Edruplex IM Injection

Vitamin B1, B6 & B12 is indicated where a deficiency of the relevant vitamins exists. It is indicated for the treatment of following diseases: Polyneuropathy of any origin such alcoholic or toxiconeuropathies as-diabetic, Neuritis, Neuralgia, Cervical Syndrome, Shoulder-arm syndrome, Lumbago, Sciatica, Myalgia, Intercostal neuralgia, Herpes Zoster, Trigeminal Neuralgia, Supportive treatment in facial paresis.

Each film-coated tablet contains: Vitamin B1 (Thiamine Mononitrate) 100 mg, Vitamin B6 (Pyridoxine Hydrochloride) 200 mg, Vitamin B12 (Cyanocobalamin) 200 microgram.
Each 3 ml ampoule contains: Thiamine Hydrochloride (Vitamin B1) 100 mg, Pyridoxine Hydrochloride (Vitamin B6) 100 mg, Cyanocobalamin (Vitamin B12) 1000 mcg.

Vitamin B1 converts carbohydrates, fatty acids and amino acids into energy, promotes healthy nerves, improves mood, strengthens the heart. Vitamin B6 forms RBCs, helps cells to make proteins, manufactures neurotransmitters e.g. serotonin and releases stored forms of energy, helps to prevent CVS diseases and stroke, helps to lift depression and eases insomnia. Vitamin B12 is essential for cell replication and important for RBC production, prevents anemia, helps to prevent depression, reduces nerve pain, numbness, tingling and lowers the risk of heart diseases.

The vitamin ingredients are absorbed well in per oral reception. It is widely distributed to most tissues and appears in breast milk. Within the cell, thiamine is mostly present as diphosphate. Thiamine is not stored to any appreciable extent in the body and amounts in excess of the body’s requirements are excreted in the urine as unchanged thiamine or as metabolites. Pyridoxine, pyridoxal and pyridoxamine are readily absorbed from the GIT following oral administration and are converted to the active forms of pyridoxal phosphate an pyridoxamine phosphate. They are stored mainly in liver where there is oxidation to 4-pyridoxic acid and other inactive metabolites, which are excreted in urine. As the dose increases, proportionally greater amounts are excreted unchanged in the urine.

Tablet: 1-3 Tablets per day or as advised by the physician.

Injection:

• In severe (acute) cases: 1 injection daily until the acute symptoms subside or taken as advised by the physician.
• In mild cases: 1 injection 2-3 times per week. Ampoules are preferably injected intramuscularly.

Use in children: There is no information on the use of this drug in children.

No drug interaction has been reported yet.

Vitamin B1, Vitamin B6 and Vitamin B12 is contraindicated in patients on levodopa therapy, and in patients with hypersensitivity to any of the ingredients of the preparation.

Generally well tolerated but allergic reactions may be observed in few cases.

Oral tablet form is recommended but due to the presence of benzyl alcohol, injection is not recommended during pregnancy & lactation.

Cyanocobalamin should not be given in patients with subacute degeneration of the spinal cord. Cyanocobalamin is not suitable form of vitamin B12 for the treatment of optic neuropathies associated with raised plasma concentrations of cyanocobalamin.

No overdosage symptoms are to be expected in the recommended dosage. If there is known overdose then treatment is symptomatic & supportive.

Specific combined vitamin preparations, Vaccines, Anti-sera & Immunoglobulin

Keep out of reach of children. Store in a cool (below 25°C temperature) and dry place, protected from light.