Hydroxocobalamin

Hydroxocobalamin

Hydroxocobalamin Recall

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Questions & Answers

Side Effects & Adverse Reactions

Avoid the intravenous route.

Folic acid is not a substitute for vitamin B12 although it may improve vitamin B12 deficient megaloblastic anemia. Exclusive use of folic acid in treating vitamin B12 deficient megaloblastic anemia could result in progressive and irreversible neurologic damage.

Blunted or impeded therapeutic response to vitamin B12 may be due to such conditions as infection, uremia, drugs having bone marrow suppressant properties such as chloramphenicol, and concurrent iron or folic acid deficiency.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

  1. Pernicious anemia, both uncomplicated and accompanied by nervous system involvement.

  2. Dietary deficiency of Vitamin B12, occurring in strict vegetarians and in their breast-fed infants. (Isolated vitamin B12 deficiency is very rare).

  3. Malabsorption of vitamin B12, resulting from structural or functional damage to the stomach, where intrinsic factor is secreted or to the ileum, where intrinsic factor facilitates vitamin B12 absorption. These conditions include tropical sprue, and nontropical sprue (idiopathic steatorrhea, gluten-induced enteropathy). Folate deficiency in these patients is usually more severe than vitamin B12 deficiency.

  4. Inadequate secretion of intrinsic factor, resulting from lesions that destroy the gastric mucosa (ingestion of corrosives, extensive neoplasia), and a number of conditions associated with a variable degree of gastric atrophy (such as multiple sclerosis, certain endocrine disorders, iron deficiency, and subtotal gastrectomy). Total gastrectomy always produces vitamin B12 deficiency.

    Structural lesions leading to vitamin B12 deficiency include regional ileitis, ileal resections, malignancies, etc.

  5. Competition for Vitamin B12 by intestinal parasites or bacteria.

    The fish tapeworm (Diphyilobothrium latum) absorbs huge quantities of vitamin B12 and infested patients often have associated gastric atrophy. The blind-loop syndrome may produce deficiency of Vitamin B12 or folate.

  6. Inadequate utilization of vitamin B12. This may occur if antimetabolites for the vitamin are employed in the treatment of neoplasia.

  7. For the Schilling Test.

History

There is currently no drug history available for this drug.

Other Information

Hydroxocobalamin injection is a sterile solution of hydroxocobalamin for intramuscular administration.

Each mL contains: Hydroxocobalamin Acetate equivalent to 1000 mcg Hydroxocobalamin, Sodium Acetate Anhydrous 0.2 mg, Glacial Acetic Acid 0.442 mg, Sodium Chloride 8.2 mg, with Methylparaben 1.5 mg and Propylparaben 0.2 mg as preservatives, in Water for Injection q.s. Additional Glacial Acetic Acid and/or Sodium Acetate may have been used to adjust pH. pH range is 3.5 to 5.0.

Hydroxocobalamin appears as dark red orthorhombic needles or as an amorphous or crystalline red powder. It is very hygroscopic in the anhydrous form, and moderately soluble in water. It has a molecular weight of 1346.37. The vitamin B12 coenzymes are very unstable in light. Hydroxocobalamin shares the cobalamin molecular structure with cyanocobalamin.

The chemical name is α-(5,6-dimethylbenzimidazoly) hydroxocobamide. The empirical formula is C62H89CoN13O15P and its structural formula is:

Hydroxocobalamin Structural Formula

The cobalt content is 4.34%.

Hydroxocobalamin Manufacturers


  • Watson Laboratories, Inc.
    Hydroxocobalamin Injection, Solution [Watson Laboratories, Inc.]
  • Remedyrepack Inc.
    Hydroxocobalamin Injection, Solution [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Hydroxocobalamin Injection, Solution [Remedyrepack Inc. ]

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