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Hydroxocobalamin
Overview
What is Hydroxocobalamin?
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 B 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 CHCoNOP and its structural formula is:
The cobalt content is 4.34%.
What does Hydroxocobalamin look like?
What are the available doses of Hydroxocobalamin?
Sorry No records found.
What should I talk to my health care provider before I take Hydroxocobalamin?
Sorry No records found
How should I use Hydroxocobalamin?
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 B is 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 B deficiency, 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 B deficiency.
In seriously ill patients it may be advisable to administer both vitamin B and folic acid while awaiting the results of distinguishing laboratory studies. It is not necessary to withhold vitamin B therapy until the precise cause of B deficiency 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.
What interacts with Hydroxocobalamin?
Sorry No Records found
What are the warnings of Hydroxocobalamin?
There is inadequate evidence for the carcinogenicity of phenazopyridine hydrochloride in humans (IARC 1987). In one limited epidemiological study, no significant excess of any cancer was observed among 2,214 patients who received phenazopyridine hydrochloride and were followed for a minimum of 3 years.
Avoid the intravenous route.
Folic acid is not a substitute for vitamin B although it may improve vitamin B deficient megaloblastic anemia. Exclusive use of folic acid in treating vitamin B deficient megaloblastic anemia could result in progressive and irreversible neurologic damage.
Blunted or impeded therapeutic response to vitamin B 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.
What are the precautions of Hydroxocobalamin?
General
The validity of diagnostic vitamin B or folic acid blood assays could be compromised by medications, and this should be considered before relying on such tests for therapy.
Vitamin B is not a substitute for folic acid and since it might improve folic acid deficient megaloblastic anemia, indiscriminate use of vitamin B could mask the true diagnosis.
Hypokalemia and thrombocytosis could occur upon conversion of severe megaloblastic to normal erythropoiesis with B therapy. Therefore, serum potassium levels and the platelet count should be monitored carefully during therapy.
Vitamin B deficiency may suppress the signs of polycythemia vera. Treatment with vitamin B may unmask this condition.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies of carcinogenicity, mutagenesis, or impairment of fertility have not been performed with hydroxocobalamin.
Pregnancy
Teratogenic Effects:
What are the side effects of Hydroxocobalamin?
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.
What should I look out for while using Hydroxocobalamin?
Hypersensitivity to any component of this medication.
Avoid the intravenous route.
Folic acid is not a substitute for vitamin B although it may improve vitamin B deficient megaloblastic anemia. Exclusive use of folic acid in treating vitamin B deficient megaloblastic anemia could result in progressive and irreversible neurologic damage.
Blunted or impeded therapeutic response to vitamin B 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.
What might happen if I take too much Hydroxocobalamin?
The intravenous LD of hydroxocobalamin in mice is greater than 50 mL/kg.
How should I store and handle Hydroxocobalamin?
Care should be exercised in the handling of REVLIMID. REVLIMID capsules should not be opened or broken. If powder from REVLIMID contacts the skin, wash the skin immediately and thoroughly with soap and water. If REVLIMID contacts the mucous membranes, flush thoroughly with water.Procedures for the proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published. Dispense no more than a 28-day supply.Care should be exercised in the handling of REVLIMID. REVLIMID capsules should not be opened or broken. If powder from REVLIMID contacts the skin, wash the skin immediately and thoroughly with soap and water. If REVLIMID contacts the mucous membranes, flush thoroughly with water.Procedures for the proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published. Dispense no more than a 28-day supply.Care should be exercised in the handling of REVLIMID. REVLIMID capsules should not be opened or broken. If powder from REVLIMID contacts the skin, wash the skin immediately and thoroughly with soap and water. If REVLIMID contacts the mucous membranes, flush thoroughly with water.Procedures for the proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published. Dispense no more than a 28-day supply.Hydroxocobalamin Injection USP, 1000 mcg/mL is available in a 30 mL multiple dose vial, individually boxed.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Vitamin B is 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.
Non-Clinical Toxicology
Hypersensitivity to any component of this medication.Avoid the intravenous route.
Folic acid is not a substitute for vitamin B although it may improve vitamin B deficient megaloblastic anemia. Exclusive use of folic acid in treating vitamin B deficient megaloblastic anemia could result in progressive and irreversible neurologic damage.
Blunted or impeded therapeutic response to vitamin B 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.
The interaction of phenazopyridine with other drugs has not been studied in a systematic manner. However, the medical literature to date suggests that no significant interactions have been reported.
The validity of diagnostic vitamin B or folic acid blood assays could be compromised by medications, and this should be considered before relying on such tests for therapy.
Vitamin B is not a substitute for folic acid and since it might improve folic acid deficient megaloblastic anemia, indiscriminate use of vitamin B could mask the true diagnosis.
Hypokalemia and thrombocytosis could occur upon conversion of severe megaloblastic to normal erythropoiesis with B therapy. Therefore, serum potassium levels and the platelet count should be monitored carefully during therapy.
Vitamin B deficiency may suppress the signs of polycythemia vera. Treatment with vitamin B may unmask this condition.
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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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