Depovit B12 Ampoules

  • Company Name: Amriya for Pharmaceuticals Industries
  • Trade Name: Depovit B12 Ampoules
  • Generic Name: Hydroxocobalamin

Composition

Each 1 ml ampoule contains:

  • Active ingredient: Hydroxocobalamin acetate 1.20 mg (Equivalent to Hydroxocobalamin… 1000 µg/ml)
  • Inactive ingredients: Sodium dihydrogen phosphate, Water for injections

Pharmacology

Depovit B12 Ampoules contain hydroxocobalamin, the most common naturally occurring stable form of vitamin B12 with prolonged action. Depovit B12 Ampoules provide a continuous supply of vitamin B12 needed to replenish body stores, thus correcting and preventing vitamin B12 deficiency.

Vitamin B12 acts as a coenzyme for various metabolic functions, including fat and carbohydrate metabolism and protein synthesis. Depovit B12 Ampoules play important roles in the metabolic pathways involved in growth, cell reproduction, hematopoiesis (blood cell formation), and nucleoprotein and myelin (the fatty sheath that protects nerve fibers) synthesis. Depovit B12 Ampoules also help in the production of nucleic acids, which form the body’s genetic material.

Deficiency of vitamin B12 leads to the development of megaloblastic anemia (a type of anemia with abnormally large red blood cells) and demyelination of nerve fibers (damage to the myelin sheath). Neurological damage can also occur as a result of vitamin B12 deficiency. Treatment with Depovit B12 Ampoules results in rapid hematological (blood-related) and neurological improvement. This is accompanied by an increase in strength, better appetite, and improvement in the soreness of the mouth and tongue. Increased sense of well-being is also achieved within the first 24 hours after initiation of therapy, and memory and orientation show dramatic improvement.

Depovit B12 Ampoules are safe, well-tolerated, and have the advantage of causing no pain or irritation at the site of injection.

Pharmacokinetics

Depovit B12 Ampoules are well absorbed following intramuscular injection. In the blood, vitamin B12 is extensively bound to specific plasma proteins, such as transcobalamins. It is stored in the liver, excreted in the bile, and undergoes enterohepatic recycling (a process where vitamin B12 is reabsorbed from the intestine after being excreted in the bile). Hydroxocobalamin is excreted more slowly than other synthetic forms of vitamin B12 due to its high protein binding. Vitamin B12 diffuses across the placenta (the organ that nourishes the fetus during pregnancy) and appears in breast milk.

Indications

  • Treatment and prevention of vitamin B12 deficiency, such as in the following conditions:
    • Pernicious anemia (a chronic autoimmune condition in which the body does not produce enough intrinsic factor, a protein needed for vitamin B12 absorption)
    • Megaloblastic anemia
    • Post-gastrectomy or ileal resection (surgery to remove part of the stomach or small intestine)
    • Inadequate secretion of the intrinsic factor resulting from gastric atrophy or lesions that destroy gastric mucosa (the lining of the stomach)
    • Congenital cobalamin malabsorption (Imerslund-Graesbeck Syndrome) and congenital intrinsic factor deficiency (both are rare genetic disorders that affect vitamin B12 absorption)
    • Strict vegetarians (people who do not eat any animal products)
    • Tobacco amblyopia (a type of vision loss caused by smoking)
    • Infection with intestinal parasites or bacteria
  • Increased requirements of vitamin B12, such as in:
    • Hemolytic anemia (a type of anemia in which red blood cells are destroyed faster than they can be replaced) and hemorrhage (excessive bleeding)
    • Thyrotoxicosis (overactive thyroid gland) and malignancy (cancer)
    • Hepatic and renal diseases (liver and kidney diseases)
    • Prevention and treatment of cyanide toxicity associated with sodium nitroprusside (a medication used to treat high blood pressure)
    • Correction of nervous manifestations and neurological disorders such as trigeminal neuralgia (a chronic nerve pain condition), herpes zoster (shingles), peripheral neuropathy (damage to the nerves outside of the brain and spinal cord), and multiple sclerosis (a chronic disease that affects the central nervous system)

Dosage

  • Anemia and severe deficiencies: 1 ampoule (I.M. – intramuscular) every other day for 1-2 weeks, then 1 ampoule every 3 months for maintenance.
  • Neurological cases: 1 ampoule (I.M.) every other day until improvement is optimal.
  • Anemia (prophylactic dose) and mild deficiencies: 1 ampoule (I.M.) every 2-3 months

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