Depofort B12 treamtent and prevention of vitamin B12 deficiency

DEPOFORT B12 AMPOULE

Company Name :

Pharco Pharmaceuticals This product contains benzyl alcohol, not for use for neonates and infants.

Trade Name :

Depofort B12 Ampoule

Generic Name :

Hydroxocobalamin

Composition :

Each Ampoule (1 ml) contains:
Hydroxocobalamin acetate 1.044 mg “equivalent to 1.0 mg Hydroxocobalamin”
Inactive ingredients: Disodium hydrogen phosphate anhydrous, Sodium Chloride, Benzyl alcohol, Glacial acetic acid, water for injection.

Pharmaceutical Form :

Ampoule

Pharmacological Action :

Depofort B12 Ampoules contain hydroxocobalamin, the commonest naturally occuring stable form of vitamin B12 with prolonged action. Depofort B12 gives 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 lunctions, including fat and carbohydrate metabolism and protein synthesis. Depofort B12 plays important roles in the metabolic pathways Involved in growth, cell reproduction, hematopoiesis and nucleoprotein and myelin synthesis. Depofort B12 helps in the production on nucleic acids which form the body genetic material. Deficiency of vitamin B 12 leads to the development of megaloblastic anemia and demyelination of nerve fibers and other neurological damages. Treatment with Depofort B12 results in rapid hematological and neurological improvement. This is accompainecfby 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 the memory and orientation show dramatic improvement. Depofort B12injections are safe, well tolerated and have the advantage of causing no pain or irritation at the site of injection.

Pharmacokinetics :

Depofort B12 is well absorbed following intramuscular injection. In the blood, vitamin B12 is extensively bound to specific plasma proteins, e.g. transcobalamins. It IS stored in the liver, excreted in the bile and undergoes enterohepatic recycling. Hydroxocobalamin is excreted more slowly than other synthetic forms of vitamin B12 due to its high protein binding. Vitamin B12 diffuses across the placenta and appears in breast milk.

Indications :

** Treamtent and prevention of vitamin B12 deficiency as in the following conditions                                                                              **Pernicious and megaloblastic anemia.
** Post-gastrectomy or ileal resection.                                              **Inadequate secretion of the intrinsic factor resulting from gastric atrophy or lesions that destroy gastric mucosa.                              **Congenital cobalamin malabsotption (Imerslund-Graesbeck syndrome) and congenital intrinsic factor deficiency. **Transcobalamin 1/ deficiency which appears between the secound and fourth month of life                                                                                                                       **Strict vegetarians and their breast-fed infants.                               **Tobaccoamblyopia.                                                                                     **Infection with intestinal parasites or bacteria.                                **Increases requirement of vitaminB12 as in:
** Pregnancy and lactation.                                                                **Hemolytic anemia and hemorrhage.                                      **Thyrotoxicosis and malignancy.                                                              **Hepatic and renal diseases
** Prevention and treatment of cyanide toxicity associated with sodium nitroprusside.                                                                            **Correction of nervous manifestations and neurologial disorders such as trigeminal neuralgia, herpes zoster, peripheral neuropathy and muttiple sclerosis.

Dosage :

-Anemia and severe deficiencies: 1 ampoule (I.M.l 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 optimum.                                                                          -Anemia (Prophylactic dose) and mild deficiencies: 1 ampoule (I.M.) every 2 – 3 months.

Contra indications :

Pregnancy, Nursing Mothers & Pediatric use:                                           – Do not administer Injections preserved with benzyl alcohol to premature infants, neonates, infants below 13 years, pregnant women or nursing mothers. Benzyl alcohol has been associated with serious adverse events & death, particularly in pediatric patients (it may cause Gasping Syndrome) Injections preservative free should be used in these populations.
– Hypersensitivity to hydroxocobalamin or cobalt.

Side effects :

Depofort B12 is well tolerated. Hypersensitivity reactions including itching, diarrhea, urticaria or peripheral vascular thrombosis rarely occur.

Drug Interactions :

Chloramphenicol may interiere with the therapeutic response to hydroxocobalamin injection.

Pregnancy & Lactation :

Depofort B12 is not harmful to the fetus in the recommended dosage. Vitamin B12 is distributed into the breast milk; however, problems in human have not been documented with intake of normal daily recommended amounts.

Warnings & Precautions :

– This product contains benzyl alcohol which is potentially toxic when administered locally in neural tissue.                                              – Hypokalemia may occur on initial treatment of patients with severe megaloblastic anemia. Vitamin B 12 therapy may unmask the signs of polycythemia vera

Packing :

A box containing 2 ampoules, 1 ml each

Storage :

Store at temperature not exceeding 30° C away from light their
(avoid freezin). Keep out of the reach of children.

Produced by :

Pharco B International
Pharco Pharmaceuticals

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