Linked Life Data

Hydroxocobalamin (Injection)

Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2538

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Hydroxocobalamin (Injection)
dailymed-instance:dosage
Protect from light. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Hydroxocobalamin injection should be given only intramuscularly. In patients with Addisonian Pernicious Anemia, parenteral therapy with vitamin Bis the recommended method of treatment and will be required for the remainder of the patient's life. Oral therapy is not dependable. In other patients with vitamin Bdeficiency, the duration of therapy and route of administration will depend upon the cause and whether or not it is reversible. Confirmatory diagnostic studies should be performed prior to initiating therapy, if possible, and the patient should be followed with appropriate studies to demonstrate hematologic improvement (Hgb, hematocrit, RBC, reticulocyte count). A diagnostic trial utilizing physiologic doses of vitamin B(1 mcg daily) and observing daily reticulocyte counts after establishing a baseline may also be performed. The observation of reticulocytosis which usually occurs between the third and tenth day of therapy confirms the diagnosis of vitamin Bdeficiency. In seriously ill patients it may be advisable to administer both vitamin Band folic acid while awaiting the results of distinguishing laboratory studies. It is not necessary to withhold vitamin Btherapy until the precise cause of Bdeficiency is established since absorption studies can be performed at any time. Serum potassium should be closely observed the first 48 hours and potassium should be administered if necessary.<br/>Treatment of Vitamin BDeficiency: Thirty mcg daily for 5 to 10 days followed by 100 to 200 mcg monthly injected intramuscularly. If the patient is critically ill, or has neurologic disease, an infectious disease or hyperthyroidism, considerably higher doses may be indicated. However, current data indicate that the optimum obtainable neurologic response may be expected with a dosage of vitamin Bsufficient to produce good hematologic response. Children may be given a total of 1 to 5 mg over a period of 2 or more weeks in doses of 100 mcg, then 30 to 50 mcg every 4 weeks for maintenance. Patients who have normal intestinal absorption may be treated with an oral therapeutic multivitamin preparation, containing 15 mcg vitamin Bdaily.<br/>Schilling Test: The flushing dose is 1000 mcg.
dailymed-instance:descripti...
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 Bcoenzymes are very unstable in light. Hydroxocobalamin shares the cobalamin molecular structure with cyanocobalamin. The chemical name is��-(5,6-dimethylbenzimidazoly) hydroxocobamide. The empirical formula is CHCoNOP and its structural formula is: The cobalt content is 4.34%.
dailymed-instance:clinicalP...
Vitamin Bis essential to growth, cell reproduction, hematopoiesis, nucleoprotein and myelin synthesis. Fifty percent of the administered dose of hydroxocobalamin disappears from the injection site in 2.5 hours. Hydroxocobalamin is bound to plasma proteins and stored in the liver. It is excreted in the bile and undergoes some enterohepatic recycling. Within 72 hours after injection of 500 to 1000 mcg of hydroxocobalamin, 16 to 66 percent of the injected dose may appear in the urine. The major portion is excreted within the first 24 hours.
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Hydroxocobalamin Injection USP, 1000 mcg/mL is available in a 30 mL multiple dose vial, individually boxed.<br/>Storage: Store at 20��-25��C (68��-77��F). [See USP controlled room temperature.]PROTECT FROM LIGHT. February 2006 Product No.: 0208-30 Watson Laboratories, Inc.Corona, CA 92880 USA 695702080591*B1
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General: The validity of diagnostic vitamin Bor folic acid blood assays could be compromised by medications, and this should be considered before relying on such tests for therapy. Vitamin Bis not a substitute for folic acid and since it might improve folic acid deficient megaloblastic anemia, indiscriminate use of vitamin Bcould mask the true diagnosis. Hypokalemia and thrombocytosis could occur upon conversion of severe megaloblastic to normal erythropoiesis with Btherapy. Therefore, serum potassium levels and the platelet count should be monitored carefully during therapy. Vitamin Bdeficiency may suppress the signs of polycythemia vera. Treatment with vitamin Bmay unmask this condition.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies of carcinogenicity, mutagenesis, or impairment of fertility have not been performed with hydroxocobalamin.<br/>Pregnancy: Teratogenic Effects: Pregnancy Category C: Animal reproduction studies have not been conducted with hydroxocobalamin. It is also not known whether hydroxocobalamin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hydroxocobalamin should be given to a pregnant woman only if clearly needed.
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The intravenous LDof hydroxocobalamin in mice is greater than 50 mL/kg.
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Hydroxocobalamin
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Hydroxocobalamin (Injection)
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Mild transient diarrhea, itching, transitory exanthema, feeling of swelling of entire body, and anaphylaxis. A few patients may experience pain after injection of hydroxocobalamin.
dailymed-instance:warning
Avoid the intravenous route. Folic acid is not a substitute for vitamin Balthough it may improve vitamin Bdeficient megaloblastic anemia. Exclusive use of folic acid in treating vitamin Bdeficient megaloblastic anemia could result in progressive and irreversible neurologic damage. Blunted or impeded therapeutic response to vitamin Bmay be due to such conditions as infection, uremia, drugs having bone marrow suppressant properties such as chloramphenicol, and concurrent iron or folic acid deficiency.
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Hydroxocobalamin