyanocobalamin (vitamin B₁₂) participates in a number of important biochemical reactions that ensure the vital activity of the body (synthesis of nucleic acids, protein, metabolism of amino acids, carbohydrates, lipids). In the body (mainly in the liver), it is converted into methylcobalamin and 5-deoxyadenosylcobalamin. Methylcobalamin participates in the reaction of converting homocysteine into methionine and S-adenosylmethionine – key reactions in the metabolism of pyrimidine and purine bases (and, consequently, DNA and RNA). In case of vitamin deficiency, methyltetrahydrofolic acid can replace it in this reaction, which disrupts folate-dependent metabolic reactions. 5-deoxyadenosylcobalamin serves as a co-factor in the isomerization of L-methylmalonyl-CoA to succinyl-CoA – an important reaction in carbohydrate and lipid metabolism. Vitamin B₁₂ deficiency leads to impaired proliferation of rapidly dividing cells of the hematopoietic tissue and epithelium, as well as to impaired formation of the myelin sheath of neurons.

Pharmacokinetics

After oral administration, Benfotiamine and pyridoxine are absorbed in the proximal intestine. The absorption of cyanocobalamin is largely determined by the presence of the “intrinsic factor of Castle” in the stomach and proximal intestine.

Benfotiamine

After oral administration of the drug, Benfotiamine is rapidly absorbed from the gastrointestinal tract. The absorption of benfotiamine occurs 5 times faster than that of ordinary thiamine. C_max is reached in less than 1 hour. The bioavailability of benfotiamine is 4-5 times higher than that of thiamine, and according to some data reaches 100%. At the cellular level, the effect of benfotiamine is 5-25 times greater than that of ordinary thiamine. It is metabolized in the liver and excreted by the kidneys.

Pyridoxine

After absorption in the gastrointestinal tract, pyridoxine is distributed throughout the human body – the highest concentrations are found in the liver and myocardium, where it is deposited. In the liver, pyridoxine is oxidized to 4-pyridoxic acid, which is excreted in the urine, maximum 2-5 hours after absorption.

Cyanocobalamin

Cyanocobalamin is absorbed in the small intestine after interaction in the stomach with the “intrinsic factor of Castle”. After absorption, vitamin B₁₂ is transported to the tissues. Excess vitamin accumulates in the liver. From the liver, it is excreted with bile into the intestine, where it is reabsorbed. Only trace amounts of this vitamin are excreted from the body through the kidneys.

Indications

As part of complex therapy for the following neurological diseases

• Polyneuropathies of various etiologies, incl. diabetic, alcoholic;
• Intercostal neuralgia, lumbosciatica, radiculopathy, cervicobrachial syndrome, radicular syndrome caused by degenerative changes of the spine;
• Facial neuritis, trigeminal neuralgia, retrobulbar neuritis.

ICD codes

Dosage Regimen

Take the tablets orally, after meals, with a sufficient amount of liquid.

For adults, the standard dosage is one tablet one to three times daily.

The maximum daily dose is three tablets.

Do not exceed the recommended daily dose.

The specific frequency of administration and total duration of therapy must be determined by a physician based on the condition being treated and the patient’s response.

For most neurological conditions, the typical treatment course lasts several weeks.

Do not use high doses for more than four weeks.

Follow the physician’s instructions regarding the need for repeated treatment courses.

Adverse Reactions

Allergic reactions skin rash, urticaria, difficulty breathing, angioedema, anaphylactic shock.

Dermatological reactions in some cases – increased sweating, acne.

Other in some cases – tachycardia.

Contraindications

• Decompensated heart failure;
• Children under 18 years of age;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

The use of Unigamma during pregnancy and lactation (breastfeeding) is not recommended.

Pediatric Use

Contraindicated: children under 18 years of age.

Special Precautions

The recommended dose of the drug should not be exceeded.

Overdose

Symptoms nausea, weakness, gastrointestinal disorders.

Treatment: activated charcoal orally, gastric lavage, symptomatic therapy.

In case of overdose, the patient should consult a doctor.

Drug Interactions

Levodopa reduces the effectiveness of Pyridoxine in therapeutic doses. When used concomitantly with cycloserine, penicillamine, epinephrine, norepinephrine, sulfonamides, a decrease in the effectiveness of Pyridoxine is possible.

Copper accelerates the destruction of benfotiamine; in addition, Benfotiamine loses its effect when the pH value increases (more than 3). With the combined use of benfotiamine with ethanol, the absorption of benfotiamine is sharply reduced.

With the combined use of cyanocobalamin with colchicine or biguanides, a decrease in the absorption of cyanocobalamin, which is part of the drug, is noted.

Storage Conditions

The drug should be stored out of the reach of children, in a dry place at a temperature from 10°C (50°F) to 30°C (86°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is dispensed 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.