Hydroxocobalamin
Generic: HYDROXOCOBALAMIN
Basic Information
Manufacturer
Actavis Pharma, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAMUSCULAR
FDA Set ID
a3087a39-f218-4f16-a1e7-17c39bb2eb69
Indications & Usage
INDICATIONS AND USAGE Pernicious anemia, both uncomplicated and accompanied by nervous system involvement.
Dietary deficiency of Vitamin B 12 , occurring in strict vegetarians and in their breast-fed infants.
(Isolated vitamin B 12 deficiency is very rare).
Malabsorption of vitamin B 12 , resulting from structural or functional damage to the stomach, where intrinsic factor is secreted or to the ileum, where intrinsic factor facilitates vitamin B 12 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 B 12 deficiency.
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 B 12 deficiency.
Structural lesions leading to vitamin B 12 deficiency include regional ileitis, ileal resections, malignancies, etc.
Competition for Vitamin B 12 by intestinal parasites or bacteria.
The fish tapeworm (Diphyllobothrium latum) absorbs huge quantities of vitamin B 12 and infested patients often have associated gastric atrophy.
The blind-loop syndrome may produce deficiency of Vitamin B 12 or folate.
Inadequate utilization of vitamin B 12 .
This may occur if antimetabolites for the vitamin are employed in the treatment of neoplasia.
For the Schilling Test.
Dietary deficiency of Vitamin B 12 , occurring in strict vegetarians and in their breast-fed infants.
(Isolated vitamin B 12 deficiency is very rare).
Malabsorption of vitamin B 12 , resulting from structural or functional damage to the stomach, where intrinsic factor is secreted or to the ileum, where intrinsic factor facilitates vitamin B 12 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 B 12 deficiency.
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 B 12 deficiency.
Structural lesions leading to vitamin B 12 deficiency include regional ileitis, ileal resections, malignancies, etc.
Competition for Vitamin B 12 by intestinal parasites or bacteria.
The fish tapeworm (Diphyllobothrium latum) absorbs huge quantities of vitamin B 12 and infested patients often have associated gastric atrophy.
The blind-loop syndrome may produce deficiency of Vitamin B 12 or folate.
Inadequate utilization of vitamin B 12 .
This may occur if antimetabolites for the vitamin are employed in the treatment of neoplasia.
For the Schilling Test.
Warnings
WARNINGS Avoid the intravenous route.
Folic acid is not a substitute for vitamin B 12 although it may improve vitamin B 12 deficient megaloblastic anemia.
Exclusive use of folic acid in treating vitamin B 12 deficient megaloblastic anemia could result in progressive and irreversible neurologic damage.
Blunted or impeded therapeutic response to vitamin B 12 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.
Folic acid is not a substitute for vitamin B 12 although it may improve vitamin B 12 deficient megaloblastic anemia.
Exclusive use of folic acid in treating vitamin B 12 deficient megaloblastic anemia could result in progressive and irreversible neurologic damage.
Blunted or impeded therapeutic response to vitamin B 12 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.
Adverse Reactions
ADVERSE REACTIONS Mild transient diarrhea, itching, transitory exanthema, feeling of swelling of entire body, and anaphylaxis.
A few patients may experience pain after injection of hydroxocobalamin.
To report SUSPECTED ADVERSE EVENTS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.
A few patients may experience pain after injection of hydroxocobalamin.
To report SUSPECTED ADVERSE EVENTS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.